Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2022-06"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/overallStatus",
"value": "TERMINATED"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2022-06-21"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2022-06-28"
},
{
"op": "add",
"path": "/protocolSection/statusModule/whyStopped",
"value": "Sponsor's decision, no safety concerns."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
"value": "Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/description",
"value": "Fulvestrant was administered orally, 500 mg administered as two 250-mg IM injections on Cycle 1 Days 1 and 15 and on Day 1 of each subsequent 28-day cycle"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Clinical Benefit was defined as CR, PR, or SD lasting more than equal to 24 weeks from randomization in participants with measurable disease at baseline, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1.\nPer RECIST v1.1 for target lesions assessed by CT or MRI: CR, Disappearance of all target lesions; PR, PR >= 30% decrease in the sum of diameters of target lesions (TL) taking as reference the baseline sum of diameters; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Disease Progression (PD), PD>= 20% increase in the sum of diameters of TL taking as reference the smallest sum on study(Nadir).\nIn addition to the relative increase of 20% sum must have demonstrate an absolute increase of at least 5mm."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "OR was defined as CR or PR, in participants with measurable disease at baseline as determined by the investigator according to RECIST v1.1."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "Time from first occurrence of a documented objective response to the first documented disease progression or death from any cause, whichever occurs first, until 6 months after the last participant is enrolled in the study (up to approximately 23 months)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "OS was defined as the time from randomization to death due to any cause."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "Randomization to death from any cause, through till the end of the study (up to approximately 32 months)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.\nAn AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.\nPreexisting conditions which worsen during a study were also considered as AEs."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"value": "Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later) up to approximately 32 months"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"value": "Plasma Concentrations of Venetoclax"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"value": "Cycle 1 Day 1: 4 hours (hrs) post-dose; Cycle 2 Day 1: pre-dose (within 1 hr) and 2, 4, 6, 8 hrs post-dose; any time during visits up to study drug discontinuation/Early Termination (up to approximately 32 months)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"value": "Plasma Concentrations of Fulvestrant (in Presence of Venetoclax)"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/description"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
"value": "Cycle 2 Day 1: pre-dose (within 1 hr); Cycle 6 Day 1: pre-dose (within 1 hr); any time during visits up to study drug discontinuation/Early Termination (up to approximately 32 months)"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7",
"value": {
"measure": "Plasma Concentrations of Fulvestrant (in Absence of Venetoclax)",
"timeFrame": "Cycle 2 Day 1: pre-dose (within 1 hr); any time during visits up to study drug discontinuation/Early Termination (up to approximately 32 months)"
}
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>Inclusion Criteria:</p><ul><li>Histological or cytological confirmation of estrogen receptor-positive (ER+) invasive carcinoma of the breast.\nER+, HER2- negative invasive carcinoma of the breast with evaluable sample for BCL-2 IHC value at the time of screening.\nParticipants who were originally diagnosed with HER2-positive breast cancer that converted to HER2-negative MBC are not eligible.</li><li>Evidence of metastatic or locally advanced disease not amenable to surgical or local therapy with curative intent.</li><li>Be postmenopausal or pre- or perimenopausal women amenable to being treated with the luteinizing hormone-releasing hormone (LHRH) agonist goserelin.</li><li>Participants must not have received more than two prior lines of hormonal therapy in the locally advanced or metastatic setting.\nIn addition, at least one line of treatment must be a CDK4/6i AND participants must have experienced disease recurrence or progression during or after CDK4/6i therapy, which must have been administered for a minimum of 8 weeks prior to progression.</li><li>Participants for whom endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at the time of entry into the study, as per national or local treatment guidelines.</li><li>Women of childbearing potential (i.e., not postmenopausal for at least 12 months or surgically sterile) must have had a negative serum pregnancy test result at screening, within 14 days prior to the first study drug administration.</li><li>For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use non-hormonal contraceptive methods with a failure rate of <1% per year during the treatment period and for up to 2 years after the last dose of study drug (or based on the local prescribing information for fulvestrant).\nWomen must refrain from donating eggs during this same period.</li><li>Willing to provide tumor biopsy sample.</li><li>Had at least one measurable lesion via RECIST v1.1.</li><li>Had an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.</li><li>Had adequate organ and marrow function.</li><li>Had a life expectancy > 3 months.</li><li>To full fill the coagulation requirements for patient with or without therapeutic anticoagulation.</li></ul><p>Exclusion criteria:</p><ul><li>Prior treatment with fulvestrant or other selective estrogen receptor degraders (SERDs), venetoclax, or any agent whose mechanism of action is to inhibit BCL-2.</li><li>Pregnant, lactating, or intending to become pregnant during the study.</li><li>Known untreated or active Central Nervous System (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control.</li><li>Prior chemotherapy in the locally advanced or metastatic setting regardless of the duration of the treatment.</li><li>Any anti-cancer therapy received within 21 days of the first dose of study drug, including chemotherapy, radiotherapy, hormonal therapy, immunotherapy, antineoplastic vaccines, or other investigational therapy.\n(Radiotherapy with palliative intent to non-target sites is allowed).</li><li>Concurrent radiotherapy to any site or prior radiotherapy within 21 days of Cycle 1 Day 1 or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response) or prior radiotherapy to > 25% of bone marrow.</li><li>Current severe, uncontrolled, systemic disease (e.g., clinically significant cardiovascular, pulmonary, metabolic or infectious disease.</li><li>Any major surgery within 28 days of the first dose of study drug or anticipation of the need for major surgery during the course of study treatment.</li><li>Consumption of one or more of the following within 3 days prior to the first dose of study drug: Grapefruit or grapefruit products; Seville oranges including marmalade containing Seville oranges; Star fruit (carambola).</li><li>Administration within 7 days prior first dose of study treatment of Steroid therapy for anti-neoplastic intent, Strong or moderate CYP3A inhibitors or Strong or moderate CYP3A inducers.</li><li>Need for current chronic corticosteroid therapy (> 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids).</li><li>Known infection with (human immunodeficiency virus) HIV or human T-cell leukemia virus 1.</li><li>Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day).</li><li>Positive test results for hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody at screening.\nParticipants who were positive for HCV antibody should have been negative for HCV by PCR to be eligible for study participation.\nParticipants with a past or resolved hepatitis B virus (HBV) infection (defined as having a positive total HBcAb and negative hepatitis B surface antigen [HbsAg]) may be included if HBV DNA is undetectable.\nThese participants should have been willing to undergo monthly DNA testing.</li><li>Participants who had a positive HCV antibody test are eligible for the study if a PCR assay is negative for HCV RNA.</li><li>History of other malignancies within the past 5 years except for treated skin basal cell carcinoma, squamous cell carcinoma, non-malignant melanoma <= 1.0 mm without ulceration, localized thyroid cancer, or cervical carcinoma in-situ.</li><li>Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study.</li><li>Cardiopulmonary dysfunction.</li><li>Other medical or psychiatric conditions that, in the opinion of the investigatory, may interfere with the participant's participation in the study.</li><li>Inability or unwillingness to swallow pills or receive intramuscular (IM) injections.</li><li>History of malabsorption syndrome or other condition that would interfere with enteral absorption.</li><li>History of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or active bowel inflammation (e.g., diverticulitis).</li><li>Concurrent hormone replacement therapy.</li><li>Inability to comply with study and follow-up procedures.</li><li>History or active cardiopulmonary dysfunction.</li><li>Known hypersensitivity to any of the study medications (fulvestrant, venetoclax) or to any of the excipients.</li></ul>"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/19/facility",
"value": "Millennium Research & Clinical Development"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/23/city",
"value": "North Melbourne"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/23/zip",
"value": "3051"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/23/geoPoint/lat",
"value": -37.79798
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/23/geoPoint/lon",
"value": 144.94512
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/groups/1/description",
"value": "Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/0/numSubjects",
"value": "25"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/1/numSubjects",
"value": "18"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/type",
"value": "Study Terminated by Sponsor"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/0/numSubjects",
"value": "22"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/1/numSubjects",
"value": "30"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4/type",
"value": "Withdrawal by Subject"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4/reasons/0/numSubjects",
"value": "3"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4/reasons/1/numSubjects",
"value": "2"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/groups/0/description",
"value": "Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/groups/1/description",
"value": "Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/title",
"value": "Ethnicity (NIH/OMB)"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/paramType",
"value": "COUNT_OF_PARTICIPANTS"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/title"
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/title",
"value": "Hispanic or Latino"
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/1",
"value": {
"title": "Not Hispanic or Latino",
"measurements": [
{
"value": "47",
"groupId": "BG000"
},
{
"value": "46",
"groupId": "BG001"
},
{
"value": "93",
"groupId": "BG002"
}
]
}
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/2",
"value": {
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "3",
"groupId": "BG000"
},
{
"value": "3",
"groupId": "BG001"
},
{
"value": "6",
"groupId": "BG002"
}
]
}
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/1"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/1"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/title",
"value": "Race (NIH/OMB)"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/paramType",
"value": "COUNT_OF_PARTICIPANTS"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/0/title"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/0/measurements/0/value",
"value": "0"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/0/measurements/1/value",
"value": "0"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/0/measurements/2/value",
"value": "0"
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/0/title",
"value": "American Indian or Alaska Native"
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/1",
"value": {
"title": "Asian",
"measurements": [
{
"value": "6",
"groupId": "BG000"
},
{
"value": "3",
"groupId": "BG001"
},
{
"value": "9",
"groupId": "BG002"
}
]
}
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/2",
"value": {
"title": "Native Hawaiian or Other Pacific Islander",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/3",
"value": {
"title": "Black or African American",
"measurements": [
{
"value": "3",
"groupId": "BG000"
},
{
"value": "2",
"groupId": "BG001"
},
{
"value": "5",
"groupId": "BG002"
}
]
}
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/4",
"value": {
"title": "White",
"measurements": [
{
"value": "40",
"groupId": "BG000"
},
{
"value": "46",
"groupId": "BG001"
},
{
"value": "86",
"groupId": "BG002"
}
]
}
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/5",
"value": {
"title": "More than one race",
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
}
]
}
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/6",
"value": {
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "2",
"groupId": "BG002"
}
]
}
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/1"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/1"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/1"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/3/classes/1"
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/populationDescription",
"value": "Intent-To-Treat (ITT) population included all randomized participants whether or not they were assigned to the arm where the study treatment was administered."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description",
"value": "Clinical Benefit was defined as CR, PR, or SD lasting more than equal to 24 weeks from randomization in participants with measurable disease at baseline, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1.\nPer RECIST v1.1 for target lesions assessed by CT or MRI: CR, Disappearance of all target lesions; PR, PR >= 30% decrease in the sum of diameters of target lesions (TL) taking as reference the baseline sum of diameters; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Disease Progression (PD), PD>= 20% increase in the sum of diameters of TL taking as reference the smallest sum on study(Nadir).\nIn addition to the relative increase of 20% sum must have demonstrate an absolute increase of at least 5mm."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
"value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/0/description",
"value": "Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/1/description",
"value": "Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
"value": "ITT population included all randomized participants whether or not they were assigned to the arm where the study treatment was administered."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
"value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/description",
"value": "Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/1/description",
"value": "Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
"value": "OR was defined as CR or PR, in participants with measurable disease at baseline as determined by the investigator according to RECIST v1.1."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame",
"value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/0/description",
"value": "Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/1/description",
"value": "Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
"value": "Time from first occurrence of a documented objective response to the first documented disease progression or death from any cause, whichever occurs first, until 6 months after the last participant is enrolled in the study (up to approximately 23 months)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/0/description",
"value": "Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/1/description",
"value": "Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/description",
"value": "OS was defined as the time from randomization to death due to any cause."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reportingStatus",
"value": "POSTED"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/anticipatedPostingDate"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame",
"value": "Randomization to death from any cause, through till the end of the study (up to approximately 32 months)"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denomUnitsSelected"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription",
"value": "ITT population included all randomized participants whether or not they were assigned to the arm where the study treatment was administered."
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/paramType",
"value": "MEDIAN"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/dispersionType",
"value": "95% Confidence Interval"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/unitOfMeasure",
"value": "Months"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups",
"value": [
{
"id": "OG000",
"title": "Venetoclax + Fulvestrant",
"description": "Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"id": "OG001",
"title": "Fulvestrant",
"description": "Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms",
"value": [
{
"units": "Participants",
"counts": [
{
"value": "51",
"groupId": "OG000"
},
{
"value": "52",
"groupId": "OG001"
}
]
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes",
"value": [
{
"categories": [
{
"measurements": [
{
"value": "19.71",
"comment": "Data for upper limit of CI was not estimable due to fewer number of participants with events.",
"groupId": "OG000",
"lowerLimit": "13.73",
"upperLimit": "NA"
},
{
"value": "NA",
"comment": "Data for median and upper limit of CI was not estimable due to fewer number of participants with events",
"groupId": "OG001",
"lowerLimit": "20.93",
"upperLimit": "NA"
}
]
}
]
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/analyses",
"value": [
{
"pValue": "0.0403",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "1.87",
"ciLowerLimit": "1.02",
"ciUpperLimit": "3.43",
"pValueComment": "P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).",
"estimateComment": "Hazard ratios were estimated by Cox regression.",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
]
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description",
"value": "An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.\nAn AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.\nPreexisting conditions which worsen during a study were also considered as AEs."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reportingStatus",
"value": "POSTED"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/anticipatedPostingDate"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame",
"value": "Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later) up to approximately 32 months"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denomUnitsSelected"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/populationDescription",
"value": "Safety-evaluable population which included all participants who received any amount of any component of the investigational or non-investigational study treatments."
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/paramType",
"value": "NUMBER"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/unitOfMeasure",
"value": "Percentage of Participants"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups",
"value": [
{
"id": "OG000",
"title": "Venetoclax + Fulvestrant",
"description": "Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"id": "OG001",
"title": "Fulvestrant",
"description": "Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms",
"value": [
{
"units": "Participants",
"counts": [
{
"value": "50",
"groupId": "OG000"
},
{
"value": "51",
"groupId": "OG001"
}
]
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes",
"value": [
{
"categories": [
{
"measurements": [
{
"value": "94.0",
"groupId": "OG000"
},
{
"value": "76.5",
"groupId": "OG001"
}
]
}
]
}
]
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/title",
"value": "Plasma Concentrations of Venetoclax"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/description"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/reportingStatus",
"value": "POSTED"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/anticipatedPostingDate"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/timeFrame",
"value": "Cycle 1 Day 1: 4 hours (hrs) post-dose; Cycle 2 Day 1: pre-dose (within 1 hr) and 2, 4, 6, 8 hrs post-dose; any time during visits up to study drug discontinuation/Early Termination (up to approximately 32 months)"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denomUnitsSelected"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/populationDescription",
"value": "Pharmacokinetic (PK) evaluable population included all participants who received at least one dose of the study drugs (either venetoclax or fulvestrant) and had evaluable PK data.\nNumber analyzed is the number of participants with data available for analyses at the given time-point."
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/paramType",
"value": "GEOMETRIC_MEAN"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/dispersionType",
"value": "Geometric Coefficient of Variation"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/unitOfMeasure",
"value": "Micrograms per Milliliters (μg/mL)"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups",
"value": [
{
"id": "OG000",
"title": "Venetoclax",
"description": "Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms",
"value": [
{
"units": "Participants",
"counts": [
{
"value": "47",
"groupId": "OG000"
}
]
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes",
"value": [
{
"title": "Cycle 1 Day 1: 4 hrs post-dose",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "47",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "1.78",
"spread": "61.8",
"groupId": "OG000"
}
]
}
]
},
{
"title": "Cycle 2 Day 1: pre-dose",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "40",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "1.04",
"spread": "85.4",
"groupId": "OG000"
}
]
}
]
},
{
"title": "Cycle 2 Day 1: 2 hrs post-dose",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "39",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "1.45",
"spread": "74.1",
"groupId": "OG000"
}
]
}
]
},
{
"title": "Cycle 2 Day 1: 4 hrs post-dose",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "40",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "2.51",
"spread": "57.2",
"groupId": "OG000"
}
]
}
]
},
{
"title": "Cycle 2 Day 1: 6 hrs post-dose",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "35",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "3.32",
"spread": "56.4",
"groupId": "OG000"
}
]
}
]
},
{
"title": "Cycle 2 Day 1: 8 hrs post-dose",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "28",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "3.55",
"spread": "57.8",
"groupId": "OG000"
}
]
}
]
},
{
"title": "Treatment discontinuation visit",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "21",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "0.0112",
"spread": "NA",
"comment": "Data for Geometric Coefficient of Variation was not reportable as more than one-third values were lower than reportable.",
"groupId": "OG000"
}
]
}
]
}
]
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/title",
"value": "Plasma Concentrations of Fulvestrant (in Presence of Venetoclax)"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/description"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/reportingStatus",
"value": "POSTED"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/anticipatedPostingDate"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/timeFrame",
"value": "Cycle 2 Day 1: pre-dose (within 1 hr); Cycle 6 Day 1: pre-dose (within 1 hr); any time during visits up to study drug discontinuation/Early Termination (up to approximately 32 months)"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/denomUnitsSelected"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/populationDescription",
"value": "PK evaluable population included all participants who received at least one dose of the study drugs (either venetoclax or fulvestrant) and had evaluable PK data.\nNumber analyzed is the number of participants with data available for analyses at the given time-point."
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/paramType",
"value": "GEOMETRIC_MEAN"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/dispersionType",
"value": "Geometric Coefficient of Variation"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/unitOfMeasure",
"value": "μg/mL"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/groups",
"value": [
{
"id": "OG000",
"title": "Fulvestrant",
"description": "Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)"
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/denoms",
"value": [
{
"units": "Participants",
"counts": [
{
"value": "42",
"groupId": "OG000"
}
]
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes",
"value": [
{
"title": "Cycle 2 Day 1: pre-dose",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "42",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "0.0129",
"spread": "37.1",
"groupId": "OG000"
}
]
}
]
},
{
"title": "Cycle 6 Day 1: pre-dose",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "7",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "0.0145",
"spread": "31.8",
"groupId": "OG000"
}
]
}
]
},
{
"title": "Treatment discontinuation visit",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "28",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "0.00985",
"spread": "29.1",
"groupId": "OG000"
}
]
}
]
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8",
"value": {
"type": "SECONDARY",
"title": "Plasma Concentrations of Fulvestrant (in Absence of Venetoclax)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "5",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Fulvestrant",
"description": "Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
}
],
"classes": [
{
"title": "Cycle 2 Day 1: pre-dose",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "5",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "0.0103",
"spread": "29.4",
"groupId": "OG000"
}
]
}
]
},
{
"title": "Treatment discontinuation visit",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "0.0139",
"spread": "NA",
"comment": "Data for Geometric Coefficient of Variation was not estimable due to lower number of participants at given timepoint.",
"groupId": "OG000"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "Cycle 2 Day 1: pre-dose (within 1 hr); any time during visits up to study drug discontinuation/Early Termination (up to approximately 32 months)",
"unitOfMeasure": "μg/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "PK evaluable population included all participants who received at least one dose of the study drugs (either venetoclax or fulvestrant) and had evaluable PK data.\nNumber of participants analyzed is the number of participants analyzed for this outcome measure.\nNumber analyzed is the number of participants with data available for analyses at the given time-point."
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/timeFrame",
"value": "Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later) up to approximately 32 months."
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/description",
"value": "<p>The 1 additional death in the Venetoclax + Fulvestrant arm compared to in the Participant Flow section, relates to a participant who had withdrawn consent from the study and later died.\nTheir death was reported in public records (reported as a post study reporting death).</p><p>All-cause mortality is for ITT population and serious and other AEs are reported for safety population.</p>"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/description",
"value": "Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected",
"value": 26
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk",
"value": 51
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/description",
"value": "Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAffected",
"value": 18
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAtRisk",
"value": 52
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/seriousNumAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6",
"value": {
"term": "Bone pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 24.0"
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/0/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/1/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/2/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/3/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/4/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/5/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/6/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/7/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/8/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/8/stats/0/numEvents",
"value": 39
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/8/stats/0/numAffected",
"value": 28
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/9/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/10/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/11/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/12/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/13/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/13/stats/1/numEvents",
"value": 9
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/13/stats/1/numAffected",
"value": 9
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/14/term",
"value": "Injection site reaction"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/14/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/14/stats/0/numEvents",
"value": 15
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/14/stats/0/numAffected",
"value": 11
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/14/stats/1/numEvents",
"value": 21
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/14/stats/1/numAffected",
"value": 15
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/15/term",
"value": "Oedema peripheral"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/15/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/15/stats/0/numEvents",
"value": 6
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/15/stats/0/numAffected",
"value": 4
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/15/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/15/stats/1/numAffected",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/term",
"value": "Hepatic pain"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/organSystem",
"value": "Hepatobiliary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/sourceVocabulary",
"value": "MedDRA 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/stats/0/numEvents",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/stats/0/numAffected",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/stats/1/numAffected",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/17/term",
"value": "Upper respiratory tract infection"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/17/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": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/19/term",
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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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"op": "replace",
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"op": "replace",
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"op": "replace",
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"op": "replace",
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"value": 0
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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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"value": 9
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"op": "replace",
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{
"op": "replace",
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"value": 2
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"op": "replace",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/25/term",
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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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"value": 10
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"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/25/stats/1/numAffected",
"value": 6
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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"value": 3
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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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"value": 1
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{
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"value": 9
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{
"op": "replace",
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"value": 8
},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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"value": 2
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"value": 1
},
{
"op": "replace",
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},
{
"op": "replace",
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},
{
"op": "replace",
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{
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"value": 5
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"op": "replace",
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{
"op": "replace",
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"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/30/term",
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},
{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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"value": 7
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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",
"path": "/resultsSection/adverseEventsModule/otherEvents/33/term",
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},
{
"op": "replace",
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"value": "MedDRA 24.0"
},
{
"op": "replace",
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{
"op": "replace",
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{
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"value": 3
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"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/34/term",
"value": "Pruritus"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/34/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",
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