Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2021-07"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2021-07-20"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2021-08-12"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2021-07-20"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
"value": "Participants were administered Venetoclax 800mg orally once daily (QD) and Fulvestrant 500mg intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
"value": "Participants were administered Fulvestrant 500mg only intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/description",
"value": "Venetoclax was administered orally, 800-mg tablet beginning on Cycle 1 Day 1 until the 9th October 2020."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/description",
"value": "Fulvestrant was administered orally, 500 mg administered as two 250-mg intramuscular (IM) injections on Cycle 1 Days 1 and 15 and on Day 1 of each subsequent 28-day cycle"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Clinical Benefit Defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) Lasting >= 24 Weeks, as Determined by the Investigator According to RECIST v1.1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "Randomization through till 6 months after the last participant is enrolled into the study."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Clinical Benefit was defined as Complete Response, Partial Response, or Stable Disease lasting more than equal to 24 weeks from randomization in participants with measurable disease at baseline, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1.\nPer RECIST v1.1 for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Disease Progression (PD), taking as reference the smallest sum on study."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "PFS was defined as the time from randomization to the first occurrence of disease progression (as determined by the investigator according to RECIST v1.1) or death from any cause, whichever occurs first."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "Randomization through till 6 months after the last participant is enrolled into the study."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "Randomization through till 6 months after the last participant is enrolled into the study."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "OR was defined as Complete Response (CR) or Partial response (PR), in participants with measurable disease at baseline as determined by the investigator according to RECIST v1.1."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "DOR was defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression (as determined by the investigator according to RECIST v1.1) or death from any cause, whichever occurs first."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "Time from first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, until 6 months after the last participant is enrolled into the study."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "Randomization to death from any cause, through till the end of the study (2 years after the last participant is enrolled)."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "Overall Survival (OS) is defined as the time from randomization to death due to any cause.\nData collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"value": "Percentage of Participants With Adverse Events (AEs)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"value": "Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later)."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.\nAn Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.\nPreexisting conditions which worsen during a study are also considered as Adverse Events.\nData collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"value": "Plasma Concentrations of Venetoclax at Specified Timepoints"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"value": "At pre-defined intervals from Cycle 1, Day 1, through till the end of treatment (2 years after the last participant is enrolled)."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"value": "The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received.\nDescriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.\nData collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"value": "Plasma Concentrations of Fulvestrant at Specified Timepoints"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
"value": "The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received.\nDescriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.\nData collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
"value": "At pre-defined intervals from Cycle 1, Day 1, through till the end of treatment (2 years after the last participant is enrolled)."
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "genentech@druginfo.com",
"phone": "800 821-8590",
"title": "Medical Communications",
"organization": "Hoffmann-La Roche"
},
"certainAgreement": {
"otherDetails": "The Study being conducted under this Agreement is part of the Overall Study.\nInvestigator is free to publish in reputable journals or to present at professional conferences the results of the study but only after the first publication or presentation that involves the Overall Study.\nThe Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.",
"restrictionType": "OTHER",
"piSponsorEmployee": false,
"restrictiveAgreement": true
},
"limitationsAndCaveats": {
"description": "Primary and secondary efficacy endpoints have been updated to report 95% confidence interval (CI) for Clinical Benefit estimate and 95% CI for the Cox proportional hazards model for PFS, following reporting conventions."
}
},
"adverseEventsModule": {
"timeFrame": "Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later).",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "The 1 additional death in the Venetoclax + Fulvestrant arm compared to in the Participant Flow section, relates to a participant who had withdrawn consent from the study and later died.\nTheir death was reported in public records (reported as a post study reporting death).",
"eventGroups": [
{
"id": "EG000",
"title": "Venetoclax + Fulvestrant",
"description": "Participants were administered Venetoclax 800mg orally once daily (QD) and Fulvestrant 500mg intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).",
"otherNumAtRisk": 50,
"deathsNumAtRisk": 50,
"otherNumAffected": 45,
"seriousNumAtRisk": 50,
"deathsNumAffected": 19,
"seriousNumAffected": 4
},
{
"id": "EG001",
"title": "Fulvestrant",
"description": "Participants were administered Fulvestrant 500mg only intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).",
"otherNumAtRisk": 51,
"deathsNumAtRisk": 51,
"otherNumAffected": 34,
"seriousNumAtRisk": 51,
"deathsNumAffected": 9,
"seriousNumAffected": 1
}
],
"otherEvents": [
{
"term": "Anaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Leukopenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Lymphopenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 7,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Neutropenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 11,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Abdominal distension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 5,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Abdominal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Abdominal pain upper",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 8,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Diarrhoea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 37,
"numAffected": 27
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 6,
"numAffected": 5
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Dry mouth",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 40,
"numAffected": 32
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 10,
"numAffected": 9
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 23,
"numAffected": 15
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Chest pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 20,
"numAffected": 18
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 8,
"numAffected": 8
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Injection site pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 12,
"numAffected": 9
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Injection site reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 7,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 7,
"numAffected": 6
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Oedema peripheral",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 6,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Hepatic pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Hepatobiliary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Upper respiratory tract infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Injection related reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 9,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Alanine aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Aspartate aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Blood alkaline phosphatase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Blood creatine phosphokinase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Weight decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Decreased appetite",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 9,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 5,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 8,
"numAffected": 6
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Back pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 6,
"numAffected": 5
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Musculoskeletal chest pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 9,
"numAffected": 8
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Pain in extremity",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Dizziness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 5,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 8,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 8,
"numAffected": 8
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Insomnia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 8,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 9,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Dyspnoea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 5,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Pruritus",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 5,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Hot flush",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 9,
"numAffected": 9
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
}
],
"seriousEvents": [
{
"term": "Pyrexia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Lower respiratory tract infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Urosepsis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Ejection fraction decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Flank pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
},
{
"term": "Pleural effusion",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 51,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 23.0"
}
],
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Clinical Benefit Defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) Lasting >= 24 Weeks, as Determined by the Investigator According to RECIST v1.1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "51",
"groupId": "OG000"
},
{
"value": "51",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Venetoclax + Fulvestrant",
"description": "Participants were administered Venetoclax 800mg orally once daily (QD) and Fulvestrant 500mg intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"id": "OG001",
"title": "Fulvestrant",
"description": "Participants were administered Fulvestrant 500mg only intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "11.8",
"groupId": "OG000",
"lowerLimit": "4.44",
"upperLimit": "23.87"
},
{
"value": "13.7",
"groupId": "OG001",
"lowerLimit": "5.70",
"upperLimit": "26.26"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.7286",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Risk Difference (RD)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "-1.96",
"ciLowerLimit": "-16.86",
"ciUpperLimit": "12.94",
"pValueComment": "P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).",
"statisticalMethod": "Cochran-Mantel-Haenszel",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "NUMBER",
"timeFrame": "Randomization through till 6 months after the last participant is enrolled into the study.",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Clinical Benefit was defined as Complete Response, Partial Response, or Stable Disease lasting more than equal to 24 weeks from randomization in participants with measurable disease at baseline, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1.\nPer RECIST v1.1 for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Disease Progression (PD), taking as reference the smallest sum on study.",
"unitOfMeasure": "Percentage of Participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "The Baseline Measurable Disease Population represented all randomized participants with measurable disease at baseline."
},
{
"type": "SECONDARY",
"title": "Progression Free Survival (PFS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "51",
"groupId": "OG000"
},
{
"value": "52",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Venetoclax + Fulvestrant",
"description": "Participants were administered Venetoclax 800mg orally once daily (QD) and Fulvestrant 500mg intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"id": "OG001",
"title": "Fulvestrant",
"description": "Participants were administered Fulvestrant 500mg only intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "2.69",
"groupId": "OG000",
"lowerLimit": "1.94",
"upperLimit": "3.71"
},
{
"value": "1.94",
"groupId": "OG001",
"lowerLimit": "1.84",
"upperLimit": "3.55"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.7853",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.94",
"ciLowerLimit": "0.61",
"ciUpperLimit": "1.45",
"pValueComment": "P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).",
"statisticalMethod": "Regression, Cox",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "Randomization through till 6 months after the last participant is enrolled into the study.",
"description": "PFS was defined as the time from randomization to the first occurrence of disease progression (as determined by the investigator according to RECIST v1.1) or death from any cause, whichever occurs first.",
"unitOfMeasure": "Months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "The Intent-To-Treat (ITT) population was defined as all randomized participants whether or not they were assigned to the arm where the study treatment was administered."
},
{
"type": "SECONDARY",
"title": "Objective Response (OR)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "51",
"groupId": "OG000"
},
{
"value": "51",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Venetoclax + Fulvestrant",
"description": "Participants were administered Venetoclax 800mg orally once daily (QD) and Fulvestrant 500mg intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"id": "OG001",
"title": "Fulvestrant",
"description": "Participants were administered Fulvestrant 500mg only intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "3.9",
"groupId": "OG000",
"lowerLimit": "0.48",
"upperLimit": "13.46"
},
{
"value": "5.9",
"groupId": "OG001",
"lowerLimit": "1.23",
"upperLimit": "16.24"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.5978",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Risk Difference (RD)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "-1.96",
"ciLowerLimit": "-12.29",
"ciUpperLimit": "8.37",
"pValueComment": "P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).",
"statisticalMethod": "Cochran-Mantel-Haenszel",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "NUMBER",
"timeFrame": "Randomization through till 6 months after the last participant is enrolled into the study.",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "OR was defined as Complete Response (CR) or Partial response (PR), in participants with measurable disease at baseline as determined by the investigator according to RECIST v1.1.",
"unitOfMeasure": "Percentage of Participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "The Baseline Measurable Disease Population represented all randomized participants with measurable disease at baseline."
},
{
"type": "SECONDARY",
"title": "Duration of Response (DOR)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2",
"groupId": "OG000"
},
{
"value": "3",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Venetoclax + Fulvestrant",
"description": "Participants were administered Venetoclax 800mg orally once daily (QD) and Fulvestrant 500mg intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"id": "OG001",
"title": "Fulvestrant",
"description": "Participants were administered Fulvestrant 500mg only intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "NA",
"comment": "0 participants had a documented objective response (i.e.\nCR or PR) so Median, Lower and Upper Limit values could not be estimated.",
"groupId": "OG000",
"lowerLimit": "NA",
"upperLimit": "NA"
},
{
"value": "3.61",
"comment": "Insufficient number of participants meant that Upper Limit value could not be estimated.",
"groupId": "OG001",
"lowerLimit": "1.94",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "Time from first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, until 6 months after the last participant is enrolled into the study.",
"description": "DOR was defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression (as determined by the investigator according to RECIST v1.1) or death from any cause, whichever occurs first.",
"unitOfMeasure": "Months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Only participants with a documented objective response were analysed for this Outcome Measure.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The explanation provided is not sufficient to understand why one or more values are not available."
]
}
},
{
"type": "SECONDARY",
"title": "Overall Survival (OS)",
"timeFrame": "Randomization to death from any cause, through till the end of the study (2 years after the last participant is enrolled).",
"description": "Overall Survival (OS) is defined as the time from randomization to death due to any cause.\nData collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.",
"reportingStatus": "NOT_POSTED",
"denomUnitsSelected": "Participants",
"anticipatedPostingDate": "2022-05"
},
{
"type": "SECONDARY",
"title": "Percentage of Participants With Adverse Events (AEs)",
"timeFrame": "Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later).",
"description": "An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.\nAn Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.\nPreexisting conditions which worsen during a study are also considered as Adverse Events.\nData collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.",
"reportingStatus": "NOT_POSTED",
"denomUnitsSelected": "Participants",
"anticipatedPostingDate": "2022-05"
},
{
"type": "SECONDARY",
"title": "Plasma Concentrations of Venetoclax at Specified Timepoints",
"timeFrame": "At pre-defined intervals from Cycle 1, Day 1, through till the end of treatment (2 years after the last participant is enrolled).",
"description": "The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received.\nDescriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.\nData collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.",
"reportingStatus": "NOT_POSTED",
"denomUnitsSelected": "Participants",
"anticipatedPostingDate": "2022-05"
},
{
"type": "SECONDARY",
"title": "Plasma Concentrations of Fulvestrant at Specified Timepoints",
"timeFrame": "At pre-defined intervals from Cycle 1, Day 1, through till the end of treatment (2 years after the last participant is enrolled).",
"description": "The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received.\nDescriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.\nData collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.",
"reportingStatus": "NOT_POSTED",
"denomUnitsSelected": "Participants",
"anticipatedPostingDate": "2022-05"
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Venetoclax + Fulvestrant",
"description": "Participants were administered Venetoclax 800mg orally once daily (QD) and Fulvestrant 500mg intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"id": "FG001",
"title": "Fulvestrant",
"description": "Participants were administered Fulvestrant 500mg only intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "51"
},
{
"groupId": "FG001",
"numSubjects": "52"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "51"
},
{
"groupId": "FG001",
"numSubjects": "52"
}
]
}
],
"dropWithdraws": [
{
"type": "Death",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "18"
},
{
"groupId": "FG001",
"numSubjects": "9"
}
]
},
{
"type": "Lost to Follow-up",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "Physician Decision",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "Withdrawal by Subject",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "3"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "Ongoing in study",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "29"
},
{
"groupId": "FG001",
"numSubjects": "40"
}
]
}
]
}
],
"recruitmentDetails": "The study was conducted at 38 centers in 5 countries.",
"preAssignmentDetails": "A total of 103 participants were randomized in this study.\nOf these, 101 participants received at least one dose of any study drug."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "51",
"groupId": "BG000"
},
{
"value": "52",
"groupId": "BG001"
},
{
"value": "103",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Venetoclax + Fulvestrant",
"description": "Participants were administered Venetoclax 800mg orally once daily (QD) and Fulvestrant 500mg intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"id": "BG001",
"title": "Fulvestrant",
"description": "Participants were administered Fulvestrant 500mg only intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)."
},
{
"id": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "57.4",
"spread": "10.6",
"groupId": "BG000"
},
{
"value": "58.8",
"spread": "11.7",
"groupId": "BG001"
},
{
"value": "58.1",
"spread": "11.1",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "MEAN",
"unitOfMeasure": "years",
"dispersionType": "STANDARD_DEVIATION"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "51",
"groupId": "BG000"
},
{
"value": "52",
"groupId": "BG001"
},
{
"value": "103",
"groupId": "BG002"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race/Ethnicity, Customized",
"classes": [
{
"title": "Hispanic or Latino",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "3",
"groupId": "BG001"
},
{
"value": "4",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Not Hispanic or Latino",
"categories": [
{
"measurements": [
{
"value": "47",
"groupId": "BG000"
},
{
"value": "46",
"groupId": "BG001"
},
{
"value": "93",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Unknown",
"categories": [
{
"measurements": [
{
"value": "3",
"groupId": "BG000"
},
{
"value": "3",
"groupId": "BG001"
},
{
"value": "6",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "Participants"
},
{
"title": "Race/Ethnicity, Customized",
"classes": [
{
"title": "Asian",
"categories": [
{
"measurements": [
{
"value": "6",
"groupId": "BG000"
},
{
"value": "3",
"groupId": "BG001"
},
{
"value": "9",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Black or African American",
"categories": [
{
"measurements": [
{
"value": "3",
"groupId": "BG000"
},
{
"value": "2",
"groupId": "BG001"
},
{
"value": "5",
"groupId": "BG002"
}
]
}
]
},
{
"title": "White",
"categories": [
{
"measurements": [
{
"value": "40",
"groupId": "BG000"
},
{
"value": "46",
"groupId": "BG001"
},
{
"value": "86",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Multiple",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Unknown",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "2",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "Participants"
}
]
}
}
},
{
"op": "add",
"path": "/annotationSection",
"value": {
"annotationModule": {
"unpostedAnnotation": {
"unpostedEvents": [
{
"date": "2021-08-11",
"type": "RESET"
}
],
"unpostedResponsibleParty": "Hoffmann-La Roche"
}
}
}
},
{
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"largeDocs": [
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