Raw JSON 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": "<p>Inclusion Criteria:</p><ul><li>Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen receptor (ER) positive breast cancer</li><li>Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1</li><li>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</li><li>Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer</li><li>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</li><li>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</li><li>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</li><li>A valid cobas PIK3CA mutation result by central testing is required</li><li>Adequate hematologic and end-organ function within 28 days prior to treatment initiation</li></ul><p>Exclusion Criteria:</p><ul><li>Human epidermal growth factor receptor 2 (HER2)-positive disease by local laboratory testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization positive)</li><li>Prior treatment with fulvestrant</li><li>Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian target of rapamycin (mTOR) inhibitor (e.g.\neverolimus), or protein kinase B (AKT) inhibitor</li><li>Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1</li><li>Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1</li><li>All acute treatment-related toxicity must have resolved to Grade less than or equal to (</=) 1 or be deemed stable by the Investigator</li><li>Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic breast cancer</li><li>Concurrent hormone replacement therapy</li><li>Known untreated or active central nervous system (CNS) metastases</li><li>Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications</li><li>History of inflammatory bowel disease or active bowel inflammation</li><li>Clinically significant cardiac or pulmonary dysfunction</li><li>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</li></ul>"
},
{
"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 Sädesairaala; Syöpätautien 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 François 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": {
"moreInfoModule": {
"pointOfContact": {
"email": "global.trial_information@roche.com",
"phone": "(+41) 616878333",
"title": "Medical Communications",
"organization": "Hoffmann-La Roche"
},
"certainAgreement": {
"otherDetails": "The Study being conducted under this Agreement is part of the Overall Study.\nInvestigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study.\nThe Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.",
"restrictionType": "OTHER",
"piSponsorEmployee": false,
"restrictiveAgreement": true
}
},
"adverseEventsModule": {
"timeFrame": "From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years",
"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": [
{
"id": "EG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
"otherNumAtRisk": 213,
"deathsNumAtRisk": 213,
"otherNumAffected": 190,
"seriousNumAtRisk": 213,
"deathsNumAffected": 57,
"seriousNumAffected": 19
},
{
"id": "EG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
"otherNumAtRisk": 416,
"deathsNumAtRisk": 416,
"otherNumAffected": 396,
"seriousNumAtRisk": 416,
"deathsNumAffected": 101,
"seriousNumAffected": 133
}
],
"otherEvents": [
{
"term": "Anaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 18
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 34
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Neutropenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 27
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Diarrhoea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 42
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 235
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 52
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 140
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 23
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 76
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Stomatitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 82
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Abdominal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 19
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 51
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Dry mouth",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 16
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 51
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 31
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 28
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Dyspepsia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 31
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Abdominal pain upper",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 23
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Gastrooesophageal reflux disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 21
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 38
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 100
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Asthenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 39
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 76
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Mucosal inflammation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 43
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Pyrexia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 41
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Urinary tract infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 34
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Upper respiratory tract infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 10
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 23
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Aspartate aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 13
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 30
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Alanine aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 31
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Weight decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 34
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Blood alkaline phosphatase increased",
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{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 2
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Confusional state",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Pancytopenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 1
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Anaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 0
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
},
{
"term": "Intracranial tumour haemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 213,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 416,
"numAffected": 1
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA version 20.1"
}
],
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "176",
"groupId": "OG000"
},
{
"value": "340",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5.39",
"groupId": "OG000",
"lowerLimit": "3.68",
"upperLimit": "7.29"
},
{
"value": "7.43",
"groupId": "OG001",
"lowerLimit": "7.26",
"upperLimit": "9.07"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.0037",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.70",
"ciLowerLimit": "0.56",
"ciUpperLimit": "0.89",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)",
"description": "PFS was defined as the time from randomization to disease progression as determined by 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.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment."
},
{
"type": "SECONDARY",
"title": "Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "134",
"groupId": "OG000"
},
{
"value": "264",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "11.9",
"groupId": "OG000",
"lowerLimit": "7.1",
"upperLimit": "18.3"
},
{
"value": "28.0",
"groupId": "OG001",
"lowerLimit": "22.7",
"upperLimit": "33.8"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.0002",
"groupIds": [
"OG000",
"OG001"
],
"statisticalMethod": "Cochran-Mantel-Haenszel",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)",
"description": "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).",
"unitOfMeasure": "percentage of participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment."
},
{
"type": "SECONDARY",
"title": "Overall Survival (OS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "176",
"groupId": "OG000"
},
{
"value": "340",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "23.56",
"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": "26.81",
"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"
}
]
}
]
}
],
"analyses": [
{
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.85",
"ciLowerLimit": "0.58",
"ciUpperLimit": "1.25",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)",
"description": "OS was defined as the time from the date of randomization to the date of death due to any cause.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment."
},
{
"type": "SECONDARY",
"title": "Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "134",
"groupId": "OG000"
},
{
"value": "264",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "37.3",
"groupId": "OG000",
"lowerLimit": "29.1",
"upperLimit": "45.7"
},
{
"value": "51.5",
"groupId": "OG001",
"lowerLimit": "45.3",
"upperLimit": "57.7"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)",
"description": "Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization.\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
"unitOfMeasure": "percentage of participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment."
},
{
"type": "SECONDARY",
"title": "Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "16",
"groupId": "OG000"
},
{
"value": "74",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "7.23",
"comment": "Upper limit of confidence interval was not estimable due to the low number of participants with events.",
"groupId": "OG000",
"lowerLimit": "6.51",
"upperLimit": "NA"
},
{
"value": "8.74",
"groupId": "OG001",
"lowerLimit": "5.72",
"upperLimit": "11.24"
}
]
}
]
}
],
"analyses": [
{
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.77",
"ciLowerLimit": "0.23",
"ciUpperLimit": "2.59",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)",
"description": "Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nDisease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.\nData are reported for participants with responses."
},
{
"type": "SECONDARY",
"title": "PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "176",
"groupId": "OG000"
},
{
"value": "340",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5.39",
"groupId": "OG000",
"lowerLimit": "3.68",
"upperLimit": "9.23"
},
{
"value": "8.97",
"groupId": "OG001",
"lowerLimit": "7.39",
"upperLimit": "9.49"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.0023",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.66",
"ciLowerLimit": "0.51",
"ciUpperLimit": "0.86",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)",
"description": "PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment."
},
{
"type": "SECONDARY",
"title": "Percentage of Participants With Adverse Events",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "213",
"groupId": "OG000"
},
{
"value": "416",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "89.7",
"groupId": "OG000"
},
{
"value": "95.4",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.",
"description": "An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.",
"unitOfMeasure": "percentage of participants",
"reportingStatus": "POSTED",
"populationDescription": "The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant."
},
{
"type": "SECONDARY",
"title": "Maximum Observed Plasma Concentration (Cmax) of Taselisib",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "417",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"title": "C1D1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "417",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "18.2",
"spread": "14.6",
"groupId": "OG000"
}
]
}
]
},
{
"title": "C2D1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "359",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "66.6",
"spread": "35.2",
"groupId": "OG000"
}
]
}
]
}
],
"paramType": "MEAN",
"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)",
"unitOfMeasure": "ng/mL",
"dispersionType": "Standard Deviation",
"reportingStatus": "POSTED",
"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."
},
{
"type": "SECONDARY",
"title": "Minimum Observed Plasma Concentration (Cmin) of Taselisib",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "417",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"title": "C2D1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "377",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "42.8",
"spread": "26.6",
"groupId": "OG000"
}
]
}
]
},
{
"title": "C6D1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "213",
"groupId": "OG000"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "35.3",
"spread": "31.5",
"groupId": "OG000"
}
]
}
]
}
],
"paramType": "MEAN",
"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)",
"unitOfMeasure": "ng/mL",
"dispersionType": "Standard Deviation",
"reportingStatus": "POSTED",
"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."
},
{
"type": "SECONDARY",
"title": "Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "176",
"groupId": "OG000"
},
{
"value": "340",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Placebo+Fulvestrant",
"description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"id": "OG001",
"title": "Taselisib+Fulvestrant",
"description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
}
],
"classes": [
{
"title": "Appetite Loss: Baseline",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "159",
"groupId": "OG000"
},
{
"value": "312",
"groupId": "OG001"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "15.9",
"spread": "25.9",
"groupId": "OG000"
},
{
"value": "15.3",
"spread": "23.3",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Appetite Loss: Change at C2D1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "147",
"groupId": "OG000"
},
{
"value": "292",
"groupId": "OG001"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "-0.2",
"spread": "25.7",
"groupId": "OG000"
},
{
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"unitOfMeasure": "score on a scale",
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"reportingStatus": "POSTED",
"populationDescription": "Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.\nData are reported for evaluable participants."
},
{
"type": "SECONDARY",
"title": "Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score",
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},
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],
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],
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},
{
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},
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}
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},
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],
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}
]
}
]
},
{
"title": "Sexual Functioning: Baseline",
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{
"units": "Participants",
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{
"value": "142",
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{
"value": "291",
"groupId": "OG001"
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]
}
],
"categories": [
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},
{
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{
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}
]
}
],
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},
{
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{
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}
],
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}
]
},
{
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"units": "Participants",
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},
{
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},
{
"title": "Sexual Functioning: Change at C6D1",
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{
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],
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}
]
},
{
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]
}
],
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]
}
]
},
{
"title": "Systematic Therapy SEs: Baseline",
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{
"units": "Participants",
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{
"value": "304",
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],
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}
]
},
{
"title": "Systematic Therapy SEs: Change at C2D1",
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"units": "Participants",
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"groupId": "OG000"
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}
],
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},
{
"title": "Systematic Therapy SEs: Change at C3D1",
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"units": "Participants",
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],
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},
{
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],
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}
]
}
]
},
{
"title": "Systematic Therapy SEs: Change at C5D1",
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"units": "Participants",
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"value": "72",
"groupId": "OG000"
},
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}
],
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{
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"groupId": "OG001"
}
]
}
]
},
{
"title": "Systematic Therapy SEs: Change at C6D1",
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{
"units": "Participants",
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],
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},
{
"title": "Systematic Therapy SEs: Change at C7D1",
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"groupId": "OG000"
},
{
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"groupId": "OG001"
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}
],
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},
{
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"groupId": "OG001"
}
]
}
]
},
{
"title": "Upset by Hair Loss: Baseline",
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{
"units": "Participants",
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{
"value": "33",
"groupId": "OG000"
},
{
"value": "63",
"groupId": "OG001"
}
]
}
],
"categories": [
{
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{
"value": "23.2",
"spread": "28.2",
"groupId": "OG000"
},
{
"value": "27.0",
"spread": "29.2",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Upset by Hair Loss: Change at C2D1",
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{
"units": "Participants",
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{
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},
{
"value": "31",
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}
]
}
],
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"groupId": "OG000"
},
{
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"spread": "22.3",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Upset by Hair Loss: Change at C3D1",
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{
"units": "Participants",
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{
"value": "13",
"groupId": "OG000"
},
{
"value": "29",
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}
]
}
],
"categories": [
{
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{
"value": "-7.7",
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"groupId": "OG000"
},
{
"value": "0.0",
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"groupId": "OG001"
}
]
}
]
},
{
"title": "Upset by Hair Loss: Change at C4D1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "13",
"groupId": "OG000"
},
{
"value": "27",
"groupId": "OG001"
}
]
}
],
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{
"measurements": [
{
"value": "2.6",
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"groupId": "OG000"
},
{
"value": "0.0",
"spread": "29.2",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Upset by Hair Loss: Change at C5D1",
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{
"units": "Participants",
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{
"value": "8",
"groupId": "OG000"
},
{
"value": "28",
"groupId": "OG001"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "0.0",
"spread": "25.2",
"groupId": "OG000"
},
{
"value": "10.7",
"spread": "27.3",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Upset by Hair Loss: Change at C6D1",
"denoms": [
{
"units": "Participants",
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{
"value": "6",
"groupId": "OG000"
},
{
"value": "26",
"groupId": "OG001"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "11.1",
"spread": "27.2",
"groupId": "OG000"
},
{
"value": "16.7",
"spread": "30.2",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Upset by Hair Loss: Change at C7D1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "26",
"groupId": "OG001"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "4.2",
"spread": "11.8",
"groupId": "OG000"
},
{
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"groupId": "OG001"
}
]
}
]
}
],
"paramType": "MEAN",
"timeFrame": "Baseline, C2D1 up to C7D1 (each cycle=28 days)",
"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.",
"unitOfMeasure": "score on a scale",
"dispersionType": "Standard Deviation",
"reportingStatus": "POSTED",
"populationDescription": "Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.\nData are reported for evaluable participants."
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Placebo+Fulvestrant",
"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": "FG001",
"title": "Taselisib+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."
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
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