Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2025-03"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2025-03-04"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2025-03-21"
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/briefSummary",
"value": "This was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone, compared to Trastuzumab alone in the adjuvant treatment of Human Epidermal Growth Factor Receptor 2 (HER2) positive early breast cancer."
},
{
"op": "add",
"path": "/protocolSection/descriptionModule/detailedDescription",
"value": "<p>Treatment allocation was stratified by blocked randomization, with three stratification factors:</p><ul><li>Hormone receptor status: Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) positive versus both negative.</li><li>Axillary lymph node involvement: not assessed because of neoadjuvant chemotherapy versus node negative versus 1-3 positive nodes versus 4 or more positive nodes.</li><li>Timing of adjuvant chemotherapy: concurrently with taxanes and targeted therapy (Design 2) and concurrently with non-anthracycline-based platinum chemotherapy and targeted therapy (Design 2B) versus all other chemotherapy completed before randomization (Design 1).\nTreatments delivered differed according to the timing and type of adjuvant chemotherapy.</li></ul><p>The primary objective of this study was to compare disease-free survival (DFS) in subjects with HER2 overexpressing and/or amplified breast cancer randomized to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks).</p><p>Secondary objectives included treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, and incidence of brain metastasis.</p><p>Based on the recommendation of the Independent Data Monitoring Committee (IDMC) at the first interim analysis (18-Aug-2011), the Lapatinib alone arm was discontinued prior to primary analysis due to futility.\nThe IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) could continued as planned with no changes.</p>"
},
{
"op": "add",
"path": "/protocolSection/designModule/designInfo/interventionModel",
"value": "PARALLEL"
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 8381
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
"value": "Lapatinib plus Trastuzumab"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/type",
"value": "EXPERIMENTAL"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
"value": "<p>Design 1: Oral lapatinib 1000 mg daily concurrent with trastuzumab 8 mg/kg IV loading dose followed by 6mg/kg IV every 3 weeks (52 weeks total).</p><p>Design 2: Trastuzumab (4mg/kg loading dose followed by 2mg/kg IV weekly) concurrent with oral lapatinib 750 mg daily and either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 every 21 days for 4 cycles (12 weeks).\nAfter completion of chemotherapy, the dose of lapatinib will be increased to 1000mg daily concurrently with trastuzumab every 3 weeks (6mg/kg without loading dose) for an additional 40 weeks (52 weeks total).</p><p>Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concurrently with oral lapatinib 750mg plus weekly trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV.\nAfter the completion of chemotherapy, trastuzumab will be administered every 3 weeks (6mg/kg without loading dose) concurrent with lapatinib 1000mg daily for an additional 40 weeks (52 weeks total).</p>"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
"value": "Drug: Lapatinib"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
"value": "Trastuzumab followed by Lapatinib"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
"value": "<p>Design 1: Trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) for 12 weeks followed by a 6 week treatment-free interval followed by oral lapatinib 1500mg daily for 34 weeks (52 weeks total).</p><p>Design 2: Trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) for 12 weeks administered concomitantly and either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 every 21 days for 4 cycles; followed by a 6 week treatment-free interval followed by oral lapatinib 1500mg daily for 34 weeks (52 weeks total).</p><p>Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) followed by a 6 week treatment-free interval followed by oral lapatinib 1500 mg daily for 28 weeks (52 weeks total).</p>"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1",
"value": "Biological: Trastuzumab"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/2/label",
"value": "Lapatinib"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/2/description",
"value": "<p>Design 1: Lapatinib 1500mg oral daily for a total of 52 weeks.</p><p>Design 2: Either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 IV every 3 weeks for 4 cycles administered concomitantly with oral lapatinib at 750mg daily.\nAfter completion of chemotherapy, oral lapatinib administered at 1500mg daily for an additional 40 weeks (52 weeks total).</p><p>Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with oral lapatinib at 750mg daily.\nAfter completion of chemotherapy, the dose of lapatinib will be increased to 1500mg oral daily for an additional 40 weeks (52 weeks total).</p>"
},
{
"op": "remove",
"path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/1"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/3/label",
"value": "Trastuzumab"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/3/type",
"value": "ACTIVE_COMPARATOR"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/3/description",
"value": "<p>Design 1: Trastuzumab 8mg/kg IV loading dose followed by 6mg/kg IV every 3 weeks for a total of 52 weeks.</p><p>Design 2: Either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 IV every 3 weeks for 4 cycles administered concomitantly with trastuzumab 4mg/kg IV loading dose followed by 2mg/kg IV weekly.\nAfter completion of chemotherapy, trastuzumab administered every 3 weeks (6mg/kg IV without loading dose) for an additional 40 weeks (52 weeks total).</p><p>Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with trastuzumab 4mg/kg IV loading dose followed by 2mg/kg IV weekly.\nAfter completion of chemotherapy, trastuzumab (6mg/kg without loading dose) every 3 weeks for an additional 40 weeks (52 weeks total).</p>"
},
{
"op": "remove",
"path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
"value": "Lapatinib"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1",
"value": "Lapatinib plus Trastuzumab"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/2",
"value": "Trastuzumab followed by Lapatinib"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames",
"value": [
"GW572016"
]
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0",
"value": "Lapatinib plus Trastuzumab"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/1",
"value": "Trastuzumab"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/2",
"value": "Trastuzumab followed by Lapatinib"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Disease-Free Survival (DFS) at the Primary Analysis"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Disease-Free Survival (DFS) was defined as the interval between randomization and the date of first occurrence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer or death without recurrence.\nOnly deaths occurring in participants whose clinical follow-up was ongoing at the time of death and who had no recurrence, contralateral breast cancer (CBC) or second primary malignancy (SPM) reported prior to death were considered as death without recurrence.\nDFS was estimated using the Kaplan Meier method.\nThe percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Disease-Free Survival (DFS) at the 10-Year Follow-Up"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "Disease-Free Survival (DFS) was defined as the interval between randomization and the date of first occurrence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer or death without recurrence.\nOnly deaths occurring in participants whose clinical follow-up was ongoing at the time of death and who had no recurrence, contralateral breast cancer (CBC) or second primary malignancy (SPM) reported prior to death were considered as death without recurrence.\nDFS was estimated using the Kaplan Meier method.\nThe percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who had disease free survival for the indicated years."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause, assessed up to approximately 10 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Overall Survival (OS) at the Primary Analysis"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "Overall Survival (OS) was defined as the time from randomization until death due to any cause.\nParticipants who had not died were censored at the last date they were known to be alive, or date of withdrawal of consent.\nOS was calculated in years as (date of death minus the date of randomization +1) divided by 365.25.\nThe percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "From randomization until death due to any cause (median follow-up of 4.5 years)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Overall Survival (OS) at the 10-Year Follow-Up"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "Overall Survival (OS) was defined as the time from randomization until death due to any cause.\nParticipants who had not died were censored at the last date they were known to be alive, or date of withdrawal of consent.\nOS was calculated in years as (date of death minus the date of randomization +1) divided by 365.25.\nThe percentile data values presented here indicate the percentage (99, 98, 95 and 90 percent) of participants who survived for the indicated years."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "From randomization until death due to any cause, assessed up to approximately 10 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Analysis of Time to Recurrence (TTR)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "Time to Recurrence (TTR) was defined as the the time from randomization to breast cancer recurrence, ignoring second primary cancers (including contralateral breast cancers and non-breast second malignancies) and counting deaths without recurrence as a competing risk."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"value": "Analysis of Time to Distant Recurrence (TTDR)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "Time to Distant Recurrence (TTDR) was defined as the the time from randomization to first distant breast cancer recurrence, ignoring locoregional recurrences and second primary cancers, (including contralateral breast cancers and non-breast second malignancies ) and counting deaths without recurrence as a competing risk."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"value": "From randomization until the date of the first occurrence of distant recurrence, assessed up to approximately 10 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5",
"value": {
"measure": "Analysis of Time to Central Nervous System (CNS) Recurrence",
"timeFrame": "From randomization until the first central nervous system recurrence, assessed up to approximately 10 years",
"description": "Time to Central Nervous System (CNS) recurrence was defined as the time from randomization to first CNS recurrence.\nBoth brain metastasis and meningitis carcinomatosa were considered."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6",
"value": {
"measure": "Cumulative Incidence of Brain Metastases",
"timeFrame": "From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years",
"description": "The cumulative incidence of brain metastases as the first site of breast cancer recurrence among treatment arms was assessed using a hierarchy of primary type and location of first DFS event in cases where more than one event was identified simultaneously.\nBecause diagnostic procedures for different types of recurrence could not be performed on exactly the same day, any diagnoses noted within a two month (60 day) period of the first reported event was considered as identified simultaneously for purposes of defining the type of the first event and the date of event was be regarded as the earliest of the relevant events."
}
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>Key Inclusion Criteria:</p><ul><li>Patients >= 18 years of age with histologically confirmed, non-metastatic, operable and over expression/amplification of HER2 (3+ by IHC and/or FISH positive) primary breast cancer, treated with definitive surgery, with baseline LVEF >= 50%, known hormone receptor status (ER/PgR or ER alone) and ECOG performance status =< 1, were included.</li><li>For Designs 1 and 2: Patients must have had received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen or a protocol specified exception.</li><li>Approved, signed written informed consent obtained prior to any study specific screening procedures.</li></ul><p>Key Exclusion Criteria:</p><ul><li>History of any prior (ipsi- and/or contralateral) invasive breast carcinoma, past (less than 10 years) or current history of malignant neoplasms, any clinically staged T4 tumor, or bilateral tumors.</li><li>Concurrent anti-cancer treatment, except hormonal therapy or radiotherapy for the present breast cancer;</li><li>Patients with positive or suspicious internal mammary nodes identified by sentinel node technique, which had not been irradiated or would not be irradiated, or patients with supraclavicular lymph node involvement.</li><li>Any prior anti-HER therapy, which includes agents that target other members of the HER family of receptors, e.g.\ngefitinib (Iressa)</li><li>(Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support;</li><li>Serious cardiac illness or medical conditions.</li><li><p>Any of the following abnormal laboratory tests immediately prior to randomization:</p><ol><li>Serum total bilirubin >1.5 x upper limit of normal (ULN).\nIn the case of known Gilbert's syndrome, a higher serum total bilirubin (<2 x ULN) was allowed;</li><li>Alanine amino transferase (ALT) or aspartate amino transferase (AST) >2.5 x ULN;</li><li>Alkaline phosphatase (ALP) >2.5 x ULN;</li><li>Serum creatinine >2.0 x ULN;</li><li>Total white blood cell count (WBC) <2.5 x 10^9/L;</li><li>Absolute neutrophil count <1.5 x 10^9/L;</li><li>Platelets <100 x 10^9/L.</li></ol></li><li>Women of childbearing potential and male patients with partners of childbearing potential, who are unable or unwilling to use adequate contraceptive measures during study treatment, and pregnant or lactating women.</li><li>Concomitant use of CYP3A4 inhibitors or inducers.</li></ul>"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/2"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/2"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/2"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/4"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/4"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/4"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/6"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/6"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/6"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/6"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/11"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/12"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/12"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/13"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/13"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/13"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/13"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/16"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/16"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/16"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/16"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/19"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/20"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/22"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/22"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/22"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/24"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/24"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/24"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/24"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/24"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/24"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/24"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/24"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/28"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/28"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/29"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/37"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/38"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/38"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/39"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/41"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/45"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/46"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/48"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/48"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/48"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/48"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/48"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/48"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/49"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/50"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/50"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/52"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/52"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/54"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/54"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/54"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/54"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/54"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/54"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/55"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/55"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/56"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/57"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/57"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/57"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/57"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/57"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/58"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/58"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/58"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/58"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/59"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/59"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/60"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/60"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/60"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/62"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/63"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/63"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/63"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/63"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/64"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/66",
"value": {
"zip": "61104",
"city": "Rockford",
"state": "Illinois",
"country": "United States",
"facility": "Novartis Investigative Site",
"geoPoint": {
"lat": 42.27113,
"lon": -89.094
}
}
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/69"
},
{
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"path": "/protocolSection/contactsLocationsModule/locations/71"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/71"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/72"
},
{
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"path": "/protocolSection/contactsLocationsModule/locations/74"
},
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}
}
},
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}
},
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"geoPoint": {
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"lon": -3.19648
}
}
},
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"city": "Huddersfield",
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}
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},
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"value": "Manchester"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/906/zip",
"value": "M20 4BX"
},
{
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{
"op": "replace",
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"city": "Northwood",
"country": "United Kingdom",
"facility": "Novartis Investigative Site",
"geoPoint": {
"lat": 51.61162,
"lon": -0.42454
}
}
},
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}
},
{
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"facility": "Novartis Investigative Site",
"geoPoint": {
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}
},
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"facility": "Novartis Investigative Site"
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},
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{
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{
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"path": "/resultsSection/participantFlowModule/preAssignmentDetails",
"value": "Based on the IDMC results from 18 August 2011, any patient enrolled onto Lapatinib arm were considered for a new treatment strategy based on discussion with their physician."
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/groups/0/title",
"value": "Lapatinib Plus Trastuzumab"
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{
"op": "replace",
"path": "/resultsSection/participantFlowModule/groups/0/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).</li><li>Design 2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.</li><li>Design 2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/groups/1/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/groups/2/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: oral lap 1500 mg daily for 52 weeks.</li><li>Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.</li><li>Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/groups/3/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\n"</li></ul>"
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},
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"achievements": [
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},
{
"groupId": "FG001",
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},
{
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{
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"op": "replace",
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"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/3/numSubjects",
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},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/type",
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"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/1/numSubjects",
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},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/2/numSubjects",
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},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/3/numSubjects",
"value": "295"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/type",
"value": "Patient did not sign ICF 12"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/0/numSubjects",
"value": "169"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/1/numSubjects",
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"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/2/numSubjects",
"value": "139"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/3/numSubjects",
"value": "167"
},
{
"op": "add",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3",
"value": {
"type": "Data unavailable due to regulatory issues",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "98"
},
{
"groupId": "FG001",
"numSubjects": "96"
},
{
"groupId": "FG002",
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{
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}
},
{
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{
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{
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{
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}
},
{
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},
{
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},
{
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{
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]
}
},
{
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"path": "/resultsSection/participantFlowModule/recruitmentDetails",
"value": "This study was conducted in 969 centers in 44 countries worldwide."
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/groups/0/title",
"value": "Lapatinib Plus Trastuzumab"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/groups/0/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).</li><li>Design 2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.</li><li>Design 2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/groups/1/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/groups/2/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: oral lap 1500 mg daily for 52 weeks.</li><li>Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.</li><li>Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/groups/3/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\n"</li></ul>"
},
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{
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{
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{
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{
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/10/categories/0/measurements/4/value",
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},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/11"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/11"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/11"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/11"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/11"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/11"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/11"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/11"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/11"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/11"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/11"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/11"
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3",
"value": {
"title": "Hormone Receptor (HR) Status",
"classes": [
{
"categories": [
{
"title": "Negative",
"measurements": [
{
"value": "890",
"groupId": "BG000"
},
{
"value": "886",
"groupId": "BG001"
},
{
"value": "903",
"groupId": "BG002"
},
{
"value": "897",
"groupId": "BG003"
},
{
"value": "3576",
"groupId": "BG004"
}
]
},
{
"title": "Positive",
"measurements": [
{
"value": "1203",
"groupId": "BG000"
},
{
"value": "1205",
"groupId": "BG001"
},
{
"value": "1197",
"groupId": "BG002"
},
{
"value": "1200",
"groupId": "BG003"
},
{
"value": "4805",
"groupId": "BG004"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"description": "HR status was determined from the percentage of Estrogen Receptor (ER) and Progesterone Receptor (PgR) cells stained positive: a) Positive: if the percentage of cells stained positive is >= 1% for either ER or PgR; b) Negative: if the percentage of cells stained positive is < 1% for both ER and PgR",
"unitOfMeasure": "Participants"
}
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/4",
"value": {
"title": "Timing of Chemotherapy",
"classes": [
{
"categories": [
{
"title": "Sequential",
"measurements": [
{
"value": "1155",
"groupId": "BG000"
},
{
"value": "1143",
"groupId": "BG001"
},
{
"value": "1168",
"groupId": "BG002"
},
{
"value": "1147",
"groupId": "BG003"
},
{
"value": "4613",
"groupId": "BG004"
}
]
},
{
"title": "Concurrent",
"measurements": [
{
"value": "938",
"groupId": "BG000"
},
{
"value": "948",
"groupId": "BG001"
},
{
"value": "932",
"groupId": "BG002"
},
{
"value": "950",
"groupId": "BG003"
},
{
"value": "3768",
"groupId": "BG004"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"description": "Timing of (neo)adjuvant chemotherapy was defined as follows: Design 1 - sequentially (all chemotherapy completed prior to randomization) versus Design 2 - concurrently with targeted therapy (taxane medication administered with targeted treatment after randomization).\nSubjects treated concurrently but without anthracycline (Design 2B) were regarded as part of Design 2 for all stratified analyses.",
"unitOfMeasure": "Participants"
}
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/5",
"value": {
"title": "Axillary Lymph Node Status",
"classes": [
{
"categories": [
{
"title": "Not applicable (neoadjuvant chemotherapy)",
"measurements": [
{
"value": "168",
"groupId": "BG000"
},
{
"value": "170",
"groupId": "BG001"
},
{
"value": "167",
"groupId": "BG002"
},
{
"value": "181",
"groupId": "BG003"
},
{
"value": "686",
"groupId": "BG004"
}
]
},
{
"title": "Node negative (no neoadjuvant chemotherapy)",
"measurements": [
{
"value": "845",
"groupId": "BG000"
},
{
"value": "842",
"groupId": "BG001"
},
{
"value": "841",
"groupId": "BG002"
},
{
"value": "844",
"groupId": "BG003"
},
{
"value": "3372",
"groupId": "BG004"
}
]
},
{
"title": "1-3 positive nodes (no neoadjuvant chemotherapy)",
"measurements": [
{
"value": "617",
"groupId": "BG000"
},
{
"value": "617",
"groupId": "BG001"
},
{
"value": "620",
"groupId": "BG002"
},
{
"value": "603",
"groupId": "BG003"
},
{
"value": "2457",
"groupId": "BG004"
}
]
},
{
"title": ">= 4 positive nodes (no neoadjuvant chemotherapy)",
"measurements": [
{
"value": "463",
"groupId": "BG000"
},
{
"value": "462",
"groupId": "BG001"
},
{
"value": "472",
"groupId": "BG002"
},
{
"value": "469",
"groupId": "BG003"
},
{
"value": "1866",
"groupId": "BG004"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"description": "Axillary Lymph Node Status was categorized as: a) Not applicable (neoadjuvant chemotherapy); b) Node negative (no neoadjuvant chemotherapy); c) 1-3 positive nodes (no neoadjuvant chemotherapy); d) >= 4 positive nodes (no neoadjuvant chemotherapy)",
"unitOfMeasure": "Participants"
}
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/title",
"value": "Disease-Free Survival (DFS) at the Primary Analysis"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description",
"value": "Disease-Free Survival (DFS) was defined as the interval between randomization and the date of first occurrence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer or death without recurrence.\nOnly deaths occurring in participants whose clinical follow-up was ongoing at the time of death and who had no recurrence, contralateral breast cancer (CBC) or second primary malignancy (SPM) reported prior to death were considered as death without recurrence.\nDFS was estimated using the Kaplan Meier method.\nThe percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/populationDescription",
"value": "Intent-to-Treat (ITT) Population.\nDFS data for the Lapatinib alone arm include date collected up to the first interim analysis (data cut-off 11th July 2011), as the Lapatinib arm was discontinued prior to the primary analysis due to futility.\nAll the other arms include data up to median follow-up of 4.5 years."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/unitOfMeasure",
"value": "Years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/0/title",
"value": "Lapatinib Plus Trastuzumab"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/0/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).</li><li>Design 2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.</li><li>Design 2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/1/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/3/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\n"</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/3/categories/0/measurements/2/value",
"value": "NA"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/3/categories/0/measurements/2/comment",
"value": "DFS data for the Lapatinib alone arm include date collected up to the first interim analysis (data cut-off 11th July 2011), as the Lapatinib arm was discontinued prior to the primary analysis due to futility"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/4/categories/0/measurements/2/value",
"value": "NA"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/4/categories/0/measurements/2/comment",
"value": "DFS data for the Lapatinib alone arm include date collected up to the first interim analysis (data cut-off 11th July 2011), as the Lapatinib arm was discontinued prior to the primary analysis due to futility"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/0/statisticalMethod",
"value": "Log Rank"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/0/ciPctValue",
"value": "95"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/0/ciLowerLimit",
"value": "0.71"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/0/ciUpperLimit",
"value": "1.00"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/0/estimateComment",
"value": "The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status."
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/0/ciNumSides",
"value": "TWO_SIDED"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/1/statisticalMethod",
"value": "Log Rank"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/1/statisticalComment",
"value": "Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/1/ciPctValue",
"value": "95"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/1/ciLowerLimit",
"value": "0.81"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/1/ciUpperLimit",
"value": "1.13"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/1/estimateComment",
"value": "The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status."
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/1/ciNumSides",
"value": "TWO_SIDED"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/2"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/title",
"value": "Disease-Free Survival (DFS) at the 10-Year Follow-Up"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
"value": "Disease-Free Survival (DFS) was defined as the interval between randomization and the date of first occurrence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer or death without recurrence.\nOnly deaths occurring in participants whose clinical follow-up was ongoing at the time of death and who had no recurrence, contralateral breast cancer (CBC) or second primary malignancy (SPM) reported prior to death were considered as death without recurrence.\nDFS was estimated using the Kaplan Meier method.\nThe percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who had disease free survival for the indicated years."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
"value": "Intent-to-Treat (ITT) Population.\nThe Lapatinib alone arm was discontinued prior to primary analysis due to futility."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/unitOfMeasure",
"value": "Years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
"value": "From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause, assessed up to approximately 10 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/title",
"value": "Lapatinib Plus Trastuzumab"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).</li><li>Design 2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.</li><li>Design 2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/1/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/2/title",
"value": "Lapatinib"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/2/description",
"value": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/3/title",
"value": "Trastuzumab"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/3/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\n"</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/2/value",
"value": "0"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/3/value",
"value": "2097"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/title",
"value": "95th Percentile"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/0/value",
"value": "1.89"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1/value",
"value": "1.27"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/2/value",
"value": "1.49"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1/title",
"value": "90th Percentile"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1/categories/0/measurements/0/value",
"value": "3.21"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1/categories/0/measurements/1/value",
"value": "2.80"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1/categories/0/measurements/2/value",
"value": "2.63"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/2/title",
"value": "85th Percentile"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/2/categories/0/measurements/0/value",
"value": "5.92"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/2/categories/0/measurements/1/value",
"value": "4.85"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/2/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/2/categories/0/measurements/2/value",
"value": "4.43"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/3/title",
"value": "80th Percentile"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/3/categories/0/measurements/0/value",
"value": "8.99"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/3/categories/0/measurements/1/value",
"value": "9.18"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/3/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/3/categories/0/measurements/2/value",
"value": "7.42"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/4"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/4"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses",
"value": [
{
"groupIds": [
"OG000",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.887",
"ciLowerLimit": "0.77",
"ciUpperLimit": "1.02",
"estimateComment": "The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.",
"nonInferiorityType": "SUPERIORITY_OR_OTHER_LEGACY"
},
{
"groupIds": [
"OG001",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.914",
"ciLowerLimit": "0.80",
"ciUpperLimit": "1.05",
"estimateComment": "The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.",
"nonInferiorityType": "SUPERIORITY_OR_OTHER_LEGACY"
}
]
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/title",
"value": "Overall Survival (OS) at the Primary Analysis"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
"value": "Overall Survival (OS) was defined as the time from randomization until death due to any cause.\nParticipants who had not died were censored at the last date they were known to be alive, or date of withdrawal of consent.\nOS was calculated in years as (date of death minus the date of randomization +1) divided by 365.25.\nThe percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
"value": "Intent-to-Treat (ITT) Population.\nZero participants were analyzed in the lapatinib arm, as the Independent Data Monitoring Committee discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab)."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/unitOfMeasure",
"value": "Years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame",
"value": "From randomization until death due to any cause (median follow-up of 4.5 years)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/0/title",
"value": "Lapatinib Plus Trastuzumab"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/0/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).</li><li>Design 2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.</li><li>Design 2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/1/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/2/title",
"value": "Lapatinib"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/2/description",
"value": "<p>Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.</p><p>Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant antiestrogen therapy when clinically indicated.</p>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/3/title",
"value": "Trastuzumab"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/3/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\n"</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms/0/counts/2/value",
"value": "0"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms/0/counts/3/value",
"value": "2097"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/title",
"value": "99th Percentile"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/0/value",
"value": "1.7"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/value",
"value": "1.2"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/1/title",
"value": "98th Percentile"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/1/categories/0/measurements/0/value",
"value": "2.2"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/1/categories/0/measurements/1/value",
"value": "1.6"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/1/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/1/categories/0/measurements/2/value",
"value": "2.1"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/2/title",
"value": "97th Percentile"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/2/categories/0/measurements/0/value",
"value": "2.8"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/2/categories/0/measurements/1/value",
"value": "2.2"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/2/categories/0/measurements/1/comment"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/2/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/2/categories/0/measurements/2/value",
"value": "2.6"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/2/categories/0/measurements/2/comment"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/3/title",
"value": "96th Percentile"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/3/categories/0/measurements/0/value",
"value": "3.4"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/3/categories/0/measurements/1/value",
"value": "2.9"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/3/categories/0/measurements/1/comment"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/3/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/3/categories/0/measurements/2/value",
"value": "3.0"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/3/categories/0/measurements/2/comment"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/4",
"value": {
"title": "95th Percentile",
"categories": [
{
"measurements": [
{
"value": "3.9",
"groupId": "OG000"
},
{
"value": "3.7",
"groupId": "OG001"
},
{
"value": "3.6",
"groupId": "OG003"
}
]
}
]
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/5",
"value": {
"title": "90th Percentile",
"categories": [
{
"measurements": [
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "5.9",
"groupId": "OG003"
}
]
}
]
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/analyses",
"value": [
{
"pValue": "0.078",
"groupIds": [
"OG000",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.80",
"ciLowerLimit": "0.62",
"ciUpperLimit": "1.03",
"estimateComment": "The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY_OR_OTHER_LEGACY",
"statisticalComment": "Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status."
},
{
"pValue": "0.433",
"groupIds": [
"OG001",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.91",
"ciLowerLimit": "0.71",
"ciUpperLimit": "1.16",
"estimateComment": "The estimate of the treatment hazard ratio (tras followed by lap versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY_OR_OTHER_LEGACY",
"statisticalComment": "Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status."
}
]
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/title",
"value": "Overall Survival (OS) at the 10-Year Follow-Up"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description",
"value": "Overall Survival (OS) was defined as the time from randomization until death due to any cause.\nParticipants who had not died were censored at the last date they were known to be alive, or date of withdrawal of consent.\nOS was calculated in years as (date of death minus the date of randomization +1) divided by 365.25.\nThe percentile data values presented here indicate the percentage (99, 98, 95 and 90 percent) of participants who survived for the indicated years."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/populationDescription",
"value": "Intent-to-Treat (ITT) Population.\nThe Lapatinib alone arm was discontinued prior to primary analysis due to futility."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/unitOfMeasure",
"value": "Years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
"value": "From randomization until death due to any cause, assessed up to approximately 10 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/0/title",
"value": "Lapatinib Plus Trastuzumab"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/0/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).</li><li>Design 2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.</li><li>Design 2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/1/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/2/title",
"value": "Lapatinib"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/2/description",
"value": "<p>Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.</p><p>Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant antiestrogen therapy when clinically indicated.</p>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/3/title",
"value": "Trastuzumab"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/3/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\n"</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/2/value",
"value": "0"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/3/value",
"value": "2097"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/title",
"value": "99th Percentile"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/value",
"value": "1.68"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/value",
"value": "1.17"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/2/value",
"value": "1.75"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/1/title",
"value": "98th Percentile"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/1/categories/0/measurements/0/value",
"value": "2.19"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/1/categories/0/measurements/1/value",
"value": "1.60"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/1/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/1/categories/0/measurements/2/value",
"value": "2.07"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/2/title",
"value": "95th Percentile"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/2/categories/0/measurements/0/value",
"value": "3.92"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/2/categories/0/measurements/1/value",
"value": "3.52"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/2/categories/0/measurements/1/comment"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/2/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/2/categories/0/measurements/2/value",
"value": "3.65"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/2/categories/0/measurements/2/comment"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/3/title",
"value": "90th Percentile"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/3/categories/0/measurements/0/value",
"value": "8.31"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/3/categories/0/measurements/1/value",
"value": "8.49"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/3/categories/0/measurements/1/comment"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/3/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/3/categories/0/measurements/2/value",
"value": "6.72"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/3/categories/0/measurements/2/comment"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/analyses",
"value": [
{
"groupIds": [
"OG000",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.853",
"ciLowerLimit": "0.70",
"ciUpperLimit": "1.03",
"estimateComment": "The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.",
"nonInferiorityType": "SUPERIORITY_OR_OTHER_LEGACY"
},
{
"groupIds": [
"OG001",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.863",
"ciLowerLimit": "0.71",
"ciUpperLimit": "1.04",
"estimateComment": "The estimate of the treatment hazard ratio (tras followed by lap versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.",
"nonInferiorityType": "SUPERIORITY_OR_OTHER_LEGACY"
}
]
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/title",
"value": "Analysis of Time to Recurrence (TTR)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/description",
"value": "Time to Recurrence (TTR) was defined as the the time from randomization to breast cancer recurrence, ignoring second primary cancers (including contralateral breast cancers and non-breast second malignancies) and counting deaths without recurrence as a competing risk."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription",
"value": "Intent-to-Treat (ITT) Population.\nThe Lapatinib alone arm was discontinued prior to primary analysis due to futility."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/paramType",
"value": "COUNT_OF_PARTICIPANTS"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/unitOfMeasure",
"value": "Participants"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame",
"value": "From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/0/title",
"value": "Lapatinib Plus Trastuzumab"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/0/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).</li><li>Design 2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.</li><li>Design 2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/1/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/2/title",
"value": "Lapatinib"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/2/description",
"value": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/3/title",
"value": "Trastuzumab"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/3/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\n"</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/2/value",
"value": "0"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/3/value",
"value": "2097"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/value",
"value": "243"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/value",
"value": "275"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/comment"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/2/value",
"value": "298"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/2/comment"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/title",
"value": "Local, regional, or distant recurrence"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/1",
"value": {
"title": "Death as a competing risk",
"measurements": [
{
"value": "43",
"groupId": "OG000"
},
{
"value": "38",
"groupId": "OG001"
},
{
"value": "46",
"groupId": "OG003"
}
]
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/2",
"value": {
"title": "Censored",
"measurements": [
{
"value": "1807",
"groupId": "OG000"
},
{
"value": "1778",
"groupId": "OG001"
},
{
"value": "1753",
"groupId": "OG003"
}
]
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/analyses",
"value": [
{
"groupIds": [
"OG000",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.811",
"ciLowerLimit": "0.68",
"ciUpperLimit": "0.96",
"nonInferiorityType": "SUPERIORITY_OR_OTHER_LEGACY",
"nonInferiorityComment": "Time to recurrence was analyzed using competing risks methodology with death (without event) as a competing risk."
},
{
"groupIds": [
"OG001",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.930",
"ciLowerLimit": "0.79",
"ciUpperLimit": "1.10",
"nonInferiorityType": "SUPERIORITY_OR_OTHER_LEGACY",
"nonInferiorityComment": "Time to recurrence was analyzed using competing risks methodology with death (without event) as a competing risk."
}
]
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/title",
"value": "Analysis of Time to Distant Recurrence (TTDR)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description",
"value": "Time to Distant Recurrence (TTDR) was defined as the the time from randomization to first distant breast cancer recurrence, ignoring locoregional recurrences and second primary cancers, (including contralateral breast cancers and non-breast second malignancies ) and counting deaths without recurrence as a competing risk."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/populationDescription",
"value": "Intent-to-Treat (ITT) Population.\nThe Lapatinib alone arm was discontinued prior to primary analysis due to futility."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/paramType",
"value": "COUNT_OF_PARTICIPANTS"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/unitOfMeasure",
"value": "Participants"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame",
"value": "From randomization until the date of the first occurrence of distant recurrence, assessed up to approximately 10 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/0/title",
"value": "Lapatinib Plus Trastuzumab"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/0/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).</li><li>Design 2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.</li><li>Design 2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/1/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/2/title",
"value": "Lapatinib"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/2/description",
"value": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/3/title",
"value": "Trastuzumab"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/3/description",
"value": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\n"</li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/0/value",
"value": "2093"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/1/value",
"value": "2091"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/2/value",
"value": "0"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/3/value",
"value": "2097"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/title"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/value",
"value": "213"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/value",
"value": "238"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/2/groupId",
"value": "OG003"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/2/value",
"value": "250"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/title",
"value": "Distant recurrence"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/1",
"value": {
"title": "Death as a competing risk",
"measurements": [
{
"value": "45",
"groupId": "OG000"
},
{
"value": "41",
"groupId": "OG001"
},
{
"value": "54",
"groupId": "OG003"
}
]
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/2",
"value": {
"title": "Censored",
"measurements": [
{
"value": "1835",
"groupId": "OG000"
},
{
"value": "1812",
"groupId": "OG001"
},
{
"value": "1793",
"groupId": "OG003"
}
]
}
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/1"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/1"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/1"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/1"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/analyses",
"value": [
{
"groupIds": [
"OG000",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.852",
"ciLowerLimit": "0.71",
"ciUpperLimit": "1.02",
"nonInferiorityType": "SUPERIORITY_OR_OTHER_LEGACY",
"nonInferiorityComment": "Time to distant recurrence was analyzed using competing risks methodology with death (without event) as a competing risk."
},
{
"groupIds": [
"OG001",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.968",
"ciLowerLimit": "0.81",
"ciUpperLimit": "1.16",
"nonInferiorityType": "SUPERIORITY_OR_OTHER_LEGACY",
"nonInferiorityComment": "Time to distant recurrence was analyzed using competing risks methodology with death (without event) as a competing risk."
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6",
"value": {
"type": "SECONDARY",
"title": "Analysis of Time to Central Nervous System (CNS) Recurrence",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "0",
"groupId": "OG002"
},
{
"value": "2097",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib Plus Trastuzumab",
"description": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).</li><li>Design 2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.</li><li>Design 2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.</li></ul>"
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.</li></ul>"
},
{
"id": "OG002",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Trastuzumab",
"description": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\n"</li></ul>"
}
],
"classes": [
{
"categories": [
{
"title": "CNS recurrence",
"measurements": [
{
"value": "91",
"groupId": "OG000"
},
{
"value": "91",
"groupId": "OG001"
},
{
"value": "95",
"groupId": "OG003"
}
]
},
{
"title": "Death as a competing risk",
"measurements": [
{
"value": "114",
"groupId": "OG000"
},
{
"value": "117",
"groupId": "OG001"
},
{
"value": "142",
"groupId": "OG003"
}
]
},
{
"title": "Censored",
"measurements": [
{
"value": "1888",
"groupId": "OG000"
},
{
"value": "1883",
"groupId": "OG001"
},
{
"value": "1860",
"groupId": "OG003"
}
]
}
]
}
],
"analyses": [
{
"groupIds": [
"OG000",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.986",
"ciLowerLimit": "0.74",
"ciUpperLimit": "1.31",
"nonInferiorityType": "SUPERIORITY_OR_OTHER_LEGACY",
"nonInferiorityComment": "Time to CNS recurrence was analyzed using competing risks methodology with death (without event) as a competing risk."
},
{
"groupIds": [
"OG001",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.980",
"ciLowerLimit": "0.74",
"ciUpperLimit": "1.31",
"nonInferiorityType": "SUPERIORITY_OR_OTHER_LEGACY",
"nonInferiorityComment": "Time to CNS recurrence was analyzed using competing risks methodology with death (without event) as a competing risk."
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "From randomization until the first central nervous system recurrence, assessed up to approximately 10 years",
"description": "Time to Central Nervous System (CNS) recurrence was defined as the time from randomization to first CNS recurrence.\nBoth brain metastasis and meningitis carcinomatosa were considered.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Intent-to-Treat (ITT) Population.\nThe Lapatinib alone arm was discontinued prior to primary analysis due to futility."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7",
"value": {
"type": "SECONDARY",
"title": "Cumulative Incidence of Brain Metastases",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "0",
"groupId": "OG002"
},
{
"value": "2097",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib Plus Trastuzumab",
"description": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).</li><li>Design 2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.</li><li>Design 2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.</li></ul>"
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.</li></ul>"
},
{
"id": "OG002",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Trastuzumab",
"description": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\n"</li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "50",
"groupId": "OG000"
},
{
"value": "52",
"groupId": "OG001"
},
{
"value": "48",
"groupId": "OG003"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years",
"description": "The cumulative incidence of brain metastases as the first site of breast cancer recurrence among treatment arms was assessed using a hierarchy of primary type and location of first DFS event in cases where more than one event was identified simultaneously.\nBecause diagnostic procedures for different types of recurrence could not be performed on exactly the same day, any diagnoses noted within a two month (60 day) period of the first reported event was considered as identified simultaneously for purposes of defining the type of the first event and the date of event was be regarded as the earliest of the relevant events.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Intent-to-Treat (ITT) Population.\nThe Lapatinib alone arm was discontinued prior to primary analysis due to futility."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8",
"value": {
"type": "POST_HOC",
"title": "All Collected Deaths",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "2100",
"groupId": "OG002"
},
{
"value": "2097",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib Plus Trastuzumab",
"description": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).</li><li>Design 2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.</li><li>Design 2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.</li></ul>"
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.</li></ul>"
},
{
"id": "OG002",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Trastuzumab",
"description": "<p>Participants received treatment per one of three designs and adjuvant radiotherapy / adjuvant anti-estrogen therapy when clinically indicated.</p><ul><li>Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.</li><li>Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.</li><li>Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\n"</li></ul>"
}
],
"classes": [
{
"title": "Pre-treatment deaths",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "2100",
"groupId": "OG002"
},
{
"value": "2097",
"groupId": "OG003"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
},
{
"value": "1",
"groupId": "OG002"
},
{
"value": "2",
"groupId": "OG003"
}
]
}
]
},
{
"title": "On-treatment deaths",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2061",
"groupId": "OG000"
},
{
"value": "2076",
"groupId": "OG001"
},
{
"value": "2056",
"groupId": "OG002"
},
{
"value": "2076",
"groupId": "OG003"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "6",
"groupId": "OG000"
},
{
"value": "5",
"groupId": "OG001"
},
{
"value": "12",
"groupId": "OG002"
},
{
"value": "3",
"groupId": "OG003"
}
]
}
]
},
{
"title": "Post-treatment deaths",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2055",
"groupId": "OG000"
},
{
"value": "2071",
"groupId": "OG001"
},
{
"value": "2044",
"groupId": "OG002"
},
{
"value": "2073",
"groupId": "OG003"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "189",
"groupId": "OG000"
},
{
"value": "190",
"groupId": "OG001"
},
{
"value": "250",
"groupId": "OG002"
},
{
"value": "228",
"groupId": "OG003"
}
]
}
]
},
{
"title": "All deaths",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "2100",
"groupId": "OG002"
},
{
"value": "2097",
"groupId": "OG003"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "196",
"groupId": "OG000"
},
{
"value": "197",
"groupId": "OG001"
},
{
"value": "263",
"groupId": "OG002"
},
{
"value": "233",
"groupId": "OG003"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "Pre-treatment deaths: Up to 14 days prior to treatment. On-treatment deaths: Up to 56 weeks. Post-treatment deaths: up to 10 years.",
"description": "<p>Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication.</p><p>On-treatment deaths were collected from first dose of study medication to 30 days after last dose of study medication (on-treatment), up to approximately 56 weeks.</p><p>Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approximately 10 years.</p>",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Intent-to-Treat (ITT) Population."
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/timeFrame",
"value": "Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 56 weeks. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 10 years."
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/description",
"value": "Deaths in the post-treatment survival follow-up were not considered adverse events.\nThe total number at risk in the post-treatment survival included patients who entered this period.\nAll-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication."
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/title",
"value": "Lapatinib Plus Trastuzumab"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/description",
"value": "Lapatinib plus Trastuzumab: Events up to 30 days post-treatment"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected",
"value": 379
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected",
"value": 1930
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected",
"value": 7
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk",
"value": 2093
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/description",
"value": "Trastuzumab followed by Lapatinib: Events up to 30 days post-treatment"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/seriousNumAffected",
"value": 299
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/otherNumAffected",
"value": 1862
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAffected",
"value": 7
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAtRisk",
"value": 2091
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/2/description",
"value": "Lapatinib: Events up to 30 days post-treatment"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/2/seriousNumAffected",
"value": 394
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/2/seriousNumAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/2/otherNumAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/eventGroups/2/deathsNumAffected",
"value": 13
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/eventGroups/2/deathsNumAtRisk",
"value": 2100
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/3/description",
"value": "Trastuzumab: Events up to 30 days post-treatment"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/3/seriousNumAffected",
"value": 251
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/3/otherNumAffected",
"value": 1649
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/eventGroups/3/deathsNumAffected",
"value": 5
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/eventGroups/3/deathsNumAtRisk",
"value": 2097
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/eventGroups/4",
"value": {
"id": "EG004",
"title": "Lapatinib Plus Trastuzumab (Post-Treatment)",
"description": "Lapatinib plus Trastuzumab (Post-Treatment) - Deaths in the post-treatment survival follow-up were not considered adverse events.",
"otherNumAtRisk": 0,
"deathsNumAtRisk": 2055,
"otherNumAffected": 0,
"seriousNumAtRisk": 0,
"deathsNumAffected": 189,
"seriousNumAffected": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/eventGroups/5",
"value": {
"id": "EG005",
"title": "Trastuzumab Followed by Lapatinib (Post-Treatment)",
"description": "Trastuzumab followed by Lapatinib (Post-Treatment) - Deaths in the post-treatment survival follow-up were not considered adverse events.",
"otherNumAtRisk": 0,
"deathsNumAtRisk": 2071,
"otherNumAffected": 0,
"seriousNumAtRisk": 0,
"deathsNumAffected": 190,
"seriousNumAffected": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/eventGroups/6",
"value": {
"id": "EG006",
"title": "Lapatinib (Post-Treatment)",
"description": "Lapatinib (Post-Treatment) - Deaths in the post-treatment survival follow-up were not considered adverse events.",
"otherNumAtRisk": 0,
"deathsNumAtRisk": 2044,
"otherNumAffected": 0,
"seriousNumAtRisk": 0,
"deathsNumAffected": 250,
"seriousNumAffected": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/eventGroups/7",
"value": {
"id": "EG007",
"title": "Trastuzumab (Post-Treatment)",
"description": "Trastuzumab (Post-Treatment) - Deaths in the post-treatment survival follow-up were not considered adverse events.",
"otherNumAtRisk": 0,
"deathsNumAtRisk": 2073,
"otherNumAffected": 0,
"seriousNumAtRisk": 0,
"deathsNumAffected": 228,
"seriousNumAffected": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/term",
"value": "AGRANULOCYTOSIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/organSystem",
"value": "Blood and lymphatic system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/term",
"value": "ANAEMIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numAffected",
"value": 7
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/1/numAffected",
"value": 6
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/2/numAffected",
"value": 13
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/3/numAffected",
"value": 7
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/term",
"value": "EOSINOPHILIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/organSystem",
"value": "Blood and lymphatic system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/term",
"value": "FEBRILE NEUTROPENIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/organSystem",
"value": "Blood and lymphatic system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/0/numAffected",
"value": 10
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/1/numAffected",
"value": 6
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/2/numAffected",
"value": 12
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/3/numAffected",
"value": 3
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/4",
"value": {
"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/6",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/7",
"value": {
"groupId": "EG007",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/term",
"value": "IRON DEFICIENCY ANAEMIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/organSystem",
"value": "Blood and lymphatic system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/7",
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"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/term",
"value": "LEUKOPENIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/organSystem",
"value": "Blood and lymphatic system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/0/numAffected",
"value": 20
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/1/numAffected",
"value": 4
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/2/numAffected",
"value": 13
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/3/numAffected",
"value": 7
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/5",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/6",
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"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/7",
"value": {
"groupId": "EG007",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/term",
"value": "NEUTROPENIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/organSystem",
"value": "Blood and lymphatic system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/0/numAffected",
"value": 37
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/1/numAffected",
"value": 21
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/2/numAffected",
"value": 36
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/3/numAffected",
"value": 20
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/4",
"value": {
"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/7",
"value": {
"groupId": "EG007",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/term",
"value": "PANCYTOPENIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/stats/3/numAffected",
"value": 0
},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/stats/5",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/stats/7",
"value": {
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"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/8/term",
"value": "THROMBOCYTOPENIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/8/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/8/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/8/stats/0/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/8/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/8/stats/2/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/8/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/8/stats/3/numAffected",
"value": 7
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/stats/3/numAffected",
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},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/stats/5",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/10/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/10/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/10/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/10/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/10/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/10/stats/2/numAffected",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/10/stats/3/numAffected",
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},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/11/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/11/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/11/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/11/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/11/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/11/stats/2/numAffected",
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},
{
"op": "replace",
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{
"op": "replace",
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},
{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/12/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/12/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/12/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/12/stats/1/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/12/stats/2/numAffected",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/12/stats/3/numAffected",
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{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/13/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/13/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/13/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/13/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/13/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/13/stats/2/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/13/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/13/stats/3/numAffected",
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},
{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/14/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/14/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/14/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/14/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/14/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/14/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/14/stats/3/numAffected",
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},
{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/15/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/15/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/15/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/15/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/15/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/15/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/15/stats/3/numAffected",
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},
{
"op": "add",
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},
{
"op": "add",
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},
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"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/16/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/16/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/16/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/16/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/16/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/16/stats/2/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/16/stats/2/numAtRisk",
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{
"op": "replace",
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{
"op": "add",
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},
{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/17/stats/2/numAffected",
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"op": "replace",
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"op": "replace",
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{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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"op": "add",
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},
{
"op": "replace",
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},
{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/19/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/19/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/19/stats/2/numAffected",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/20/sourceVocabulary",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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},
{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/21/stats/1/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/21/stats/2/numAffected",
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"op": "replace",
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},
{
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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"op": "replace",
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},
{
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{
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{
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},
{
"op": "replace",
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{
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{
"op": "replace",
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},
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{
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{
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{
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{
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{
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{
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{
"op": "replace",
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{
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{
"op": "replace",
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{
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},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
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{
"op": "replace",
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"op": "add",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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"op": "replace",
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"groupId": "EG006",
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}
},
{
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/30/term",
"value": "SUPRAVENTRICULAR TACHYCARDIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/30/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/30/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/30/stats/2/numAffected",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/30/stats/3/numAffected",
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},
{
"op": "add",
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}
},
{
"op": "add",
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"value": {
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},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/30/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/term",
"value": "VENTRICULAR ARRHYTHMIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/organSystem",
"value": "Cardiac disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/stats/2/numAffected",
"value": 1
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/stats/3/numAffected",
"value": 0
},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/stats/5",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/stats/6",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/term",
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},
{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/2/numAffected",
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/4",
"value": {
"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/5",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/6",
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},
{
"op": "add",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/stats/3/numAffected",
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},
{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "replace",
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},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/34/stats/1/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/34/stats/2/numAffected",
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{
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{
"op": "replace",
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{
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/35/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/35/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/35/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/35/stats/1/numAffected",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "add",
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},
{
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{
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{
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},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
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},
{
"op": "replace",
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{
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{
"op": "replace",
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{
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{
"op": "replace",
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{
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},
{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
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{
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"op": "add",
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},
{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/40/sourceVocabulary",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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{
"op": "add",
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"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/41/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/41/sourceVocabulary",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/41/stats/1/numAffected",
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{
"op": "replace",
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{
"op": "replace",
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"op": "add",
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{
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{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/42/stats/0/numAffected",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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"op": "add",
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"op": "add",
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"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
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"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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}
},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/128/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/128/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/128/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/128/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/128/stats/2/numAffected",
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/128/stats/3/numAffected",
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},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/128/stats/5",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/129/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/129/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/129/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/129/stats/0/numAffected",
"value": 4
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/129/stats/1/numAffected",
"value": 4
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/129/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/129/stats/3/numAffected",
"value": 4
},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/129/stats/5",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/129/stats/6",
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}
},
{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/130/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/130/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/130/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/130/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/130/stats/4",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/130/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/130/stats/7",
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"groupId": "EG007",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/131/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/131/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/131/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/131/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/131/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/131/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/131/stats/3/numAffected",
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},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/132/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/132/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/132/stats/2/numAtRisk",
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{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/133/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/133/stats/2/numAtRisk",
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{
"op": "add",
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},
{
"op": "add",
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{
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},
{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/134/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/134/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/134/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/134/stats/2/numAtRisk",
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
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},
{
"op": "replace",
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{
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{
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/135/stats/2/numAtRisk",
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{
"op": "add",
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},
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},
{
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},
{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
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{
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"path": "/resultsSection/adverseEventsModule/seriousEvents/136/sourceVocabulary",
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{
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{
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/136/stats/2/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/136/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/136/stats/3/numAffected",
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{
"op": "add",
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},
{
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},
{
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},
{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/137/organSystem",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/137/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/137/stats/3/numAffected",
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{
"op": "add",
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{
"op": "add",
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},
{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/138/stats/2/numAffected",
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{
"op": "replace",
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{
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},
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},
{
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},
{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/139/sourceVocabulary",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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"op": "add",
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"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/140/sourceVocabulary",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/140/stats/2/numAtRisk",
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{
"op": "replace",
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"op": "add",
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{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/141/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/141/sourceVocabulary",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/141/stats/2/numAtRisk",
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{
"op": "add",
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},
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"op": "add",
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"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
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{
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{
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{
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{
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{
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"op": "replace",
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"op": "add",
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},
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"op": "add",
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{
"op": "replace",
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{
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{
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/146/stats/2/numAffected",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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{
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{
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{
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{
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/147/stats/1/numAffected",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "add",
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{
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{
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"op": "replace",
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},
{
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},
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},
{
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{
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{
"op": "replace",
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},
{
"op": "replace",
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{
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{
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},
{
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},
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{
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{
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{
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{
"op": "replace",
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"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
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{
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{
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{
"op": "replace",
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{
"op": "replace",
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"op": "replace",
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{
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"op": "replace",
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"op": "replace",
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"path": "/resultsSection/adverseEventsModule/seriousEvents/157/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/157/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/158/term",
"value": "GASTROENTERITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/158/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/158/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/158/stats/0/numAffected",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/158/stats/1/numAffected",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/158/stats/2/numAffected",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/158/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/158/stats/4",
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"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/158/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/158/stats/6",
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"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/158/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/159/term",
"value": "GASTROENTERITIS VIRAL"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/159/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/159/stats/2/numAtRisk",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/159/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/159/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/159/stats/6",
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"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/159/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/160/term",
"value": "GASTROINTESTINAL INFECTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/160/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/160/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/160/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/160/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/160/stats/4",
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"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/160/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/160/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/160/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/161/term",
"value": "H1N1 INFLUENZA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/161/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/161/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/161/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/161/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/161/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/161/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/161/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/161/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/162/term",
"value": "HEPATITIS B"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/162/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/162/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/162/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/162/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/162/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/162/stats/4",
"value": {
"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/162/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/162/stats/6",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/163/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/163/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/163/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/163/stats/4",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/163/stats/5",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/163/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/163/stats/7",
"value": {
"groupId": "EG007",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/164/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/164/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/164/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/164/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/164/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/164/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/164/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/164/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/164/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/164/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/164/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/165/term",
"value": "HERPES ZOSTER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/165/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/165/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/165/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/165/stats/1/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/165/stats/2/numAffected",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/165/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/165/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/165/stats/4",
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"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/165/stats/5",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/166/term",
"value": "IMPLANT SITE CELLULITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/166/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/166/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/166/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/166/stats/3/numAffected",
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},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/166/stats/5",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/166/stats/6",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/167/term",
"value": "INFECTED CYST"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/167/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/167/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/167/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/167/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/167/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/167/stats/3/numAffected",
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},
{
"op": "add",
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"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/167/stats/5",
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}
},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/168/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/168/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/168/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/168/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/168/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/168/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/168/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/168/stats/5",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/168/stats/6",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/169/term",
"value": "INFECTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/169/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/169/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/169/stats/0/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/169/stats/2/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/169/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/169/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/169/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/169/stats/5",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/170/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/170/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/170/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/170/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/170/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/170/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/170/stats/5",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/171/term",
"value": "INFLUENZA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/171/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/171/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/171/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/171/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/171/stats/5",
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}
},
{
"op": "add",
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},
{
"op": "add",
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"groupId": "EG007",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/172/term",
"value": "INTERVERTEBRAL DISCITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/172/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/172/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/172/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/172/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/172/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/172/stats/3/numAffected",
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},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/172/stats/5",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/173/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/173/sourceVocabulary",
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},
{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/173/stats/2/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/173/stats/2/numAtRisk",
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},
{
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"path": "/resultsSection/adverseEventsModule/seriousEvents/174/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/174/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/174/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/174/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/174/stats/2/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/174/stats/2/numAtRisk",
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{
"op": "add",
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{
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{
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/175/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/175/stats/2/numAtRisk",
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{
"op": "add",
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{
"op": "add",
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{
"op": "add",
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{
"op": "add",
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},
{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/176/stats/1/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/176/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/176/stats/3/numAffected",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
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{
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/177/stats/2/numAtRisk",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
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},
{
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{
"op": "replace",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/178/stats/0/numAffected",
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},
{
"op": "replace",
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},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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},
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},
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"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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},
{
"op": "replace",
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},
{
"op": "replace",
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{
"op": "replace",
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},
{
"op": "replace",
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{
"op": "add",
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}
},
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},
{
"op": "replace",
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{
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{
"op": "replace",
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{
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{
"op": "replace",
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{
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{
"op": "add",
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},
{
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{
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{
"op": "replace",
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{
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{
"op": "replace",
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{
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{
"op": "replace",
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"op": "add",
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},
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{
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},
{
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{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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},
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{
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{
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{
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{
"op": "replace",
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{
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"op": "add",
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{
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{
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{
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{
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{
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},
{
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{
"op": "replace",
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{
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{
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
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"op": "replace",
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"op": "replace",
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{
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{
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{
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{
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{
"op": "replace",
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{
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{
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{
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{
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/205/stats/1/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/205/stats/2/numAffected",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
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{
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/207/stats/2/numAffected",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
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{
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{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/208/stats/2/numAffected",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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{
"op": "add",
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"op": "add",
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},
{
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/209/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/209/sourceVocabulary",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
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{
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{
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{
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{
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{
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{
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{
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{
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{
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{
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
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"op": "add",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/216/organSystem",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/218/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/218/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/218/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/218/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/218/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/218/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/218/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/218/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/218/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/219/term",
"value": "UPPER RESPIRATORY TRACT INFECTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/219/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/219/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/219/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/219/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/219/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/219/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/219/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/219/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/220/term",
"value": "UPPER RESPIRATORY TRACT INFECTION BACTERIAL"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/220/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/220/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/220/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/220/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/220/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/220/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/220/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/221/term",
"value": "URINARY TRACT INFECTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/221/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/221/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/221/stats/0/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/221/stats/1/numAffected",
"value": 6
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/221/stats/2/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/221/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/221/stats/3/numAffected",
"value": 7
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/221/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/221/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/221/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/221/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/222/term",
"value": "UROSEPSIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/222/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/222/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/222/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/222/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/222/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/222/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/222/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/222/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/222/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/223/term",
"value": "VIRAL INFECTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/223/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/223/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/223/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/223/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/223/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/223/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/223/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/223/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/223/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/224/term",
"value": "WOUND INFECTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/224/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/224/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/224/stats/1/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/224/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/224/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/224/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/224/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/224/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/224/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/224/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/225/term",
"value": "WOUND INFECTION BACTERIAL"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/225/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/225/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/225/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/225/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/225/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/225/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/225/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/225/stats/6",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/225/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/226/term",
"value": "ALCOHOL POISONING"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/226/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/226/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/226/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/226/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/226/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/226/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/226/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/226/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/226/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/227/term",
"value": "ANKLE FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/227/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/227/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/227/stats/3/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/227/stats/4",
"value": {
"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/227/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/227/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/227/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/228/term",
"value": "CARBON MONOXIDE POISONING"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/228/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/228/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/228/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/228/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/228/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/228/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/228/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/229/term",
"value": "CONCUSSION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/229/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/229/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/229/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/229/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/229/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/229/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/229/stats/5",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/229/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/229/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/230/term",
"value": "CONTUSION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/230/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/230/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/230/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/230/stats/4",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/230/stats/5",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/230/stats/6",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/230/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/231/term",
"value": "FIBULA FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/231/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/231/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/231/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/231/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/231/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/231/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/231/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/232/term",
"value": "FOOT FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/232/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/232/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/232/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/232/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/232/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/232/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/232/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/233/term",
"value": "FOREIGN BODY"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/233/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/233/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/233/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/233/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/233/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/233/stats/4",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/233/stats/5",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/233/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/233/stats/7",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/234/term",
"value": "FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/234/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/234/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/234/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/234/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/234/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/234/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/234/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/234/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/234/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/235/term",
"value": "FRACTURED COCCYX"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/235/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/235/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/235/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/235/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/235/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/235/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/235/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/235/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/235/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/236/term",
"value": "HIP FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/236/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/236/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/236/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/236/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/236/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/236/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/236/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/236/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/236/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/236/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/237/term",
"value": "HUMERUS FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/237/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/237/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/237/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/237/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/237/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/237/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/237/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/237/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/237/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/238/term",
"value": "INFUSION RELATED REACTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/238/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/238/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/238/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/238/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/238/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/238/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/238/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/239/term",
"value": "LIGAMENT INJURY"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/239/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/239/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/239/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/239/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/239/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/239/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/239/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/239/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/239/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/240/term",
"value": "LIGAMENT SPRAIN"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/240/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/240/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/240/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/240/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/240/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/240/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/240/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/240/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/240/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/241/term",
"value": "LOWER LIMB FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/241/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/241/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/241/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/241/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/241/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/241/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/241/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/241/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/241/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/242/term",
"value": "MULTIPLE INJURIES"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/242/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/242/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/242/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/242/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/242/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/242/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/242/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/243/term",
"value": "PELVIC FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/243/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/243/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/243/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/243/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/243/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/243/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/243/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/243/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/243/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/244/term",
"value": "RADIATION FIBROSIS - LUNG"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/244/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/244/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/244/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/244/stats/2/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/244/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/244/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/244/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/244/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/244/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/244/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/245/term",
"value": "RADIATION PNEUMONITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/245/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/245/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/245/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/245/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/245/stats/2/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/245/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/245/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/245/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/245/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/245/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/246/term",
"value": "RADIATION SKIN INJURY"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/246/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/246/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/246/stats/1/numAffected",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/246/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/246/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/246/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/246/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/246/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/246/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/247/term",
"value": "RADIUS FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/247/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/247/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/247/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/247/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/247/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/247/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/247/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/248/term",
"value": "RIB FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/248/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/248/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/248/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/248/stats/1/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/248/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/248/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/248/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/248/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/248/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/249/term",
"value": "ROAD TRAFFIC ACCIDENT"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/249/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/249/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/249/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/249/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/249/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/249/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/249/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/249/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/249/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/250/term",
"value": "SEROMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/250/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/250/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/250/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/250/stats/1/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/250/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/250/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/250/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/250/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/250/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/250/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/251/term",
"value": "SPINAL COMPRESSION FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/251/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/251/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/251/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/251/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/251/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/251/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/251/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/251/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/251/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/252/term",
"value": "SPINAL FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/252/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/252/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/252/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/252/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/252/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/252/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/252/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/252/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/252/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/253/term",
"value": "STERNAL FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/253/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/253/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/253/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/253/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/253/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/253/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/253/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/253/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/253/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/254/term",
"value": "SUBDURAL HAEMORRHAGE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/254/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/254/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/254/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/254/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/254/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/254/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/254/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/255/term",
"value": "THERMAL BURN"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/255/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/255/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/255/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/255/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/255/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/255/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/255/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/256/term",
"value": "TIBIA FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/256/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/256/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/256/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/256/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/256/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/256/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/256/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/256/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/257/term",
"value": "UPPER LIMB FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/257/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/257/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/257/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/257/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/257/stats/3/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/257/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/257/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/257/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/257/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/258/term",
"value": "WOUND COMPLICATION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/258/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/258/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/258/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/258/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/258/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/258/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/258/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/258/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/258/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/258/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/259/term",
"value": "WRIST FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/259/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/259/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/259/stats/2/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/259/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/259/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/259/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/259/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/259/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/259/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/260/term",
"value": "ALANINE AMINOTRANSFERASE INCREASED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/260/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/260/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/260/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/260/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/260/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/260/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/260/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/260/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/261/term",
"value": "AMYLASE INCREASED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/261/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/261/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/261/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/261/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/261/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/261/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/261/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/261/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/262/term",
"value": "BLOOD ALKALINE PHOSPHATASE INCREASED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/262/organSystem",
"value": "Investigations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/262/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/262/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/262/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/262/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/262/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/262/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/263/term",
"value": "BLOOD BILIRUBIN INCREASED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/263/organSystem",
"value": "Investigations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/263/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/263/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/263/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/263/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/263/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/263/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/263/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/263/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/264/term",
"value": "BLOOD CREATININE INCREASED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/264/organSystem",
"value": "Investigations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/264/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/264/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/264/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/264/stats/3/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/264/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/264/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
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{
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/265/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/265/stats/2/numAtRisk",
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{
"op": "replace",
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{
"op": "add",
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"op": "add",
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{
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{
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{
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{
"op": "replace",
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{
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{
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"op": "add",
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{
"op": "add",
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{
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{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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{
"op": "add",
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"op": "add",
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{
"op": "add",
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{
"op": "replace",
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{
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{
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{
"op": "add",
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{
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{
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"op": "add",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/277/organSystem",
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{
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{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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},
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{
"op": "replace",
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{
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/280/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/280/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/280/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/280/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/280/stats/2/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/280/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/280/stats/3/numAffected",
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{
"op": "add",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/280/stats/5",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/280/stats/6",
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{
"op": "add",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/281/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/281/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/281/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/281/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/281/stats/2/numAtRisk",
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{
"op": "add",
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{
"op": "add",
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{
"op": "add",
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{
"op": "add",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/282/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/282/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/282/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/282/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/282/stats/2/numAtRisk",
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{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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{
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},
{
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"path": "/resultsSection/adverseEventsModule/seriousEvents/283/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/283/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/283/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/283/stats/2/numAtRisk",
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{
"op": "add",
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{
"op": "add",
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{
"op": "add",
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},
{
"op": "add",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/284/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/284/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/284/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/284/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/284/stats/2/numAffected",
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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{
"op": "add",
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{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/285/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/285/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/285/stats/0/numAffected",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/285/stats/2/numAffected",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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{
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{
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/286/organSystem",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/286/stats/1/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/286/stats/2/numAtRisk",
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{
"op": "replace",
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{
"op": "add",
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{
"op": "add",
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},
{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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"op": "add",
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{
"op": "add",
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{
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{
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/288/organSystem",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/288/stats/1/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/288/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/288/stats/3/numAffected",
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{
"op": "add",
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},
{
"op": "add",
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"op": "add",
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"op": "add",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/289/organSystem",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/289/stats/2/numAtRisk",
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{
"op": "add",
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{
"op": "add",
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},
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"op": "add",
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},
{
"op": "add",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/290/organSystem",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/292/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/292/sourceVocabulary",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "add",
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{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/293/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/293/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/293/stats/0/numAffected",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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"op": "add",
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{
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
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{
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{
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/310/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/310/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/310/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/310/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/310/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/310/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/310/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/310/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/311/term",
"value": "PAIN IN EXTREMITY"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/311/organSystem",
"value": "Musculoskeletal and connective tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/311/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/311/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/311/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/311/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/311/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/311/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/311/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/311/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/312/term",
"value": "SCLERODERMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/312/organSystem",
"value": "Musculoskeletal and connective tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/312/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/312/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/312/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/312/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/312/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/312/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/313/term",
"value": "SPONDYLOLISTHESIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/313/organSystem",
"value": "Musculoskeletal and connective tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/313/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/313/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/313/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/313/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/313/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/313/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/313/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/313/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/314/term",
"value": "SYNOVIAL CYST"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/314/organSystem",
"value": "Musculoskeletal and connective tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/314/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/314/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/314/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/314/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/314/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/314/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/314/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/314/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/315/term",
"value": "SYNOVITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/315/organSystem",
"value": "Musculoskeletal and connective tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/315/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/315/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/315/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/315/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/315/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/315/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/316/term",
"value": "ACUTE LYMPHOCYTIC LEUKAEMIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/316/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/316/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/316/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/316/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/316/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/316/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/316/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/317/term",
"value": "ACUTE PROMYELOCYTIC LEUKAEMIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/317/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/317/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/317/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/317/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/317/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/317/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/317/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/317/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/317/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/318/term",
"value": "ADENOCARCINOMA OF COLON"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/318/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/318/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/318/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/318/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/318/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/318/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/318/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/318/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/318/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/319/term",
"value": "BENIGN BREAST NEOPLASM"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/319/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/319/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/319/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/319/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/319/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/319/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/320/term",
"value": "BENIGN OVARIAN TUMOUR"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/320/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/320/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/320/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/320/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/320/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/320/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/320/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/320/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/320/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/321/term",
"value": "BLADDER NEOPLASM"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/321/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/321/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/321/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/321/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/321/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/321/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/321/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/321/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/321/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/322/term",
"value": "BORDERLINE OVARIAN TUMOUR"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/322/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/322/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/322/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/322/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/322/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/322/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/322/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/323/term",
"value": "BREAST CANCER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/323/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/323/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/323/stats/0/numAffected",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/323/stats/1/numAffected",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/323/stats/2/numAffected",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/323/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/323/stats/3/numAffected",
"value": 4
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/323/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/323/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/323/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/323/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/324/term",
"value": "BREAST CANCER IN SITU"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/324/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/324/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/324/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/324/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/324/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/324/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/324/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/324/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/325/term",
"value": "COLON CANCER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/325/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/325/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/325/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/325/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/325/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/325/stats/3/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/325/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/325/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/325/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/325/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/326/term",
"value": "ENDOMETRIAL ADENOCARCINOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/326/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/326/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/326/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/326/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/326/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/326/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/326/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/327/term",
"value": "GASTRIC CANCER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/327/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/327/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/327/stats/2/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/327/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/327/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/327/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/327/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/327/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/327/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/328/term",
"value": "GASTROINTESTINAL CARCINOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/328/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/328/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/328/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/328/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/328/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/328/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/328/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/328/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/328/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/329/term",
"value": "GASTROINTESTINAL STROMAL TUMOUR"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/329/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/329/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/329/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/329/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/329/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/329/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/329/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/329/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/330/term",
"value": "HAEMANGIOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/330/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/330/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/330/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/330/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/330/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/330/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/330/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/331/term",
"value": "INTRADUCTAL PAPILLOMA OF BREAST"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/331/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/331/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/331/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/331/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/331/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/331/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/331/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/331/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/331/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/332/term",
"value": "INTRADUCTAL PROLIFERATIVE BREAST LESION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/332/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/332/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/332/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/332/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/332/stats/3/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/332/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/332/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/332/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/332/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/333/term",
"value": "LEIOMYOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/333/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/333/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/333/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/333/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/333/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/333/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/333/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/334/term",
"value": "LEIOMYOSARCOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/334/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/334/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/334/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/334/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/334/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/334/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/334/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/335/term",
"value": "LENTIGO MALIGNA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/335/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/335/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/335/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/335/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/335/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/335/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/335/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/336/term",
"value": "LIPOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/336/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/336/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/336/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/336/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/336/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/336/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/336/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/336/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/336/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/337/term",
"value": "MALIGNANT MELANOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/337/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/337/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/337/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/337/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/337/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/337/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/338/term",
"value": "MELANOCYTIC NAEVUS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/338/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/338/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/338/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/338/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/338/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/338/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/338/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/338/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/338/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/339/term",
"value": "MENINGIOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/339/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/339/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/339/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/339/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/339/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/339/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/339/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/339/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/339/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/340/term",
"value": "MENINGIOMA BENIGN"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/340/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/340/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/340/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/340/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/340/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/340/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/341/term",
"value": "METASTASES TO CENTRAL NERVOUS SYSTEM"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/341/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/341/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/341/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/341/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/341/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/341/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/341/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/341/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/342/term",
"value": "NEUROENDOCRINE TUMOUR"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/342/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/342/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/342/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/342/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/342/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/342/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/342/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/342/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/342/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/343/term",
"value": "OVARIAN ADENOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/343/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/343/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/343/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/343/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/343/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/343/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/343/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/343/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/343/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/344/term",
"value": "OVARIAN CANCER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/344/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/344/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/344/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/344/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/344/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/344/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/344/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/344/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/344/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/345/term",
"value": "OVARIAN GERM CELL TERATOMA BENIGN"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/345/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/345/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/345/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/345/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/345/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/345/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/345/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/345/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/346/term",
"value": "OVARIAN NEOPLASM"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/346/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/346/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/346/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/346/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/346/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/346/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/346/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/346/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/346/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/347/term",
"value": "PANCREATIC CARCINOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/347/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/347/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/347/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/347/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/347/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/347/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/347/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/348/term",
"value": "PAPILLARY THYROID CANCER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/348/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/348/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/348/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/348/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/348/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/348/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/348/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/348/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/348/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/348/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/349/term",
"value": "PARATHYROID TUMOUR BENIGN"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/349/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/349/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/349/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/349/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/349/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/349/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/349/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/350/term",
"value": "PLASMA CELL MYELOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/350/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/350/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/350/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/350/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/350/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/350/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/350/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/351/term",
"value": "RECTAL CANCER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/351/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/351/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/351/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/351/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/351/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/351/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/351/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/351/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/351/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/352/term",
"value": "SMALL CELL LUNG CANCER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/352/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/352/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/352/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/352/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/352/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/352/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/352/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/352/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/352/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/353/term",
"value": "SQUAMOUS CELL CARCINOMA OF THE VULVA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/353/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/353/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/353/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/353/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/353/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/353/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/353/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/353/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/354/term",
"value": "SUPERFICIAL SPREADING MELANOMA STAGE UNSPECIFIED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/354/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/354/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/354/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/354/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/354/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/354/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/354/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/355/term",
"value": "THYROID CANCER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/355/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/355/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/355/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/355/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/355/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/355/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/355/stats/3/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/355/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/355/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/355/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/355/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/356/term",
"value": "TRANSITIONAL CELL CARCINOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/356/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/356/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/356/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/356/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/356/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/356/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/356/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/356/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/356/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/357/term",
"value": "UTERINE CANCER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/357/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/357/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/357/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/357/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/357/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/357/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/357/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/358/term",
"value": "UTERINE LEIOMYOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/358/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/358/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/358/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/358/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/358/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/358/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/358/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/358/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/358/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/358/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/358/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/359/term",
"value": "AMYOTROPHIC LATERAL SCLEROSIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/359/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/359/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/359/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/359/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/359/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/359/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/359/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/360/term",
"value": "BRAIN HYPOXIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/360/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/360/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/360/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/360/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/360/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/360/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/360/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/360/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/360/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/361/term",
"value": "CEREBELLAR ATAXIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/361/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/361/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/361/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/361/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/361/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/361/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/361/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/361/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/361/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/362/term",
"value": "CEREBROVASCULAR ACCIDENT"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/362/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/362/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/362/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/362/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/362/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/362/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/362/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/362/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/362/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/362/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/363/term",
"value": "DIZZINESS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/363/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/363/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/363/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/363/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/363/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/363/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/363/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/363/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/363/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/364/term",
"value": "EPILEPSY"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/364/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/364/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/364/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/364/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/364/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/364/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/364/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/364/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/365/term",
"value": "FACIAL PARALYSIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/365/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/365/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/365/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/365/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/365/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/365/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/365/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/365/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/365/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/366/term",
"value": "HEADACHE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/366/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/366/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/366/stats/0/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/366/stats/2/numAffected",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/366/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/366/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/366/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/366/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/366/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/366/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/367/term",
"value": "HYPOTONIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/367/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/367/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/367/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/367/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/367/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/367/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/367/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/367/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/367/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/368/term",
"value": "INTRACRANIAL ANEURYSM"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/368/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/368/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/368/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/368/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/368/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/368/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/368/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/368/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/368/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/369/term",
"value": "MIGRAINE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/369/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/369/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/369/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/369/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/369/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/369/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/369/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/369/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/369/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/370/term",
"value": "MOTOR NEURONE DISEASE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/370/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/370/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/370/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/370/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/370/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/370/stats/4",
"value": {
"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/370/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/370/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/370/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/371/term",
"value": "NEUROPATHY PERIPHERAL"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/371/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/371/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/371/stats/1/numAffected",
"value": 4
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/371/stats/2/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/371/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
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"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/371/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/371/stats/6",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/371/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/372/term",
"value": "PERIPHERAL MOTOR NEUROPATHY"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/372/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/372/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/372/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/372/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/372/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/372/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/372/stats/5",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/373/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/373/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/373/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/373/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/373/stats/4",
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"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/373/stats/5",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/373/stats/6",
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},
{
"op": "add",
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"groupId": "EG007",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/374/term",
"value": "POLYNEUROPATHY"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/374/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/374/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/374/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/374/stats/2/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/374/stats/2/numAtRisk",
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{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/375/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/375/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/375/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/375/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/375/stats/4",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/376/term",
"value": "SEIZURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/376/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/376/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/376/stats/0/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/376/stats/2/numAffected",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/376/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/376/stats/3/numAffected",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/377/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/377/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/377/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/377/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/377/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/377/stats/3/numAffected",
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{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/378/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/378/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/378/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/378/stats/2/numAtRisk",
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},
{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/379/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/379/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/379/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/379/stats/3/numAffected",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/380/term",
"value": "SYNCOPE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/380/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/380/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/380/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/380/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/380/stats/2/numAffected",
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/380/stats/3/numAffected",
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{
"op": "add",
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},
{
"op": "add",
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},
{
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{
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},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/381/stats/2/numAtRisk",
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{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/382/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/382/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/382/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/382/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/382/stats/3/numAffected",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/383/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/383/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/383/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/383/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/383/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/383/stats/2/numAtRisk",
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{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/384/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/384/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/384/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/384/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/384/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/384/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/384/stats/3/numAffected",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/385/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/385/sourceVocabulary",
"value": "MedDRA (24.1)"
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/385/stats/2/numAtRisk",
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},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/385/stats/5",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/386/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/386/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/386/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/386/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/386/stats/2/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/386/stats/2/numAtRisk",
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},
{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/387/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/387/sourceVocabulary",
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/388/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/388/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/388/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/388/stats/0/numAffected",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/388/stats/1/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/388/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/388/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/388/stats/3/numAffected",
"value": 3
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/388/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/388/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/388/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/388/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/389/term",
"value": "INSOMNIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/389/organSystem",
"value": "Psychiatric disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/389/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/389/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/389/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/389/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/389/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/389/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/389/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/389/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/390/term",
"value": "MAJOR DEPRESSION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/390/organSystem",
"value": "Psychiatric disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/390/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/390/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/390/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/390/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/390/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/390/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/390/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/391/term",
"value": "MENTAL DISORDER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/391/organSystem",
"value": "Psychiatric disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/391/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/391/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/391/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/391/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/391/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/391/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/391/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/391/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/392/term",
"value": "RESTLESSNESS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/392/organSystem",
"value": "Psychiatric disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/392/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/392/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/392/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/392/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/392/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/392/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/392/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/392/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/393/term",
"value": "SCHIZOPHRENIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/393/organSystem",
"value": "Psychiatric disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/393/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/393/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/393/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/393/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/393/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/393/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/393/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/393/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/394/term",
"value": "SUICIDE ATTEMPT"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/394/organSystem",
"value": "Psychiatric disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/394/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/394/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/394/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/394/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/394/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/394/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/394/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/394/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/395/term",
"value": "ACUTE KIDNEY INJURY"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/395/organSystem",
"value": "Renal and urinary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/395/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/395/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/395/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/395/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/395/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/395/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/395/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/395/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/396/term",
"value": "CALCULUS URINARY"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/396/organSystem",
"value": "Renal and urinary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/396/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/396/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/396/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/396/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/396/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/396/stats/5",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/396/stats/6",
"value": {
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"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/396/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/397/term",
"value": "NEPHRITIC SYNDROME"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/397/organSystem",
"value": "Renal and urinary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/397/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/397/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/397/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/397/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/397/stats/4",
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"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/397/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/397/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/397/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/398/term",
"value": "NEPHROLITHIASIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/398/organSystem",
"value": "Renal and urinary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/398/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/398/stats/1/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/398/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/398/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/398/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/398/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/398/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/399/term",
"value": "RENAL COLIC"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/399/organSystem",
"value": "Renal and urinary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/399/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/399/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/399/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/399/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/399/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/399/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/399/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/399/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/400/term",
"value": "RENAL FAILURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/400/organSystem",
"value": "Renal and urinary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/400/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/400/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/400/stats/2/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/400/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/400/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/400/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/400/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/400/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/400/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/401/term",
"value": "URETHRAL OBSTRUCTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/401/organSystem",
"value": "Renal and urinary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/401/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/401/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/401/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/401/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/401/stats/4",
"value": {
"groupId": "EG004",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/401/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/401/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/401/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/402/term",
"value": "URINARY BLADDER HAEMORRHAGE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/402/organSystem",
"value": "Renal and urinary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/402/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/402/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/402/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/402/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/402/stats/4",
"value": {
"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/402/stats/5",
"value": {
"groupId": "EG005",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/402/stats/6",
"value": {
"groupId": "EG006",
"numAtRisk": 0
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/402/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/403/term",
"value": "ADENOMYOSIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/403/organSystem",
"value": "Reproductive system and breast disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/403/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/403/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/403/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/403/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/403/stats/4",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/403/stats/5",
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},
{
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"path": "/resultsSection/adverseEventsModule/seriousEvents/403/stats/6",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/403/stats/7",
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"groupId": "EG007",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/404/term",
"value": "BREAST CALCIFICATIONS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/404/organSystem",
"value": "Reproductive system and breast disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/404/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/404/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/404/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/404/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/404/stats/3/numAffected",
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{
"op": "add",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/404/stats/5",
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{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/404/stats/6",
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{
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/405/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/405/organSystem",
"value": "Reproductive system and breast disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/405/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/405/stats/2/numAtRisk",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/405/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/405/stats/5",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/405/stats/6",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/405/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/406/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/406/organSystem",
"value": "Reproductive system and breast disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/406/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/406/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/406/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/406/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/406/stats/4",
"value": {
"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/406/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/406/stats/6",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/406/stats/7",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/407/term",
"value": "BREAST HAEMATOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/407/organSystem",
"value": "Reproductive system and breast disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/407/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/407/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/407/stats/4",
"value": {
"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/407/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/407/stats/6",
"value": {
"groupId": "EG006",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/407/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/408/term",
"value": "BREAST INFLAMMATION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/408/organSystem",
"value": "Reproductive system and breast disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/408/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/408/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/408/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/408/stats/3/numAffected",
"value": 0
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/408/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/408/stats/7",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/409/term",
"value": "BREAST NECROSIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/409/organSystem",
"value": "Reproductive system and breast disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/409/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/409/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/409/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/409/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/409/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/409/stats/6",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/409/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/410/term",
"value": "BREAST SWELLING"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/410/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/410/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/410/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/410/stats/3/numAffected",
"value": 0
},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/410/stats/5",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/410/stats/6",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/411/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/411/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/411/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/411/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/411/stats/2/numAtRisk",
"value": 2056
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{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/412/term",
"value": "INTERMENSTRUAL BLEEDING"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/412/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/412/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/412/stats/2/numAtRisk",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/412/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/412/stats/5",
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}
},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/413/term",
"value": "OVARIAN CYST"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/413/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/413/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/413/stats/1/numAffected",
"value": 4
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/413/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/413/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/413/stats/3/numAffected",
"value": 3
},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/413/stats/5",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/414/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/414/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/414/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/414/stats/2/numAtRisk",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/414/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/414/stats/5",
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}
},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/415/term",
"value": "PELVIC PAIN"
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/415/organSystem",
"value": "Reproductive system and breast disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/415/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/415/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/415/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/415/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/415/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/415/stats/5",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/415/stats/6",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/416/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/416/organSystem",
"value": "Reproductive system and breast disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/416/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/416/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/416/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/416/stats/2/numAtRisk",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/416/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/416/stats/5",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/417/term",
"value": "UTERINE POLYP"
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/417/organSystem",
"value": "Reproductive system and breast disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/417/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/417/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/417/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/417/stats/3/numAffected",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/418/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/418/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/418/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/418/stats/2/numAffected",
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/434/stats/2/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/434/stats/2/numAtRisk",
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{
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"op": "add",
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{
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{
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{
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{
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{
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{
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{
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{
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{
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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},
{
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{
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{
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{
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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"op": "add",
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},
{
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/438/stats/2/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/438/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/438/stats/3/numAffected",
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{
"op": "add",
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},
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},
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"op": "add",
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},
{
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{
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{
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/439/stats/2/numAtRisk",
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{
"op": "add",
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},
{
"op": "add",
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{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
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{
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{
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"path": "/resultsSection/adverseEventsModule/seriousEvents/440/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/440/stats/1/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/440/stats/2/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/440/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/440/stats/3/numAffected",
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{
"op": "add",
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},
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},
{
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{
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{
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{
"op": "replace",
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{
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"op": "add",
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"op": "add",
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{
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{
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{
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{
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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"op": "add",
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},
{
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{
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{
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{
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{
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{
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"path": "/resultsSection/adverseEventsModule/seriousEvents/443/stats/2/numAtRisk",
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"op": "add",
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{
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{
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{
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{
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{
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/444/stats/3/numAffected",
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{
"op": "add",
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{
"op": "add",
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{
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{
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{
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{
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{
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/445/stats/3/numAffected",
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{
"op": "add",
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"op": "add",
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{
"op": "add",
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{
"op": "add",
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{
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/446/stats/3/numAffected",
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{
"op": "add",
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},
{
"op": "add",
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{
"op": "add",
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"op": "add",
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},
{
"op": "replace",
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{
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/447/stats/3/numAffected",
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"op": "add",
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},
{
"op": "add",
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"op": "add",
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},
{
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{
"op": "replace",
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{
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{
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{
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{
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"op": "add",
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"op": "add",
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{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/448/stats/7",
"value": {
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/449/term",
"value": "CUTANEOUS VASCULITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/449/organSystem",
"value": "Skin and subcutaneous tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/449/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/449/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/449/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/449/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/449/stats/4",
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"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/449/stats/5",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/449/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/449/stats/7",
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"groupId": "EG007",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/450/term",
"value": "DERMATITIS ACNEIFORM"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/450/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/450/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/450/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/450/stats/2/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/450/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/450/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/450/stats/4",
"value": {
"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/450/stats/5",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/450/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/450/stats/7",
"value": {
"groupId": "EG007",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/451/term",
"value": "ERYTHEMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/451/organSystem",
"value": "Skin and subcutaneous tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/451/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/451/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/451/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/451/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/451/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/451/stats/4",
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"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/451/stats/5",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/451/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/451/stats/7",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/452/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/452/organSystem",
"value": "Skin and subcutaneous tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/452/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/452/stats/2/numAtRisk",
"value": 2056
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/452/stats/4",
"value": {
"groupId": "EG004",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/452/stats/5",
"value": {
"groupId": "EG005",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/452/stats/6",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/452/stats/7",
"value": {
"groupId": "EG007",
"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/453/term",
"value": "HYPERTROPHIC SCAR"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/453/organSystem",
"value": "Skin and subcutaneous tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/453/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/453/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/453/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/453/stats/3/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/453/stats/4",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/453/stats/5",
"value": {
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/453/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/453/stats/7",
"value": {
"groupId": "EG007",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/454/term",
"value": "NAIL DISORDER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/454/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/454/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/454/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/454/stats/2/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/454/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/454/stats/3/numAffected",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/454/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/454/stats/5",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/454/stats/6",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/454/stats/7",
"value": {
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/455/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/455/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/455/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/455/stats/0/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/455/stats/2/numAtRisk",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/455/stats/3/numAffected",
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},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/455/stats/6",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/456/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/456/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/456/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/456/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/456/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/456/stats/2/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/456/stats/2/numAtRisk",
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},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/456/stats/5",
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}
},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/457/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/457/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/457/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/457/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/457/stats/2/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/457/stats/2/numAtRisk",
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{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/457/stats/5",
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}
},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/458/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/458/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/458/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/458/stats/0/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/458/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/458/stats/2/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/458/stats/2/numAtRisk",
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},
{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/459/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/459/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/459/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/459/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/459/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/459/stats/2/numAtRisk",
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{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/459/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/459/stats/5",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/460/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/460/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/460/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/460/stats/0/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/460/stats/2/numAtRisk",
"value": 2056
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/460/stats/3/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/460/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/460/stats/5",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/460/stats/7",
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"numAtRisk": 0
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/461/term",
"value": "SKIN SWELLING"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/461/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/461/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/461/stats/2/numAtRisk",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/461/stats/4",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/461/stats/5",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/461/stats/6",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/462/term",
"value": "SKIN ULCER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/462/organSystem",
"value": "Skin and subcutaneous tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/462/sourceVocabulary",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/462/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/462/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/462/stats/3/numAffected",
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},
{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/462/stats/6",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/463/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/463/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/463/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/463/stats/2/numAtRisk",
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{
"op": "add",
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}
},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/464/term",
"value": "URTICARIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/464/organSystem",
"value": "Skin and subcutaneous tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/464/sourceVocabulary",
"value": "MedDRA (24.1)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/464/stats/2/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/464/stats/2/numAtRisk",
"value": 2056
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{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/464/stats/5",
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/464/stats/6",
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{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/465/term",
"value": "CIRCULATORY COLLAPSE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/465/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/465/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/465/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/465/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/465/stats/3/numAffected",
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},
{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/465/stats/5",
"value": {
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},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/465/stats/6",
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},
{
"op": "add",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/466/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/466/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/466/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/466/stats/0/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/466/stats/1/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/466/stats/2/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/466/stats/2/numAtRisk",
"value": 2056
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{
"op": "add",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/466/stats/5",
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}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/466/stats/6",
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},
{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/467/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/467/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/467/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/467/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/467/stats/2/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/467/stats/2/numAtRisk",
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{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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}
},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/468/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/468/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/468/stats/0/numAffected",
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/468/stats/2/numAtRisk",
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{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/469/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/469/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/469/sourceVocabulary",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/469/stats/1/numAffected",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/469/stats/2/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/469/stats/2/numAtRisk",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/469/stats/3/numAffected",
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{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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{
"op": "add",
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{
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/470/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/470/sourceVocabulary",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/470/stats/2/numAffected",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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{
"op": "add",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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}
},
{
"op": "add",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/472/stats/3/numAffected",
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{
"op": "add",
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{
"op": "add",
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{
"op": "add",
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"op": "add",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/473/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/473/stats/1/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/473/stats/2/numAffected",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/473/stats/2/numAtRisk",
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{
"op": "add",
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{
"op": "add",
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"op": "add",
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"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/474/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/474/sourceVocabulary",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/474/stats/2/numAtRisk",
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{
"op": "add",
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{
"op": "add",
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{
"op": "add",
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{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/475/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/475/organSystem",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/475/stats/2/numAffected",
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{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/475/stats/3/numAffected",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/476/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/476/sourceVocabulary",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "add",
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{
"op": "add",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/477/organSystem",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/477/sourceVocabulary",
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{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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{
"op": "add",
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{
"op": "add",
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}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/478/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/478/organSystem",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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},
{
"op": "add",
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{
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{
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{
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{
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{
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},
{
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{
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{
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{
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{
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{
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{
"op": "replace",
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