Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2022-07"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/overallStatus",
"value": "TERMINATED"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2021-06-29"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2022-07-11"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2022-07-12"
},
{
"op": "add",
"path": "/protocolSection/statusModule/whyStopped",
"value": "The Sponsor discontinued the manufacturing and development of taselisib due to modest clinical benefit and limited tolerability."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1",
"value": {
"measure": "PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis",
"timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)",
"description": "PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression."
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions)."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Overall Survival (OS) at Primary Analysis"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "OS was defined as the time from the date of randomization to the date of death due to any cause."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "OS at Final Analysis"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "OS was defined as the time from the date of randomization to the date of death due to any cause."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "From randomization up to death from any cause (up to approximately 6.2 years)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"value": "Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization.\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"value": "Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"value": "Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization.\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"value": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6",
"value": {
"measure": "Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis",
"timeFrame": "Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)",
"description": "Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nDisease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7",
"value": {
"measure": "Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis",
"timeFrame": "Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)",
"description": "Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nDisease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/8",
"value": {
"measure": "PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis",
"timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)",
"description": "PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/9",
"value": {
"measure": "PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis",
"timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)",
"description": "PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/10",
"value": {
"measure": "Percentage of Participants With Adverse Events at Primary Analysis",
"timeFrame": "From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.",
"description": "An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/11",
"value": {
"measure": "Percentage of Participants With Adverse Events at Final Analysis",
"timeFrame": "From randomization up to approximately 6.2 years",
"description": "An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution."
}
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/groups/0/description",
"value": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/groups/1/description",
"value": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/0/numSubjects",
"value": "100"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/1/numSubjects",
"value": "197"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/0/numSubjects",
"value": "24"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/1/numSubjects",
"value": "37"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/0/numSubjects",
"value": "4"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/1/numSubjects",
"value": "15"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/0/numSubjects",
"value": "85"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/1/numSubjects",
"value": "165"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4/type",
"value": "Study Terminated by Sponsor"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4/reasons/0/numSubjects",
"value": "1"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4/reasons/1/numSubjects",
"value": "3"
},
{
"op": "add",
"path": "/resultsSection/participantFlowModule/preAssignmentDetails",
"value": "The study enrolled postmenopausal women with estrogen receptor-positive and human epidermal receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who had disease recurrence or progression during or after aromatase inhibitor therapy.\nRandomization was stratified by three factors: 1) visceral versus non-visceral disease, 2) sensitivity versus non-sensitivity to most recent endocrine therapy, and 3) geographical region."
},
{
"op": "add",
"path": "/resultsSection/participantFlowModule/recruitmentDetails",
"value": "This study was conducted at 155 centers in 28 countries."
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/2/title",
"value": "Not Stated"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/2/categories/0/measurements/0/value",
"value": "15"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/2/categories/0/measurements/1/value",
"value": "15"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/2/categories/0/measurements/2/value",
"value": "30"
},
{
"op": "add",
"path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/3",
"value": {
"title": "Unknown",
"categories": [
{
"measurements": [
{
"value": "7",
"groupId": "BG000"
},
{
"value": "20",
"groupId": "BG001"
},
{
"value": "27",
"groupId": "BG002"
}
]
}
]
}
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/title",
"value": "Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/type",
"value": "PRIMARY"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/title",
"value": "PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
"value": "PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
"value": "Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/paramType",
"value": "MEDIAN"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/unitOfMeasure",
"value": "months"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
"value": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/0/value",
"value": "176"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/1/value",
"value": "340"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/0/value",
"value": "5.55"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/0/lowerLimit",
"value": "3.75"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/0/upperLimit",
"value": "7.33"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1/value",
"value": "8.05"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1/lowerLimit",
"value": "7.33"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1/upperLimit",
"value": "9.10"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/pValue",
"value": "0.0008"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/statisticalMethod",
"value": "Log Rank"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/paramType",
"value": "Hazard Ratio (HR)"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/paramValue",
"value": "0.71"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/ciPctValue",
"value": "95"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/ciNumSides",
"value": "TWO_SIDED"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/ciLowerLimit",
"value": "0.58"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/ciUpperLimit",
"value": "0.87"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/title",
"value": "Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
"value": "PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions)."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
"value": "Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/paramType",
"value": "NUMBER"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/unitOfMeasure",
"value": "percentage of participants"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame",
"value": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms/0/counts/0/value",
"value": "134"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms/0/counts/1/value",
"value": "264"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/0/value",
"value": "11.9"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/0/lowerLimit",
"value": "7.1"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/0/upperLimit",
"value": "18.3"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/0/comment"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/value",
"value": "28.0"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/lowerLimit",
"value": "22.7"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/upperLimit",
"value": "33.8"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/comment"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/analyses/0/paramType",
"value": "Odds Ratio (OR)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/analyses/0/paramValue",
"value": "3.0"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/analyses/0/ciLowerLimit",
"value": "1.6"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/analyses/0/ciUpperLimit",
"value": "5.4"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/analyses/0/pValue",
"value": "0.0002"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/analyses/0/statisticalMethod",
"value": "Cochran-Mantel-Haenszel"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/title",
"value": "Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description",
"value": "PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions)."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
"value": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/value",
"value": "13.4"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/lowerLimit",
"value": "8.2"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/upperLimit",
"value": "20.2"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/value",
"value": "31.1"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/lowerLimit",
"value": "25.5"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/upperLimit",
"value": "36.8"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/analyses",
"value": [
{
"pValue": "<0.0001",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Odds Ratio (OR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "3.1",
"ciLowerLimit": "1.7",
"ciUpperLimit": "5.4",
"statisticalMethod": "Cochran-Mantel-Haenszel",
"nonInferiorityType": "SUPERIORITY"
}
]
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/title",
"value": "Overall Survival (OS) at Primary Analysis"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/description",
"value": "OS was defined as the time from the date of randomization to the date of death due to any cause."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription",
"value": "Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame",
"value": "From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/0/value",
"value": "176"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/1/value",
"value": "340"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/value",
"value": "23.56"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/lowerLimit",
"value": "18.00"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/value",
"value": "26.81"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/lowerLimit",
"value": "21.29"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/upperLimit",
"value": "NA"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/comment",
"value": "Upper limit of confidence interval was not estimable due to the low number of participants with events."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/analyses/0/paramValue",
"value": "0.85"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/analyses/0/ciLowerLimit",
"value": "0.58"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/analyses/0/ciUpperLimit",
"value": "1.25"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/analyses/0/pValue",
"value": "0.4151"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/analyses/0/statisticalMethod",
"value": "Log Rank"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/title",
"value": "OS at Final Analysis"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description",
"value": "OS was defined as the time from the date of randomization to the date of death due to any cause."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame",
"value": "From randomization up to death from any cause (up to approximately 6.2 years)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/value",
"value": "27.93"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/lowerLimit",
"value": "24.38"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/upperLimit",
"value": "NA"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/comment",
"value": "Upper limit of confidence interval was not estimable due to the low number of participants with events."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/value",
"value": "27.79"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/lowerLimit",
"value": "24.25"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/upperLimit",
"value": "33.35"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/analyses/0/pValue",
"value": "0.9974"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/analyses/0/paramValue",
"value": "1.00"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/analyses/0/ciLowerLimit",
"value": "0.75"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/analyses/0/ciUpperLimit",
"value": "1.33"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/title",
"value": "Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/description",
"value": "Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization.\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/populationDescription",
"value": "Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/timeFrame",
"value": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/0/value",
"value": "134"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/1/value",
"value": "264"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/0/value",
"value": "37.3"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/0/lowerLimit",
"value": "29.1"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/0/upperLimit",
"value": "45.7"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/value",
"value": "51.5"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/lowerLimit",
"value": "45.3"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/upperLimit",
"value": "57.7"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/dispersionType",
"value": "95% Confidence Interval"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/analyses",
"value": [
{
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Odds Ratio (OR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "1.9",
"ciLowerLimit": "1.2",
"ciUpperLimit": "2.9",
"nonInferiorityType": "SUPERIORITY"
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7",
"value": {
"type": "SECONDARY",
"title": "Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "134",
"groupId": "OG000"
},
{
"value": "264",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "45.5",
"groupId": "OG000",
"lowerLimit": "37.2",
"upperLimit": "54.3"
},
{
"value": "59.5",
"groupId": "OG001",
"lowerLimit": "53.6",
"upperLimit": "65.4"
}
]
}
]
}
],
"analyses": [
{
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Odds Ratio (OR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "1.9",
"ciLowerLimit": "1.2",
"ciUpperLimit": "3.0",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)",
"description": "Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization.\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
"unitOfMeasure": "percentage of participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8",
"value": {
"type": "SECONDARY",
"title": "Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "16",
"groupId": "OG000"
},
{
"value": "74",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "7.23",
"comment": "Upper limit of confidence interval was not estimable due to the low number of participants with events.",
"groupId": "OG000",
"lowerLimit": "6.51",
"upperLimit": "NA"
},
{
"value": "8.74",
"groupId": "OG001",
"lowerLimit": "5.72",
"upperLimit": "11.24"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.6708",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.77",
"ciLowerLimit": "0.23",
"ciUpperLimit": "2.59",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)",
"description": "Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nDisease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.\nData are reported for participants with responses."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9",
"value": {
"type": "SECONDARY",
"title": "Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "18",
"groupId": "OG000"
},
{
"value": "82",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "7.39",
"groupId": "OG000",
"lowerLimit": "4.67",
"upperLimit": "23.95"
},
{
"value": "8.97",
"groupId": "OG001",
"lowerLimit": "7.36",
"upperLimit": "12.91"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.8286",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "1.09",
"ciLowerLimit": "0.51",
"ciUpperLimit": "2.35",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)",
"description": "Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nDisease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.\nData are reported for participants with responses."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/10",
"value": {
"type": "SECONDARY",
"title": "PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "176",
"groupId": "OG000"
},
{
"value": "340",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5.39",
"groupId": "OG000",
"lowerLimit": "3.68",
"upperLimit": "9.23"
},
{
"value": "8.97",
"groupId": "OG001",
"lowerLimit": "7.39",
"upperLimit": "9.49"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.0023",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.66",
"ciLowerLimit": "0.51",
"ciUpperLimit": "0.86",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)",
"description": "PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/11",
"value": {
"type": "SECONDARY",
"title": "PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "176",
"groupId": "OG000"
},
{
"value": "340",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5.55",
"groupId": "OG000",
"lowerLimit": "3.68",
"upperLimit": "9.30"
},
{
"value": "9.20",
"groupId": "OG001",
"lowerLimit": "8.15",
"upperLimit": "10.87"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.0095",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.72",
"ciLowerLimit": "0.56",
"ciUpperLimit": "0.92",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)",
"description": "PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/12",
"value": {
"type": "SECONDARY",
"title": "Percentage of Participants With Adverse Events at Primary Analysis",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "213",
"groupId": "OG000"
},
{
"value": "416",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "89.7",
"groupId": "OG000"
},
{
"value": "95.4",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.",
"description": "An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.",
"unitOfMeasure": "percentage of participants",
"reportingStatus": "POSTED",
"populationDescription": "The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/13",
"value": {
"type": "SECONDARY",
"title": "Percentage of Participants With Adverse Events at Final Analysis",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "213",
"groupId": "OG000"
},
{
"value": "416",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "91.1",
"groupId": "OG000"
},
{
"value": "97.1",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization up to approximately 6.2 years",
"description": "An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.",
"unitOfMeasure": "percentage of participants",
"reportingStatus": "POSTED",
"populationDescription": "The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant."
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/timeFrame",
"value": "From randomization up to the end of study, approximately 6.2 years"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/description",
"value": "All-cause mortality was reported based on the ITT population: all randomized participants regardless of whether they received any amount of study treatment.\nSerious and non-serious adverse events were reported based on the safety-evaluable population: all randomized participants who received at least one dose of taselisib, placebo or fulvestrant regardless of the PIK3CA-mutation status of their tumors with participants allocated to the treatment arm associated with the regimen actually received."
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected",
"value": 100
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk",
"value": 214
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected",
"value": 23
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected",
"value": 183
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAffected",
"value": 197
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAtRisk",
"value": 417
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/seriousNumAffected",
"value": 154
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/term",
"value": "ANAEMIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/organSystem",
"value": "Blood and lymphatic system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/term",
"value": "PANCYTOPENIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/organSystem",
"value": "Blood and lymphatic system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/term",
"value": "ATRIAL FIBRILLATION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/organSystem",
"value": "Cardiac disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/term",
"value": "CARDIAC FAILURE CONGESTIVE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/organSystem",
"value": "Cardiac disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/0/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/term",
"value": "MYOCARDIAL INFARCTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/organSystem",
"value": "Cardiac disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/term",
"value": "SUPRAVENTRICULAR TACHYCARDIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/organSystem",
"value": "Cardiac disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/term",
"value": "ABDOMINAL PAIN"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/term",
"value": "ABDOMINAL PAIN UPPER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/7/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/8/term",
"value": "ALCOHOLIC PANCREATITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/8/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/8/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/8/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/term",
"value": "COLITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/stats/1/numAffected",
"value": 16
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/9/stats/1/numEvents",
"value": 17
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/10/term",
"value": "DIARRHOEA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/10/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/10/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/10/stats/1/numAffected",
"value": 37
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/10/stats/1/numEvents",
"value": 40
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/11/term",
"value": "DYSPEPSIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/11/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/11/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/11/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/12/term",
"value": "DYSPHAGIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/12/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/12/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/12/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/13/term",
"value": "ENTERITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/13/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/13/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/13/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/14/term",
"value": "ENTEROCOLITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/14/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/14/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/14/stats/1/numAffected",
"value": 3
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/14/stats/1/numEvents",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/15/term",
"value": "GASTRIC ULCER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/15/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/15/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/15/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/16/term",
"value": "GASTRITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/16/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/16/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/16/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/16/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/17/term",
"value": "NAUSEA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/17/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/17/stats/0/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/17/stats/0/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/17/stats/1/numAffected",
"value": 4
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/17/stats/1/numEvents",
"value": 5
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/18/term",
"value": "OESOPHAGEAL ULCER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/18/organSystem",
"value": "Gastrointestinal disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/18/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/18/stats/0/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/18/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/18/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/18/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/19/term",
"value": "OESOPHAGITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/19/organSystem",
"value": "Gastrointestinal disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/19/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/19/stats/0/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/19/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/19/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/19/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/20/term",
"value": "PANCREATITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/20/organSystem",
"value": "Gastrointestinal disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/20/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/20/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/20/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/20/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/21/term",
"value": "PANCREATITIS ACUTE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/21/organSystem",
"value": "Gastrointestinal disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/21/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/21/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/21/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/22/term",
"value": "SMALL INTESTINAL OBSTRUCTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/22/organSystem",
"value": "Gastrointestinal disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/22/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/22/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/22/stats/1/numEvents",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/23/term",
"value": "STOMATITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/23/organSystem",
"value": "Gastrointestinal disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/23/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/23/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/23/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/23/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/24/term",
"value": "VOMITING"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/24/organSystem",
"value": "Gastrointestinal disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/24/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/24/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/24/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/24/stats/1/numAffected",
"value": 4
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/24/stats/1/numEvents",
"value": 4
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/25/term",
"value": "ASTHENIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/25/organSystem",
"value": "General disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/25/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/25/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/25/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/26/term",
"value": "CHEST DISCOMFORT"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/26/organSystem",
"value": "General disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/26/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/26/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/26/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/26/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/27/term",
"value": "CHEST PAIN"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/27/organSystem",
"value": "General disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/27/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/27/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/27/stats/1/numAffected",
"value": 3
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/27/stats/1/numEvents",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/28/term",
"value": "CHILLS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/28/organSystem",
"value": "General disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/28/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/28/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/28/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/28/stats/1/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/28/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/29/term",
"value": "DEATH"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/29/organSystem",
"value": "General disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/29/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/29/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/29/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/29/stats/1/numAffected",
"value": 3
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/29/stats/1/numEvents",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/30/term",
"value": "FATIGUE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/30/organSystem",
"value": "General disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/30/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/30/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/30/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/30/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/30/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/term",
"value": "MUCOSAL INFLAMMATION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/organSystem",
"value": "General disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/term",
"value": "PAIN"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/organSystem",
"value": "General disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/1/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/term",
"value": "PYREXIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/organSystem",
"value": "General disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/stats/0/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/stats/0/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/stats/1/numAffected",
"value": 3
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/33/stats/1/numEvents",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/34/term",
"value": "SWELLING FACE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/34/organSystem",
"value": "General disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/34/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/34/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/34/stats/1/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/34/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/35/term",
"value": "CHOLECYSTITIS ACUTE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/35/organSystem",
"value": "Hepatobiliary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/35/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/35/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/35/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/36/term",
"value": "CHOLELITHIASIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/36/organSystem",
"value": "Hepatobiliary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/36/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/36/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/36/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/37/term",
"value": "HEPATOTOXICITY"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/37/organSystem",
"value": "Hepatobiliary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/37/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/37/stats/0/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/37/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/37/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/38/term",
"value": "ANAPHYLACTIC SHOCK"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/38/organSystem",
"value": "Immune system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/38/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/38/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/38/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/39/term",
"value": "APPENDICITIS PERFORATED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/39/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/39/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/39/stats/0/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/39/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/39/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/40/term",
"value": "ATYPICAL MYCOBACTERIAL PNEUMONIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/40/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/40/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/40/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/40/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/41/term",
"value": "BRONCHITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/41/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/41/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/41/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/41/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/42/term",
"value": "CELLULITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/42/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/42/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/42/stats/0/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/42/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/42/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/42/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/43/term",
"value": "CHOLERA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/43/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/43/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/43/stats/0/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/43/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/43/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/43/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/44/term",
"value": "CLOSTRIDIUM DIFFICILE COLITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/44/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/44/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/44/stats/0/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/44/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/44/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/44/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/45/term",
"value": "CYSTITIS ESCHERICHIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/45/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/45/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/45/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/45/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/45/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/46/term",
"value": "DIARRHOEA INFECTIOUS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/46/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/46/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/46/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/46/stats/1/numAffected",
"value": 3
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/46/stats/1/numEvents",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/47/term",
"value": "ENTEROCOLITIS INFECTIOUS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/47/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/47/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/47/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/47/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/47/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/48/term",
"value": "GASTROENTERITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/48/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/48/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/48/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/48/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/48/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/49/term",
"value": "GASTROENTERITIS VIRAL"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/49/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/49/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/49/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/49/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/50/term",
"value": "HERPES ZOSTER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/50/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/50/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/50/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/50/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/51/term",
"value": "LOWER RESPIRATORY TRACT INFECTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/51/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/51/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/51/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/51/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/52/term",
"value": "PNEUMONIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/52/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/52/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/52/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/52/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/52/stats/1/numAffected",
"value": 10
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/52/stats/1/numEvents",
"value": 10
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/53/term",
"value": "RESPIRATORY TRACT INFECTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/53/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/53/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/53/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/53/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/54/term",
"value": "SEPSIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/54/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/54/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/54/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/54/stats/1/numAffected",
"value": 5
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/54/stats/1/numEvents",
"value": 5
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/55/term",
"value": "SEPTIC ARTHRITIS STAPHYLOCOCCAL"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/55/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/55/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/55/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/55/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/55/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/56/term",
"value": "SKIN INFECTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/56/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/56/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/56/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/56/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/56/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/57/term",
"value": "URINARY TRACT INFECTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/57/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/57/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/57/stats/0/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/57/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/57/stats/1/numAffected",
"value": 3
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/57/stats/1/numEvents",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/58/term",
"value": "UROSEPSIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/58/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/58/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/58/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/58/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/59/term",
"value": "VIRAL INFECTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/59/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/59/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/59/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/59/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/60/term",
"value": "CLAVICLE FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/60/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/60/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/60/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/60/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/61/term",
"value": "FALL"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/61/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/61/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/61/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/61/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/61/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/62/term",
"value": "FEMORAL NECK FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/62/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/62/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/62/stats/0/numEvents",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/62/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/63/term",
"value": "FEMUR FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/63/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/63/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/63/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/63/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/63/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/64/term",
"value": "HIP FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/64/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/64/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/64/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/64/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/64/stats/1/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/64/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/65/term",
"value": "JOINT DISLOCATION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/65/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/65/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/65/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/65/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/66/term",
"value": "TOXICITY TO VARIOUS AGENTS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/66/organSystem",
"value": "Injury, poisoning and procedural complications"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/66/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/66/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/66/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/67/term",
"value": "WRIST FRACTURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/67/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/67/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/67/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/67/stats/1/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/67/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/68/term",
"value": "ALANINE AMINOTRANSFERASE INCREASED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/68/organSystem",
"value": "Investigations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/68/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/68/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/68/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/68/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/68/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/69/term",
"value": "ASPARTATE AMINOTRANSFERASE INCREASED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/69/organSystem",
"value": "Investigations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/69/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/69/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/69/stats/0/numEvents",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/69/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/70/term",
"value": "WHITE BLOOD CELL COUNT DECREASED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/70/organSystem",
"value": "Investigations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/70/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/70/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/70/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/70/stats/1/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/70/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/71/term",
"value": "DECREASED APPETITE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/71/organSystem",
"value": "Metabolism and nutrition disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/71/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/71/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/71/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/72/term",
"value": "DEHYDRATION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/72/organSystem",
"value": "Metabolism and nutrition disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/72/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/72/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/72/stats/1/numAffected",
"value": 7
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/72/stats/1/numEvents",
"value": 7
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/73/term",
"value": "HYPERGLYCAEMIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/73/organSystem",
"value": "Metabolism and nutrition disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/73/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/73/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/73/stats/1/numAffected",
"value": 7
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/73/stats/1/numEvents",
"value": 7
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/74/term",
"value": "ARTHRALGIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/74/organSystem",
"value": "Musculoskeletal and connective tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/74/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/74/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/74/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/74/stats/1/numEvents",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/75/term",
"value": "BACK PAIN"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/75/organSystem",
"value": "Musculoskeletal and connective tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/75/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/75/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/75/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/76/term",
"value": "COCCYDYNIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/76/organSystem",
"value": "Musculoskeletal and connective tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/76/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/76/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/76/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/77/term",
"value": "MUSCLE SPASMS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/77/organSystem",
"value": "Musculoskeletal and connective tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/77/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/77/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/77/stats/0/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/77/stats/1/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/77/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/78/term",
"value": "MUSCULAR WEAKNESS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/78/organSystem",
"value": "Musculoskeletal and connective tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/78/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/78/stats/0/numEvents",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/78/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/79/term",
"value": "OSTEONECROSIS OF JAW"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/79/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/79/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/79/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/79/stats/1/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/79/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/80/term",
"value": "RHABDOMYOLYSIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/80/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/80/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/80/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/81/term",
"value": "HEPATOCELLULAR CARCINOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/81/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/81/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/81/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/81/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/82/term",
"value": "INTRACRANIAL TUMOUR HAEMORRHAGE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/82/organSystem",
"value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/82/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/82/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/82/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/83/term",
"value": "CEREBRAL HAEMATOMA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/83/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/83/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/83/stats/0/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/83/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/83/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/83/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/84/term",
"value": "CEREBROVASCULAR ACCIDENT"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/84/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/84/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/84/stats/0/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/84/stats/0/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/84/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/84/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/85/term",
"value": "FACIAL PARALYSIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/85/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/85/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/85/stats/0/numEvents",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/85/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/86/term",
"value": "HEADACHE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/86/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/86/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/86/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/86/stats/1/numAffected",
"value": 3
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/86/stats/1/numEvents",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/87/term",
"value": "HYPOAESTHESIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/87/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/87/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/87/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/87/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/87/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/88/term",
"value": "TRANSIENT ISCHAEMIC ATTACK"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/88/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/88/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/88/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/88/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/89/term",
"value": "TRIGEMINAL NEURALGIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/89/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/89/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/89/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/89/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/90/term",
"value": "VITH NERVE PARALYSIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/90/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/90/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/90/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/90/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/90/stats/1/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/90/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/91/term",
"value": "CONFUSIONAL STATE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/91/organSystem",
"value": "Psychiatric disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/91/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/91/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/91/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/92/term",
"value": "MENTAL STATUS CHANGES"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/92/organSystem",
"value": "Psychiatric disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/92/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/92/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/92/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/92/stats/1/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/93/term",
"value": "ACUTE KIDNEY INJURY"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/93/organSystem",
"value": "Renal and urinary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/93/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/93/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/93/stats/1/numAffected",
"value": 4
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/93/stats/1/numEvents",
"value": 4
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/94/term",
"value": "HAEMATURIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/94/organSystem",
"value": "Renal and urinary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/94/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/94/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/94/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/95/term",
"value": "RENAL FAILURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/95/organSystem",
"value": "Renal and urinary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/95/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/95/stats/0/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/95/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/95/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/95/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/96/term",
"value": "URETEROLITHIASIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/96/organSystem",
"value": "Renal and urinary disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/96/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/96/stats/0/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/96/stats/1/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/96/stats/1/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/97/term",
"value": "INTERMENSTRUAL BLEEDING"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/97/organSystem",
"value": "Reproductive system and breast disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/97/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/97/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/97/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/97/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/98/term",
"value": "ACUTE RESPIRATORY DISTRESS SYNDROME"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/98/organSystem",
"value": "Respiratory, thoracic and mediastinal disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/98/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/98/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/98/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/99/term",
"value": "ACUTE RESPIRATORY FAILURE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/99/organSystem",
"value": "Respiratory, thoracic and mediastinal disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/99/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/99/stats/0/numEvents",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/99/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/100/term",
"value": "COUGH"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/100/organSystem",
"value": "Respiratory, thoracic and mediastinal disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/100/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/100/stats/0/numAffected",
"value": 0
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/100/stats/0/numEvents",
"value": 0
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/100/stats/1/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/100/stats/1/numEvents",
"value": 1
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/101/term",
"value": "DYSPNOEA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/101/organSystem",
"value": "Respiratory, thoracic and mediastinal disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/101/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/101/stats/0/numAffected",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/101/stats/0/numEvents",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/101/stats/1/numEvents",
"value": 1
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/102",
"value": {
"term": "INTERSTITIAL LUNG DISEASE",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/103",
"value": {
"term": "PLEURAL EFFUSION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/104",
"value": {
"term": "PLEURITIC PAIN",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/105",
"value": {
"term": "PNEUMONITIS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 10,
"numAffected": 10
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/106",
"value": {
"term": "PNEUMOTHORAX",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/107",
"value": {
"term": "PULMONARY EMBOLISM",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/108",
"value": {
"term": "PULMONARY OEDEMA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/109",
"value": {
"term": "RESPIRATORY FAILURE",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/110",
"value": {
"term": "DRUG ERUPTION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/111",
"value": {
"term": "PRURITUS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/112",
"value": {
"term": "RASH",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/113",
"value": {
"term": "RASH MACULO-PAPULAR",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/114",
"value": {
"term": "TOXIC SKIN ERUPTION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/115",
"value": {
"term": "EMBOLISM",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/116",
"value": {
"term": "EMBOLISM VENOUS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/117",
"value": {
"term": "HYPERTENSION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/118",
"value": {
"term": "SHOCK",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/0/term",
"value": "ANAEMIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/0/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/0/stats/0/numAffected",
"value": 20
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/0/stats/0/numEvents",
"value": 23
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/0/stats/1/numAffected",
"value": 44
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/0/stats/1/numEvents",
"value": 62
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/1/term",
"value": "NEUTROPENIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/1/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/1/stats/0/numAffected",
"value": 9
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/1/stats/0/numEvents",
"value": 12
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/1/stats/1/numAffected",
"value": 28
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/1/stats/1/numEvents",
"value": 39
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/2/term",
"value": "ABDOMINAL PAIN"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/2/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/2/stats/0/numAffected",
"value": 20
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/2/stats/0/numEvents",
"value": 25
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/2/stats/1/numAffected",
"value": 55
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/2/stats/1/numEvents",
"value": 67
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/3/term",
"value": "ABDOMINAL PAIN UPPER"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/3/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/3/stats/0/numAffected",
"value": 8
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/3/stats/0/numEvents",
"value": 8
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/3/stats/1/numAffected",
"value": 31
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/3/stats/1/numEvents",
"value": 35
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/4/term",
"value": "CONSTIPATION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/4/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/4/stats/0/numAffected",
"value": 32
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/4/stats/0/numEvents",
"value": 36
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/4/stats/1/numAffected",
"value": 32
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/4/stats/1/numEvents",
"value": 36
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/5/term",
"value": "DIARRHOEA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/5/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/5/stats/0/numAffected",
"value": 45
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/5/stats/0/numEvents",
"value": 76
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/5/stats/1/numAffected",
"value": 255
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/5/stats/1/numEvents",
"value": 602
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/6/term",
"value": "DRY MOUTH"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/6/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/6/stats/0/numAffected",
"value": 18
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/6/stats/0/numEvents",
"value": 19
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/6/stats/1/numAffected",
"value": 55
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/6/stats/1/numEvents",
"value": 62
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/7/term",
"value": "DYSPEPSIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/7/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/7/stats/0/numAffected",
"value": 5
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/7/stats/0/numEvents",
"value": 5
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/7/stats/1/numAffected",
"value": 32
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/7/stats/1/numEvents",
"value": 51
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/8/term",
"value": "GASTROOESOPHAGEAL REFLUX DISEASE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/8/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/8/stats/0/numAffected",
"value": 4
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/8/stats/0/numEvents",
"value": 4
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/8/stats/1/numAffected",
"value": 23
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/8/stats/1/numEvents",
"value": 25
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/9/term",
"value": "NAUSEA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/9/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/9/stats/0/numAffected",
"value": 54
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/9/stats/0/numEvents",
"value": 71
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/9/stats/1/numAffected",
"value": 154
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/9/stats/1/numEvents",
"value": 233
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/10/term",
"value": "STOMATITIS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/10/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/10/stats/0/numAffected",
"value": 8
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/10/stats/0/numEvents",
"value": 11
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/10/stats/1/numAffected",
"value": 87
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/10/stats/1/numEvents",
"value": 139
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/11/term",
"value": "VOMITING"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/11/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/11/stats/0/numAffected",
"value": 25
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/11/stats/0/numEvents",
"value": 41
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/11/stats/1/numAffected",
"value": 86
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/11/stats/1/numEvents",
"value": 116
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/12/term",
"value": "ASTHENIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/12/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/12/stats/0/numAffected",
"value": 40
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/12/stats/0/numEvents",
"value": 65
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/12/stats/1/numAffected",
"value": 77
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/12/stats/1/numEvents",
"value": 104
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/13/term",
"value": "FATIGUE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/13/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/13/stats/0/numAffected",
"value": 40
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/13/stats/0/numEvents",
"value": 51
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/13/stats/1/numAffected",
"value": 105
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/13/stats/1/numEvents",
"value": 134
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/14/term",
"value": "MUCOSAL INFLAMMATION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/14/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/14/stats/0/numEvents",
"value": 15
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/14/stats/1/numAffected",
"value": 44
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/14/stats/1/numEvents",
"value": 67
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/15/term",
"value": "OEDEMA PERIPHERAL"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/15/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/15/stats/0/numAffected",
"value": 11
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/15/stats/0/numEvents",
"value": 13
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/15/stats/1/numAffected",
"value": 19
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/15/stats/1/numEvents",
"value": 25
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/term",
"value": "PYREXIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/organSystem",
"value": "General disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/stats/0/numAffected",
"value": 9
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/stats/0/numEvents",
"value": 10
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/stats/1/numAffected",
"value": 48
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/16/stats/1/numEvents",
"value": 61
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/17/term",
"value": "UPPER RESPIRATORY TRACT INFECTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/17/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/17/stats/0/numAffected",
"value": 11
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/17/stats/0/numEvents",
"value": 17
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/17/stats/1/numAffected",
"value": 33
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/17/stats/1/numEvents",
"value": 41
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/18/term",
"value": "URINARY TRACT INFECTION"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/18/organSystem",
"value": "Infections and infestations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/18/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/18/stats/0/numAffected",
"value": 9
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/18/stats/0/numEvents",
"value": 10
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/18/stats/1/numAffected",
"value": 38
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/18/stats/1/numEvents",
"value": 50
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/19/term",
"value": "ALANINE AMINOTRANSFERASE INCREASED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/19/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/19/stats/0/numEvents",
"value": 13
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/19/stats/1/numAffected",
"value": 36
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/19/stats/1/numEvents",
"value": 47
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/20/term",
"value": "ASPARTATE AMINOTRANSFERASE INCREASED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/20/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/20/stats/0/numAffected",
"value": 15
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/20/stats/0/numEvents",
"value": 19
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/20/stats/1/numAffected",
"value": 35
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/20/stats/1/numEvents",
"value": 47
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/21/term",
"value": "BLOOD ALKALINE PHOSPHATASE INCREASED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/21/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/21/stats/0/numEvents",
"value": 12
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/21/stats/1/numAffected",
"value": 15
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/21/stats/1/numEvents",
"value": 17
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/22/term",
"value": "BLOOD CREATININE INCREASED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/22/organSystem",
"value": "Investigations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/22/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/22/stats/0/numAffected",
"value": 6
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/22/stats/0/numEvents",
"value": 7
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/22/stats/1/numAffected",
"value": 25
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/22/stats/1/numEvents",
"value": 28
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/23/term",
"value": "WEIGHT DECREASED"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/23/organSystem",
"value": "Investigations"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/23/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/23/stats/0/numAffected",
"value": 6
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/23/stats/0/numEvents",
"value": 6
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/23/stats/1/numAffected",
"value": 42
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/23/stats/1/numEvents",
"value": 50
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/24/term",
"value": "DECREASED APPETITE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/24/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/24/stats/0/numAffected",
"value": 23
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/24/stats/0/numEvents",
"value": 25
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/24/stats/1/numAffected",
"value": 119
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/24/stats/1/numEvents",
"value": 136
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/25/term",
"value": "HYPERGLYCAEMIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/25/organSystem",
"value": "Metabolism and nutrition disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/25/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/25/stats/0/numAffected",
"value": 21
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/25/stats/0/numEvents",
"value": 26
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/25/stats/1/numAffected",
"value": 166
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/25/stats/1/numEvents",
"value": 233
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/26/term",
"value": "HYPOKALAEMIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/26/organSystem",
"value": "Metabolism and nutrition disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/26/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/26/stats/0/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/26/stats/0/numEvents",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/26/stats/1/numAffected",
"value": 31
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/26/stats/1/numEvents",
"value": 37
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/27/term",
"value": "ARTHRALGIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/27/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/27/stats/0/numAffected",
"value": 35
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/27/stats/0/numEvents",
"value": 50
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/27/stats/1/numAffected",
"value": 69
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/27/stats/1/numEvents",
"value": 95
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/28/term",
"value": "BACK PAIN"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/28/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/28/stats/0/numAffected",
"value": 28
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/28/stats/0/numEvents",
"value": 32
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/28/stats/1/numAffected",
"value": 62
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/28/stats/1/numEvents",
"value": 82
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/29/term",
"value": "BONE PAIN"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/29/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/29/stats/0/numAffected",
"value": 17
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/29/stats/0/numEvents",
"value": 19
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/29/stats/1/numAffected",
"value": 24
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/29/stats/1/numEvents",
"value": 26
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/30/term",
"value": "MUSCLE SPASMS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/30/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/30/stats/0/numAffected",
"value": 6
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/30/stats/0/numEvents",
"value": 8
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/30/stats/1/numAffected",
"value": 32
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/30/stats/1/numEvents",
"value": 34
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/31/term",
"value": "MYALGIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/31/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/31/stats/0/numAffected",
"value": 14
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/31/stats/0/numEvents",
"value": 14
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/31/stats/1/numAffected",
"value": 36
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/31/stats/1/numEvents",
"value": 42
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/32/term",
"value": "PAIN IN EXTREMITY"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/32/organSystem",
"value": "Musculoskeletal and connective tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/32/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/32/stats/0/numAffected",
"value": 19
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/32/stats/0/numEvents",
"value": 27
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/32/stats/1/numAffected",
"value": 33
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/32/stats/1/numEvents",
"value": 42
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/33/term",
"value": "DIZZINESS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/33/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/33/stats/0/numEvents",
"value": 23
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/33/stats/1/numAffected",
"value": 46
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/33/stats/1/numEvents",
"value": 58
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/34/term",
"value": "DYSGEUSIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/34/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/34/stats/0/numAffected",
"value": 5
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/34/stats/0/numEvents",
"value": 5
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/34/stats/1/numAffected",
"value": 36
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/34/stats/1/numEvents",
"value": 41
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/35/term",
"value": "HEADACHE"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/35/organSystem",
"value": "Nervous system disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/35/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/35/stats/0/numAffected",
"value": 27
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/35/stats/0/numEvents",
"value": 38
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/35/stats/1/numAffected",
"value": 88
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/35/stats/1/numEvents",
"value": 122
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/36/term",
"value": "INSOMNIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/36/organSystem",
"value": "Psychiatric disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/36/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/36/stats/0/numAffected",
"value": 18
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/36/stats/0/numEvents",
"value": 19
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/36/stats/1/numAffected",
"value": 37
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/36/stats/1/numEvents",
"value": 40
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/37/term",
"value": "COUGH"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/37/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/37/stats/0/numAffected",
"value": 34
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/37/stats/0/numEvents",
"value": 41
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/37/stats/1/numAffected",
"value": 64
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/37/stats/1/numEvents",
"value": 78
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/38/term",
"value": "DYSPNOEA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/38/organSystem",
"value": "Respiratory, thoracic and mediastinal disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/38/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/38/stats/0/numAffected",
"value": 17
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/38/stats/0/numEvents",
"value": 17
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/38/stats/1/numAffected",
"value": 50
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/38/stats/1/numEvents",
"value": 53
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/39/term",
"value": "ALOPECIA"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/39/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/39/stats/0/numAffected",
"value": 6
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/39/stats/0/numEvents",
"value": 6
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/39/stats/1/numAffected",
"value": 50
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/39/stats/1/numEvents",
"value": 53
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/40/term",
"value": "DRY SKIN"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/40/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/40/stats/0/numAffected",
"value": 10
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/40/stats/0/numEvents",
"value": 10
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/40/stats/1/numAffected",
"value": 37
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/40/stats/1/numEvents",
"value": 40
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/41/term",
"value": "PRURITUS"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/41/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/41/stats/0/numAffected",
"value": 18
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/41/stats/0/numEvents",
"value": 28
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/41/stats/1/numAffected",
"value": 52
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/41/stats/1/numEvents",
"value": 75
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/42/term",
"value": "RASH"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/42/organSystem",
"value": "Skin and subcutaneous tissue disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/42/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/42/stats/0/numAffected",
"value": 17
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/42/stats/0/numEvents",
"value": 24
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/42/stats/1/numAffected",
"value": 80
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/42/stats/1/numEvents",
"value": 116
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/43/term",
"value": "HOT FLUSH"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/43/sourceVocabulary",
"value": "MedDRA version 24.0"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/43/stats/0/numAffected",
"value": 27
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/43/stats/0/numEvents",
"value": 27
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/otherEvents/43/stats/1/numAffected",
"value": 24
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/43/stats/1/numEvents",
"value": 26
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/otherEvents/44",
"value": {
"term": "HYPERTENSION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numEvents": 16,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numEvents": 42,
"numAffected": 33
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 24.0"
}
},
{
"op": "replace",
"path": "/resultsSection/moreInfoModule/pointOfContact/email",
"value": "genentech@druginfo.com"
},
{
"op": "replace",
"path": "/resultsSection/moreInfoModule/pointOfContact/phone",
"value": "800 821-8590"
}
]