Study of Ipatasertib or Apitolisib With Abiraterone Aceta... | NCT01485861 | Trialant
NCT01485861
Sponsor
Genentech, Inc.
Status
Completed
Last Update Posted
Sep 14, 2023Actual
Enrollment
298Actual
Phase
Phase 1Phase 2
Conditions
Prostate Cancer
Interventions
Abiraterone
Apitolisib
Ipatasertib
Placebo
Prednisone
Prednisolone
Countries
United States
Czechia
France
Greece
Italy
Netherlands
Romania
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01485861
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GO27983
Secondary IDs
ID
Type
Description
Link
2011-004126-10
EudraCT Number
Brief Title
Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
Official Title
A Phase Ib/II Study of Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Acronym
Not provided
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
Aug 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 11, 2012Actual
Primary Completion Date
Sep 1, 2015Actual
Completion Date
Aug 31, 2022Actual
First Submitted Date
Dec 2, 2011
First Submission Date that Met QC Criteria
Dec 2, 2011
First Posted Date
Dec 6, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 17, 2023
Results First Submitted that Met QC Criteria
Aug 17, 2023
Results First Posted Date
Sep 14, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 17, 2023
Last Update Posted Date
Sep 14, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone.
Detailed Description
Not provided
Conditions Module
Conditions
Prostate Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
298Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase Ib: Ipatasertib 400 mg + abiraterone
Experimental
Participants will receive ipatasertib 400 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Drug: Abiraterone
Drug: Ipatasertib
Drug: Prednisone
Drug: Prednisolone
Phase Ib: Apitolisib 30 mg + abiraterone
Experimental
Participants will receive apitolisib 30 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Drug: Abiraterone
Drug: Apitolisib
Drug: Prednisone
Drug: Prednisolone
Phase II: Ipatasertib 400 mg + abiraterone
Experimental
Participants will receive Ipatasertib 400 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Drug: Abiraterone
Drug: Ipatasertib
Drug: Prednisone
Drug: Prednisolone
Phase II: Ipatasertib 200 mg + abiraterone
Experimental
Participants will receive Ipatasertib 200 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Abiraterone
Drug
Orally once daily
Phase II: Ipatasertib 200 mg + abiraterone
Phase II: Ipatasertib 400 mg + abiraterone
Phase II: Placebo + abiraterone
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase Ib: Percentage of Participants With Dose-Limiting Toxicities (DLTs)
DLT: 1 of the following toxicities, at least possibly related to ipatasertib or apitolisib. 1) Grade ≥ 3 non-hematologic, non-hepatic major organ AE; 2) Grade ≥ 3 febrile neutropenia; 3) Grade ≥ 4 neutropenia (absolute neutrophils less than [<] 500 per microliter) lasting greater than (>) 7 days; 4) Grade ≥3 thrombocytopenia associated with acute hemorrhage; 5) Grade ≥4 thrombocytopenia; 6) Grade ≥4 anemia; 7) 1 episode of fasting Grade ≥4 hyperglycemia or 3 episodes of fasting Grade 3 hyperglycemia on separate days within 7 days, as determined by laboratory blood glucose evaluation; 8) Grade ≥3 elevation lasting for > 48 hours for hepatic transaminase or liver-specific alkaline phosphatase or total bilirubin. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0.
Days 1 to 28 of Cycle 1 (Cycle length = 28 days)
Phase Ib: Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 10 months).
Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib
RP2D is a dose of a drug which would be used in Phase II stage of the study. RP2D was to be determined based on maximum tolerated dose (MTD) in Phase Ib stage of the study. The highest dose level (in 3+3 escalation scheme) with an acceptable safety profile and with a minimum of 6 participants at which fewer than one-third of participants experienced a DLT was declared the MTD and RP2D.
Phase Ib: Maximum Plasma Concentration (Cmax) of Ipatasertib When Co-Administered With Abiraterone
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: Time to Cmax (Tmax) of Ipatasertib When Co-Administered With Abiraterone
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed metastatic or advanced prostate adenocarcinoma that has been previously treated with docetaxel-based therapy and has progressed during treatment of at least one hormonal therapy(prior docetaxel is not required for the safety cohort)
Two rising PSA levels greater than or equal to (>/=) 2 ng/mL measured >/= 1 week apart or radiographic evidence of disease progression in soft tissue or bone
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
Adequate hematologic and organ function
Documented willingness to use an effective means of contraception
Safety cohort only: agreement to use CGM for first cycle of treatment
Exclusion Criteria:
History of Type I or Type II diabetes mellitus requiring insulin; safety cohort: patients who are receiving any pharmacologic treatment for diabetes are not eligible
New York Heart Association Class III or IV heart failure or Left ventricular ejection fraction < 50% or ventricular arrhythmia requiring medication
Significant atherosclerotic disease, as evidenced by: unstable angina, history of myocardial infarction within 6 months prior to Day 1, or cerebrovascular accident within 6 months prior to Day 1
Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs or active inflammatory disease which requires immunosuppressive therapy
Clinically significant history of liver disease
History of adrenal insufficiency or hyperaldosteronism
Phase II only: Previous therapy for prostate cancer with 17 alpha-hydroxylase/C17,20-lyase inhibitors, including abiraterone
Phase II only: Previous treatment for prostate cancer with Protein kinase B phosphatidylinositol 3 kinase and/or mammalian target of rapamycin inhibitors
Need for chronic corticosteroid therapy of >/= 20 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressant
Accepts Healthy Volunteers
No
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Genentech, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
HonorHealth Research Institute ? Bisgrove
Scottsdale
Arizona
85258
United States
Pacific Hematology Oncology Associates
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
The study consisted of 3 stages: Phase Ib determined recommended Phase II doses (RP2D) for ipatasertib and apitolisib in combination with abiraterone and prednisone/prednisolone. Phase II stage compared ipatasertib (400 mg or 200 mg daily) versus placebo each combined with abiraterone and prednisone/prednisolone. The third stage included the safety cohort.
Recruitment Details
The study was conducted at 55 centers in 10 countries.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
FG001
Phase Ib: Apitolisib 30 mg
Periods
Title
Milestones
Reasons Not Completed
Phase Ib
Type
Comment
Milestone Data
STARTED
Intent-To-Treat (ITT) population based on randomization
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
In Phase II participants and investigators were blinded with regard to treatment status (i.e., ipatasertib vs. placebo). Phase Ib and the safety cohort were open-label.
Who Masked
ParticipantInvestigator
Drug: Abiraterone
Drug: Ipatasertib
Drug: Prednisone
Drug: Prednisolone
Phase II: Placebo + abiraterone
Placebo Comparator
Participants will receive placebo (for Ipatasertib) once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Participants will receive ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.
rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on a second bone scan ≥ 4 weeks later (< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization).
Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Phase II: rPFS in Participants With Institute of Cancer Research (ICR) Phosphatase and Tensin Homolog (PTEN) Loss
rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (RECIST 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on 2nd bone scan ≥ 4 weeks later (< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss". Number of participants analyzed=participants with PTEN loss.
Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: Area Under The Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ipatasertib When Co-Administered With Abiraterone
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: Total Body Clearance (CL/F) of Ipatasertib When Co-Administered With Abiraterone
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: Accumulation Ratio of Ipatasertib When Co-Administered With Abiraterone
Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: Cmax of G-037720 (Metabolite of Ipatasertib)
G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: Tmax of G-037720 (Metabolite of Ipatasertib)
G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: AUC0-24 of G-037720 (Metabolite of Ipatasertib)
G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: Accumulation Ratio of G-037720 (Metabolite of Ipatasertib)
G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation. Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: Cmax of Apitolisib When Co-Administered With Abiraterone
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: Tmax of Apitolisib When Co-Administered With Abiraterone
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: AUC0-24 of Apitolisib When Co-Administered With Abiraterone
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: Tmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: Plasma Half-Life of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase Ib: Accumulation Ratio of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Accumulation Ratio was caculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Phase II: Overall Survival (ITT Population)
Overall survival was defined as the interval between the date of screening and death due to any cause. Overall survival was estimated using Kaplan Meier method.
Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)
Phase II: Overall Survival in Participants With ICR IHC PTEN Loss
Overall survival was defined as the interval between the date of randomization and death from any cause. Overall survival was estimated using Kaplan Meier method. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)
Phase II: Percentage of Participants With PSA Progression (ITT Population)
PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 nanogram per milliliter (ng/mL) from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later.
Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Phase II: Percentage of Participants With PSA Progression in Participants With ICR PTEN Loss
PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Phase II: Time to PSA Progression (ITT Population)
Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later.
Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Phase II: Time to PSA Progression in Participants With ICR PTEN Loss
Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Phase II: Percentage of Participants With PSA Response (ITT Population)
PSA response was defined as a > 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement.
Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)
Phase II: Percentage of Participants With PSA Response in Participants With ICR PTEN Loss
PSA response was defined as a > 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)
Phase II: Percentage of Participants With Objective Response (ITT Population)
Objective response was defined as having a confirm response (CR) or partial response (PR) according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.
Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Phase II: Percentage of Participants With Objective Response in Participants With ICR PTEN Loss
Objective response was defined as having a CR or PR according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss". Number of participants analyzed=participants with PTEN loss and evaluable for this endpoint.
Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Phase II: Duration of Tumor Response (ITT Population)
Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method.
Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Phase II: Duration of Tumor Response in Participants With ICR PTEN Loss
Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method.
Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Phase II: Percentage of Participants With Circulating Tumor Cells (CTC) Reduction Response (ITT Population)
CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline.
Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)
Phase II: Percentage of Participants With CTC Reduction Response in Participants With ICR PTEN Loss
CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)
Phase II: Percentage of Participants With CTC Conversion (ITT Population)
CTC conversion was defined as a decline to < 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline.
Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)
Phase II: Percentage of Participants With CTC Conversion in Participants With ICR PTEN Loss
CTC conversion was defined as a decline to < 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)
Phase II: Percentage of Participants With Pain Progression (ITT Population)
Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10).
Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)
Phase II: Percentage of Participants With Pain Progression in Participants With ICR PTEN Loss
Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)
Phase II: Time to Pain Progression (ITT Population)
Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10).
Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)
Phase II: Time to Pain Progression in Participants With ICR PTEN Loss
Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression: ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of 4questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)
Phase II: Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 8.9 years)
Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
Lyon
69008
France
Hia Du Val De Grace
Paris
75230
France
Institut Curie; Oncologie Medicale
Paris
75231
France
GH Paris Saint Joseph; Hopital De Jour Oncologie
Paris
75674
France
Hopital d'Instruction des Armees de Begin
Saint-Mandé
94160
France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif
94805
France
Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
Athens
115 28
Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion
711 10
Greece
University Hospital of Larissa; Oncology
Larissa
413 35
Greece
University Hospital of Patras Medical Oncology
Pátrai
265 04
Greece
Metropolitan Hospital; 2Nd Oncology Clinic
Piraeus
185 47
Greece
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola
Emilia-Romagna
47014
Italy
Azienda Ospedaliera Istituti Ospitalieri
Cremona
Lombardy
26100
Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milan
Lombardy
20132
Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan
Lombardy
20133
Italy
Ospedale S. Donato; Divisione Di Reumatologia
Arezzo
Tuscany
52100
Italy
Het Nederlands Kanker Inst
Amsterdam
1066 EC
Netherlands
Vu Medisch Centrum; Afdeling Longziekten
Amsterdam
1081 HV
Netherlands
UMC St Radboud
Nijmegen
6525 GA
Netherlands
Sint Franciscus Gasthuis; Inwendige Geneeskunde
Rotterdam
3045 PM
Netherlands
MC Haaglanden; Oncologie
The Hague
2512 VA
Netherlands
Sf. Constantin Hospital; Oncology
Brasov
500019
Romania
Prof. Dr. Th. Burghele Clin Urology Hosp
Bucharest
050659
Romania
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca
400015
Romania
ONCOMED - Medical Centre
Timișoara
300239
Romania
Municipal Hosp Turdal; Oncology
Turda
401103
Romania
Hospital General Universitario de Elche; Servicio de Oncologia
Elche
Alicante
03203
Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona
Barcelona
08916
Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell
Barcelona
8208
Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Sant Andreu de la Barca
Barcelona
08740
Spain
Clinica Universitaria de Navarra
Pamplona
Navarre
31008
Spain
Hospital General Universitario Gregorio Marañon
Madrid
28007
Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid
28041
Spain
Hospital Madrid Norte Sanchinarro
Madrid
28050
Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga
29010
Spain
Queen Elizabeth Hospital; Centre for Clinical Haematology
Birmingham
B15 2TH
United Kingdom
Gartnavel General Hospital
Glasgow
G12 0XH
United Kingdom
St. James University Hospital; Pharmacy Department
Leeds
LS9 7TF
United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool
L7 8YA
United Kingdom
Sarah Cannon Research Institute
London
W1G 6AD
United Kingdom
The Royal Marsden Hospital
Sutton
SM2 5PT
United Kingdom
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
FG002
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
FG003
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
FG004
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
FG005
Safety Cohort: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.
FG00014 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Safety Population
Based on treatment received
FG00014 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00014 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Physician Decision
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG004
Progression of disease
FG0005 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Phase II
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00284 subjects
FG00386 subjects
FG00483 subjects
FG0050 subjects
Safety Population
FG0000 subjects
FG0010 subjects
FG00284 subjects
FG00388 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00283 subjects
FG00386 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG00267 subjects
FG003
Safety Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00525 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Intent-To-Treat (ITT) Population included all participants allocated to the treatment arm according to randomization.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
BG001
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
BG002
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
BG003
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
BG004
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
BG005
Safety Cohort: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00014
BG0016
BG00284
BG00386
BG00483
BG00525
BG006298
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00068.1± 9.1
BG00169.3± 9.3
BG00266.9± 8.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase Ib: Percentage of Participants With Dose-Limiting Toxicities (DLTs)
DLT: 1 of the following toxicities, at least possibly related to ipatasertib or apitolisib. 1) Grade ≥ 3 non-hematologic, non-hepatic major organ AE; 2) Grade ≥ 3 febrile neutropenia; 3) Grade ≥ 4 neutropenia (absolute neutrophils less than [<] 500 per microliter) lasting greater than (>) 7 days; 4) Grade ≥3 thrombocytopenia associated with acute hemorrhage; 5) Grade ≥4 thrombocytopenia; 6) Grade ≥4 anemia; 7) 1 episode of fasting Grade ≥4 hyperglycemia or 3 episodes of fasting Grade 3 hyperglycemia on separate days within 7 days, as determined by laboratory blood glucose evaluation; 8) Grade ≥3 elevation lasting for > 48 hours for hepatic transaminase or liver-specific alkaline phosphatase or total bilirubin. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0.
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment on Day 1 of Cycle 1.
Posted
Number
percentage of participants
Days 1 to 28 of Cycle 1 (Cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00014
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Primary
Phase Ib: Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment on Day 1 of Cycle 1.
Posted
Number
percentage of participants
Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 10 months).
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Primary
Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib
RP2D is a dose of a drug which would be used in Phase II stage of the study. RP2D was to be determined based on maximum tolerated dose (MTD) in Phase Ib stage of the study. The highest dose level (in 3+3 escalation scheme) with an acceptable safety profile and with a minimum of 6 participants at which fewer than one-third of participants experienced a DLT was declared the MTD and RP2D.
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment on Day 1 of Cycle 1.
Posted
Number
milligrams (mg)
Days 1 to 28 of Cycle 1 (Cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on a second bone scan ≥ 4 weeks later (< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization).
The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Posted
Median
90% Confidence Interval
months
Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Primary
Phase II: rPFS in Participants With Institute of Cancer Research (ICR) Phosphatase and Tensin Homolog (PTEN) Loss
rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (RECIST 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on 2nd bone scan ≥ 4 weeks later (< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss". Number of participants analyzed=participants with PTEN loss.
The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.
Posted
Median
90% Confidence Interval
months
Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Secondary
Phase Ib: Maximum Plasma Concentration (Cmax) of Ipatasertib When Co-Administered With Abiraterone
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Time to Cmax (Tmax) of Ipatasertib When Co-Administered With Abiraterone
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Median
Full Range
hours
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Area Under The Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ipatasertib When Co-Administered With Abiraterone
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL*hours
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Total Body Clearance (CL/F) of Ipatasertib When Co-Administered With Abiraterone
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
milliliter per hour (mL/h)
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Accumulation Ratio of Ipatasertib When Co-Administered With Abiraterone
Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Cmax of G-037720 (Metabolite of Ipatasertib)
G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Tmax of G-037720 (Metabolite of Ipatasertib)
G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Median
Full Range
hours
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: AUC0-24 of G-037720 (Metabolite of Ipatasertib)
G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL*hour
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Accumulation Ratio of G-037720 (Metabolite of Ipatasertib)
G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation. Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Cmax of Apitolisib When Co-Administered With Abiraterone
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Tmax of Apitolisib When Co-Administered With Abiraterone
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Median
Full Range
hours
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: AUC0-24 of Apitolisib When Co-Administered With Abiraterone
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL*hours
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Tmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Median
Full Range
hours
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL*hr
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Plasma Half-Life of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Accumulation Ratio of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Accumulation Ratio was caculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
Secondary
Phase II: Overall Survival (ITT Population)
Overall survival was defined as the interval between the date of screening and death due to any cause. Overall survival was estimated using Kaplan Meier method.
The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Posted
Median
95% Confidence Interval
Months
Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG002
Phase II: Placebo + Abiraterone
Secondary
Phase II: Overall Survival in Participants With ICR IHC PTEN Loss
Overall survival was defined as the interval between the date of randomization and death from any cause. Overall survival was estimated using Kaplan Meier method. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.
Posted
Median
95% Confidence Interval
months
Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG002
Secondary
Phase II: Percentage of Participants With PSA Progression (ITT Population)
PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 nanogram per milliliter (ng/mL) from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later.
The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Posted
Number
percentage of participants
Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Secondary
Phase II: Percentage of Participants With PSA Progression in Participants With ICR PTEN Loss
PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.
Posted
Number
percentage of participants
Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Secondary
Phase II: Time to PSA Progression (ITT Population)
Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later.
The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Posted
Median
90% Confidence Interval
months
Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Secondary
Phase II: Time to PSA Progression in Participants With ICR PTEN Loss
Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.
Posted
Median
90% Confidence Interval
Months
Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Secondary
Phase II: Percentage of Participants With PSA Response (ITT Population)
PSA response was defined as a > 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement.
The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Posted
Number
90% Confidence Interval
Percentage of Participants
Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG002
Phase II: Placebo + Abiraterone
Secondary
Phase II: Percentage of Participants With PSA Response in Participants With ICR PTEN Loss
PSA response was defined as a > 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG002
Secondary
Phase II: Percentage of Participants With Objective Response (ITT Population)
Objective response was defined as having a confirm response (CR) or partial response (PR) according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.
The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation. Data presented below is only for participants included in the actual analysis.
Posted
Number
90% Confidence Interval
percentage of participants
Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Secondary
Phase II: Percentage of Participants With Objective Response in Participants With ICR PTEN Loss
Objective response was defined as having a CR or PR according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss". Number of participants analyzed=participants with PTEN loss and evaluable for this endpoint.
The PTEN Loss population was defined as all randomised participants with PTEN loss tumours. Data presented below is only for participants included in the actual analysis.
Posted
Number
90% Confidence Interval
percentage of participants
Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Secondary
Phase II: Duration of Tumor Response (ITT Population)
Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method.
The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation. Data presented below is only for participants who had achieved an objective response.
Posted
Median
90% Confidence Interval
months
Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Secondary
Phase II: Duration of Tumor Response in Participants With ICR PTEN Loss
Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method.
The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.
Posted
Median
90% Confidence Interval
months
Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Secondary
Phase II: Percentage of Participants With Circulating Tumor Cells (CTC) Reduction Response (ITT Population)
CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline.
The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation. Data presented below is only for participants with CTC > 0 cells/7.5 milliliters (mL) at baseline.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG002
Phase II: Placebo + Abiraterone
Secondary
Phase II: Percentage of Participants With CTC Reduction Response in Participants With ICR PTEN Loss
CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
The PTEN Loss population was defined as all randomised participants with PTEN loss tumours. Data presented below is only for PTEN loss participants with CTC > 0 cells/7.5 milliliters (mL) at baseline.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Secondary
Phase II: Percentage of Participants With CTC Conversion (ITT Population)
CTC conversion was defined as a decline to < 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline.
The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation. Data presented below is only for participants with CTC > 0 cells/7.5 milliliters (mL) at baseline.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG002
Phase II: Placebo + Abiraterone
Secondary
Phase II: Percentage of Participants With CTC Conversion in Participants With ICR PTEN Loss
CTC conversion was defined as a decline to < 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
The PTEN Loss population was defined as all randomised participants with PTEN loss tumours. Data presented below is only for PTEN loss participants with CTC > 0 cells/7.5 milliliters (mL) at baseline.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Secondary
Phase II: Percentage of Participants With Pain Progression (ITT Population)
Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10).
The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Posted
Number
percentage of participants
Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Secondary
Phase II: Percentage of Participants With Pain Progression in Participants With ICR PTEN Loss
Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.
Posted
Number
percentage of participants
Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Secondary
Phase II: Time to Pain Progression (ITT Population)
Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10).
The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Posted
Median
90% Confidence Interval
months
Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Secondary
Phase II: Time to Pain Progression in Participants With ICR PTEN Loss
Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression: ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of 4questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".
The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.
Posted
Median
90% Confidence Interval
months
Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Secondary
Phase II: Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment.
Posted
Number
percentage of participants
Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 8.9 years)
ID
Title
Description
OG000
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG002
Phase II: Placebo + Abiraterone
Secondary
Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data. Data were only analyzed in ipatasertib treatment arms. Total number analyzed represents all participants with evaluations at one or more time points.
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
Secondary
Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations
G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.
The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data. Data were only analyzed in ipatasertib treatment arms. Total number analyzed represents all participants with evaluations at one or more time points.
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Time Frame
Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
Description
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
1
14
9
14
14
14
EG001
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
0
6
5
6
6
6
EG002
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
67
84
43
84
82
84
EG003
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
71
86
42
88
79
88
EG004
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
68
83
18
81
76
81
EG005
Safety Cohort: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.
2
25
6
25
25
25
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG0032 events2 affected88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
COAGULOPATHY
Blood and lymphatic system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
HAEMOLYTIC URAEMIC SYNDROME
Blood and lymphatic system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
ATRIOVENTRICULAR BLOCK
Cardiac disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
BRADYCARDIA
Cardiac disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
CARDIAC FAILURE ACUTE
Cardiac disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
LEFT VENTRICULAR FAILURE
Cardiac disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
SUPRAVENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
CHORIORETINOPATHY
Eye disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ASCITES
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected84 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ENTERITIS
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
ENTEROCOLITIS
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
FAECALOMA
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
HAEMATOCHEZIA
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
LOWER GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
PHARYNGO-OESOPHAGEAL DIVERTICULUM
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
UPPER GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ASTHENIA
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
DEATH
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
DISEASE PROGRESSION
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
FATIGUE
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
GENERAL PHYSICAL HEALTH DETERIORATION
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
MALAISE
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
PAIN
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0023 events2 affected84 at risk
EG003
PYREXIA
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
OSTEOMYELITIS
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected84 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0011 events1 affected6 at risk
EG0023 events3 affected84 at risk
EG003
PYELONEPHRITIS
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
PYELONEPHRITIS ACUTE
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
SEPSIS
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
SEPTIC SHOCK
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
SPINAL CORD INFECTION
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
TUBERCULOSIS
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0026 events5 affected84 at risk
EG003
UROSEPSIS
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
VASCULAR DEVICE INFECTION
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ACCIDENTAL OVERDOSE
Injury, poisoning and procedural complications
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
RADIUS FRACTURE
Injury, poisoning and procedural complications
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
SKULL FRACTURE
Injury, poisoning and procedural complications
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
SUBDURAL HAEMATOMA
Injury, poisoning and procedural complications
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ULNA FRACTURE
Injury, poisoning and procedural complications
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
UPPER LIMB FRACTURE
Injury, poisoning and procedural complications
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
HAEMATOCRIT DECREASED
Investigations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected84 at risk
EG003
DIABETES MELLITUS INADEQUATE CONTROL
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
DIABETIC METABOLIC DECOMPENSATION
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
FAILURE TO THRIVE
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0012 events2 affected6 at risk
EG0022 events2 affected84 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
KETOACIDOSIS
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
HAEMATOMA MUSCLE
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
OSTEOLYSIS
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
SPINAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected84 at risk
EG003
PROSTATE CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected6 at risk
EG0023 events3 affected84 at risk
EG003
PROSTATIC ADENOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
SMALL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
SQUAMOUS CELL CARCINOMA OF SKIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
CEREBRAL HAEMATOMA
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
CEREBRAL HAEMORRHAGE
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ISCHAEMIC STROKE
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
NERVOUS SYSTEM DISORDER
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
SPINAL CORD COMPRESSION
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
VASCULAR ENCEPHALOPATHY
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
BLADDER PERFORATION
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
CALCULUS URINARY
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected84 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
NEPHROPATHY TOXIC
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
RENAL COLIC
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
URETERIC OBSTRUCTION
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
URETERIC STENOSIS
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
URETEROLITHIASIS
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected84 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
PELVIC PAIN
Reproductive system and breast disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
PROSTATITIS
Reproductive system and breast disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
ACUTE PULMONARY OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
INTERSTITIAL LUNG DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected84 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected84 at risk
EG003
TOXIC SKIN ERUPTION
Skin and subcutaneous tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
AORTIC ANEURYSM RUPTURE
Vascular disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected84 at risk
EG003
PELVIC VENOUS THROMBOSIS
Vascular disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
THROMBOSIS
Vascular disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
MULTIPLE FRACTURES
Injury, poisoning and procedural complications
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ROAD TRAFFIC ACCIDENT
Injury, poisoning and procedural complications
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
MALNUTRITION
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
DECUBITUS ULCER
Skin and subcutaneous tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0011 events1 affected6 at risk
EG00225 events19 affected84 at risk
EG00337 events18 affected88 at risk
EG00413 events8 affected81 at risk
EG0054 events2 affected25 at risk
PANCYTOPENIA
Blood and lymphatic system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected84 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG00212 events9 affected84 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0023 events2 affected84 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG00210 events8 affected84 at risk
EG003
CHEILOSIS
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0012 events2 affected6 at risk
EG0028 events8 affected84 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG00014 events9 affected14 at risk
EG0016 events4 affected6 at risk
EG002198 events65 affected84 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0011 events1 affected6 at risk
EG0023 events3 affected84 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected6 at risk
EG0029 events9 affected84 at risk
EG003
ERUCTATION
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0023 events3 affected84 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG00011 events6 affected14 at risk
EG0014 events4 affected6 at risk
EG00274 events45 affected84 at risk
EG003
ORAL DISORDER
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected84 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
RETCHING
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected84 at risk
EG003
TONGUE DISCOLOURATION
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected84 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG00014 events9 affected14 at risk
EG0013 events3 affected6 at risk
EG00242 events27 affected84 at risk
EG003
ASTHENIA
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0004 events4 affected14 at risk
EG0011 events1 affected6 at risk
EG00236 events23 affected84 at risk
EG003
FATIGUE
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG00011 events9 affected14 at risk
EG0011 events1 affected6 at risk
EG00236 events22 affected84 at risk
EG003
GAIT DISTURBANCE
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0003 events3 affected14 at risk
EG0010 events0 affected6 at risk
EG0024 events3 affected84 at risk
EG003
OEDEMA
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG00213 events10 affected84 at risk
EG003
PAIN
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0027 events7 affected84 at risk
EG003
PYREXIA
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0013 events3 affected6 at risk
EG00228 events12 affected84 at risk
EG003
THIRST
General disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected84 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0025 events5 affected84 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0010 events0 affected6 at risk
EG0026 events5 affected84 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0003 events2 affected14 at risk
EG0010 events0 affected6 at risk
EG00216 events14 affected84 at risk
EG003
FUNGAL URETHRITIS
Infections and infestations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
MENISCUS INJURY
Injury, poisoning and procedural complications
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0028 events5 affected84 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected84 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0027 events7 affected84 at risk
EG003
BLOOD URINE PRESENT
Investigations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0005 events5 affected14 at risk
EG0011 events1 affected6 at risk
EG00231 events21 affected84 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0003 events3 affected14 at risk
EG0012 events2 affected6 at risk
EG0023 events3 affected84 at risk
EG003
FAILURE TO THRIVE
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected84 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0007 events6 affected14 at risk
EG0014 events2 affected6 at risk
EG00226 events19 affected84 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected84 at risk
EG003
HYPERTRIGLYCERIDAEMIA
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0029 events6 affected84 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected6 at risk
EG00220 events8 affected84 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0026 events6 affected84 at risk
EG003
HYPOVOLAEMIA
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected84 at risk
EG003
INCREASED APPETITE
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0004 events2 affected14 at risk
EG0011 events1 affected6 at risk
EG00233 events17 affected84 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG00225 events18 affected84 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected6 at risk
EG00220 events12 affected84 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected84 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0025 events3 affected84 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected84 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG00219 events7 affected84 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0005 events4 affected14 at risk
EG0011 events1 affected6 at risk
EG0028 events6 affected84 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected84 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0003 events2 affected14 at risk
EG0010 events0 affected6 at risk
EG00215 events13 affected84 at risk
EG003
PAIN IN JAW
Musculoskeletal and connective tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0024 events3 affected84 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0004 events3 affected14 at risk
EG0010 events0 affected6 at risk
EG00216 events11 affected84 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0028 events6 affected84 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0003 events2 affected14 at risk
EG0010 events0 affected6 at risk
EG00214 events9 affected84 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
LETHARGY
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected84 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0023 events3 affected84 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0023 events3 affected84 at risk
EG003
AGITATION
Psychiatric disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0023 events3 affected84 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0010 events0 affected6 at risk
EG0023 events3 affected84 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG00211 events9 affected84 at risk
EG003
RESTLESSNESS
Psychiatric disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected6 at risk
EG0024 events2 affected84 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0029 events8 affected84 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG00216 events10 affected84 at risk
EG003
HYPERTONIC BLADDER
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0023 events3 affected84 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected6 at risk
EG0023 events3 affected84 at risk
EG003
RENAL PAIN
Renal and urinary disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected84 at risk
EG003
PELVIC PAIN
Reproductive system and breast disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0028 events7 affected84 at risk
EG003
PENILE PAIN
Reproductive system and breast disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG00213 events7 affected84 at risk
EG003
DRY THROAT
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected84 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected84 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG00213 events11 affected84 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0011 events1 affected6 at risk
EG0023 events3 affected84 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected84 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected84 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected84 at risk
EG003
ECCHYMOSIS
Skin and subcutaneous tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
HAEMORRHAGE SUBCUTANEOUS
Skin and subcutaneous tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected6 at risk
EG0022 events1 affected84 at risk
EG003
ONYCHOLYSIS
Skin and subcutaneous tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected84 at risk
EG003
NIGHT SWEATS
Skin and subcutaneous tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0024 events3 affected84 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0015 events3 affected6 at risk
EG00216 events10 affected84 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0003 events2 affected14 at risk
EG0013 events2 affected6 at risk
EG0029 events4 affected84 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected6 at risk
EG00210 events10 affected84 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG00215 events11 affected84 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected6 at risk
EG0023 events3 affected84 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0028 events4 affected84 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0026 events3 affected84 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
TASTE DISORDER
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
TREMOR
Nervous system disorders
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected84 at risk
EG003
BLOOD TRIGLYCERIDES INCREASED
Investigations
MedDRA18.1/23.1/25.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected84 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator 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. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Communications
Hoffmann-La Roche
800 821-8590
genentech@druginfo.com
ID
Term
D011471
Prostatic Neoplasms
Ancestor Terms
ID
Term
D005834
Genital Neoplasms, Male
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D005832
Genital Diseases, Male
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D011469
Prostatic Diseases
D052801
Male Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C089740
abiraterone
C583616
ipatasertib
D011241
Prednisone
D011239
Prednisolone
Ancestor Terms
ID
Term
D011244
Pregnadienediols
D011245
Pregnadienes
D011278
Pregnanes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
D011246
Pregnadienetriols
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
81 subjects
FG0050 subjects
0 subjects
FG0050 subjects
83 subjects
FG0050 subjects
71 subjects
FG00468 subjects
FG0050 subjects
Progression of Disease
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0026 subjects
FG0033 subjects
FG0044 subjects
FG0050 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0033 subjects
FG0045 subjects
FG0050 subjects
Study Ended
FG0000 subjects
FG0010 subjects
FG0027 subjects
FG0038 subjects
FG0046 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG00525 subjects
0 subjects
FG0040 subjects
FG0052 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0055 subjects
Progression of Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0059 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0056 subjects
Discontinuation of Survival Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
68.8
± 7.2
BG00467.6± 7.8
BG00573.7± 8.8
BG00668.3± 8.2
0
BG0030
BG0040
BG0050
BG0060
Male
BG00014
BG0016
BG00284
BG00386
BG00483
BG00525
BG006298
4
BG0035
BG0044
BG0051
BG00614
Not Hispanic or Latino
BG00013
BG0016
BG00270
BG00363
BG00468
BG00524
BG006244
Unknown or Not Reported
BG0001
BG0010
BG00210
BG00318
BG00411
BG0050
BG00640
0
BG0030
BG0040
BG0050
BG0060
Asian
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0061
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
Black or African American
BG0001
BG0011
BG0025
BG0031
BG0041
BG0050
BG0069
White
BG00013
BG0015
BG00273
BG00375
BG00473
BG00524
BG006263
More than one race
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0061
Unknown or Not Reported
BG0000
BG0010
BG0025
BG0039
BG0049
BG0050
BG00623
Units
Counts
Participants
OG00014
OG0016
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
Units
Counts
Participants
OG00014
OG0016
Title
Denominators
Categories
Ipatasertib
ParticipantsOG00014
ParticipantsOG0010
Title
Measurements
OG000400
Apitolisib
ParticipantsOG0000
ParticipantsOG0016
Title
Measurements
OG001NABased on safety analysis further testing of apitolisib arm was discontinued.
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00084
OG00186
OG00283
Title
Denominators
Categories
Title
Measurements
OG0008.18(6.67 to 10.87)
OG0018.31(6.44 to 10.48)
OG0026.37(4.60 to 8.34)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Log Rank
0.1606
Hazard Ratio (HR)
0.77
2-Sided
90
0.56
1.04
Superiority
Unstratified
OG001
OG002
Log Rank
0.5300
Hazard Ratio (HR)
0.89
2-Sided
90
0.66
1.20
Superiority
Unstratified
OG000
OG002
Log Rank
0.1689
Hazard Ratio (HR)
0.75
2-Sided
90
0.54
1.05
Superiority
Strata are: prior enzalutamide (Yes vs. No), progression factor (prostate-specific antigen [PSA] only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).
OG001
OG002
Log Rank
0.7484
Hazard Ratio (HR)
0.94
2-Sided
90
0.69
1.28
Superiority
Strata are: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00025
OG00125
OG00221
Title
Denominators
Categories
Title
Measurements
OG00011.53(6.67 to 13.73)
OG00111.10(6.34 to 16.36)
OG0024.60(4.40 to 6.37)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Log Rank
0.0064
Hazard Ratio (HR)
0.39
2-Sided
90
0.22
0.70
Superiority
Unstratified
OG001
OG002
Log Rank
0.0285
Hazard Ratio (HR)
0.46
2-Sided
90
0.25
0.83
Superiority
Unstratified
14
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00014
Title
Measurements
OG000269± 41.3
Cycle 1, Day 15
ParticipantsOG00012
Title
Measurements
OG000466± 36.2
14
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00014
Title
Measurements
OG0002.00(0.97 to 4.05)
Cycle 1, Day 15
ParticipantsOG00012
Title
Measurements
OG0002.02(1.00 to 6.00)
14
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00014
Title
Measurements
OG0001710± 54.7
Cycle 1, Day 15
ParticipantsOG00012
Title
Measurements
OG0003290± 37.0
12
Title
Denominators
Categories
Title
Measurements
OG00099600± 50.7
12
Title
Denominators
Categories
Title
Measurements
OG0001.82± 40.9
14
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00014
Title
Measurements
OG000117± 64.4
Cycle 1, Day 15
ParticipantsOG00012
Title
Measurements
OG000326± 42.4
14
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00014
Title
Measurements
OG0002.00(1.00 to 4.05)
Cycle 1, Day 15
ParticipantsOG00012
Title
Measurements
OG0002.10(1.00 to 6.00)
14
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00014
Title
Measurements
OG000839± 70.3
Cycle 1, Day 15
ParticipantsOG00012
Title
Measurements
OG0002850± 71.7
12
Title
Denominators
Categories
Title
Measurements
OG0002.79± 54.4
6
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG0006
Title
Measurements
OG000190± 35.2
Cycle 1, Day 15
ParticipantsOG0002
Title
Measurements
OG000193± 16.2
6
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG0006
Title
Measurements
OG0002.02(1.00 to 4.10)
Cycle 1, Day 15
ParticipantsOG0002
Title
Measurements
OG0002.04(2.00 to 2.08)
6
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG0006
Title
Measurements
OG0001600± 47.5
Cycle 1, Day 15
ParticipantsOG0002
Title
Measurements
OG0001640± 5.65
14
OG0016
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00014
ParticipantsOG0016
Title
Measurements
OG000151± 123.6
OG00188.2± 218
Cycle 1, Day 15
ParticipantsOG00012
ParticipantsOG0012
Title
Measurements
OG000140± 124.4
OG001
14
OG0016
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00014
ParticipantsOG0016
Title
Measurements
OG0002.05(2.00 to 6.45)
OG0012.01(1.00 to 4.03)
Cycle 1, Day 15
ParticipantsOG00012
ParticipantsOG0012
Title
Measurements
OG0002.17(2.00 to 6.00)
OG001
12
OG0016
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00012
ParticipantsOG0016
Title
Measurements
OG000749± 92.0
OG001475± 203.4
Cycle 1, Day 15
ParticipantsOG0006
ParticipantsOG0011
Title
Measurements
OG000961± 87.2
OG001
10
OG0015
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00010
ParticipantsOG0015
Title
Measurements
OG0005.25± 13.0
OG0017.68± 26.2
Cycle 1, Day 15
ParticipantsOG0006
ParticipantsOG0011
Title
Measurements
OG0006.92± 23.5
OG001
OG00012
OG0011
Title
Denominators
Categories
Title
Measurements
OG0000.823± 70.7
OG0010.882± NAGeometric Coefficient of Variation could not be estimated as only 1 participant was evaluated.
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00084
OG00186
OG00283
Title
Denominators
Categories
Title
Measurements
OG00018.27(16.66 to 24.21)
OG00117.31(13.83 to 22.41)
OG00218.37(13.80 to 20.96)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Log Rank
0.4170
Hazard Ratio (HR)
0.87
2-Sided
95
0.62
1.22
Superiority
Unstratified
OG001
OG002
Log Rank
0.6712
Hazard Ratio (HR)
0.93
2-Sided
95
0.67
1.30
Superiority
Unstratified
OG000
OG002
Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).
Log Rank
0.5164
Hazard Ratio (HR)
0.89
2-Sided
95
0.62
1.27
Superiority
OG001
OG002
Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).
Log Rank
0.8955
Hazard Ratio (HR)
1.02
2-Sided
95
0.72
1.44
Superiority
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00025
OG00125
OG00221
Title
Denominators
Categories
Title
Measurements
OG00017.12(12.32 to 28.02)
OG00128.45(13.24 to 33.28)
OG00217.28(11.30 to 20.96)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Log Rank
0.1472
Hazard Ratio (HR)
0.63
2-Sided
95
0.33
1.19
Superiority
Unstratified
OG001
OG002
Log Rank
0.0157
Hazard Ratio (HR)
0.45
2-Sided
95
0.23
0.87
Superiority
Unstratified
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00084
OG00186
OG00283
Title
Denominators
Categories
Title
Measurements
OG00057.1
OG00169.8
OG00272.3
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00025
OG00125
OG00221
Title
Denominators
Categories
Title
Measurements
OG00072.0
OG00164.0
OG00266.7
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00084
OG00186
OG00283
Title
Denominators
Categories
Title
Measurements
OG0005.55± 4.17(4.17 to 7.39)
OG0013.78± 2.79(2.79 to 5.49)
OG0023.71± 2.79(2.79 to 4.67)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Log Rank
= 0.0665
Hazard Ratio (HR)
0.70
2-Sided
90
0.51
0.97
Superiority
OG001
OG002
Log Rank
= 0.9319
Hazard Ratio (HR)
0.99
2-Sided
90
0.73
1.33
Superiority
OG000
OG002
Strata were: prior Enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).
Log Rank
= 0.0710
Hazard Ratio (HR)
0.70
2-Sided
90
0.50
0.97
Superiority
OG001
OG002
Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).
Log Rank
= 0.7890
Hazard Ratio (HR)
0.95
2-Sided
90
0.70
1.31
Superiority
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00025
OG00125
OG00221
Title
Denominators
Categories
Title
Measurements
OG0003.71± 2.99(2.99 to 8.18)
OG0012.92± 2.07(2.07 to 7.39)
OG0022.79± 1.02(1.02 to 4.67)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Log Rank
= 0.2906
Hazard Ratio (HR)
0.68
2-Sided
90
0.37
1.25
Superiority
OG001
OG002
Log Rank
= 0.2716
Hazard Ratio (HR)
0.65
2-Sided
90
0.35
1.22
Superiority
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00084
OG00186
OG00283
Title
Denominators
Categories
Title
Measurements
OG00036.9(28.11 to 46.40)
OG00133.7(25.29 to 42.93)
OG00234.9(26.25 to 43.75)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Chi-squared
= 0.7913
Difference in response rates
1.97
2-Sided
90
-10.25
14.18
Superiority
Unstratified
OG001
OG002
Chi-squared
= 0.8675
Difference in response rates
-1.22
2-Sided
90
-13.24
10.80
Superiority
Unstratified
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00025
OG00125
OG00221
Title
Denominators
Categories
Title
Measurements
OG00040.0(24.57 to 58.32)
OG00144.0(26.99 to 61.06)
OG00228.6(13.24 to 46.41)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Chi-squared
= 0.4176
Difference in response rates
11.43
2-Sided
90
-11.43
58.32
Superiority
OG001
OG002
Chi-squared
= 0.2802
Difference in response rates
15.43
2-Sided
90
-7.58
38.44
Superiority
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00037
OG00139
OG00235
Title
Denominators
Categories
Title
Measurements
OG00032.4± 20.56(20.56 to 46.41)
OG00123.1± 13.69(13.69 to 35.63)
OG00222.9± 11.91(11.91 to 36.46)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Chi-squared
= 0.3646
Difference in response rates
9.58
2-Sided
90
-7.65
26.80
Superiority
OG001
OG002
Chi-squared
= 0.9821
Difference in response rates
0.22
2-Sided
90
-15.89
16.33
Superiority
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG0009
OG00115
OG0027
Title
Denominators
Categories
Title
Measurements
OG00011.1(1.16 to 39.09)
OG00126.7(12.18 to 50.00)
OG00214.3(1.49 to 50.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Chi-squared
= 0.8489
Difference in response rates
-3.17
2-Sided
90
-30.93
24.58
Superiority
OG001
OG002
Chi-squared
= 0.5186
Difference in response rates
12.38
2-Sided
90
-16.36
41.12
Superiority
OG001
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00012
OG0019
OG0028
Title
Denominators
Categories
Title
Measurements
OG0008.77(3.75 to NA)Data was not evaluable due to an insufficient number of events.
OG001NA(6.47 to NA)Data was not evaluable due to an insufficient number of events.
OG002NA(2.76 to NA)Data was not evaluable due to an insufficient number of events.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Log Rank
= 0.6780
Hazard Ratio (HR)
1.31
2-Sided
90
0.45
3.80
Superiority
Unstratified
OG001
OG002
Log Rank
= 0.8372
Hazard Ratio (HR)
0.85
2-Sided
90
0.24
3.02
Superiority
Unstratified
OG000
OG002
Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).
Log Rank
= 0.7733
Hazard Ratio (HR)
0.77
2-Sided
90
0.17
3.50
Superiority
OG001
OG002
Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).
Log Rank
= 0.4227
Hazard Ratio (HR)
2.46
2-Sided
90
0.36
16.59
Superiority
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG0001
OG0014
OG0021
Title
Denominators
Categories
Title
Measurements
OG0008.77(NA to NA)NA = Not estimable due to limited number of events observed
OG001NA(0.99 to NA)NA = Not estimable due to limited number of events observed
OG002NA(NA to NA)NA = Not estimable due to limited number of events observed
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Log Rank
= 0.3173
Hazard Ratio (HR)
999.99
2-Sided
90
0.00
NA = Not estimable due to limited number of events observed
>
Superiority
OG001
OG002
Log Rank
= 0.6171
Hazard Ratio (HR)
999.99
2-Sided
90
0.00
NA = Not estimable due to limited number of events observed
>
Superiority
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00058
OG00162
OG00263
Title
Denominators
Categories
Title
Measurements
OG00067.2(56.44 to 77.37)
OG00171.0(61.07 to 80.32)
OG00263.5(52.41 to 73.60)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Chi-squared
= 0.6652
Difference in response rates
3.75
2-Sided
90
-10.47
17.97
Superiority
OG001
OG002
Chi-squared
= 0.3734
Difference in response rates
7.48
2-Sided
90
-6.29
21.24
Superiority
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00020
OG00120
OG00217
Title
Denominators
Categories
Title
Measurements
OG00075.0(55.80 to 87.42)
OG00175.0(55.80 to 87.42)
OG00270.6(50.00 to 85.95)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Chi-squared
= 0.7633
Difference in response rates
4.41
2-Sided
90
-19.76
28.58
Superiority
OG001
OG002
Chi-squared
= 0.7633
Difference in response rates
4.41
2-Sided
90
-19.76
28.58
Superiority
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00041
OG00147
OG00248
Title
Denominators
Categories
Title
Measurements
OG00043.9± 31.18(31.18 to 57.87)
OG00146.8± 34.48(34.48 to 59.72)
OG00241.7± 29.59(29.59 to 54.55)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Chi-squared
= 0.8317
Difference in response rates
2.24
2-Sided
90
-15.07
19.54
Superiority
OG001
OG002
Chi-squared
= 0.6139
Difference in response rates
5.14
2-Sided
90
-11.60
21.88
Superiority
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00012
OG00118
OG00222
Title
Denominators
Categories
Title
Measurements
OG00066.7(39.84 to 84.58)
OG00122.2(10.06 to 41.88)
OG00231.8(18.11 to 50.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Chi-squared
= 0.0505
Difference in response rates
34.85
2-Sided
90
7.14
62.56
Superiority
OG001
OG002
Chi-squared
= 0.4989
Difference in response rates
-9.60
2-Sided
90
-32.54
13.35
Superiority
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00084
OG00186
OG00283
Title
Denominators
Categories
Title
Measurements
OG00033.3
OG00134.9
OG00234.9
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00025
OG00125
OG00221
Title
Denominators
Categories
Title
Measurements
OG00040.0
OG00128.0
OG00233.3
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00084
OG00186
OG00283
Title
Denominators
Categories
Title
Measurements
OG00013.90(8.61 to NA)Data was not evaluable because of an insufficient number of events.
OG00116.16(8.54 to NA)Data was not evaluable because of an insufficient number of events.
OG00215.15(11.07 to NA)Data was not evaluable because of an insufficient number of events.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Log Rank
= 0.8483
Hazard Ratio (HR)
0.95
2-Sided
90
0.61
1.47
Superiority
Unstratified
OG001
OG002
Log Rank
= 0.7850
Hazard Ratio (HR)
1.08
2-Sided
90
0.70
1.65
Superiority
Unstratified
OG000
OG002
Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).
Log Rank
= 0.8847
Hazard Ratio (HR)
1.04
2-Sided
90
0.66
1.65
Superiority
OG001
OG002
Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).
Log Rank
= 0.8647
Hazard Ratio (HR)
1.05
2-Sided
90
0.67
1.63
Superiority
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
OG002
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00025
OG00125
OG00221
Title
Denominators
Categories
Title
Measurements
OG00016.49(7.59 to 16.49)
OG001NA(8.28 to NA)Data was not evaluable because of an insufficient number of events.
OG0026.93(5.65 to NA)Data was not evaluable because of an insufficient number of events.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Log Rank
= 0.8271
Hazard Ratio (HR)
0.89
2-Sided
90
0.39
2.06
Superiority
OG001
OG002
Log Rank
= 0.7383
Hazard Ratio (HR)
0.84
2-Sided
90
0.35
2.02
Superiority
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Units
Counts
Participants
OG00084
OG00188
OG00281
Title
Denominators
Categories
Title
Measurements
OG00098.8
OG00196.6
OG00293.8
OG00083
OG00186
Title
Denominators
Categories
Cycle 1, Day 1: 1 hour postdose
ParticipantsOG00043
ParticipantsOG00147
Title
Measurements
OG000101± 359.5
OG00163.4± 187.2
Cycle 1, Day 1: 4 hours postdose
ParticipantsOG00072
ParticipantsOG00176
Title
Measurements
OG000180± 103.4
OG001
Cycle 1, Day 15: predose
ParticipantsOG00074
ParticipantsOG00181
Title
Measurements
OG00053.1± 97.2
OG001
Cycle 1, Day 15: 2 hours postdose
ParticipantsOG00069
ParticipantsOG00177
Title
Measurements
OG000213± 174.3
OG001
Cycle 1, Day 15: 4 hours postdose
ParticipantsOG00072
ParticipantsOG00177
Title
Measurements
OG000272± 137.9
OG001
Cycle 2, Day 1: predose
ParticipantsOG00073
ParticipantsOG00182
Title
Measurements
OG00046.7± 138.6
OG001
Cycle 2, Day 1: 1-4 hours postdose
ParticipantsOG00070
ParticipantsOG00182
Title
Measurements
OG000243± 94.4
OG001
Units
Counts
Participants
OG00082
OG00186
Title
Denominators
Categories
Cycle 1, Day 1: 1 hour postdose
ParticipantsOG00035
ParticipantsOG00140
Title
Measurements
OG00034.7± 223.1
OG00113.9± 268.9
Cycle 1, Day 1: 4 hours postdose
ParticipantsOG00069
ParticipantsOG00175
Title
Measurements
OG000101± 61.8
OG001
Cycle 1, Day 15: predose
ParticipantsOG00073
ParticipantsOG00180
Title
Measurements
OG00044.1± 92.4
OG001
Cycle 1, Day 15: 2 hours postdose
ParticipantsOG00069
ParticipantsOG00177
Title
Measurements
OG000121± 159.4
OG001
Cycle 1, Day 15: 4 hours postdose
ParticipantsOG00072
ParticipantsOG00176
Title
Measurements
OG000178± 134.0
OG001
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
2 events
2 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0042 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0042 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
1 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
2 events
2 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0042 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
2 events
2 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
6 events
5 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
3 events
3 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
2 events
2 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
2 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
2 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
3 events
2 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
2 events
2 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
2 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
2 events
2 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0044 events3 affected81 at risk
EG0050 events0 affected25 at risk
13 events
10 affected
88 at risk
EG0043 events3 affected81 at risk
EG0052 events2 affected25 at risk
2 events
2 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
5 events
4 affected
88 at risk
EG0047 events5 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
26 events
18 affected
88 at risk
EG00422 events16 affected81 at risk
EG0050 events0 affected25 at risk
72 events
42 affected
88 at risk
EG00436 events20 affected81 at risk
EG00563 events17 affected25 at risk
0 events
0 affected
88 at risk
EG0044 events4 affected81 at risk
EG0050 events0 affected25 at risk
8 events
7 affected
88 at risk
EG0043 events3 affected81 at risk
EG0056 events3 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
5 events
5 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
44 events
31 affected
88 at risk
EG00430 events21 affected81 at risk
EG00524 events12 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
3 events
2 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
69 events
24 affected
88 at risk
EG00424 events12 affected81 at risk
EG00512 events5 affected25 at risk
24 events
20 affected
88 at risk
EG00415 events13 affected81 at risk
EG0054 events2 affected25 at risk
37 events
25 affected
88 at risk
EG00432 events24 affected81 at risk
EG0057 events5 affected25 at risk
1 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
11 events
9 affected
88 at risk
EG0047 events7 affected81 at risk
EG0050 events0 affected25 at risk
14 events
9 affected
88 at risk
EG0042 events2 affected81 at risk
EG0051 events1 affected25 at risk
16 events
12 affected
88 at risk
EG00413 events9 affected81 at risk
EG0055 events4 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
4 events
4 affected
88 at risk
EG0043 events3 affected81 at risk
EG0050 events0 affected25 at risk
9 events
7 affected
88 at risk
EG0043 events3 affected81 at risk
EG0050 events0 affected25 at risk
12 events
7 affected
88 at risk
EG0049 events6 affected81 at risk
EG0053 events3 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
5 events
4 affected
88 at risk
EG0041 events1 affected81 at risk
EG00510 events3 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0051 events1 affected25 at risk
5 events
4 affected
88 at risk
EG0042 events1 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
28 events
21 affected
88 at risk
EG00413 events12 affected81 at risk
EG0053 events2 affected25 at risk
2 events
2 affected
88 at risk
EG0042 events2 affected81 at risk
EG0052 events2 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
12 events
7 affected
88 at risk
EG0048 events5 affected81 at risk
EG00518 events8 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
4 events
3 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
5 events
4 affected
88 at risk
EG0045 events4 affected81 at risk
EG0051 events1 affected25 at risk
13 events
6 affected
88 at risk
EG0049 events7 affected81 at risk
EG0057 events4 affected25 at risk
1 events
1 affected
88 at risk
EG0042 events2 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
30 events
17 affected
88 at risk
EG00427 events21 affected81 at risk
EG0053 events3 affected25 at risk
41 events
20 affected
88 at risk
EG00428 events20 affected81 at risk
EG0053 events1 affected25 at risk
15 events
12 affected
88 at risk
EG00420 events18 affected81 at risk
EG0051 events1 affected25 at risk
3 events
3 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
6 events
6 affected
88 at risk
EG0042 events2 affected81 at risk
EG0050 events0 affected25 at risk
8 events
7 affected
88 at risk
EG0043 events3 affected81 at risk
EG0050 events0 affected25 at risk
8 events
5 affected
88 at risk
EG00410 events7 affected81 at risk
EG0050 events0 affected25 at risk
3 events
3 affected
88 at risk
EG0045 events5 affected81 at risk
EG0050 events0 affected25 at risk
4 events
4 affected
88 at risk
EG0043 events3 affected81 at risk
EG0051 events1 affected25 at risk
24 events
13 affected
88 at risk
EG00414 events8 affected81 at risk
EG0054 events4 affected25 at risk
1 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
8 events
6 affected
88 at risk
EG0045 events5 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0043 events3 affected81 at risk
EG0052 events2 affected25 at risk
5 events
5 affected
88 at risk
EG0049 events6 affected81 at risk
EG0051 events1 affected25 at risk
9 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
9 events
5 affected
88 at risk
EG0043 events3 affected81 at risk
EG0050 events0 affected25 at risk
2 events
2 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
5 events
5 affected
88 at risk
EG0043 events3 affected81 at risk
EG0052 events2 affected25 at risk
3 events
3 affected
88 at risk
EG0041 events1 affected81 at risk
EG0051 events1 affected25 at risk
10 events
10 affected
88 at risk
EG0045 events5 affected81 at risk
EG0052 events2 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
2 events
2 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
4 events
2 affected
88 at risk
EG0042 events2 affected81 at risk
EG0052 events2 affected25 at risk
13 events
6 affected
88 at risk
EG0046 events5 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
2 events
2 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
11 events
9 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
7 events
5 affected
88 at risk
EG0040 events0 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
7 events
6 affected
88 at risk
EG0047 events7 affected81 at risk
EG0051 events1 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
3 events
2 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
10 events
9 affected
88 at risk
EG0047 events6 affected81 at risk
EG0055 events3 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
2 events
2 affected
88 at risk
EG0041 events1 affected81 at risk
EG0051 events1 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
4 events
4 affected
88 at risk
EG0044 events2 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0044 events3 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0051 events1 affected25 at risk
7 events
5 affected
88 at risk
EG0043 events3 affected81 at risk
EG0053 events2 affected25 at risk
2 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG00514 events7 affected25 at risk
5 events
5 affected
88 at risk
EG0047 events7 affected81 at risk
EG0050 events0 affected25 at risk
13 events
12 affected
88 at risk
EG00412 events9 affected81 at risk
EG0051 events1 affected25 at risk
1 events
1 affected
88 at risk
EG0041 events1 affected81 at risk
EG0050 events0 affected25 at risk
4 events
2 affected
88 at risk
EG0043 events3 affected81 at risk
EG0053 events3 affected25 at risk
2 events
2 affected
88 at risk
EG0041 events1 affected81 at risk
EG00512 events3 affected25 at risk
4 events
3 affected
88 at risk
EG0041 events1 affected81 at risk
EG0053 events3 affected25 at risk
0 events
0 affected
88 at risk
EG0041 events1 affected81 at risk
EG0052 events2 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0050 events0 affected25 at risk
1 events
1 affected
88 at risk
EG0040 events0 affected81 at risk
EG0052 events2 affected25 at risk
0 events
0 affected
88 at risk
EG0040 events0 affected81 at risk
EG0052 events2 affected25 at risk
52.7
± 182
3.04
(2.00 to 4.08)
220
± NA
Geometric Coefficient of Variation could not be estimated as only 1 participant was evaluated.
14.70
± NA
Geometric Coefficient of Variation could not be estimated as only 1 participant was evaluated.