{"changed_paths":["/protocolSection/statusModule/statusVerifiedDate","/protocolSection/statusModule/lastUpdateSubmitDate","/protocolSection/statusModule/lastUpdatePostDateStruct/date","/protocolSection/statusModule/resultsFirstSubmitDate","/protocolSection/statusModule/resultsFirstSubmitQcDate","/protocolSection/statusModule/resultsFirstPostDateStruct","/protocolSection/armsInterventionsModule/armGroups/0/description","/protocolSection/armsInterventionsModule/armGroups/1/description","/protocolSection/armsInterventionsModule/interventions/0/description","/protocolSection/armsInterventionsModule/interventions/1/description","/protocolSection/armsInterventionsModule/interventions/2/description","/protocolSection/outcomesModule/primaryOutcomes/0/measure","/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/primaryOutcomes/0/description","/protocolSection/outcomesModule/secondaryOutcomes/0/measure","/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/0/description","/protocolSection/outcomesModule/secondaryOutcomes/1/measure","/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/1/description","/protocolSection/outcomesModule/secondaryOutcomes/2/description","/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/3/description","/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/4/description","/protocolSection/outcomesModule/secondaryOutcomes/5/measure","/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/5/description","/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/8/measure","/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/8/description","/protocolSection/outcomesModule/secondaryOutcomes/9/measure","/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/9/description","/protocolSection/eligibilityModule/eligibilityCriteria","/protocolSection/contactsLocationsModule/locations/51","/protocolSection/contactsLocationsModule/locations/52","/protocolSection/contactsLocationsModule/locations/52","/protocolSection/contactsLocationsModule/locations/53","/protocolSection/contactsLocationsModule/locations/54","/protocolSection/contactsLocationsModule/locations/54","/protocolSection/contactsLocationsModule/locations/62/facility","/protocolSection/contactsLocationsModule/locations/62/city","/protocolSection/contactsLocationsModule/locations/62/geoPoint","/protocolSection/contactsLocationsModule/locations/66/facility","/protocolSection/contactsLocationsModule/locations/148/facility","/protocolSection/contactsLocationsModule/locations/151/facility","/protocolSection/contactsLocationsModule/locations/152/facility","/protocolSection/contactsLocationsModule/locations/154/facility","/annotationSection","/hasResults","/resultsSection","/documentSection"],"citation_text":"TrialDiff Evidence Record evt_NCT02340221_v45_v46_5cd1295c7ea3. ClinicalTrials.gov NCT02340221, versions 45-46. Evidence version 1.","claims_not_supported":["That the amendment was scientifically unjustified.","That the change constitutes misconduct or wrongdoing.","That sponsor intent can be inferred from this registry change.","That the change caused or altered the trial's results.","That the change was or was not disclosed in a manuscript.","That TrialDiff determines regulatory compliance or non-compliance.","That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.","That event-class membership is a validated global review-priority ranking."],"claims_supported":["TrialDiff compared ClinicalTrials.gov record version 45 to version 46 for NCT02340221.","The JSON Patch for this comparison has hash 16f65020f8080602797bdd8a1baa634a07ba08c7505d42410585a22c807c49a3.","The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.","The deterministic triage label was high; before timing adjustment it was high.","The triage label is uncalibrated metadata, not a validated review-priority finding.","The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.","A registry field under an arm or intervention module changed between ClinicalTrials.gov versions 45 and 46.","The timing context for the from-version record was late_recruitment.","The deterministic rules that fired were: arms_or_interventions_change, eligibility_criteria_change.","The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/armsInterventionsModule/armGroups/0/description, /protocolSection/armsInterventionsModule/armGroups/1/description, /protocolSection/armsInterventionsModule/interventions/0/description, /protocolSection/armsInterventionsModule/interventions/1/description, /protocolSection/armsInterventionsModule/interventions/2/description, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/8/measure, /protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/8/description, /protocolSection/outcomesModule/secondaryOutcomes/9/measure, /protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/9/description, /protocolSection/eligibilityModule/eligibilityCriteria, /protocolSection/contactsLocationsModule/locations/51, /protocolSection/contactsLocationsModule/locations/52, /protocolSection/contactsLocationsModule/locations/52, /protocolSection/contactsLocationsModule/locations/53, /protocolSection/contactsLocationsModule/locations/54, /protocolSection/contactsLocationsModule/locations/54, /protocolSection/contactsLocationsModule/locations/62/facility, /protocolSection/contactsLocationsModule/locations/62/city, /protocolSection/contactsLocationsModule/locations/62/geoPoint, /protocolSection/contactsLocationsModule/locations/66/facility, /protocolSection/contactsLocationsModule/locations/148/facility, /protocolSection/contactsLocationsModule/locations/151/facility, /protocolSection/contactsLocationsModule/locations/152/facility, /protocolSection/contactsLocationsModule/locations/154/facility, /annotationSection, /hasResults, /resultsSection, /documentSection.","An outcome path changed between versions 45 and 46 in a patch that also carried a hasResults or resultsSection co-occurrence signal."],"classification":{"calibration_status":"uncalibrated","categories":["arm_intervention_change","eligibility_change","results_reconciliation"],"category":"arm_intervention_change","deterministic_rules":["arms_or_interventions_change","eligibility_criteria_change"],"event_class_rule_set_hash":"07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0","event_classes":["outcome_edit_cooccurs_with_results_posting"],"rule_set_hash":"318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86","severity":"high","severity_pre_timing":"high","timing_context":"late_recruitment","triage_label":"high","triage_rule_set_hash":"af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b","value_signals":[{"category":"results_reconciliation","paths":["/protocolSection/outcomesModule/primaryOutcomes/0/description","/protocolSection/outcomesModule/primaryOutcomes/0/measure","/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/0/description","/protocolSection/outcomesModule/secondaryOutcomes/0/measure","/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/1/description","/protocolSection/outcomesModule/secondaryOutcomes/1/measure","/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/2/description","/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/3/description","/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/4/description","/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/5/description","/protocolSection/outcomesModule/secondaryOutcomes/5/measure","/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/8/description","/protocolSection/outcomesModule/secondaryOutcomes/8/measure","/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/9/description","/protocolSection/outcomesModule/secondaryOutcomes/9/measure","/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame"],"severity":"low","signal":"results_reconciliation_outcome_suppression"}]},"event_id":"evt_NCT02340221_v45_v46_5cd1295c7ea3","evidence_version":1,"patch":[{"op":"replace","path":"/protocolSection/statusModule/statusVerifiedDate","value":"2019-01"},{"op":"replace","path":"/protocolSection/statusModule/lastUpdateSubmitDate","value":"2019-01-22"},{"op":"replace","path":"/protocolSection/statusModule/lastUpdatePostDateStruct/date","value":"2019-01-25"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstSubmitDate","value":"2018-12-18"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstSubmitQcDate","value":"2019-01-22"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstPostDateStruct","value":{"date":"2019-01-25","type":"ACTUAL"}},{"op":"replace","path":"/protocolSection/armsInterventionsModule/armGroups/0/description","value":"Participants received taselisib 4 milligrams (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":"/protocolSection/armsInterventionsModule/armGroups/1/description","value":"Participants received placebo taken orally once daily (QD) beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by intramuscular (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":"/protocolSection/armsInterventionsModule/interventions/0/description","value":"Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm."},{"op":"replace","path":"/protocolSection/armsInterventionsModule/interventions/1/description","value":"Placebo matching to taselisib was administered as per the schedule specified in the respective arm."},{"op":"replace","path":"/protocolSection/armsInterventionsModule/interventions/2/description","value":"Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms."},{"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)"},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/0/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":"add","path":"/protocolSection/outcomesModule/primaryOutcomes/0/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 millimeters (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"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/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":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/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/measure","value":"Overall Survival (OS)"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame","value":"From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)"},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/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/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/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":"/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame","value":"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)"},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/3/description","value":"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":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/4/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":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/4/description","value":"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":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/5/measure","value":"Percentage of Participants With Adverse Events"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame","value":"From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years."},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/5/description","value":"An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame","value":"1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days)"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/8/measure","value":"Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame","value":"Baseline, C2D1 up to C7D1 (each cycle=28 days)"},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/8/description","value":"The EORTC QLQ-C30 consists of 30 questions that comprise aspects of participant's functioning assessment (physical, emotional, role, cognitive, and social); symptom scales (fatigue; nausea, vomiting, and pain; the global health/quality of life [QoL]); and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), within a recall period of "the past week."\nMost questions used a 4-point scale (1=Not at all to 4=Very much; two questions used a 7-point scale (1=Very poor to 7=Excellent).\nScores were averaged and transformed to a 0-100 scale; a higher score for Global Qol/functional scales=better level of functioning; a higher score for symptom scale=greater degree of symptoms."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/9/measure","value":"Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame","value":"Baseline, C2D1 up to C7D1 (each cycle=28 days)"},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/9/description","value":"EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms).\nQuestions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much).\nScores were averaged and transformed to a 0-100 scale.\nHigher scores for the functional scales indicated a higher/better level of functioning/healthy functioning.\nHigher scores for the symptom scales indicated worse symptoms."},{"op":"replace","path":"/protocolSection/eligibilityModule/eligibilityCriteria","value":"
Inclusion Criteria:
Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen receptor (ER) positive breast cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participants for whom endocrine therapy (example [e.g.], fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer
Radiologic/objective evidence of breast cancer recurrence or progression while on or within 12 months of the end of adjuvant treatment with an aromatase inhibitor (AI), or progression while on or within 1 month of the end of prior AI treatment for locally advanced or metastatic breast cancer
Measurable disease via Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) or non-measurable, evaluable disease with at least one evaluable bone lesion via RECIST v1.1
Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutation testing
A valid cobas PIK3CA mutation result by central testing is required
Adequate hematologic and end-organ function within 28 days prior to treatment initiation
Exclusion Criteria:
Human epidermal growth factor receptor 2 (HER2)-positive disease by local laboratory testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization positive)
Prior treatment with fulvestrant
Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian target of rapamycin (mTOR) inhibitor (e.g.\neverolimus), or protein kinase B (AKT) inhibitor
Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1
Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1
All acute treatment-related toxicity must have resolved to Grade less than or equal to (</=) 1 or be deemed stable by the Investigator
Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic breast cancer
Concurrent hormone replacement therapy
Known untreated or active central nervous system (CNS) metastases
Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications
History of inflammatory bowel disease or active bowel inflammation
Clinically significant cardiac or pulmonary dysfunction
Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B or C virus
"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/51"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/52"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/52"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/53"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/54"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/54"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/62/facility","value":"KYS S\u00e4desairaala; Sy\u00f6p\u00e4tautien poliklinikka"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/62/city","value":"Kuopio"},{"op":"add","path":"/protocolSection/contactsLocationsModule/locations/62/geoPoint","value":{"lat":62.89238,"lon":27.67703}},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/66/facility","value":"Centre Georges Fran\u00e7ois Leclerc; Service Pharmacie, Bp 77980"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/148/facility","value":"National Cancer Center; Neurology"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/151/facility","value":"Severance Hospital, Yonsei University Health System; Pharmacy"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/152/facility","value":"Asan Medical Center - Oncology"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/154/facility","value":"Samsung Medical Center - Neurology"},{"op":"remove","path":"/annotationSection"},{"op":"replace","path":"/hasResults","value":true},{"op":"add","path":"/resultsSection","value":{"adverseEventsModule":{"description":"The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant regardless of the PIK3CA-mutation status of their tumors and separately for the subgroups of participants with and without detectable PIK3CA-mutant tumors, with participants allocated to the treatment arm associated with the regimen actually received.","eventGroups":[{"deathsNumAffected":57,"deathsNumAtRisk":213,"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":"EG000","otherNumAffected":190,"otherNumAtRisk":213,"seriousNumAffected":19,"seriousNumAtRisk":213,"title":"Placebo+Fulvestrant"},{"deathsNumAffected":101,"deathsNumAtRisk":416,"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.","id":"EG001","otherNumAffected":396,"otherNumAtRisk":416,"seriousNumAffected":133,"seriousNumAtRisk":416,"title":"Taselisib+Fulvestrant"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":213},{"groupId":"EG001","numAffected":34,"numAtRisk":416}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":213},{"groupId":"EG001","numAffected":27,"numAtRisk":416}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":213},{"groupId":"EG001","numAffected":235,"numAtRisk":416}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":213},{"groupId":"EG001","numAffected":140,"numAtRisk":416}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":213},{"groupId":"EG001","numAffected":76,"numAtRisk":416}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":213},{"groupId":"EG001","numAffected":82,"numAtRisk":416}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":213},{"groupId":"EG001","numAffected":51,"numAtRisk":416}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":213},{"groupId":"EG001","numAffected":51,"numAtRisk":416}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":213},{"groupId":"EG001","numAffected":28,"numAtRisk":416}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":213},{"groupId":"EG001","numAffected":31,"numAtRisk":416}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":213},{"groupId":"EG001","numAffected":23,"numAtRisk":416}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":213},{"groupId":"EG001","numAffected":21,"numAtRisk":416}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":213},{"groupId":"EG001","numAffected":100,"numAtRisk":416}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":213},{"groupId":"EG001","numAffected":76,"numAtRisk":416}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":213},{"groupId":"EG001","numAffected":43,"numAtRisk":416}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":213},{"groupId":"EG001","numAffected":41,"numAtRisk":416}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":213},{"groupId":"EG001","numAffected":34,"numAtRisk":416}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":213},{"groupId":"EG001","numAffected":23,"numAtRisk":416}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":213},{"groupId":"EG001","numAffected":30,"numAtRisk":416}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":213},{"groupId":"EG001","numAffected":31,"numAtRisk":416}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":213},{"groupId":"EG001","numAffected":34,"numAtRisk":416}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":213},{"groupId":"EG001","numAffected":10,"numAtRisk":416}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":213},{"groupId":"EG001","numAffected":157,"numAtRisk":416}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":213},{"groupId":"EG001","numAffected":109,"numAtRisk":416}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":213},{"groupId":"EG001","numAffected":24,"numAtRisk":416}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":213},{"groupId":"EG001","numAffected":53,"numAtRisk":416}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":213},{"groupId":"EG001","numAffected":47,"numAtRisk":416}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":213},{"groupId":"EG001","numAffected":34,"numAtRisk":416}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":213},{"groupId":"EG001","numAffected":33,"numAtRisk":416}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":213},{"groupId":"EG001","numAffected":25,"numAtRisk":416}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":213},{"groupId":"EG001","numAffected":19,"numAtRisk":416}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":213},{"groupId":"EG001","numAffected":30,"numAtRisk":416}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":213},{"groupId":"EG001","numAffected":83,"numAtRisk":416}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":213},{"groupId":"EG001","numAffected":41,"numAtRisk":416}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":213},{"groupId":"EG001","numAffected":40,"numAtRisk":416}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":213},{"groupId":"EG001","numAffected":33,"numAtRisk":416}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":213},{"groupId":"EG001","numAffected":53,"numAtRisk":416}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":213},{"groupId":"EG001","numAffected":42,"numAtRisk":416}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":213},{"groupId":"EG001","numAffected":74,"numAtRisk":416}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":213},{"groupId":"EG001","numAffected":45,"numAtRisk":416}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":213},{"groupId":"EG001","numAffected":47,"numAtRisk":416}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":213},{"groupId":"EG001","numAffected":32,"numAtRisk":416}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":213},{"groupId":"EG001","numAffected":22,"numAtRisk":416}],"term":"Hot flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":213},{"groupId":"EG001","numAffected":28,"numAtRisk":416}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":32,"numAtRisk":416}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":14,"numAtRisk":416}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":4,"numAtRisk":416}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":3,"numAtRisk":416}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":2,"numAtRisk":416}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":2,"numAtRisk":416}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":2,"numAtRisk":416}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Alcoholic pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Gastric ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Gastroduodenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Oesophageal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":9,"numAtRisk":416}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":5,"numAtRisk":416}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":3,"numAtRisk":416}],"term":"Diarrhoea infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":2,"numAtRisk":416}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":2,"numAtRisk":416}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Appendicitis perforated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Atypical mycobacterial pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Cystitis escherichia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":9,"numAtRisk":416}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":0,"numAtRisk":416}],"term":"Pleuritic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":0,"numAtRisk":416}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":6,"numAtRisk":416}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":6,"numAtRisk":416}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":3,"numAtRisk":416}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":2,"numAtRisk":416}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":0,"numAtRisk":416}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":3,"numAtRisk":416}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Cerebral haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Trigeminal neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":0,"numAtRisk":416}],"term":"Facial paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":0,"numAtRisk":416}],"term":"VIth nerve paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":2,"numAtRisk":416}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Clavicle fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Joint dislocation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Toxicity to various agents"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":0,"numAtRisk":416}],"term":"Wrist fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Rash generalised"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Toxic skin eruption"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":0,"numAtRisk":416}],"term":"Swelling face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Coccydynia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Rhabdomyolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":0,"numAtRisk":416}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":0,"numAtRisk":416}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":0,"numAtRisk":416}],"term":"Osteonecrosis of jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":2,"numAtRisk":416}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Embolism venous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Hepatotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":2,"numAtRisk":416}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":2,"numAtRisk":416}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":213},{"groupId":"EG001","numAffected":0,"numAtRisk":416}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":213},{"groupId":"EG001","numAffected":1,"numAtRisk":416}],"term":"Intracranial tumour haemorrhage"}],"timeFrame":"From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years"},"baselineCharacteristicsModule":{"denoms":[{"counts":[{"groupId":"BG000","value":"214"},{"groupId":"BG001","value":"417"},{"groupId":"BG002","value":"631"}],"units":"Participants"}],"groups":[{"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":"BG000","title":"Placebo+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.","id":"BG001","title":"Taselisib+Fulvestrant"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"10.0","value":"60.7"},{"groupId":"BG001","spread":"9.9","value":"60.1"},{"groupId":"BG002","spread":"9.9","value":"60.3"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"214"},{"groupId":"BG001","value":"417"},{"groupId":"BG002","value":"631"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"166"},{"groupId":"BG001","value":"334"},{"groupId":"BG002","value":"500"}]}],"title":"Not Hispanic or Latino"},{"categories":[{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"48"},{"groupId":"BG002","value":"74"}]}],"title":"Hispanic or Latino"},{"categories":[{"measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"57"}]}],"title":"Unknown"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"147"},{"groupId":"BG001","value":"285"},{"groupId":"BG002","value":"432"}]}],"title":"White"},{"categories":[{"measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"110"}]}],"title":"Asian"},{"categories":[{"measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"44"}]}],"title":"Unknown"},{"categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"37"}]}],"title":"American Indian or Alaska Native"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]}],"title":"Black or African American"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"}]}],"title":"Native Hawaiian or Other Pacific Islander"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}],"title":"Multiple"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"}],"populationDescription":"The intent-to-treat (ITT) population included all randomized participants regardless of whether they received any amount of study treatment."},"moreInfoModule":{"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.","piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true},"pointOfContact":{"email":"global.trial_information@roche.com","organization":"Hoffmann-La Roche","phone":"(+41) 616878333","title":"Medical Communications"}},"outcomeMeasuresModule":{"outcomeMeasures":[{"analyses":[{"ciLowerLimit":"0.56","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.89","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0037","paramType":"Hazard Ratio (HR)","paramValue":"0.70","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.68","upperLimit":"7.29","value":"5.39"},{"groupId":"OG001","lowerLimit":"7.26","upperLimit":"9.07","value":"7.43"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"340"}],"units":"Participants"}],"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 millimeters (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.","dispersionType":"95% Confidence Interval","groups":[{"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":"OG000","title":"Placebo+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.","id":"OG001","title":"Taselisib+Fulvestrant"}],"paramType":"MEDIAN","populationDescription":"Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.","reportingStatus":"POSTED","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)","title":"Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)","type":"PRIMARY","unitOfMeasure":"months"},{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0002","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.1","upperLimit":"18.3","value":"11.9"},{"groupId":"OG001","lowerLimit":"22.7","upperLimit":"33.8","value":"28.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"264"}],"units":"Participants"}],"description":"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).","dispersionType":"95% Confidence Interval","groups":[{"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":"OG000","title":"Placebo+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.","id":"OG001","title":"Taselisib+Fulvestrant"}],"paramType":"NUMBER","populationDescription":"Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.","reportingStatus":"POSTED","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)","title":"Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1","type":"SECONDARY","unitOfMeasure":"percentage of participants"},{"analyses":[{"ciLowerLimit":"0.58","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.25","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.85"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper limit of confidence interval was not estimable due to the low number of participants with events.","groupId":"OG000","lowerLimit":"18.00","upperLimit":"NA","value":"23.56"},{"comment":"Upper limit of confidence interval was not estimable due to the low number of participants with events.","groupId":"OG001","lowerLimit":"21.29","upperLimit":"NA","value":"26.81"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"340"}],"units":"Participants"}],"description":"OS was defined as the time from the date of randomization to the date of death due to any cause.","dispersionType":"95% Confidence Interval","groups":[{"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":"OG000","title":"Placebo+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.","id":"OG001","title":"Taselisib+Fulvestrant"}],"paramType":"MEDIAN","populationDescription":"Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.","reportingStatus":"POSTED","timeFrame":"From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"months"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"29.1","upperLimit":"45.7","value":"37.3"},{"groupId":"OG001","lowerLimit":"45.3","upperLimit":"57.7","value":"51.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"264"}],"units":"Participants"}],"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.","dispersionType":"95% Confidence Interval","groups":[{"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":"OG000","title":"Placebo+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.","id":"OG001","title":"Taselisib+Fulvestrant"}],"paramType":"NUMBER","populationDescription":"Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.","reportingStatus":"POSTED","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)","title":"Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1","type":"SECONDARY","unitOfMeasure":"percentage of participants"},{"analyses":[{"ciLowerLimit":"0.23","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.59","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.77"}],"classes":[{"categories":[{"measurements":[{"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":"7.23"},{"groupId":"OG001","lowerLimit":"5.72","upperLimit":"11.24","value":"8.74"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"74"}],"units":"Participants"}],"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.","dispersionType":"95% Confidence Interval","groups":[{"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":"OG000","title":"Placebo+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.","id":"OG001","title":"Taselisib+Fulvestrant"}],"paramType":"MEDIAN","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.","reportingStatus":"POSTED","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)","title":"Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1","type":"SECONDARY","unitOfMeasure":"months"},{"analyses":[{"ciLowerLimit":"0.51","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.86","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0023","paramType":"Hazard Ratio (HR)","paramValue":"0.66","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.68","upperLimit":"9.23","value":"5.39"},{"groupId":"OG001","lowerLimit":"7.39","upperLimit":"9.49","value":"8.97"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"340"}],"units":"Participants"}],"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.","dispersionType":"95% Confidence Interval","groups":[{"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":"OG000","title":"Placebo+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.","id":"OG001","title":"Taselisib+Fulvestrant"}],"paramType":"MEDIAN","populationDescription":"Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.","reportingStatus":"POSTED","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)","title":"PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1","type":"SECONDARY","unitOfMeasure":"months"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"89.7"},{"groupId":"OG001","value":"95.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"213"},{"groupId":"OG001","value":"416"}],"units":"Participants"}],"description":"An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.","groups":[{"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":"OG000","title":"Placebo+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.","id":"OG001","title":"Taselisib+Fulvestrant"}],"paramType":"NUMBER","populationDescription":"The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant.","reportingStatus":"POSTED","timeFrame":"From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.","title":"Percentage of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"percentage of participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.6","value":"18.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"417"}],"units":"Participants"}],"title":"C1D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"35.2","value":"66.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"359"}],"units":"Participants"}],"title":"C2D1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"417"}],"units":"Participants"}],"dispersionType":"Standard Deviation","groups":[{"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.","id":"OG000","title":"Taselisib+Fulvestrant"}],"paramType":"MEAN","populationDescription":"The Pharmacokinetic (PK) population included all participants who received at least one dose of taselisib and provided valid (adequately documented dose time and PK sample time) PK assessments.","reportingStatus":"POSTED","timeFrame":"1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days)","title":"Maximum Observed Plasma Concentration (Cmax) of Taselisib","type":"SECONDARY","unitOfMeasure":"ng/mL"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.6","value":"42.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"377"}],"units":"Participants"}],"title":"C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"31.5","value":"35.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"213"}],"units":"Participants"}],"title":"C6D1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"417"}],"units":"Participants"}],"dispersionType":"Standard Deviation","groups":[{"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.","id":"OG000","title":"Taselisib+Fulvestrant"}],"paramType":"MEAN","populationDescription":"The PK population included all participants who received at least one dose of taselisib and provided valid (adequately documented dose time and PK sample time) PK assessments.","reportingStatus":"POSTED","timeFrame":"1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days)","title":"Minimum Observed Plasma Concentration (Cmin) of Taselisib","type":"SECONDARY","unitOfMeasure":"ng/mL"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.9","value":"15.9"},{"groupId":"OG001","spread":"23.3","value":"15.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"312"}],"units":"Participants"}],"title":"Appetite Loss: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.7","value":"-0.2"},{"groupId":"OG001","spread":"26.2","value":"6.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"292"}],"units":"Participants"}],"title":"Appetite Loss: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.2","value":"-4.3"},{"groupId":"OG001","spread":"28.1","value":"8.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"title":"Appetite Loss: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.1","value":"-1.7"},{"groupId":"OG001","spread":"28.1","value":"8.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Appetite Loss: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.6","value":"-0.4"},{"groupId":"OG001","spread":"27.2","value":"6.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"206"}],"units":"Participants"}],"title":"Appetite Loss: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.3","value":"-0.5"},{"groupId":"OG001","spread":"27.2","value":"6.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Appetite Loss: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.7","value":"-5.7"},{"groupId":"OG001","spread":"26.5","value":"4.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Appetite Loss: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.1","value":"85.3"},{"groupId":"OG001","spread":"18.7","value":"85.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"312"}],"units":"Participants"}],"title":"Cognitive Functioning: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.5","value":"0.7"},{"groupId":"OG001","spread":"16.8","value":"-1.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"292"}],"units":"Participants"}],"title":"Cognitive Functioning: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.9","value":"0.9"},{"groupId":"OG001","spread":"19.1","value":"-2.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"title":"Cognitive Functioning: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.9","value":"1.8"},{"groupId":"OG001","spread":"18.4","value":"-1.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Cognitive Functioning: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.7","value":"-1.5"},{"groupId":"OG001","spread":"17.7","value":"-3.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"title":"Cognitive Functioning: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.5","value":"-0.5"},{"groupId":"OG001","spread":"17.6","value":"-2.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Cognitive Functioning: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.1","value":"-2.3"},{"groupId":"OG001","spread":"18.8","value":"-0.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Cognitive Functioning: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.9","value":"15.8"},{"groupId":"OG001","spread":"23.7","value":"14.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"312"}],"units":"Participants"}],"title":"Constipation: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.0","value":"0.0"},{"groupId":"OG001","spread":"21.1","value":"-6.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"291"}],"units":"Participants"}],"title":"Constipation: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.0","value":"-2.3"},{"groupId":"OG001","spread":"20.8","value":"-4.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"title":"Constipation: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.6","value":"-2.7"},{"groupId":"OG001","spread":"22.0","value":"-5.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Constipation: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.7","value":"-1.3"},{"groupId":"OG001","spread":"21.0","value":"-4.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"title":"Constipation: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.3","value":"-3.0"},{"groupId":"OG001","spread":"21.8","value":"-3.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"170"}],"units":"Participants"}],"title":"Constipation: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.5","value":"-4.6"},{"groupId":"OG001","spread":"22.5","value":"-6.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Constipation: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.1","value":"6.3"},{"groupId":"OG001","spread":"14.4","value":"5.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"311"}],"units":"Participants"}],"title":"Diarrhoea: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.9","value":"-0.5"},{"groupId":"OG001","spread":"22.4","value":"10.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"292"}],"units":"Participants"}],"title":"Diarrhoea: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.6","value":"-0.9"},{"groupId":"OG001","spread":"26.3","value":"13.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"title":"Diarrhoea: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.0","value":"-2.7"},{"groupId":"OG001","spread":"28.9","value":"13.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Diarrhoea: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.4","value":"-2.6"},{"groupId":"OG001","spread":"27.7","value":"11.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"title":"Diarrhoea: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.4","value":"-2.0"},{"groupId":"OG001","spread":"29.1","value":"14.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Diarrhoea: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.7","value":"1.1"},{"groupId":"OG001","spread":"30.9","value":"15.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Diarrhoea: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.0","value":"15.0"},{"groupId":"OG001","spread":"22.2","value":"15.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"311"}],"units":"Participants"}],"title":"Dyspnoea: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.5","value":"4.1"},{"groupId":"OG001","spread":"19.5","value":"-2.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"291"}],"units":"Participants"}],"title":"Dyspnoea: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.3","value":"2.8"},{"groupId":"OG001","spread":"20.9","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"title":"Dyspnoea: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.2","value":"0.7"},{"groupId":"OG001","spread":"23.3","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Dyspnoea: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.5","value":"2.6"},{"groupId":"OG001","spread":"23.2","value":"1.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"title":"Dyspnoea: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.6","value":"3.0"},{"groupId":"OG001","spread":"23.4","value":"0.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"170"}],"units":"Participants"}],"title":"Dyspnoea: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.5","value":"1.7"},{"groupId":"OG001","spread":"21.2","value":"-2.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Dyspnoea: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.1","value":"73.1"},{"groupId":"OG001","spread":"22.1","value":"71.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"312"}],"units":"Participants"}],"title":"Emotional Functioning: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.9","value":"4.0"},{"groupId":"OG001","spread":"18.5","value":"5.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"292"}],"units":"Participants"}],"title":"Emotional Functioning: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.1","value":"4.5"},{"groupId":"OG001","spread":"21.6","value":"2.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"title":"Emotional Functioning: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.5","value":"4.5"},{"groupId":"OG001","spread":"19.7","value":"2.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Emotional Functioning: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.1","value":"5.2"},{"groupId":"OG001","spread":"21.8","value":"-0.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"title":"Emotional Functioning: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.5","value":"2.1"},{"groupId":"OG001","spread":"21.6","value":"2.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Emotional Functioning: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.7","value":"5.3"},{"groupId":"OG001","spread":"19.7","value":"2.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Emotional Functioning: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.5","value":"30.8"},{"groupId":"OG001","spread":"22.0","value":"30.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"312"}],"units":"Participants"}],"title":"Fatigue: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.2","value":"2.0"},{"groupId":"OG001","spread":"18.8","value":"-0.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"292"}],"units":"Participants"}],"title":"Fatigue: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.5","value":"-1.5"},{"groupId":"OG001","spread":"21.5","value":"1.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"title":"Fatigue: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.1","value":"-0.2"},{"groupId":"OG001","spread":"21.9","value":"2.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Fatigue: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.8","value":"-0.1"},{"groupId":"OG001","spread":"20.4","value":"2.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"title":"Fatigue: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.0","value":"3.3"},{"groupId":"OG001","spread":"20.5","value":"2.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Fatigue: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.0","value":"1.0"},{"groupId":"OG001","spread":"20.5","value":"1.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Fatigue: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.8","value":"18.5"},{"groupId":"OG001","spread":"27.1","value":"19.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"310"}],"units":"Participants"}],"title":"Financial Difficulties: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.4","value":"-1.1"},{"groupId":"OG001","spread":"21.4","value":"-2.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"287"}],"units":"Participants"}],"title":"Financial Difficulties: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.9","value":"-0.9"},{"groupId":"OG001","spread":"24.4","value":"-1.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"258"}],"units":"Participants"}],"title":"Financial Difficulties: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.1","value":"0.7"},{"groupId":"OG001","spread":"23.7","value":"-0.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"230"}],"units":"Participants"}],"title":"Financial Difficulties: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.0","value":"-0.4"},{"groupId":"OG001","spread":"24.9","value":"0.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"205"}],"units":"Participants"}],"title":"Financial Difficulties: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.1","value":"5.6"},{"groupId":"OG001","spread":"23.6","value":"0.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"169"}],"units":"Participants"}],"title":"Financial Difficulties: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.1","value":"-0.6"},{"groupId":"OG001","spread":"23.1","value":"2.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"143"}],"units":"Participants"}],"title":"Financial Difficulties: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.4","value":"65.2"},{"groupId":"OG001","spread":"20.3","value":"67.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"311"}],"units":"Participants"}],"title":"Global Health Status/ QoL: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.7","value":"-0.1"},{"groupId":"OG001","spread":"19.9","value":"1.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"291"}],"units":"Participants"}],"title":"Global Health Status/ QoL: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.5","value":"-1.0"},{"groupId":"OG001","spread":"20.9","value":"-1.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"259"}],"units":"Participants"}],"title":"Global Health Status/ QoL: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.6","value":"-1.5"},{"groupId":"OG001","spread":"20.3","value":"-1.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"230"}],"units":"Participants"}],"title":"Global Health Status/ QoL: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.9","value":"0.3"},{"groupId":"OG001","spread":"20.3","value":"-2.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"title":"Global Health Status/ QoL: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.6","value":"-1.6"},{"groupId":"OG001","spread":"19.5","value":"-3.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Global Health Status/ QoL: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.9","value":"-1.1"},{"groupId":"OG001","spread":"18.9","value":"-1.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Global Health Status/ QoL: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.6","value":"26.0"},{"groupId":"OG001","spread":"27.7","value":"26.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"311"}],"units":"Participants"}],"title":"Insomnia: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.4","value":"-0.9"},{"groupId":"OG001","spread":"23.7","value":"-3.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"289"}],"units":"Participants"}],"title":"Insomnia: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.1","value":"-3.4"},{"groupId":"OG001","spread":"26.4","value":"-4.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"title":"Insomnia: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.9","value":"-4.0"},{"groupId":"OG001","spread":"26.8","value":"-1.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Insomnia: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.1","value":"-0.4"},{"groupId":"OG001","spread":"25.6","value":"-3.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"206"}],"units":"Participants"}],"title":"Insomnia: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.3","value":"-2.0"},{"groupId":"OG001","spread":"28.2","value":"-2.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"170"}],"units":"Participants"}],"title":"Insomnia: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.2","value":"-4.1"},{"groupId":"OG001","spread":"27.2","value":"-1.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Insomnia: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.4","value":"5.9"},{"groupId":"OG001","spread":"13.7","value":"6.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"312"}],"units":"Participants"}],"title":"Nausea/Vomiting: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.9","value":"0.1"},{"groupId":"OG001","spread":"18.1","value":"1.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"292"}],"units":"Participants"}],"title":"Nausea/Vomiting: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.2","value":"0.7"},{"groupId":"OG001","spread":"17.6","value":"2.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"title":"Nausea/Vomiting: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.9","value":"0.3"},{"groupId":"OG001","spread":"18.6","value":"2.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Nausea/Vomiting: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.3","value":"-1.1"},{"groupId":"OG001","spread":"15.4","value":"0.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"title":"Nausea/Vomiting: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.0","value":"1.5"},{"groupId":"OG001","spread":"15.9","value":"-0.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Nausea/Vomiting: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.5","value":"2.6"},{"groupId":"OG001","spread":"18.8","value":"2.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Nausea/Vomiting: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.4","value":"28.0"},{"groupId":"OG001","spread":"24.9","value":"27.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"312"}],"units":"Participants"}],"title":"Pain: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.0","value":"-0.2"},{"groupId":"OG001","spread":"20.8","value":"-5.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"292"}],"units":"Participants"}],"title":"Pain: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.3","value":"-3.7"},{"groupId":"OG001","spread":"22.6","value":"-3.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"title":"Pain: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.7","value":"-3.2"},{"groupId":"OG001","spread":"24.2","value":"-1.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Pain: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.2","value":"-3.3"},{"groupId":"OG001","spread":"22.9","value":"-4.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"title":"Pain: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.0","value":"-1.0"},{"groupId":"OG001","spread":"22.5","value":"-2.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Pain: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.5","value":"0.3"},{"groupId":"OG001","spread":"19.8","value":"-4.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Pain: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.9","value":"76.7"},{"groupId":"OG001","spread":"18.8","value":"78.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"311"}],"units":"Participants"}],"title":"Physical Functioning: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.4","value":"-1.1"},{"groupId":"OG001","spread":"12.7","value":"1.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"292"}],"units":"Participants"}],"title":"Physical Functioning: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.1","value":"2.0"},{"groupId":"OG001","spread":"15.7","value":"0.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"title":"Physical Functioning: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.1","value":"1.5"},{"groupId":"OG001","spread":"15.7","value":"0.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Physical Functioning: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.7","value":"2.0"},{"groupId":"OG001","spread":"13.5","value":"1.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"title":"Physical Functioning: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.4","value":"0.9"},{"groupId":"OG001","spread":"14.9","value":"1.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Physical Functioning: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.2","value":"1.6"},{"groupId":"OG001","spread":"14.2","value":"0.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Physical Functioning: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.6","value":"79.1"},{"groupId":"OG001","spread":"24.0","value":"78.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"312"}],"units":"Participants"}],"title":"Role Functioning: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.3","value":"-2.0"},{"groupId":"OG001","spread":"21.5","value":"1.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"292"}],"units":"Participants"}],"title":"Role Functioning: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.4","value":"-0.4"},{"groupId":"OG001","spread":"23.9","value":"-1.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"title":"Role Functioning: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.0","value":"0.3"},{"groupId":"OG001","spread":"24.2","value":"0.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Role Functioning: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.5","value":"1.8"},{"groupId":"OG001","spread":"21.6","value":"-1.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"title":"Role Functioning: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.8","value":"-1.3"},{"groupId":"OG001","spread":"23.4","value":"-1.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Role Functioning: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.6","value":"-0.3"},{"groupId":"OG001","spread":"22.9","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Role Functioning: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.8","value":"83.2"},{"groupId":"OG001","spread":"23.1","value":"81.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"312"}],"units":"Participants"}],"title":"Social Functioning: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.9","value":"-0.8"},{"groupId":"OG001","spread":"20.0","value":"2.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"292"}],"units":"Participants"}],"title":"Social Functioning: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.9","value":"1.3"},{"groupId":"OG001","spread":"23.2","value":"-0.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"259"}],"units":"Participants"}],"title":"Social Functioning: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.2","value":"1.8"},{"groupId":"OG001","spread":"21.3","value":"-0.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Social Functioning: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.4","value":"0.9"},{"groupId":"OG001","spread":"23.3","value":"-1.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"title":"Social Functioning: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.1","value":"-0.8"},{"groupId":"OG001","spread":"23.4","value":"-1.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"170"}],"units":"Participants"}],"title":"Social Functioning: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.2","value":"0.6"},{"groupId":"OG001","spread":"19.7","value":"0.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Social Functioning: Change at C7D1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"340"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 consists of 30 questions that comprise aspects of participant's functioning assessment (physical, emotional, role, cognitive, and social); symptom scales (fatigue; nausea, vomiting, and pain; the global health/quality of life [QoL]); and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), within a recall period of "the past week."\nMost questions used a 4-point scale (1=Not at all to 4=Very much; two questions used a 7-point scale (1=Very poor to 7=Excellent).\nScores were averaged and transformed to a 0-100 scale; a higher score for Global Qol/functional scales=better level of functioning; a higher score for symptom scale=greater degree of symptoms.","dispersionType":"Standard Deviation","groups":[{"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":"OG000","title":"Placebo+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.","id":"OG001","title":"Taselisib+Fulvestrant"}],"paramType":"MEAN","populationDescription":"Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.\nData are reported for evaluable participants.","reportingStatus":"POSTED","timeFrame":"Baseline, C2D1 up to C7D1 (each cycle=28 days)","title":"Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score","type":"SECONDARY","unitOfMeasure":"score on a scale"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.8","value":"15.5"},{"groupId":"OG001","spread":"21.1","value":"19.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"304"}],"units":"Participants"}],"title":"Arm Symptoms: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.4","value":"0.1"},{"groupId":"OG001","spread":"15.6","value":"-5.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"282"}],"units":"Participants"}],"title":"Arm Symptoms: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.5","value":"-0.7"},{"groupId":"OG001","spread":"17.4","value":"-6.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"250"}],"units":"Participants"}],"title":"Arm Symptoms: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.9","value":"-1.4"},{"groupId":"OG001","spread":"15.8","value":"-5.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"219"}],"units":"Participants"}],"title":"Arm Symptoms: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.0","value":"0.8"},{"groupId":"OG001","spread":"15.7","value":"-6.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"203"}],"units":"Participants"}],"title":"Arm Symptoms: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.8","value":"1.1"},{"groupId":"OG001","spread":"18.5","value":"-5.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"167"}],"units":"Participants"}],"title":"Arm Symptoms: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.7","value":"-1.2"},{"groupId":"OG001","spread":"15.2","value":"-6.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"140"}],"units":"Participants"}],"title":"Arm Symptoms: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.7","value":"82.0"},{"groupId":"OG001","spread":"22.5","value":"80.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"300"}],"units":"Participants"}],"title":"Body Image: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.9","value":"1.8"},{"groupId":"OG001","spread":"16.5","value":"1.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"276"}],"units":"Participants"}],"title":"Body Image: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.0","value":"1.6"},{"groupId":"OG001","spread":"20.6","value":"1.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"106"},{"groupId":"OG001","value":"242"}],"units":"Participants"}],"title":"Body Image: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.8","value":"1.1"},{"groupId":"OG001","spread":"20.6","value":"1.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"214"}],"units":"Participants"}],"title":"Body Image: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.5","value":"0.2"},{"groupId":"OG001","spread":"17.5","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"198"}],"units":"Participants"}],"title":"Body Image: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.0","value":"1.1"},{"groupId":"OG001","spread":"18.2","value":"0.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"164"}],"units":"Participants"}],"title":"Body Image: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.8","value":"5.6"},{"groupId":"OG001","spread":"18.2","value":"-0.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"137"}],"units":"Participants"}],"title":"Body Image: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.6","value":"8.7"},{"groupId":"OG001","spread":"14.1","value":"11.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"304"}],"units":"Participants"}],"title":"Breast Symptoms: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.7","value":"0.0"},{"groupId":"OG001","spread":"11.8","value":"-3.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"282"}],"units":"Participants"}],"title":"Breast Symptoms: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.3","value":"-0.8"},{"groupId":"OG001","spread":"11.6","value":"-3.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"250"}],"units":"Participants"}],"title":"Breast Symptoms: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.2","value":"0.1"},{"groupId":"OG001","spread":"11.8","value":"-3.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"220"}],"units":"Participants"}],"title":"Breast Symptoms: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.5","value":"-0.9"},{"groupId":"OG001","spread":"11.7","value":"-2.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"203"}],"units":"Participants"}],"title":"Breast Symptoms: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.0","value":"1.7"},{"groupId":"OG001","spread":"12.9","value":"-2.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"167"}],"units":"Participants"}],"title":"Breast Symptoms: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.6","value":"0.3"},{"groupId":"OG001","spread":"13.1","value":"-3.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"140"}],"units":"Participants"}],"title":"Breast Symptoms: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"31.5","value":"47.4"},{"groupId":"OG001","spread":"29.6","value":"47.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"303"}],"units":"Participants"}],"title":"Future Perspective: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.1","value":"3.4"},{"groupId":"OG001","spread":"27.4","value":"6.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"281"}],"units":"Participants"}],"title":"Future Perspective: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.5","value":"5.1"},{"groupId":"OG001","spread":"30.5","value":"4.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"247"}],"units":"Participants"}],"title":"Future Perspective: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.7","value":"6.0"},{"groupId":"OG001","spread":"29.2","value":"7.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"220"}],"units":"Participants"}],"title":"Future Perspective: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.3","value":"6.0"},{"groupId":"OG001","spread":"26.8","value":"5.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"202"}],"units":"Participants"}],"title":"Future Perspective: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.8","value":"6.9"},{"groupId":"OG001","spread":"31.4","value":"9.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"167"}],"units":"Participants"}],"title":"Future Perspective: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.4","value":"12.9"},{"groupId":"OG001","spread":"30.2","value":"7.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"139"}],"units":"Participants"}],"title":"Future Perspective: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.7","value":"51.9"},{"groupId":"OG001","spread":"26.6","value":"62.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"61"}],"units":"Participants"}],"title":"Sexual Enjoyment: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.2","value":"5.9"},{"groupId":"OG001","spread":"18.1","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"title":"Sexual Enjoyment: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.1","value":"4.8"},{"groupId":"OG001","spread":"24.0","value":"1.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"26"}],"units":"Participants"}],"title":"Sexual Enjoyment: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.4","value":"-8.3"},{"groupId":"OG001","spread":"24.7","value":"4.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"24"}],"units":"Participants"}],"title":"Sexual Enjoyment: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.0","value":"-4.8"},{"groupId":"OG001","spread":"29.7","value":"2.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"26"}],"units":"Participants"}],"title":"Sexual Enjoyment: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.9","value":"-6.7"},{"groupId":"OG001","spread":"24.3","value":"-5.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"17"}],"units":"Participants"}],"title":"Sexual Enjoyment: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.8","value":"-13.3"},{"groupId":"OG001","spread":"20.4","value":"9.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"title":"Sexual Enjoyment: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.9","value":"89.6"},{"groupId":"OG001","spread":"17.3","value":"89.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"142"},{"groupId":"OG001","value":"291"}],"units":"Participants"}],"title":"Sexual Functioning: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.0","value":"1.6"},{"groupId":"OG001","spread":"14.2","value":"1.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"267"}],"units":"Participants"}],"title":"Sexual Functioning: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"10.6","value":"1.4"},{"groupId":"OG001","spread":"15.6","value":"1.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"235"}],"units":"Participants"}],"title":"Sexual Functioning: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.4","value":"1.9"},{"groupId":"OG001","spread":"13.9","value":"1.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"203"}],"units":"Participants"}],"title":"Sexual Functioning: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.6","value":"-0.8"},{"groupId":"OG001","spread":"15.1","value":"2.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"186"}],"units":"Participants"}],"title":"Sexual Functioning: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.8","value":"2.4"},{"groupId":"OG001","spread":"15.0","value":"2.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"156"}],"units":"Participants"}],"title":"Sexual Functioning: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.1","value":"2.7"},{"groupId":"OG001","spread":"15.7","value":"2.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"132"}],"units":"Participants"}],"title":"Sexual Functioning: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.2","value":"15.7"},{"groupId":"OG001","spread":"12.0","value":"14.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"304"}],"units":"Participants"}],"title":"Systematic Therapy SEs: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.4","value":"0.2"},{"groupId":"OG001","spread":"11.0","value":"2.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"282"}],"units":"Participants"}],"title":"Systematic Therapy SEs: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.4","value":"1.2"},{"groupId":"OG001","spread":"13.6","value":"4.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"250"}],"units":"Participants"}],"title":"Systematic Therapy SEs: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.2","value":"1.5"},{"groupId":"OG001","spread":"13.3","value":"4.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"220"}],"units":"Participants"}],"title":"Systematic Therapy SEs: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.8","value":"2.4"},{"groupId":"OG001","spread":"14.1","value":"5.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"203"}],"units":"Participants"}],"title":"Systematic Therapy SEs: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.2","value":"2.9"},{"groupId":"OG001","spread":"15.6","value":"5.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"167"}],"units":"Participants"}],"title":"Systematic Therapy SEs: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.7","value":"3.5"},{"groupId":"OG001","spread":"15.0","value":"4.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"140"}],"units":"Participants"}],"title":"Systematic Therapy SEs: Change at C7D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.2","value":"23.2"},{"groupId":"OG001","spread":"29.2","value":"27.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"63"}],"units":"Participants"}],"title":"Upset by Hair Loss: Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.1","value":"-11.9"},{"groupId":"OG001","spread":"22.3","value":"-4.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"31"}],"units":"Participants"}],"title":"Upset by Hair Loss: Change at C2D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.9","value":"-7.7"},{"groupId":"OG001","spread":"26.7","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"29"}],"units":"Participants"}],"title":"Upset by Hair Loss: Change at C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.5","value":"2.6"},{"groupId":"OG001","spread":"29.2","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"27"}],"units":"Participants"}],"title":"Upset by Hair Loss: Change at C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.2","value":"0.0"},{"groupId":"OG001","spread":"27.3","value":"10.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Upset by Hair Loss: Change at C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.2","value":"11.1"},{"groupId":"OG001","spread":"30.2","value":"16.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"26"}],"units":"Participants"}],"title":"Upset by Hair Loss: Change at C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.8","value":"4.2"},{"groupId":"OG001","spread":"32.9","value":"14.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"26"}],"units":"Participants"}],"title":"Upset by Hair Loss: Change at C7D1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"340"}],"units":"Participants"}],"description":"EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms).\nQuestions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much).\nScores were averaged and transformed to a 0-100 scale.\nHigher scores for the functional scales indicated a higher/better level of functioning/healthy functioning.\nHigher scores for the symptom scales indicated worse symptoms.","dispersionType":"Standard Deviation","groups":[{"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":"OG000","title":"Placebo+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.","id":"OG001","title":"Taselisib+Fulvestrant"}],"paramType":"MEAN","populationDescription":"Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.\nData are reported for evaluable participants.","reportingStatus":"POSTED","timeFrame":"Baseline, C2D1 up to C7D1 (each cycle=28 days)","title":"Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score","type":"SECONDARY","unitOfMeasure":"score on a scale"}]},"participantFlowModule":{"groups":[{"description":"Participants received placebo taken orally once daily (QD) beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by intramuscular (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":"FG000","title":"Placebo+Fulvestrant"},{"description":"Participants received taselisib 4 milligrams (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.","id":"FG001","title":"Taselisib+Fulvestrant"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"58"},{"groupId":"FG001","numSubjects":"101"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"22"}],"type":"Withdrawal by Participant"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Reason Not Specified"},{"reasons":[{"groupId":"FG000","numSubjects":"140"},{"groupId":"FG001","numSubjects":"290"}],"type":"Continued on study"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"214"},{"groupId":"FG001","numSubjects":"417"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"214"},{"groupId":"FG001","numSubjects":"417"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}}},{"op":"add","path":"/documentSection","value":{"largeDocumentModule":{"largeDocs":[{"date":"2018-06-24","filename":"Prot_SAP_000.pdf","hasIcf":false,"hasProtocol":true,"hasSap":true,"label":"Study Protocol and Statistical Analysis Plan","size":3939812,"typeAbbrev":"Prot_SAP","uploadDate":"2018-12-18T16:16"}]}}}],"provenance":{"from_snapshot_hash":"e599ad8817f171a2051de02ec3449f3083433fffd020268456af4498d353751c","materiality_event_hash":"a01a9262684b42e7e083c85c23b3e7b7cffb5c99421021dd66fec6f7477c873f","patch_hash":"16f65020f8080602797bdd8a1baa634a07ba08c7505d42410585a22c807c49a3","patch_raw_hash":"171ad55dbd5a5af217e6f4eb022228624c141e5f22879ebc117b7ee3f8285c5c","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT02340221/history/45?patchToVersion=46","to_snapshot_hash":"b5f049c177822374870b29c6267edd76cfb72167bde762f4875b61daf0778ecc"},"review_question":"What source document explains this registry amendment, and does it change interpretation of the trial record?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT02340221","nct_id":"NCT02340221"},"versions":{"from_version":45,"submitted_date":"2019-01-22","to_version":46}}