A Study of Multiple Immunotherapy-Based Treatment Combina... | NCT03280563 | Trialant
NCT03280563
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Nov 10, 2025Actual
Enrollment
144Actual
Phase
Phase 1Phase 2
Conditions
Breast Neoplasms
Interventions
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Bevacizumab
Entinostat
Exemestane
Fulvestrant
Ipatasertib
Tamoxifen
Abemaciclib
Countries
United States
Israel
South Korea
Protocol Section
Identification Module
NCT ID
NCT03280563
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CO39611
Secondary IDs
ID
Type
Description
Link
2017-000335-14
EudraCT Number
Brief Title
A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
Official Title
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Hormone Receptor-Positive HER2-Negative Breast Cancer (MORPHEUS-HR+ Breast Cancer)
Acronym
MORPHEUS HR+BC
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Oct 2025
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
Dec 22, 2017Actual
Primary Completion Date
Sep 26, 2024Actual
Completion Date
Sep 26, 2024Actual
First Submitted Date
Sep 11, 2017
First Submission Date that Met QC Criteria
Sep 11, 2017
First Posted Date
Sep 12, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Sep 22, 2025
Results First Submitted that Met QC Criteria
Oct 23, 2025
Results First Posted Date
Nov 10, 2025Actual
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
Oct 23, 2025
Last Update Posted Date
Nov 10, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor in the first- or second-line setting, such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and/or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.
Detailed Description
Not provided
Conditions Module
Conditions
Breast Neoplasms
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
144Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stage 1: Fulvestrant
Active Comparator
Participants will receive fulvestrant until unacceptable toxicity or disease progression according to RECIST v1.1.
Drug: Fulvestrant
Stage 1: Atezolizumab + Entinostat
Experimental
Participants will receive doublet combination treatment with atezolizumab plus entinostat until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Drug: Entinostat
Stage 1: Atezolizumab + Fulvestrant
Experimental
Participants will receive doublet combination treatment with atezolizumab plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Drug: Fulvestrant
Stage 1: Atezolizumab + Ipatasertib
Experimental
Participants will receive doublet combination treatment with atezolizumab plus ipatasertib until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Prior to enrollment into this arm, the first 6 participants in the study will complete a safety run-in with atezolizumab plus ipatasertib.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Drug
Atezolizumab will be given as 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle. This regimen will apply to all arms except when given with entinostat in Stage 1, or exemestane or tamoxifen in Stage 2, in which atezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Stage 1: Percentage of Participants With Objective Response
Objective response rate (ORR) was defined as the percentage of participants with an objective response of complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) that have a reduction in short axis to < 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. Percentages have been rounded off to the nearest whole number.
Up to 50.4 months
Secondary Outcomes
Measure
Description
Time Frame
Stage 1: Progression-free Survival (PFS)
PFS was defined as the time from randomization to the date of the first recorded occurrence of PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study including baseline in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for PFS.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria for Both Stages:
Measurable disease per RECIST v1.1
Adequate hematologic and end organ function
Disease progression during or after first- or second-line hormonal therapy with CDK4/6 inhibitor
Inclusion Criteria for Stage 1:
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Metastatic or inoperable, locally advanced, histologically or cytologically confirmed invasive HR-positive HER2-negative breast cancer
Recommended for endocrine therapy, and cytotoxic chemotherapy not indicated at study entry
Recurrence or progression following most recent systemic breast cancer therapy
Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease
Postmenopausal according to protocol-defined criteria
Life expectancy >3 months
Available tumor specimen for determination of PD-L1 status
Inclusion Criteria for Stage 2:
ECOG performance status of 0-2
Ability to initiate treatment within 3 months after disease progression or unacceptable toxicity on a Stage 1 regimen
Exclusion Criteria for Both Stages:
Significant or uncontrolled comorbid disease as specified in the protocol
Uncontrolled tumor-related pain
Autoimmune disease except for stable/controlled hypothyroidism, Type 1 diabetes mellitus, or certain dermatologic conditions
Positive human immunodeficiency virus test
Active hepatitis B or C
Active tuberculosis
Severe infection within 4 weeks and/or antibiotics within 2 weeks prior to study treatment
Prior allogeneic stem cell or solid organ transplantation
History of malignancy other than breast cancer within 2 years prior to screening except those with negligible risk of metastasis/death
History of or known hypersensitivity to study drug or excipients
For patients entering Stage 2, recovery from all immunotherapy-related adverse events to Grade 1 or better or to baseline at the time of consent
Exclusion Criteria for Stage 1:
Prior fulvestrant or cytotoxic chemotherapy for metastatic breast cancer, or certain other agents as specified in the protocol
Unresolved AEs from prior anti-cancer therapy
Eligibility only for the control arm
Prior treatment with inhibitors as specified in the protocol
Exclusion Criteria for Stage 2:
Unacceptable toxicity with atezolizumab during Stage 1
Uncontrolled cardiovascular disease or coagulation disorder, including use of anticoagulants as specified in the protocol
Significant abdominal or intestinal manifestations within 6 months prior to treatment
Grade 2 or higher proteinuria
Accepts Healthy Volunteers
No
Sex
Female
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
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Alabama at Birmingham
Birmingham
Alabama
35249
United States
UCSF Helen Diller Family CCC
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 two stages: Stage 1: participants were randomized to either the control arm (fulvestrant) or the experimental arms. Stage 2: participants from Stage 1 who experienced unacceptable toxicity, disease progression (PD), or loss of clinical benefit received treatment in Stage 2. Stage 1 participants who did not enter Stage 2 and Stage 2 participants who completed treatment entered the long-term survival follow-up.
Recruitment Details
A total of 144 participants with inoperable locally advanced or metastatic hormone receptor-positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer took part in the study at 26 investigative sites across the United States of America and South Korea from 22 December 2017 to 26 September 2024. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Fulvestrant Control
Participants received fulvestrant, 500 milligrams (mg), as an intramuscular (IM) injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG001
Periods
Title
Milestones
Reasons Not Completed
Stage 1
Type
Comment
Milestone Data
STARTED
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
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Feb 7, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Ipatasertib
Stage 1: Atezolizumab + Ipatasertib + Fulvestrant
Experimental
Participants will receive triplet combination treatment with atezolizumab plus ipatasertib plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Prior to enrollment into this arm, the first 6 participants in the study will complete a safety run-in with atezolizumab plus ipatasertib.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Those who progress or experience unacceptable toxicity during treatment in Stage 1 may be eligible to enter Stage 2. Participants will receive triplet combination therapy with atezolizumab plus bevacizumab plus one of three endocrine therapies (fulvestrant, exemestane, or tamoxifen) selected by the physician. Treatment in Stage 2 will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Drug: Bevacizumab
Drug: Exemestane
Drug: Fulvestrant
Drug: Tamoxifen
Stage 1: Mandatory On-Treatment Biopsy
Experimental
For experimental combination arms that demonstrate clinical activity during the preliminary phase, the Sponsor may open enrollment into a separate mandatory on-treatment biopsy cohort for that combination.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Drug: Entinostat
Drug: Fulvestrant
Drug: Ipatasertib
Drug: Abemaciclib
Stage 1: Atezolizumab + Abemaciclib + Fulvestrant
Experimental
Participants will receive triplet combination treatment with atezolizumab plus abemaciclib plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Bevacizumab will be given as 10 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 15 of each 28-day cycle in the regimen containing fulvestrant. When given with exemestane or tamoxifen, bevacizumab will be given as 15 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Abemaciclib will be given as 150mg twice daily during each 28-day cycle.
Stage 1: Atezolizumab + Abemaciclib + Fulvestrant
Stage 1: Mandatory On-Treatment Biopsy
From randomization to the first occurrence of PD or death (up to 51.9 months)
Stage 1: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of participants with stable disease (SD) ≥ 24 weeks or with confirmed CR or PR, as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) having a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Percentages have been rounded off to the nearest whole number.
Up to 51.9 months
Stage 1: Overall Survival (OS)
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier method was used to estimate the median for OS.
From randomization to death (up to 62.2 months)
Stage 1: Percentage of Participants Event-free for OS at Month 18
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at Month 18. Percentages have been rounded off to the nearest whole number.
At Month 18
Stage 1: Duration of Response (DOR)
DOR was defined as the time from the first occurrence of a documented objective response (CR or PR) to the first date of recorded PD or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) having a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in study including baseline in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Participants who did not have documented PD or death, DOR was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for DOR.
From first occurrence of a documented OR to the first date of recorded PD or death (up to 50.4 months)
Stages 1 and 2: Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be 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.
SAE = serious adverse events; AESIs = adverse events of special interest.
From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months)
Stage 1: Plasma Concentration of Entinostat
Predose on Day 1 of Cycles 1 and 2; 2-4 hours postdose on Day 1 Cycle 1 (Cycle length = 21 days)
Stage 1: Plasma Concentration of Abemaciclib
Predose on Day 1 of Cycles 1, 2 and 3, and on Day 15 Cycle 1; 4-8 hours postdose on Day 1 Cycle 1 (Cycle length = 28 days)
Stage 1: Plasma Concentration of Ipatasertib
Predose and Postdose at 1 Hour, 2 Hour, 4 Hour, and 6 Hour on Day 15 Cycle 1; Post dose at 1-3 Hour on Day 15 Cycle 3 (Cycle length = 28 days)
Stage 1: Plasma Concentration of Fulvestrant
Predose on Day 1 of Cycle 2 and Cycle 3 (Cycle length = 28 days)
Stage 2: Plasma Concentration of Fulvestrant
Nominal time restarted to 0 at Stage 2. PK data for Stage was analyzed and reported for the subgroups [crossover arms (Stage 1 to Stage 2)] only.
Predose on Day 1 of Cycles 2 and 3 (Cycle length = 21 days)
Stage 2: Serum Concentration of Atezolizumab
Nominal time restarted to 0 at Stage 2; RO5541267 = atezolizumab. PK data for Stage was analyzed and reported for the subgroups [crossover arms (Stage 1 to Stage 2)] only.
Predose on Day 1 of Cycles 1, 2, 3, 4, 8 and 12; 30 minutes (mins) postdose on Day 1 Cycle 1; postdose on Day 120 and Treatment Discontinuation Visit (Cycle length = 21 days)
Stage 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be treatment-emergent ADA-negative if they were ADA-negative or were missing data at baseline and all post-baseline samples were negative, or if they were ADA-positive at baseline but did not have any post-baseline samples with a titer that was at least 0.60 t.u. greater than the titer of the baseline sample (treatment unaffected). Participants with a positive post-baseline sample has been reported here.
Post-baseline (up to approximately 134 days)
San Francisco
California
94158
United States
Stanford Cancer Institute
Stanford
California
94305-5456
United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance
California
90502
United States
Wellness Oncology and Hematology - Main Office
West Hills
California
91307
United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta
Georgia
30060
United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore
Maryland
21231
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Levine Cancer Institute
Charlotte
North Carolina
28204
United States
Providence Cancer Center
Portland
Oregon
97231
United States
UPMC Pinnacle Health System
Harrisburg
Pennsylvania
17102
United States
Thomas Jefferson University Hospital
Philadelphia
Pennsylvania
19107
United States
Univ of Pittsburgh Sch of Med
Pittsburgh
Pennsylvania
15213
United States
Sarah Cannon Research Institute / Tennessee Oncology
Nashville
Tennessee
37203
United States
Rambam Medical Center
Haifa
3109601
Israel
Shaare Zedek Medical Center
Jerusalem
9103102
Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva
4941492
Israel
Sheba Medical Center
Ramat Gan
5262100
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv
64239
Israel
National Cancer Center
Gyeonggi-do
10408
South Korea
Seoul National University Hospital
Seoul
03080
South Korea
University of Ulsan College of Medicine - Asan Medical Center
Seoul
05505
South Korea
Stage 1: Fulvestrant + Atezolizumab
Participants received fulvestrant (fulv), 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab (atezo) 840 mg as an intravenous (IV) infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG002
Stage 1: Fulvestrant + Atezolizumab + Ipatasertib
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib (ipat), 400 mg, orally (PO), once a day (QD), on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG003
Stage 1: Atezolizumab + Ipatasertib
Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG004
Stage 1: Atezolizumab + Entinostat
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat (entino), 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG005
Stage 1: Fulvestrant + Atezolizumab + Abemaciclib
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib (abem), 150 mg, PO, twice daily (BID) until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG006
Stage 2: Atezolizumab + Bevacizumab + Fulvestrant
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
FG007
Stage 2: Atezolizumab + Bevacizumab + Exemestane
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
FG008
Stage 2: Atezolizumab + Bevacizumab + Tamoxifen
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
FG00025 subjects
FG00131 subjects
FG00227 subjects
FG0036 subjects
FG00415 subjects
FG00540 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Safety-evaluable (SE) Population
SE population included all participants who received any amount of study treatment.
FG00020 subjects
FG00130 subjects
FG00226 subjects
FG0036 subjects
FG00415 subjects
FG00539 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
COMPLETED
FG00018 subjects
FG00128 subjects
FG00224 subjects
FG0036 subjects
FG00415 subjects
FG00533 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0007 subjects
FG0013 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0057 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Study Ended by Sponsor
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0005 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Reason Not Specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Stage 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00613 subjects6 participants from Stage 1: Atezo+Entino, 3 from Stage 1: Atezo+Ipat, 1 each from Stage 1: Fulv control, Stage 1: Atezo+Fulv, Stage 1: Atezo+Fulv+Ipat and Stage 1: Atezo+Fulv+Abem arms entered this arm in Stage 2.
FG0074 subjects2 participants from Stage 1: Atezo+Fulv+Ipat and 2 participant from Stage 1: Fulv control arms entered this arm in Stage 2.
FG0083 subjects2 participants from Stage 1: Atezo+Fulv and 1 participant from Stage 1: Atezo+Fulv+Ipat arms entered this arm in Stage 2.
SE Population
SE population included all participants who received any amount of study treatment.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
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
Long-term Survival Follow-up
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00125 subjects
FG00220 subjects
FG0033 subjects
FG0049 subjects
FG00532 subjects
FG00611 subjects
FG0073 subjects
FG0083 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG00015 subjects
FG00125 subjects
FG00220 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Death
FG00010 subjects
FG00114 subjects
FG00215 subjects
FG003
Randomized population included all participants enrolled, regardless if treatment was received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Fulvestrant Control
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG001
Stage 1: Fulvestrant + Atezolizumab
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG002
Stage 1: Fulvestrant + Atezolizumab + Ipatasertib
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG003
Stage 1: Atezolizumab + Ipatasertib
Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG004
Stage 1: Atezolizumab + Entinostat
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG005
Stage 1: Fulvestrant + Atezolizumab + Abemaciclib
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG006
Stage 2: Atezolizumab + Bevacizumab + Fulvestrant
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
BG007
Stage 2: Atezolizumab + Bevacizumab + Exemestane
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
BG008
Stage 2: Atezolizumab + Bevacizumab + Tamoxifen
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00025
BG00131
BG00227
BG0036
BG00415
BG00540
BG00613
BG0074
BG0083
BG009164
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Count of Participants
Participants
Title
Denominators
Categories
Stage 1
ParticipantsBG00025
ParticipantsBG00131
ParticipantsBG00227
ParticipantsBG003
Sex: Female, Male
Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Count of Participants
Participants
Title
Denominators
Categories
Stage 1
ParticipantsBG00025
ParticipantsBG00131
ParticipantsBG002
Ethnicity (NIH/OMB)
Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Count of Participants
Participants
Title
Denominators
Categories
Stage 1
ParticipantsBG00025
ParticipantsBG00131
ParticipantsBG002
Race (NIH/OMB)
Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Count of Participants
Participants
Title
Denominators
Categories
Stage 1
ParticipantsBG00025
ParticipantsBG00131
ParticipantsBG002
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
Stage 1: Percentage of Participants With Objective Response
Objective response rate (ORR) was defined as the percentage of participants with an objective response of complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) that have a reduction in short axis to < 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. Percentages have been rounded off to the nearest whole number.
Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 50.4 months
ID
Title
Description
OG000
Fulvestrant Control
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG001
Stage 1: Fulvestrant + Atezolizumab
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG002
Stage 1: Fulvestrant + Atezolizumab + Ipatasertib
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1: Atezolizumab + Ipatasertib
Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG004
Stage 1: Atezolizumab + Entinostat
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1: Fulvestrant + Atezolizumab + Abemaciclib
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG00020
OG00130
OG00226
OG003
Title
Denominators
Categories
Title
Measurements
OG00010.0(1.23 to 31.70)
OG00110.0(2.11 to 26.53)
OG00226.9(11.57 to 47.79)
OG003
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
OG001
Difference in Overall Response Rates
0.00
2-Sided
95
-21.14
21.14
Superiority
OG000
OG002
Secondary
Stage 1: Progression-free Survival (PFS)
PFS was defined as the time from randomization to the date of the first recorded occurrence of PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study including baseline in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for PFS.
Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
Posted
Median
95% Confidence Interval
months
From randomization to the first occurrence of PD or death (up to 51.9 months)
ID
Title
Description
OG000
Fulvestrant Control
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG001
Stage 1: Fulvestrant + Atezolizumab
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Secondary
Stage 1: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of participants with stable disease (SD) ≥ 24 weeks or with confirmed CR or PR, as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) having a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Percentages have been rounded off to the nearest whole number.
Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 51.9 months
ID
Title
Description
OG000
Fulvestrant Control
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG001
Stage 1: Fulvestrant + Atezolizumab
Secondary
Stage 1: Overall Survival (OS)
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier method was used to estimate the median for OS.
Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
Posted
Median
95% Confidence Interval
months
From randomization to death (up to 62.2 months)
ID
Title
Description
OG000
Fulvestrant Control
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG001
Stage 1: Fulvestrant + Atezolizumab
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG002
Stage 1: Fulvestrant + Atezolizumab + Ipatasertib
Secondary
Stage 1: Percentage of Participants Event-free for OS at Month 18
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at Month 18. Percentages have been rounded off to the nearest whole number.
Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included all participants with data available for analysis.
Posted
Number
95% Confidence Interval
percentage of participants
At Month 18
ID
Title
Description
OG000
Fulvestrant Control
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG001
Stage 1: Fulvestrant + Atezolizumab
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Secondary
Stage 1: Duration of Response (DOR)
DOR was defined as the time from the first occurrence of a documented objective response (CR or PR) to the first date of recorded PD or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) having a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in study including baseline in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Participants who did not have documented PD or death, DOR was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for DOR.
Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants with an objective response (CR or PR).
Posted
Median
95% Confidence Interval
months
From first occurrence of a documented OR to the first date of recorded PD or death (up to 50.4 months)
ID
Title
Description
OG000
Fulvestrant Control
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Secondary
Stages 1 and 2: Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be 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.
SAE = serious adverse events; AESIs = adverse events of special interest.
SE population included all participants who received any amount of study treatment.
Posted
Count of Participants
Participants
From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months)
ID
Title
Description
OG000
Fulvestrant Control
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG001
Stage 1: Fulvestrant + Atezolizumab
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Secondary
Stage 1: Plasma Concentration of Entinostat
Pharmacokinetic (PK) population included all participants who received at least one dose of atezolizumab and drugs given in combination with atezolizumab during Stage 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Predose on Day 1 of Cycles 1 and 2; 2-4 hours postdose on Day 1 Cycle 1 (Cycle length = 21 days)
ID
Title
Description
OG000
Stage 1: Atezolizumab + Entinostat
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG000
Secondary
Stage 1: Plasma Concentration of Abemaciclib
PK population included all participants who received at least one dose of atezolizumab and drugs given in combination with atezolizumab during Stage 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms per milliliter (µg/mL)
Predose on Day 1 of Cycles 1, 2 and 3, and on Day 15 Cycle 1; 4-8 hours postdose on Day 1 Cycle 1 (Cycle length = 28 days)
ID
Title
Description
OG000
Stage 1: Fulvestrant + Atezolizumab + Abemaciclib
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG000
Secondary
Stage 1: Plasma Concentration of Ipatasertib
PK population included all participants who received at least one dose of atezolizumab and drugs given in combination with atezolizumab during Stage 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Predose and Postdose at 1 Hour, 2 Hour, 4 Hour, and 6 Hour on Day 15 Cycle 1; Post dose at 1-3 Hour on Day 15 Cycle 3 (Cycle length = 28 days)
ID
Title
Description
OG000
Stage 1: Fulv + Atezo + Ipat
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG001
Stage 1: Atezo + Ipat
Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Secondary
Stage 1: Plasma Concentration of Fulvestrant
PK population included all participants who received at least one dose of atezolizumab and drugs given in combination with atezolizumab during Stage 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Predose on Day 1 of Cycle 2 and Cycle 3 (Cycle length = 28 days)
ID
Title
Description
OG000
Stage 1: Fulv + Atezo + Abem
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG001
Stage 1: Fulve + Atezo
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Secondary
Stage 2: Plasma Concentration of Fulvestrant
Nominal time restarted to 0 at Stage 2. PK data for Stage was analyzed and reported for the subgroups [crossover arms (Stage 1 to Stage 2)] only.
PK population included all participants who received at least one dose of atezolizumab and drugs given in combination with atezolizumab during Stage 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Predose on Day 1 of Cycles 2 and 3 (Cycle length = 21 days)
Participants in Stage 1 who received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle (1 cycle = 21 days), and had PD, entered Stage 2 and received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants in Stage 1 who received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle (1 cycle = 28 days), and had PD, entered Stage 2 and received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Secondary
Stage 2: Serum Concentration of Atezolizumab
Nominal time restarted to 0 at Stage 2; RO5541267 = atezolizumab. PK data for Stage was analyzed and reported for the subgroups [crossover arms (Stage 1 to Stage 2)] only.
PK population included all participants who received at least one dose of atezolizumab and drugs given in combination with atezolizumab during Stage 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Predose on Day 1 of Cycles 1, 2, 3, 4, 8 and 12; 30 minutes (mins) postdose on Day 1 Cycle 1; postdose on Day 120 and Treatment Discontinuation Visit (Cycle length = 21 days)
Participants in Stage 1 who received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID (1 cycle = 28 days), and had PD, entered Stage 2 and received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, and bevacizumab, 10 mg /kg, as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Stage 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be treatment-emergent ADA-negative if they were ADA-negative or were missing data at baseline and all post-baseline samples were negative, or if they were ADA-positive at baseline but did not have any post-baseline samples with a titer that was at least 0.60 t.u. greater than the titer of the baseline sample (treatment unaffected). Participants with a positive post-baseline sample has been reported here.
Pharmacodynamic (PD) population included all participants in the atezolizumab plus entinostat arm with at least one ADA assessment.
Posted
Count of Participants
Participants
Post-baseline (up to approximately 134 days)
ID
Title
Description
OG000
Stage 2: Atezolizumab + Bevacizumab + Fulvestrant
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Time Frame
From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months)
Description
All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received.
SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
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
Fulvestrant Control
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
12
25
2
20
18
20
EG001
Stage 1: Fulvestrant + Atezolizumab
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
16
31
3
30
28
30
EG002
Stage 1: Fulvestrant + Atezolizumab + Ipatasertib
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
15
27
12
26
25
26
EG003
Stage 1: Atezolizumab + Ipatasertib
Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
3
6
3
6
6
6
EG004
Stage 1: Atezolizumab + Entinostat
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
6
15
4
15
15
15
EG005
Stage 1: Fulvestrant + Atezolizumab + Abemaciclib
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
23
40
14
39
38
39
EG006
Stage 2: Atezolizumab + Bevacizumab + Fulvestrant
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
11
13
1
13
12
13
EG007
Stage 2: Atezolizumab + Bevacizumab + Exemestane
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
2
4
1
4
3
4
EG008
Stage 2: Atezolizumab + Bevacizumab + Tamoxifen
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
3
3
0
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Immune-mediated adrenal insufficiency
Endocrine disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Pyrexia
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Epstein-Barr virus infection
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Myxofibrosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Amnesia
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0023 events3 affected26 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0023 events3 affected26 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 27.1
Systematic Assessment
EG0002 events1 affected20 at risk
EG0018 events4 affected30 at risk
EG0023 events2 affected26 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected15 at risk
EG00517 events13 affected39 at risk
EG0067 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Palpitations
Cardiac disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0012 events1 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Cataract
Eye disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Dry eye
Eye disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Eyelid skin dryness
Eye disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Vision blurred
Eye disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0013 events3 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0014 events4 affected30 at risk
EG0022 events2 affected26 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0014 events3 affected30 at risk
EG0022 events2 affected26 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0003 events3 affected20 at risk
EG0018 events7 affected30 at risk
EG00214 events12 affected26 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0019 events6 affected30 at risk
EG00233 events14 affected26 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0002 events2 affected20 at risk
EG0011 events1 affected30 at risk
EG0023 events3 affected26 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected26 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0005 events4 affected20 at risk
EG00114 events8 affected30 at risk
EG00223 events14 affected26 at risk
EG003
Oral discomfort
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events2 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0014 events3 affected30 at risk
EG00212 events7 affected26 at risk
EG003
Asthenia
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected26 at risk
EG003
Catheter site pain
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Chest discomfort
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Chest pain
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Chills
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Discomfort
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Fatigue
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0005 events4 affected20 at risk
EG00113 events11 affected30 at risk
EG00210 events9 affected26 at risk
EG003
Injection site pain
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Mucosal inflammation
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Oedema peripheral
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Pain
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0002 events2 affected20 at risk
EG0013 events3 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Pyrexia
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0002 events2 affected20 at risk
EG0013 events3 affected30 at risk
EG0027 events6 affected26 at risk
EG003
Swelling
General disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
COVID-19
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Candida infection
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Eye infection
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Gingivitis
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Oral herpes
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Periodontitis
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Postoperative abscess
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Skin infection
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Tooth infection
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0002 events2 affected20 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0012 events2 affected30 at risk
EG0022 events2 affected26 at risk
EG003
Viral infection
Infections and infestations
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0025 events2 affected26 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0023 events1 affected26 at risk
EG003
Mouth injury
Injury, poisoning and procedural complications
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0012 events2 affected30 at risk
EG0025 events4 affected26 at risk
EG003
Amylase increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0013 events3 affected30 at risk
EG0025 events4 affected26 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0024 events3 affected26 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Blood creatinine increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Liver function test increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events3 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Platelet count decreased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Wall motion score index abnormal
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Weight decreased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Weight increased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected26 at risk
EG003
White blood cell count decreased
Investigations
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 27.1
Systematic Assessment
EG0002 events2 affected20 at risk
EG0015 events4 affected30 at risk
EG0025 events5 affected26 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected26 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0023 events3 affected26 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected26 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0006 events5 affected20 at risk
EG00113 events10 affected30 at risk
EG0024 events3 affected26 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected26 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0003 events3 affected20 at risk
EG0014 events4 affected30 at risk
EG0023 events2 affected26 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0023 events1 affected26 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0003 events2 affected20 at risk
EG0015 events4 affected30 at risk
EG0026 events3 affected26 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Polymyalgia rheumatica
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0003 events3 affected20 at risk
EG0014 events3 affected30 at risk
EG0024 events2 affected26 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0002 events2 affected20 at risk
EG0015 events5 affected30 at risk
EG0025 events5 affected26 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0002 events1 affected20 at risk
EG0011 events1 affected30 at risk
EG0023 events2 affected26 at risk
EG003
Hypokinesia
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Lethargy
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected26 at risk
EG003
Tremor
Nervous system disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Procedural anxiety
Psychiatric disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Autoimmune lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0019 events7 affected30 at risk
EG0028 events7 affected26 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0013 events3 affected30 at risk
EG0024 events3 affected26 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0014 events3 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0022 events2 affected26 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events1 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events3 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected26 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Panniculitis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Pigmentation disorder
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0002 events2 affected20 at risk
EG0014 events4 affected30 at risk
EG0023 events3 affected26 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events3 affected30 at risk
EG00218 events14 affected26 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0014 events3 affected30 at risk
EG0023 events3 affected26 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected30 at risk
EG0023 events1 affected26 at risk
EG003
Hot flush
Vascular disorders
MedDRA Version 27.1
Systematic Assessment
EG0002 events2 affected20 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected26 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events1 affected30 at risk
EG0023 events2 affected26 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 27.1
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected26 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.
Hormones, Hormone Substitutes, and Hormone Antagonists
D013267
Stilbenes
D001597
Benzylidene Compounds
D001555
Benzene Derivatives
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG00613 subjects
FG0074 subjects
FG0083 subjects
0 subjects
FG0050 subjects
FG00611 subjects
FG0073 subjects
FG0083 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0071 subjects
FG0080 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
9 subjects
FG00532 subjects
FG00611 subjects
FG0073 subjects
FG0083 subjects
3 subjects
FG0046 subjects
FG00518 subjects
FG00611 subjects
FG0071 subjects
FG0083 subjects
Study Ended by Sponsor
FG0004 subjects
FG0019 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG00513 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0042 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
6
ParticipantsBG00415
ParticipantsBG00540
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG009144
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Between 18 and 65 years
BG00021
BG00123
BG00222
BG0035
BG004
>=65 years
BG0004
BG0018
BG0025
BG0031
BG004
Stage 2
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG00613
ParticipantsBG0074
ParticipantsBG0083
ParticipantsBG00920
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
27
ParticipantsBG0036
ParticipantsBG00415
ParticipantsBG00540
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG009144
Title
Measurements
Female
BG00025
BG00131
BG00227
BG0036
BG00415
BG00540
BG0060
BG0070
BG0080
BG009144
Male
BG0000
BG0010
BG0020
BG0030
BG004
Stage 2
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG00613
ParticipantsBG0074
ParticipantsBG0083
ParticipantsBG00920
Title
Measurements
Female
BG0000
BG0010
BG0020
BG003
27
ParticipantsBG0036
ParticipantsBG00415
ParticipantsBG00540
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG009144
Title
Measurements
Hispanic or Latino
BG0001
BG0011
BG0021
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0093
Not Hispanic or Latino
BG00023
BG00128
BG00225
BG0036
BG004
Unknown or Not Reported
BG0001
BG0012
BG0021
BG0030
BG004
Stage 2
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG00613
ParticipantsBG0074
ParticipantsBG0083
ParticipantsBG00920
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG003
27
ParticipantsBG0036
ParticipantsBG00415
ParticipantsBG00540
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG009144
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Asian
BG0008
BG00110
BG00211
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0001
BG0013
BG0022
BG0030
BG004
White
BG00012
BG00116
BG00212
BG0036
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0004
BG0012
BG0022
BG0030
BG004
Stage 2
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG00613
ParticipantsBG0074
ParticipantsBG0083
ParticipantsBG00920
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG003
6
OG00415
OG00538
16.7
(0.42 to 64.12)
OG0046.7(0.17 to 31.95)
OG00526.3(13.40 to 43.10)
Difference in Overall Response Rates
16.92
2-Sided
95
-9.03
42.88
Superiority
OG000
OG003
Difference in Overall Response Rates
6.67
2-Sided
95
-36.76
50.09
Superiority
OG000
OG004
Difference in Overall Response Rates
-3.33
2-Sided
95
-27.39
20.73
Superiority
OG000
OG005
Difference in Overall Response Rates
16.32
2-Sided
95
-6.71
39.34
Superiority
OG002
Stage 1: Fulvestrant + Atezolizumab + Ipatasertib
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1: Atezolizumab + Ipatasertib
Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG004
Stage 1: Atezolizumab + Entinostat
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1: Fulvestrant + Atezolizumab + Abemaciclib
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG00020
OG00130
OG00226
OG0036
OG00415
OG00538
Title
Denominators
Categories
Title
Measurements
OG0001.95(1.45 to 4.93)
OG0013.15(1.51 to 7.79)
OG0025.86(1.64 to 11.24)
OG0032.28(1.41 to NA)The upper limit of the 95% confidence interval (CI) was not estimable due to an insufficient number of participants with events.
OG0041.82(1.48 to 3.84)
OG0056.28(5.13 to 11.73)
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
OG001
Hazard Ratio (HR)
0.91
2-Sided
95
0.50
1.66
Superiority
OG000
OG002
Hazard Ratio (HR)
0.64
2-Sided
95
0.35
1.20
Superiority
OG000
OG003
Hazard Ratio (HR)
1.25
2-Sided
95
0.45
3.48
Superiority
OG000
OG004
Hazard Ratio (HR)
1.55
2-Sided
95
0.74
3.23
Superiority
OG000
OG005
Hazard Ratio (HR)
0.50
2-Sided
95
0.28
0.88
Superiority
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG002
Stage 1: Fulvestrant + Atezolizumab + Ipatasertib
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1: Atezolizumab + Ipatasertib
Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG004
Stage 1: Atezolizumab + Entinostat
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1: Fulvestrant + Atezolizumab + Abemaciclib
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG00020
OG00130
OG00226
OG0036
OG00415
OG00538
Title
Denominators
Categories
Title
Measurements
OG00015.0(3.21 to 37.89)
OG00126.7(12.28 to 45.89)
OG00242.3(23.35 to 63.08)
OG00316.7(0.42 to 64.12)
OG0046.7(0.17 to 31.95)
OG00542.1(26.31 to 59.18)
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1: Atezolizumab + Ipatasertib
Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG004
Stage 1: Atezolizumab + Entinostat
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1: Fulvestrant + Atezolizumab + Abemaciclib
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG00020
OG00130
OG00226
OG0036
OG00415
OG00538
Title
Denominators
Categories
Title
Measurements
OG00026.02(9.13 to 35.09)
OG00126.48(15.87 to 46.46)
OG00226.91(20.93 to 47.41)
OG00310.91(5.59 to NA)Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
OG00423.10(15.24 to NA)Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
OG00526.71(22.60 to 36.17)
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
OG001
Hazard Ratio (HR)
0.77
2-Sided
95
0.36
1.65
Superiority
OG000
OG002
Hazard Ratio (HR)
0.74
2-Sided
95
0.34
1.58
Superiority
OG000
OG003
Hazard Ratio (HR)
2.26
2-Sided
95
0.55
9.34
Superiority
OG000
OG004
Hazard Ratio (HR)
0.74
2-Sided
95
0.28
2.01
Superiority
OG000
OG005
Hazard Ratio (HR)
0.72
2-Sided
95
0.35
1.46
Superiority
OG002
Stage 1: Fulvestrant + Atezolizumab + Ipatasertib
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1: Atezolizumab + Ipatasertib
Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG004
Stage 1: Atezolizumab + Entinostat
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1: Fulvestrant + Atezolizumab + Abemaciclib
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG00010
OG00115
OG00216
OG0036
OG0045
OG00526
Title
Denominators
Categories
Title
Measurements
OG00063.91(40.55 to 87.26)
OG00163.16(43.97 to 82.35)
OG00281.61(65.22 to 98.00)
OG003NA(NA to NA)The number and 95% CI was not estimable due to an insufficient number of participants with events.
OG00475.76(45.17 to 100.00)
OG00574.40(59.97 to 88.84)
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
OG001
Difference in Event Free Rate
-0.75
2-Sided
95
-30.98
29.48
Superiority
OG000
OG002
Difference in Event Free Rate
17.70
2-Sided
95
-10.84
46.23
Superiority
OG000
OG004
Difference in Event Free Rate
11.85
2-Sided
95
-26.63
50.33
Superiority
OG000
OG005
Difference in Event Free Rate
10.49
2-Sided
95
-16.96
37.95
Superiority
OG001
Stage 1: Fulvestrant + Atezolizumab
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG002
Stage 1: Fulvestrant + Atezolizumab + Ipatasertib
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1: Atezolizumab + Ipatasertib
Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG004
Stage 1: Atezolizumab + Entinostat
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1: Fulvestrant + Atezolizumab + Abemaciclib
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0031
OG0041
OG00510
Title
Denominators
Categories
Title
Measurements
OG00013.03(10.15 to NA)The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
OG0015.88(3.29 to NA)The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
OG00211.07(7.85 to 20.70)
OG0034.40(NA to NA)The 95% CI was not estimable for a single participant.
OG0042.46(NA to NA)The 95% CI was not estimable for a single participant.
OG00513.36(8.87 to 17.02)
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
OG001
Hazard Ratio (HR)
1.07
2-Sided
95
0.15
7.90
Superiority
OG000
OG002
Hazard Ratio (HR)
0.80
2-Sided
95
0.15
4.20
Superiority
OG000
OG005
Hazard Ratio (HR)
0.76
2-Sided
95
0.15
3.84
Superiority
OG002
Stage 1: Fulvestrant + Atezolizumab + Ipatasertib
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1: Atezolizumab + Ipatasertib
Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG004
Stage 1: Atezolizumab + Entinostat
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1: Fulvestrant + Atezolizumab + Abemaciclib
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG006
Stage 2: Atezolizumab + Bevacizumab + Fulvestrant
Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
OG007
Stage 2: Atezolizumab + Bevacizumab + Exemestane
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
OG008
Stage 2: Atezolizumab + Bevacizumab + Tamoxifen
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Units
Counts
Participants
OG00020
OG00130
OG00226
OG0036
OG00415
OG00539
OG00613
OG0074
OG0083
Title
Denominators
Categories
Title
Measurements
OG00018
OG00128
OG00226
OG0036
OG00415
OG00539
OG00612
OG0073
OG0083
14
Title
Denominators
Categories
Predose on Cycle 1 Day 1
ParticipantsOG00013
Title
Measurements
OG000NA± NAThe geometric mean and geometric coefficient of variation were not estimable as sample were below the limit of quantification (BLQ).
2-4 Hrs Postdose on Cycle 1 Day 1
ParticipantsOG00014
Title
Measurements
OG00022.3± 91.0
Predose on Cycle 2 Day 1
ParticipantsOG00014
Title
Measurements
OG0002.12± 60.3
31
Title
Denominators
Categories
Predose on Cycle 1 Day 1
ParticipantsOG0003
Title
Measurements
OG0000.00417± 50.3
4-8 Hour Postdose on Cycle 1 Day 1
ParticipantsOG00025
Title
Measurements
OG0000.0581± 170.0
Predose on Cycle 1 Day 15
ParticipantsOG00030
Title
Measurements
OG0000.319± 57.4
Predose on Cycle 2 Day 1
ParticipantsOG00031
Title
Measurements
OG0000.108± 573.7
Predose on Cycle 3 Day 1
ParticipantsOG00025
Title
Measurements
OG0000.144± 177.7
Units
Counts
Participants
OG00011
OG0012
Title
Denominators
Categories
Predose on Cycle 1 Day 15
ParticipantsOG00011
ParticipantsOG0012
Title
Measurements
OG0000.0353± 248.9
OG0010.0105± 10113.9
1 Hour Postdose on Cycle 1 Day 15
ParticipantsOG0006
ParticipantsOG0012
Title
Measurements
OG0000.154± 185.0
OG001
2 Hour Postdose on Cycle 1 Day 15
ParticipantsOG0005
ParticipantsOG0011
Title
Measurements
OG0000.447± 53.7
OG001
4 Hour Postdose on Cycle 1 Day 15
ParticipantsOG0005
ParticipantsOG0011
Title
Measurements
OG0000.273± 45.9
OG001
6 Hour Postdose on Cycle 1 Day 15
ParticipantsOG0005
ParticipantsOG0011
Title
Measurements
OG0000.203± 45.4
OG001
1-3 Hour Postdose on Cycle 3 Day 15
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG0000.576± 25.9
OG001
OG002
Stage 1: Fulv + Atezo + Ipat
Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG0001
OG0019
OG0027
Title
Denominators
Categories
Predose on Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0019
ParticipantsOG0027
Title
Measurements
OG0000.0127± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
Participants in Stage 1 who received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each cycle (1 cycle = 28 days), and had PD, entered Stage 2 and received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Units
Counts
Participants
OG0003
OG0011
OG0023
Title
Denominators
Categories
Predose on Day 1 Cycle 2 (Stage 2)
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0023
Title
Measurements
OG0000.0207± 14.1
OG0010.00938± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG0020.0142± 41.2
Predose on Day 1 Cycle 3 (Stage 2)
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
Title
Measurements
OG000
Participants in Stage 1 who received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle (1 cycle = 21 days), and had PD, entered Stage 2 and received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, and bevacizumab, 10 mg /kg, as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants in Stage 1 who received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle (1 cycle = 28 days), and had PD, entered Stage 2 and received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, and bevacizumab, 10 mg /kg, as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants in Stage 1 who received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then every 4 weeks (Q4W) thereafter along with atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle (1 cycle = 28 days) and had PD, entered Stage 2 and received atezolizumab, 1200 mg, and bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
Participants in Stage 1 who received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each cycle (1 cycle = 28 days), and had PD, entered Stage 2 and received atezolizumab, 1200 mg, and bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days).
Participants in Stage 1 who received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each cycle (1 cycle = 28 days), and had PD, entered Stage 2 and received atezolizumab, 1200 mg, and bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
Participants in Stage 1 who received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle (1 cycle = 28 days), and had PD, entered Stage 2 and received atezolizumab, 1200 mg, and bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days).
Participants in Stage 1 who received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle (1 cycle = 28 days), and had PD, entered Stage 2 and received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, and bevacizumab, 10 mg /kg, as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants in Stage 1 who received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each cycle (1 cycle = 28 days), and had PD, entered Stage 2 and received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, and bevacizumab, 10 mg /kg, as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Units
Counts
Participants
OG0001
OG0015
OG0021
OG0032
OG0041
OG0051
OG0061
OG0071
OG0083
Title
Denominators
Categories
Predose on Day 1 Cycle 1 (Stage 2)
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0021
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0082
Title
Measurements
OG000217± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG001128± 49.2
OG002443± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG003
30 mins postdose on Day 1 Cycle 1 (Stage 2)
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0021
ParticipantsOG0032
Predose on Day 1 Cycle 2 (Stage 2)
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0021
ParticipantsOG0032
Predose on Day 1 Cycle 3 (Stage 2)
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0032
Predose on Day 1 Cycle 4 (Stage 2)
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0031
Predose on Day 1 Cycle 8 (Stage 2)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Predose on Day 1 Cycle 12 (Stage 2)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Postdose on Day 120 (Stage 2)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Treatment Discontinuation Visit (Stage 2)
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0031
OG001
Stage 2: Atezolizumab + Bevacizumab + Exemestane
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
OG002
Stage 2: Atezolizumab + Bevacizumab + Tamoxifen
Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Units
Counts
Participants
OG00010
OG0012
OG0023
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
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6 at risk
EG0040 events0 affected15 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
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EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0043 events3 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
2 events
2 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0043 events2 affected15 at risk
EG00526 events10 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0042 events2 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0059 events9 affected39 at risk
EG0061 events1 affected13 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0053 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0043 events3 affected15 at risk
EG0059 events9 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
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EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
3 events
3 affected
6 at risk
EG0041 events1 affected15 at risk
EG0056 events4 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
6 events
4 affected
6 at risk
EG0043 events2 affected15 at risk
EG00555 events33 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0042 events2 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0042 events1 affected15 at risk
EG0055 events5 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
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EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
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EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
6 events
4 affected
6 at risk
EG0045 events5 affected15 at risk
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EG0065 events5 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0061 events1 affected13 at risk
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0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0055 events5 affected39 at risk
EG0060 events0 affected13 at risk
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0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
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EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
4 events
3 affected
6 at risk
EG0046 events4 affected15 at risk
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EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
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EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
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0 events
0 affected
6 at risk
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0 events
0 affected
6 at risk
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0 events
0 affected
6 at risk
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0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
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3 events
3 affected
6 at risk
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EG0068 events7 affected13 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
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0 events
0 affected
6 at risk
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0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
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EG0080 events0 affected3 at risk
2 events
2 affected
6 at risk
EG0043 events3 affected15 at risk
EG0052 events2 affected39 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0044 events3 affected15 at risk
EG00523 events5 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
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EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
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EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
2 events
2 affected
6 at risk
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EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
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EG0055 events4 affected39 at risk
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0 events
0 affected
6 at risk
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0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
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EG0060 events0 affected13 at risk
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0 events
0 affected
6 at risk
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0 events
0 affected
6 at risk
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0 events
0 affected
6 at risk
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0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
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0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
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0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
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EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
3 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
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EG0062 events2 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
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EG0050 events0 affected39 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0053 events3 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
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EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
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EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0043 events2 affected15 at risk
EG00513 events6 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
3 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0042 events2 affected15 at risk
EG00515 events8 affected39 at risk
EG0062 events2 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0051 events1 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG00511 events6 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0054 events3 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG00536 events9 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG00511 events5 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0056 events6 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0042 events2 affected15 at risk
EG0058 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
5 events
4 affected
6 at risk
EG0044 events4 affected15 at risk
EG00514 events13 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected15 at risk
EG0053 events3 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0054 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0072 events1 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0055 events4 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0044 events2 affected15 at risk
EG0054 events4 affected39 at risk
EG0063 events3 affected13 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected15 at risk
EG00512 events10 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0053 events3 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0045 events4 affected15 at risk
EG0055 events5 affected39 at risk
EG0063 events2 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0057 events5 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0062 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
3 events
3 affected
6 at risk
EG0043 events3 affected15 at risk
EG0053 events3 affected39 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0053 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0043 events3 affected15 at risk
EG0056 events5 affected39 at risk
EG0066 events3 affected13 at risk
EG0071 events1 affected4 at risk
EG0081 events1 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0065 events4 affected13 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0062 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
4 events
3 affected
6 at risk
EG0044 events4 affected15 at risk
EG0054 events3 affected39 at risk
EG0061 events1 affected13 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0042 events2 affected15 at risk
EG0052 events2 affected39 at risk
EG0061 events1 affected13 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG00512 events9 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG00513 events10 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected15 at risk
EG0054 events4 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected15 at risk
EG0052 events1 affected39 at risk
EG0068 events6 affected13 at risk
EG0072 events1 affected4 at risk
EG0081 events1 affected3 at risk
2 events
2 affected
6 at risk
EG0041 events1 affected15 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
12
BG00528
BG0060
BG0070
BG0080
BG009111
3
BG00512
BG0060
BG0070
BG0080
BG00933
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Between 18 and 65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG00610
BG0073
BG0081
BG00914
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0063
BG0071
BG0082
BG0096
0
BG0050
BG0060
BG0070
BG0080
BG0090
0
BG0040
BG0050
BG00613
BG0074
BG0083
BG00920
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
14
BG00540
BG0060
BG0070
BG0080
BG009136
1
BG0050
BG0060
BG0070
BG0080
BG0095
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Not Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG00613
BG0073
BG0083
BG00919
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0080
BG0091
5
BG00515
BG0060
BG0070
BG0080
BG00949
0
BG0050
BG0060
BG0070
BG0080
BG0090
0
BG0051
BG0060
BG0070
BG0080
BG0097
9
BG00524
BG0060
BG0070
BG0080
BG00979
0
BG0050
BG0060
BG0070
BG0080
BG0090
1
BG0050
BG0060
BG0070
BG0080
BG0099
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0071
BG0080
BG0092
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
White
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG00612
BG0070
BG0083
BG00915
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0073
BG0080
BG0093
0.203
± 38.5
0.398
± NA
Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
0.303
± NA
Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
0.227
± NA
Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
0.0664
± NA
Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
0.0107
± 40.3
OG0020.0121± 38.0
0.0121
± 39.3
OG0010.0175± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG0020.0132± 10.3
160
± 209.6
OG004277± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG005167± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG006NA± NAThe geometric mean and geometric coefficient of variation were not estimable as samples were BLQ.
OG007NA± NAThe geometric mean and geometric coefficient of variation were not estimable as samples were BLQ.
OG00816.3± 63062.7
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0082
Title
Measurements
OG000617± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG001388± 22.3
OG002907± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG003725± 52.9
OG0041030± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG005679± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG006498± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG008491± 16.3
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0083
Title
Measurements
OG000202± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG001251± 35.8
OG002434± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG003211± 143.9
OG004373± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG005253± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG006141± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG007136± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG008227± 65.2
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0082
Title
Measurements
OG001318± 8.8
OG003208± 93.2
OG004333± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG005284± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG007220± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG008274± 47.4
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0082
Title
Measurements
OG001302± 20.8
OG003115± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG004341± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG005310± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG007238± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG008309± 35.2
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
Title
Measurements
OG008131± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
Title
Measurements
OG008182± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0081
Title
Measurements
OG00127.4± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG00330.0± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG00622.6± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG0087.38± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0083
Title
Measurements
OG001250± 18.9
OG002450± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG003130± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
OG007201± NASince only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.