A Study Evaluating Targeted Therapies in Participants Who... | NCT04632992 | Trialant
NCT04632992
Sponsor
Genentech, Inc.
Status
Completed
Last Update Posted
Jan 8, 2025Actual
Enrollment
252Actual
Phase
Phase 2
Conditions
Advanced Unresectable or Metastatic Solid Malignancy
Interventions
Entrectinib
Inavolisib
Alectinib
Ipatasertib
Atezolizumab
Trastuzumab Emtansine
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
Tucatinib
Investigator's Choice of Chemotherapy
Paclitaxel
Tiragolumab
Pralsetinib
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04632992
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ML42439
Secondary IDs
Not provided
Brief Title
A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
Official Title
MyTACTIC: An Open-Label Phase II Study Evaluating Targeted Therapies in Patients Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
Acronym
MyTACTIC
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
Dec 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 13, 2021Actual
Primary Completion Date
Dec 4, 2023Actual
Completion Date
Feb 27, 2024Actual
First Submitted Date
Nov 12, 2020
First Submission Date that Met QC Criteria
Nov 12, 2020
First Posted Date
Nov 17, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Nov 11, 2024
Results First Submitted that Met QC Criteria
Dec 16, 2024
Results First Posted Date
Jan 8, 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
Dec 16, 2024
Last Update Posted Date
Jan 8, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
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 is a Phase II, multicenter, non-randomized, open-label, multi-arm study designed to evaluate the safety and efficacy of targeted therapies as single agents or in rational, specified combinations in participants with advanced unresectable or metastatic solid tumors determined to harbor specific biomarkers.
Patients will be enrolled based on local testing performed at a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory. The multi-arm structure of the MyTACTIC study allows patients with solid tumors to be treated with a drug or drug regimen tailored to their biomarker identified at screening.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Unresectable or Metastatic Solid Malignancy
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
252Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A: Entrectinib
Experimental
Participants in this treatment arm must have a positive tumor biomarker result for ROS1 gene fusion.
Drug: Entrectinib
Arm B: Inavolisib
Experimental
Participants in this treatment arm must have a positive tumor biomarker result for PI3KCA activating mutation.
Drug: Inavolisib
Arm C: Alectinib
Experimental
Participants in this treatment arm must have a positive tumor biomarker result for ALK rearrangement tumors.
Drug: Alectinib
Arm D: Ipatasertib
Experimental
Participants in this treatment arm must have a positive tumor biomarker result for either AKT1/2/3 activating mutation or PTEN loss/loss of function.
Drug: Ipatasertib
Arm E: Atezolizumab + Investigator's Choice of Chemotherapy
Experimental
Participants in this treatment arm must have a positive tumor biomarker result for either tumor mutational burden (TMB) high or microsatellite instability (MSI) high/deficient mismatch repair (dMMR).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Entrectinib
Drug
Entrectinib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 600 milligrams (mg) per day once a day (QD) until disease progression, intolerable toxicity, or consent withdrawal.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Confirmed Objective Response Rate (ORR) Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria for Primary Central Nervous System (CNS) Tumors
Confirmed objective response rate (cORR)=percentage of participants with best response as complete response (CR) or partial response (PR) for measurable disease & CR for non-measurable disease. Confirmation=CR/PR on 2 consecutive visits ≥4 weeks apart for 3-week cycles & ≥6 weeks apart for 4-week cycles. Per RECIST, CR=disappearance of all target lesions. PR= ≥30% decrease in sum of diameters of target lesions, in absence of CR. Per RANO, CR=complete disappearance of all measurable & non-measurable disease for ≥4 weeks; no new lesions/abnormality on T2/FLAIR imaging; stable/improved non-enhancing lesions; participants must be off corticosteroids or on physiological doses; clinical status stable/improved. PR= ≥50% decrease in the sum of products of perpendicular diameters of measurable enhancing lesions on T2/FLAIR imaging for ≥4 weeks; no progression of non-measurable T1 disease; stable/improved non-enhancing lesions; corticosteroid dose ≤ baseline; clinical status stable/improved.
Up to 32 months
Secondary Outcomes
Measure
Description
Time Frame
Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
PFS=time from start of treatment to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first, per RECIST v1.1, or RANO. Per RECIST, PD=≥20% increase in sum of diameters of lesions, using the smallest sum during the study as reference, including baseline (BL). Per RANO, PD= ≥25% increase in sum of products of perpendicular diameters of enhancing lesions compared to smallest tumor measurement at BL/best response, on stable/increasing corticosteroids (CS) dose; Significant/ ≥25% increase of T2/FLAIR non-enhancing lesion on stable/increasing CS dose compared to BL/best response after therapy start; Presence of new lesions/increase of enhancement; Clear progression of non-measurable disease; Definite clinical deterioration only due to tumor/decrease in CS dose; Failure to return for evaluation due to death/deterioration. Kaplan-Meier methodology was used to estimate PFS; patients without an event were censored on the last available assessment day.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic solid malignancy
Positive biomarker results from a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory and availability of a full report of the testing results. This may be from a tissue or blood sample.
Evaluable or measurable disease
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Life expectancy ≥8 weeks
Adequate hematologic and end-organ function, as defined in the protocol, obtained within 14 days prior to initiation of study treatment
Agrees to take measures to prevent pregnancy in the patient or partner
In addition to the general inclusion criteria above, there are treatment-specific inclusion criteria that apply for each respective treatment arm (as detailed in the protocol)
Exclusion Criteria:
Current participation or enrollment in another therapeutic clinical trial
Symptomatic or actively progressing CNS metastases (asymptomatic patients with treated or untreated CNS metastases may be eligible, provided all protocol-defined criteria are met)
History of leptomeningeal disease, unless noted otherwise for a specific treatment arm of the study
Wide field radiotherapy within 14 days prior to start of study treatment
Stereotactic radiosurgery within 7 days prior to start of study treatment
Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infections, or any active infection that, in the opinion of the investigator, could impact patient safety
Receipt of any anticancer drug/biologic or investigational treatment 21 days prior to Cycle 1, Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1, Day 1 (androgen blockage may be continued for male patients with prostate cancer)
Known human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection with status outside of study-allowed criteria
History of or concurrent serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study
History of malignancy other than disease under study within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
Major surgical procedure, other than for diagnosis, or significant traumatic injury within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
Pregnant or breastfeeding, or intending to become pregnant during the study
In addition to the general exclusion criteria above, there are treatment-specific exclusion criteria that apply for each respective treatment arm (as detailed in the protocol)
Zuniga RM, VanderWalde A, Schwartzberg LS, Spigel DR, Passler L, Hong J, Howland M, Darbonne WC, Szado T, Daniel D. Impact of community recruitment and inclusion initiatives on enrollment in the biomarker-driven MyTACTIC trial. Future Oncol. 2026 Jan;22(1):59-69. doi: 10.1080/14796694.2025.2595690. Epub 2025 Dec 15.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Participants in this multi-arm study were treated with a drug or drug regimen tailored to their biomarker identified at screening. A total of 15 arms (Arms A to O) were planned for this study. However, no participants were enrolled in Arm A.
Recruitment Details
A total of 252 participants with advanced unresectable or metastatic solid tumors with positive biomarker result took part in the study across 38 investigative sites in the United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm B: Inavolisib (GDC-0077)
Participants with a positive tumor biomarker result for phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) activating mutation self-administered inavolisib 9 milligrams (mg), orally, once a day (QD) until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
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
Yes
No
No
Study Protocol
Feb 28, 2023
Nov 11, 2024
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
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel 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: Atezolizumab
Drug: Investigator's Choice of Chemotherapy
Arm F: Trastuzumab Emtansine + Atezolizumab
Experimental
Participants in this treatment arm must have a positive tumor biomarker result for human epidermal growth factor receptor 2 (HER2) mutations or amplification without known TMB high or MSI high/dMMR.
Drug: Atezolizumab
Drug: Trastuzumab Emtansine
Arm G: PH FDC SC
Experimental
Participants in this treatment arm must have a positive tumor biomarker result for HER2 mutation or amplification without known TMB high or MSI high/dMMR.
Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
Arm H: PH FDC SC + Investigator's Choice of Chemotherapy
Experimental
Participants in this treatment arm must have a positive tumor biomarker result for HER2 mutation or amplification without known TMB high or MSI high/dMMR.
Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
Drug: Investigator's Choice of Chemotherapy
Arm I: Trastuzumab Emtansine + Tucatinib
Experimental
Participants in this treatment arm must have a positive tumor biomarker result for HER2 mutation or amplification without known TMB high or MSI high/dMMR.
Drug: Trastuzumab Emtansine
Drug: Tucatinib
Arm J: Trastuzumab Emtansine + Atezolizumab
Experimental
Participants in this treatment arm must have positive tumor biomarker results for HER2 mutation or amplification and TMB high or MSI high/dMMR.
Drug: Atezolizumab
Drug: Trastuzumab Emtansine
Arm K: Ipatasertib + Atezolizumab
Experimental
Participants in this treatment arm must have a positive tumor biomarker result for PI3KCA activating mutation.
Drug: Ipatasertib
Drug: Atezolizumab
Arm L: Ipatasertib + Atezolizumab
Experimental
Participants in this treatment arm must have a positive tumor biomarker result for either AKT1/2/3 activating mutation or PTEN loss/loss of function.
Drug: Ipatasertib
Drug: Atezolizumab
Arm M: Ipatasertib + Paclitaxel
Experimental
Participants in this treatment arm must have a positive tumor biomarker results for PI3KCA activating mutations and either AKT1/2/3 activating mutation or PTEN loss/loss of function.
Drug: Ipatasertib
Drug: Paclitaxel
Arm N: Atezolizumab + Tiragolumab
Experimental
Participants in this treatment arm must have a positive tumor biomarker result for either TMB high or MSI high/dMMR.
Drug: Atezolizumab
Drug: Tiragolumab
Arm O: Pralsetinib
Experimental
Participants in this treatment arm must have a positive tumor biomarker result for RET fusion.
Drug: Pralsetinib
Arm A: Entrectinib
Rozlytrekâ„¢
RG6268
RO7102122
Inavolisib
Drug
Inavolisib will be self-administered by participants orally at home (except on clinic days) at the same time each day, on a starting dose of 9 mg/day QD until disease progression, intolerable toxicity, or consent withdrawal.
Arm B: Inavolisib
GDC-0077
RG6114
RO7113755
Alectinib
Drug
Alectinib will be self-administered by participants orally at home (except on clinic days), at the same times each day, on a starting dose of 600 mg twice a day (BID) until disease progression, intolerable toxicity, or consent withdrawal.
Arm C: Alectinib
Alecensa®
RG7853
RO5424802
Ipatasertib
Drug
Ipatasertib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 400 mg QD until disease progression, intolerable toxicity, or consent withdrawal.
Arm D: Ipatasertib
Arm K: Ipatasertib + Atezolizumab
Arm L: Ipatasertib + Atezolizumab
Arm M: Ipatasertib + Paclitaxel
GDC-0068
RG7440
RO5532961
Atezolizumab
Drug
Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg for participants on Day 1 of each 21-day cycle until unacceptable toxicity or progressive disease (or loss of clinical benefit).
Arm E: Atezolizumab + Investigator's Choice of Chemotherapy
Arm F: Trastuzumab Emtansine + Atezolizumab
Arm J: Trastuzumab Emtansine + Atezolizumab
Arm K: Ipatasertib + Atezolizumab
Arm L: Ipatasertib + Atezolizumab
Arm N: Atezolizumab + Tiragolumab
Tecentriq®
RG7446
RO5541267
Trastuzumab Emtansine
Drug
Trastuzumab emtansine will be administered at 3.6 mg per kilogram (kg) of body weight by IV infusion every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.
Arm F: Trastuzumab Emtansine + Atezolizumab
Arm I: Trastuzumab Emtansine + Tucatinib
Arm J: Trastuzumab Emtansine + Atezolizumab
Kadcyla®
RG3502
RO5304020
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
Drug
PH FDC SC will be administered subcutaneously (SC) at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab once every 3 weeks.
Arm G: PH FDC SC
Arm H: PH FDC SC + Investigator's Choice of Chemotherapy
PHESGOâ„¢
PH FDC SC
Fixed dose combination of trastuzumab and pertuzumab administered subcutaneously
RG6264
RO7198574
Tucatinib
Drug
Tucatinib 300 mg will be administered orally BID continuously starting from Cycle 1 Day 1 onwards.
Arm I: Trastuzumab Emtansine + Tucatinib
Tukysaâ„¢
Investigator's Choice of Chemotherapy
Drug
Chemotherapy will consist of docetaxel, paclitaxel, or capecitabine, as determined by the investigator, and will be administered per the respective package insert and institutional guidelines.
Arm E: Atezolizumab + Investigator's Choice of Chemotherapy
Arm H: PH FDC SC + Investigator's Choice of Chemotherapy
Paclitaxel
Drug
The dose of paclitaxel is 80 mg/m2 administered by IV infusion on Days 1, 8, and 15 of each 28-day cycle. The paclitaxel infusion will be delivered over at least 60 minutes for each dose per institutional guidelines and administered after the oral dose of ipatasertib.
Arm M: Ipatasertib + Paclitaxel
Tiragolumab
Drug
Following the administration of atezolizumab and an observation period, participants will receive 600 mg tiragolumab at a fixed dose administered by IV infusion on Day 1 of each 21-day cycle.
Arm N: Atezolizumab + Tiragolumab
RG6058
RO7092284
MTIG7192A
Pralsetinib
Drug
Pralsetinib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 400 mg/day (four 100-mg capsules per day) once a day (QD) until disease progression, intolerable toxicity, or consent withdrawal.
Arm O: Pralsetinib
GAVRETOâ„¢
RG6396
RO7499790
Time from start of treatment to the first occurrence of disease progression or death from any cause (Up to 32 months)
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
DOR was defined as the time from the date of the first confirmed complete response (CR) or partial response (PR) to disease progression (PD) or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1 or RANO. CR & PR were defined per RECIST or RANO as outlined in the description for the cORR outcome measure (OM). PD was defined per RECIST or RANO as outlined in the description for the PFS OM. Kaplan-Meier methodology was used to estimate the median DOR. The 95% confidence intervals for the median DOR were computed by the method of Brookmeyer and Crowley. Participants who did not experience death or PD were censored on the day of the last available assessment.
Time from the date of the first confirmed CR/PR to PD or death from any cause (Up to 32 months)
PFS Rate at Month 3, 6, 9, and 12 as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
The PFS rates were calculated using the Kaplan-Meier (KM) method to estimate the percent survival probability of participants (i.e., PFS event-free: did not experience PD or death from any cause) in each treatment arm at landmark timepoints. The 95% confidence intervals for each PFS rate were computed by the method of Greenwood. PFS was defined as the time from the start of study treatment to the first occurrence of PD or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1 or RANO. PD was defined per RECIST or RANO as outlined in the description for the PFS OM. Participants who did not experience death or PD were censored on the day of the last available assessment. The number analyzed per landmark timepoint actually represents the number of participants who remained at risk of experiencing a PFS event at that timepoint. Percentages are rounded off to the nearest decimal point.
At Months 3, 6, 9 and 12
Percentage of Participants With Disease Control, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
Disease control rate was defined as the percentage of participants whose best response was confirmed CR, confirmed PR, or a response of CR, PR, stable disease (SD), or non-CR/non-PD for a minimum of 98 days for 28-day cycle arms or 70 days for 21-day cycle arms after the first treatment date. CR & PR were defined per RECIST/RANO as outlined in the description for the cORR OM. SD per RECIST: Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. SD per RANO: Participant does not qualify for CR, PR, or minor response or PD; Stable non-enhancing (T2/FLAIR) lesions or abnormalities on same or lower dose of corticosteroids compared to baseline; No new lesions or new T2 or FLAIR abnormalities apart from those consistent with radiation effect, & no new or increased enhancement; Participants on a should be corticosteroid dose that is not greater than dose at baseline scan & is stable or improved clinically; Clinical status, stable/improved.
Up to 32 months
Number of Participants With at Least One Adverse Event (AE) and Severity of AEs Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
An AE is an untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with the product. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to it. AEs were graded for severity according to NCI CTCAE v5.0. Grade 1= Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3 = Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4= Life-threatening consequences/urgent intervention indicated; Grade 5= Death related to adverse event.
From initiation of study drug until 28 days after the final dose of study drugs other than atezolizumab and until 90 days after the final dose of atezolizumab (Up to 32 months)
Oro Valley
Arizona
85755-6216
United States
Genesis Cancer Center
Hot Springs
Arkansas
71913
United States
California Cancer Associates for Research and Excellence - Encinitas
Encinitas
California
92024-1328
United States
Los Angeles Hematology Oncology Medical Group
Los Angeles
California
90017
United States
Pacific Cancer Care - Monterey
Monterey
California
93940
United States
Kaiser Permanente - San Francisco Medical Center
San Francisco
California
94118
United States
Sarcoma Oncology Center
Santa Monica
California
90403
United States
Kaiser Permanente Medical Ctr
Vallejo
California
94589
United States
Ventura County Hematology Oncology Specialists
Ventura
California
93003
United States
Eastern CT Hematology and Oncology Associates
Norwich
Connecticut
06360-2740
United States
SCRI Florida Cancer Specialists South
Fort Myers
Florida
33916
United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg
Florida
33705-1400
United States
Florida Cancer Specialists - PAN - SCRI - PPDS
Tallahassee
Florida
32308
United States
Florida Cancer Specialists - EAST - SCRI - PPDS
West Palm Beach
Florida
33401-3406
United States
St Luke?s Cancer Institute
Boise
Idaho
83712
United States
Hematology and Oncology Clinic
Baton Rouge
Louisiana
70809
United States
Saint Agnes Hospital - Baltimore - Hunt - PPDS
Baltimore
Maryland
21229-5201
United States
Ascension St. John Hospital
Detroit
Michigan
48236
United States
Frontier Cancer Center and Blood Institute
Billings
Montana
59102
United States
Southeast Nebraska Cancer Center
Lincoln
Nebraska
68510-2496
United States
New Jersey Hematology Oncology Associates LLC
Brick
New Jersey
08724-3009
United States
Astera Cancer Care East Brunswick
East Brunswick
New Jersey
08816
United States
Central Park Hematology and Oncology
New York
New York
10028-0506
United States
Eastchester Center for Cancer Care
The Bronx
New York
10469
United States
New York Cancer & Blood Specialists
The Bronx
New York
10469
United States
Messino Cancer Centers
Asheville
North Carolina
28806
United States
Gabrail Cancer Center
Canton
Ohio
44718
United States
Tri County Hematologyoncology
Canton
Ohio
44718
United States
SCRI Mark H. Zangmeister Center
Columbus
Ohio
43219
United States
Kaiser Permanente Center For Health Research
Portland
Oregon
97227
United States
Sarah Cannon Research Institute / Tennessee Oncology
Chattanooga
Tennessee
37404
United States
The West Clinic, PC dba West Cancer Center
Memphis
Tennessee
38138
United States
SCRI Oncology Partners
Nashville
Tennessee
37203
United States
The Center for Cancer and Blood Disorders - PPDS
Fort Worth
Texas
76104-4611
United States
Mays Cancer Center at UT Health San Antonio MD Anderson Cancer
San Antonio
Texas
78229
United States
Virginia Commonwealth University - Massey Cancer Center
Richmond
Virginia
23219
United States
Northwest Medical Specialties B
Federal Way
Washington
98003
United States
FG001
Arm C: Alectinib
Participants with a positive tumor biomarker result for anaplastic lymphoma kinase (ALK) gene fusion self-administered alectinib, 600 mg, orally, twice a day (BID) until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
FG002
Arm D: Ipatasertib
Participants with a positive tumor biomarker result for phosphatase and tensin homolog (PTEN) loss/loss-of-function or protein kinase B (AKT) activating mutation self-administered ipatasertib, 400 mg orally, QD until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
FG003
Arm E: Atezolizumab + Chemotherapy
Participants with a positive tumor biomarker result for tumor mutational burden-high (TMB-H) or microsatellite instability high (MSI-H) or deficient mismatch repair (dMMR) received atezolizumab,1200 mg, as intravenous (IV) infusion, on Day 1 of each 21-day cycle in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine) until disease progression, loss of clinical benefit, or unacceptable toxicity whichever occurs first.
FG004
Arm F: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for human epidermal growth factor receptor 2 (HER2) gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 milligrams/kilograms (mg/kg), as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
FG005
Arm G: PH FDC SC
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as subcutaneous (SC) injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2.
FG006
Arm H: PH FDC SC + Chemotherapy
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2 in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine).
FG007
Arm I: Trastuzumab Emtansine + Tucatinib
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received trastuzumab emtansine, 3.6 mg/kg as IV infusion, every 21 days in combination with tucatinib, 300 mg, orally, BID starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity, whichever occurs first.
FG008
Arm J: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation plus TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 mg/kg, as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
FG009
Arm K: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PIK3CA activating mutation received ipatasertib, 400 mg, orally QD in combination with atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
FG010
Arm L: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD and received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or intolerable toxicity, whichever occurs first.
FG011
Arm M: Ipatasertib + Paclitaxel
Participants with a positive tumor biomarker result for co-mutations in PIK3CA activating mutations and PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD on Days 1 to 21 of 28-day cycles and received paclitaxel, 80 milligrams per meter square (mg/m^2), as IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
FG012
Arm N: Atezolizumab + Tiragolumab
Participants with a positive tumor biomarker result for TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
FG013
Arm O: Pralsetinib
Participants with a positive tumor biomarker result for rearranged during transfection (RET) gene fusion self-administered pralsetinib, 400 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
FG00026 subjects
FG0015 subjects
FG00226 subjects
FG00325 subjects
FG00425 subjects
FG00513 subjects
FG0068 subjects
FG00723 subjects
FG00819 subjects
FG00928 subjects
FG01025 subjects
FG0113 subjects
FG01223 subjects
FG0133 subjects
COMPLETED
FG0002 subjects
FG0013 subjects
FG0025 subjects
FG0034 subjects
FG0045 subjects
FG0054 subjects
FG0060 subjects
FG0075 subjects
FG0083 subjects
FG0094 subjects
FG0105 subjects
FG0111 subjects
FG0126 subjects
FG0131 subjects
NOT COMPLETED
FG00024 subjects
FG0012 subjects
FG00221 subjects
FG00321 subjects
FG00420 subjects
FG0059 subjects
FG0068 subjects
FG00718 subjects
FG00816 subjects
FG00924 subjects
FG01020 subjects
FG0112 subjects
FG01217 subjects
FG0132 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
Death
FG00017 subjects
FG0011 subjects
FG00214 subjects
FG00314 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Reason not Specified
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0011 subjects
FG0025 subjects
FG0034 subjects
FG004
Safety evaluable population included all participants who received at least one dose of the study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm B: Inavolisib (GDC-0077)
Participants with a positive tumor biomarker result for PIK3CA activating mutation self-administered inavolisib 9 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
BG001
Arm C: Alectinib
Participants with a positive tumor biomarker result for ALK gene fusion self-administered alectinib, 600 mg, orally, BID until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
BG002
Arm D: Ipatasertib
Participants with a positive tumor biomarker result for phosphatase and tensin homolog (PTEN) loss/loss-of-function or protein kinase B (AKT) activating mutation self-administered ipatasertib, 400 mg orally, QD until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
BG003
Arm E: Atezolizumab + Chemotherapy
Participants with a positive tumor biomarker result for TMB-H or MSI-H or dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine) until disease progression, loss of clinical benefit, or unacceptable toxicity whichever occurs first.
BG004
Arm F: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for human epidermal growth factor receptor 2 (HER2) gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 milligrams/kilograms (mg/kg), as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
BG005
Arm G: PH FDC SC
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as subcutaneous (SC) injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2.
BG006
Arm H: PH FDC SC + Chemotherapy
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2 in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine).
BG007
Arm I: Trastuzumab Emtansine + Tucatinib
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received trastuzumab emtansine, 3.6 mg/kg as IV infusion, every 21 days in combination with tucatinib, 300 mg, orally, BID starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity, whichever occurs first.
BG008
Arm J: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation plus TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 mg/kg, as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
BG009
Arm K: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PIK3CA activating mutation received ipatasertib, 400 mg, orally QD in combination with atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
BG010
Arm L: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD and received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or intolerable toxicity, whichever occurs first.
BG011
Arm M: Ipatasertib + Paclitaxel
Participants with a positive tumor biomarker result for co-mutations in PIK3CA activating mutations and PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD on Days 1 to 21 of 28-day cycles and received paclitaxel, 80 mg/m^2, as IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
BG012
Arm N: Atezolizumab + Tiragolumab
Participants with a positive tumor biomarker result for TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
BG013
Arm O: Pralsetinib
Participants with a positive tumor biomarker result for RET gene fusion self-administered pralsetinib, 400 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00026
BG0015
BG00226
BG00325
BG00425
BG00513
BG0068
BG00723
BG00819
BG00928
BG01025
BG0113
BG01223
BG0133
BG014252
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00064.5± 11.5
BG00162.6± 6.7
BG00266.7± 10.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00018
BG0014
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Confirmed Objective Response Rate (ORR) Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria for Primary Central Nervous System (CNS) Tumors
Confirmed objective response rate (cORR)=percentage of participants with best response as complete response (CR) or partial response (PR) for measurable disease & CR for non-measurable disease. Confirmation=CR/PR on 2 consecutive visits ≥4 weeks apart for 3-week cycles & ≥6 weeks apart for 4-week cycles. Per RECIST, CR=disappearance of all target lesions. PR= ≥30% decrease in sum of diameters of target lesions, in absence of CR. Per RANO, CR=complete disappearance of all measurable & non-measurable disease for ≥4 weeks; no new lesions/abnormality on T2/FLAIR imaging; stable/improved non-enhancing lesions; participants must be off corticosteroids or on physiological doses; clinical status stable/improved. PR= ≥50% decrease in the sum of products of perpendicular diameters of measurable enhancing lesions on T2/FLAIR imaging for ≥4 weeks; no progression of non-measurable T1 disease; stable/improved non-enhancing lesions; corticosteroid dose ≤ baseline; clinical status stable/improved.
Efficacy population included all participants who received at least one dose of study treatment and either had at least one post-baseline tumor assessment or discontinued treatment for any reason. Percentages have been rounded off to the nearest decimal point.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 32 months
ID
Title
Description
OG000
Arm B: Inavolisib (GDC-0077)
Participants with a positive tumor biomarker result for PIK3CA activating mutation self-administered inavolisib 9 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
OG001
Arm C: Alectinib
Participants with a positive tumor biomarker result for ALK gene fusion self-administered alectinib, 600 mg, orally, BID until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG002
Arm D: Ipatasertib
Participants with a positive tumor biomarker result for phosphatase and tensin homolog (PTEN) loss/loss-of-function or protein kinase B (AKT) activating mutation self-administered ipatasertib, 400 mg orally, QD until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG003
Arm E: Atezolizumab + Chemotherapy
Participants with a positive tumor biomarker result for TMB-H or MSI-H or dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine) until disease progression, loss of clinical benefit, or unacceptable toxicity whichever occurs first.
OG004
Arm F: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for human epidermal growth factor receptor 2 (HER2) gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 milligrams/kilograms (mg/kg), as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
Units
Counts
Participants
OG00026
OG0015
OG00226
OG003
Title
Denominators
Categories
Title
Measurements
OG00011.5(2.4 to 30.2)
OG00120.0(0.5 to 71.6)
OG00211.5(2.4 to 30.2)
OG003
Secondary
Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
PFS=time from start of treatment to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first, per RECIST v1.1, or RANO. Per RECIST, PD=≥20% increase in sum of diameters of lesions, using the smallest sum during the study as reference, including baseline (BL). Per RANO, PD= ≥25% increase in sum of products of perpendicular diameters of enhancing lesions compared to smallest tumor measurement at BL/best response, on stable/increasing corticosteroids (CS) dose; Significant/ ≥25% increase of T2/FLAIR non-enhancing lesion on stable/increasing CS dose compared to BL/best response after therapy start; Presence of new lesions/increase of enhancement; Clear progression of non-measurable disease; Definite clinical deterioration only due to tumor/decrease in CS dose; Failure to return for evaluation due to death/deterioration. Kaplan-Meier methodology was used to estimate PFS; patients without an event were censored on the last available assessment day.
Efficacy population included all participants who received at least one dose of study treatment and either had at least one post-baseline tumor assessment or discontinued treatment for any reason. Participants who did not experience death or disease progression were censored on the day of the last available assessment.
Posted
Median
95% Confidence Interval
months
Time from start of treatment to the first occurrence of disease progression or death from any cause (Up to 32 months)
ID
Title
Description
OG000
Arm B: Inavolisib (GDC-0077)
Participants with a positive tumor biomarker result for PIK3CA activating mutation self-administered inavolisib 9 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
Secondary
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
DOR was defined as the time from the date of the first confirmed complete response (CR) or partial response (PR) to disease progression (PD) or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1 or RANO. CR & PR were defined per RECIST or RANO as outlined in the description for the cORR outcome measure (OM). PD was defined per RECIST or RANO as outlined in the description for the PFS OM. Kaplan-Meier methodology was used to estimate the median DOR. The 95% confidence intervals for the median DOR were computed by the method of Brookmeyer and Crowley. Participants who did not experience death or PD were censored on the day of the last available assessment.
Efficacy population included all participants who received at least one dose of study treatment and either had at least one post-baseline tumor assessment or discontinued treatment for any reason. Participants who achieved a confirmed CR/PR were analyzed for this outcome measure.
Posted
Median
95% Confidence Interval
months
Time from the date of the first confirmed CR/PR to PD or death from any cause (Up to 32 months)
ID
Title
Description
OG000
Arm B: Inavolisib (GDC-0077)
Participants with a positive tumor biomarker result for PIK3CA activating mutation self-administered inavolisib 9 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
OG001
Arm C: Alectinib
Secondary
PFS Rate at Month 3, 6, 9, and 12 as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
The PFS rates were calculated using the Kaplan-Meier (KM) method to estimate the percent survival probability of participants (i.e., PFS event-free: did not experience PD or death from any cause) in each treatment arm at landmark timepoints. The 95% confidence intervals for each PFS rate were computed by the method of Greenwood. PFS was defined as the time from the start of study treatment to the first occurrence of PD or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1 or RANO. PD was defined per RECIST or RANO as outlined in the description for the PFS OM. Participants who did not experience death or PD were censored on the day of the last available assessment. The number analyzed per landmark timepoint actually represents the number of participants who remained at risk of experiencing a PFS event at that timepoint. Percentages are rounded off to the nearest decimal point.
Efficacy population included all participants who received at least one dose of study treatment and either had at least one post-baseline tumor assessment or discontinued treatment for any reason. The number analyzed per timepoint is the number of participants (out of the overall number of participants analyzed for PFS per arm) who remained at risk for a PFS event at that timepoint. Different participants may have contributed data for each timepoint.
Posted
Number
95% Confidence Interval
percent probability
At Months 3, 6, 9 and 12
ID
Title
Description
OG000
Arm B: Inavolisib (GDC-0077)
Participants with a positive tumor biomarker result for PIK3CA activating mutation self-administered inavolisib 9 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
Secondary
Percentage of Participants With Disease Control, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
Disease control rate was defined as the percentage of participants whose best response was confirmed CR, confirmed PR, or a response of CR, PR, stable disease (SD), or non-CR/non-PD for a minimum of 98 days for 28-day cycle arms or 70 days for 21-day cycle arms after the first treatment date. CR & PR were defined per RECIST/RANO as outlined in the description for the cORR OM. SD per RECIST: Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. SD per RANO: Participant does not qualify for CR, PR, or minor response or PD; Stable non-enhancing (T2/FLAIR) lesions or abnormalities on same or lower dose of corticosteroids compared to baseline; No new lesions or new T2 or FLAIR abnormalities apart from those consistent with radiation effect, & no new or increased enhancement; Participants on a should be corticosteroid dose that is not greater than dose at baseline scan & is stable or improved clinically; Clinical status, stable/improved.
Efficacy population included all participants who received at least one dose of study treatment and either had at least one post-baseline tumor assessment or discontinued treatment for any reason. Percentages have been rounded off to the nearest decimal point.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 32 months
ID
Title
Description
OG000
Arm B: Inavolisib (GDC-0077)
Participants with a positive tumor biomarker result for PIK3CA activating mutation self-administered inavolisib 9 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
Secondary
Number of Participants With at Least One Adverse Event (AE) and Severity of AEs Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
An AE is an untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with the product. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to it. AEs were graded for severity according to NCI CTCAE v5.0. Grade 1= Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3 = Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4= Life-threatening consequences/urgent intervention indicated; Grade 5= Death related to adverse event.
Safety evaluable population included all participants who received at least one dose of the study drug.
Posted
Count of Participants
Participants
From initiation of study drug until 28 days after the final dose of study drugs other than atezolizumab and until 90 days after the final dose of atezolizumab (Up to 32 months)
ID
Title
Description
OG000
Arm B: Inavolisib (GDC-0077)
Participants with a positive tumor biomarker result for PIK3CA activating mutation self-administered inavolisib 9 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
Time Frame
From initiation of study drug until 28 days after the final dose of study drugs other than atezolizumab and until 90 days after the final dose of atezolizumab (Up to 32 months)
Description
Safety evaluable population included all participants who received at least one dose of the study drug.
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
Arm B: Inavolisib (GDC-0077)
Participants with a positive tumor biomarker result for PIK3CA activating mutation self-administered inavolisib 9 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
19
26
5
26
25
26
EG001
Arm C: Alectinib
Participants with a positive tumor biomarker result for ALK gene fusion self-administered alectinib, 600 mg, orally, BID until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
1
5
2
5
5
5
EG002
Arm D: Ipatasertib
Participants with a positive tumor biomarker result for phosphatase and tensin homolog (PTEN) loss/loss-of-function or protein kinase B (AKT) activating mutation self-administered ipatasertib, 400 mg orally, QD until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
16
26
6
26
25
26
EG003
Arm E: Atezolizumab + Chemotherapy
Participants with a positive tumor biomarker result for TMB-H or MSI-H or dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine) until disease progression, loss of clinical benefit, or unacceptable toxicity whichever occurs first.
16
25
11
25
25
25
EG004
Arm F: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for human epidermal growth factor receptor 2 (HER2) gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 milligrams/kilograms (mg/kg), as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
16
25
9
25
23
25
EG005
Arm G: PH FDC SC
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as subcutaneous (SC) injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2.
6
13
2
13
11
13
EG006
Arm H: PH FDC SC + Chemotherapy
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2 in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine).
8
8
2
8
8
8
EG007
Arm I: Trastuzumab Emtansine + Tucatinib
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received trastuzumab emtansine, 3.6 mg/kg as IV infusion, every 21 days in combination with tucatinib, 300 mg, orally, BID starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity, whichever occurs first.
14
23
6
23
23
23
EG008
Arm J: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation plus TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 mg/kg, as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
16
19
7
19
19
19
EG009
Arm K: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PIK3CA activating mutation received ipatasertib, 400 mg, orally QD in combination with atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
22
28
10
28
26
28
EG010
Arm L: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD and received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or intolerable toxicity, whichever occurs first.
10
25
8
25
25
25
EG011
Arm M: Ipatasertib + Paclitaxel
Participants with a positive tumor biomarker result for co-mutations in PIK3CA activating mutations and PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD on Days 1 to 21 of 28-day cycles and received paclitaxel, 80 mg/m^2, as IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
2
3
2
3
3
3
EG012
Arm N: Atezolizumab + Tiragolumab
Participants with a positive tumor biomarker result for TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
10
23
6
23
21
23
EG013
Arm O: Pralsetinib
Participants with a positive tumor biomarker result for RET gene fusion self-administered pralsetinib, 400 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
1
3
2
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected13 at risk
EG0060 events0 affected8 at risk
EG0072 events2 affected23 at risk
EG0080 events0 affected19 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected23 at risk
EG0131 events1 affected3 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Gastrointestinal fistula
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Asthenia
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Chest pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Fatigue
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Pyrexia
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Acute hepatic failure
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Colonic abscess
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Gangrene
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Septic shock
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Wound infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Seizure
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Device breakage
Product Issues
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Device malfunction
Product Issues
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Device occlusion
Product Issues
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Arterial haemorrhage
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 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 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected5 at risk
EG0024 events2 affected26 at risk
EG0037 events5 affected25 at risk
EG0045 events5 affected25 at risk
EG0052 events2 affected13 at risk
EG0060 events0 affected8 at risk
EG0077 events5 affected23 at risk
EG0081 events1 affected19 at risk
EG0093 events3 affected28 at risk
EG0101 events1 affected25 at risk
EG0113 events3 affected3 at risk
EG0127 events6 affected23 at risk
EG0133 events2 affected3 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0002 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Dry eye
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Vision blurred
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Visual impairment
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0007 events6 affected26 at risk
EG0010 events0 affected5 at risk
EG0023 events3 affected26 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0004 events4 affected26 at risk
EG0011 events1 affected5 at risk
EG0026 events4 affected26 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0007 events6 affected26 at risk
EG0010 events0 affected5 at risk
EG00235 events19 affected26 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0005 events5 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected26 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0025 events5 affected26 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0008 events7 affected26 at risk
EG0012 events2 affected5 at risk
EG00215 events13 affected26 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0008 events5 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected26 at risk
EG0010 events0 affected5 at risk
EG0029 events6 affected26 at risk
EG003
Asthenia
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected26 at risk
EG003
Chills
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Fatigue
General disorders
MedDRA 26.1
Systematic Assessment
EG0009 events9 affected26 at risk
EG0011 events1 affected5 at risk
EG0027 events5 affected26 at risk
EG003
Gait disturbance
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Influenza like illness
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Injection site reaction
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Localised oedema
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Mass
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Oedema
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Performance status decreased
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Peripheral swelling
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Pyrexia
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected26 at risk
EG003
Candida infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Colonic abscess
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Cystitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected26 at risk
EG003
Otitis media
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Penile infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Skin infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Tinea infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0013 events2 affected5 at risk
EG0023 events3 affected26 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0005 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0002 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Incorrect dose administered
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Injection related reaction
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected5 at risk
EG0022 events1 affected26 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Underdose
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0011 events1 affected5 at risk
EG0025 events4 affected26 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected26 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0024 events3 affected26 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0003 events1 affected26 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Blood creatinine decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Blood glucose increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Blood iron decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Cardiac murmur
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected5 at risk
EG0022 events1 affected26 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Occult blood
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Weight decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0005 events4 affected26 at risk
EG0011 events1 affected5 at risk
EG0022 events2 affected26 at risk
EG003
Weight increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected26 at risk
EG0011 events1 affected5 at risk
EG0026 events6 affected26 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0026 events5 affected26 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG00017 events12 affected26 at risk
EG0010 events0 affected5 at risk
EG0025 events5 affected26 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected26 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0002 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected26 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected26 at risk
EG0011 events1 affected5 at risk
EG0026 events5 affected26 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected5 at risk
EG0023 events3 affected26 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0012 events1 affected5 at risk
EG0022 events1 affected26 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0023 events3 affected26 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0006 events6 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0002 events1 affected26 at risk
EG0012 events2 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0002 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Tremor
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Vaginal cyst
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Aphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected26 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0003 events2 affected26 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected26 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected5 at risk
EG0023 events3 affected26 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Skin weeping
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Flushing
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected26 at risk
EG003
Hot flush
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected26 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected5 at risk
EG0022 events2 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.
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as subcutaneous (SC) injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2.
OG006
Arm H: PH FDC SC + Chemotherapy
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2 in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine).
OG007
Arm I: Trastuzumab Emtansine + Tucatinib
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received trastuzumab emtansine, 3.6 mg/kg as IV infusion, every 21 days in combination with tucatinib, 300 mg, orally, BID starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity, whichever occurs first.
OG008
Arm J: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation plus TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 mg/kg, as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG009
Arm K: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PIK3CA activating mutation received ipatasertib, 400 mg, orally QD in combination with atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG010
Arm L: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD and received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or intolerable toxicity, whichever occurs first.
OG011
Arm M: Ipatasertib + Paclitaxel
Participants with a positive tumor biomarker result for co-mutations in PIK3CA activating mutations and PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD on Days 1 to 21 of 28-day cycles and received paclitaxel, 80 mg/m^2, as IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG012
Arm N: Atezolizumab + Tiragolumab
Participants with a positive tumor biomarker result for TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG013
Arm O: Pralsetinib
Participants with a positive tumor biomarker result for RET gene fusion self-administered pralsetinib, 400 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
25
OG00425
OG00513
OG0068
OG00723
OG00819
OG00928
OG01025
OG0113
OG01223
OG0133
28.0
(12.1 to 49.4)
OG00412.0(2.5 to 31.2)
OG0050.0(0.0 to 24.7)
OG0060.0(0.0 to 36.9)
OG00713.0(2.8 to 33.6)
OG0080.0(0.0 to 17.6)
OG0090.0(0.0 to 12.3)
OG0100.0(0.0 to 13.7)
OG01166.7(9.4 to 99.2)
OG01221.7(7.5 to 43.7)
OG01333.3(0.8 to 90.6)
OG001
Arm C: Alectinib
Participants with a positive tumor biomarker result for ALK gene fusion self-administered alectinib, 600 mg, orally, BID until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG002
Arm D: Ipatasertib
Participants with a positive tumor biomarker result for phosphatase and tensin homolog (PTEN) loss/loss-of-function or protein kinase B (AKT) activating mutation self-administered ipatasertib, 400 mg orally, QD until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG003
Arm E: Atezolizumab + Chemotherapy
Participants with a positive tumor biomarker result for TMB-H or MSI-H or dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine) until disease progression, loss of clinical benefit, or unacceptable toxicity whichever occurs first.
OG004
Arm F: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for human epidermal growth factor receptor 2 (HER2) gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 milligrams/kilograms (mg/kg), as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG005
Arm G: PH FDC SC
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as subcutaneous (SC) injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2.
OG006
Arm H: PH FDC SC + Chemotherapy
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2 in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine).
OG007
Arm I: Trastuzumab Emtansine + Tucatinib
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received trastuzumab emtansine, 3.6 mg/kg as IV infusion, every 21 days in combination with tucatinib, 300 mg, orally, BID starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity, whichever occurs first.
OG008
Arm J: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation plus TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 mg/kg, as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG009
Arm K: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PIK3CA activating mutation received ipatasertib, 400 mg, orally QD in combination with atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG010
Arm L: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD and received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or intolerable toxicity, whichever occurs first.
OG011
Arm M: Ipatasertib + Paclitaxel
Participants with a positive tumor biomarker result for co-mutations in PIK3CA activating mutations and PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD on Days 1 to 21 of 28-day cycles and received paclitaxel, 80 mg/m^2, as IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG012
Arm N: Atezolizumab + Tiragolumab
Participants with a positive tumor biomarker result for TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG013
Arm O: Pralsetinib
Participants with a positive tumor biomarker result for RET gene fusion self-administered pralsetinib, 400 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
Units
Counts
Participants
OG00026
OG0015
OG00226
OG00325
OG00425
OG00513
OG0068
OG00723
OG00819
OG00928
OG01025
OG0113
OG01223
OG0133
Title
Denominators
Categories
Title
Measurements
OG0004.24(1.84 to 8.08)
OG0014.98(1.54 to NA)The upper limit of the 95% confidence interval (CI) was not estimable because there was an insufficient number of events.
OG0023.48(1.87 to 6.47)
OG0033.94(2.17 to 8.38)
OG0044.73(2.07 to 10.22)
OG0052.46(1.77 to 5.16)
OG0063.02(1.54 to 5.52)
OG0072.69(1.94 to 6.18)
OG0081.87(1.71 to 2.20)
OG0092.10(1.64 to 3.48)
OG0103.61(2.33 to 6.34)
OG0115.98(1.28 to NA)The upper limit of the 95% CI was not estimable because there was an insufficient number of events.
OG0124.76(1.87 to 16.43)
OG0137.10(1.84 to NA)The upper limit of the 95% CI was not estimable because there was an insufficient number of events.
Participants with a positive tumor biomarker result for ALK gene fusion self-administered alectinib, 600 mg, orally, BID until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG002
Arm D: Ipatasertib
Participants with a positive tumor biomarker result for phosphatase and tensin homolog (PTEN) loss/loss-of-function or protein kinase B (AKT) activating mutation self-administered ipatasertib, 400 mg orally, QD until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG003
Arm E: Atezolizumab + Chemotherapy
Participants with a positive tumor biomarker result for TMB-H or MSI-H or dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine) until disease progression, loss of clinical benefit, or unacceptable toxicity whichever occurs first.
OG004
Arm F: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for human epidermal growth factor receptor 2 (HER2) gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 milligrams/kilograms (mg/kg), as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG005
Arm G: PH FDC SC
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as subcutaneous (SC) injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2.
OG006
Arm H: PH FDC SC + Chemotherapy
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2 in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine).
OG007
Arm I: Trastuzumab Emtansine + Tucatinib
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received trastuzumab emtansine, 3.6 mg/kg as IV infusion, every 21 days in combination with tucatinib, 300 mg, orally, BID starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity, whichever occurs first.
OG008
Arm J: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation plus TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 mg/kg, as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG009
Arm K: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PIK3CA activating mutation received ipatasertib, 400 mg, orally QD in combination with atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG010
Arm L: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD and received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or intolerable toxicity, whichever occurs first.
OG011
Arm M: Ipatasertib + Paclitaxel
Participants with a positive tumor biomarker result for co-mutations in PIK3CA activating mutations and PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD on Days 1 to 21 of 28-day cycles and received paclitaxel, 80 mg/m^2, as IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG012
Arm N: Atezolizumab + Tiragolumab
Participants with a positive tumor biomarker result for TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG013
Arm O: Pralsetinib
Participants with a positive tumor biomarker result for RET gene fusion self-administered pralsetinib, 400 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
Units
Counts
Participants
OG0003
OG0011
OG0023
OG0037
OG0043
OG0050
OG0060
OG0073
OG0080
OG0090
OG0100
OG0112
OG0125
OG0131
Title
Denominators
Categories
Title
Measurements
OG0005.6(5.3 to NA)The upper limit of the 95% CI was not estimable because there was an insufficient number of events.
OG0016.5(NA to NA)The 95% CI was not estimable because only one participant had confirmed response, but the median was estimable because the participant had experienced an event.
OG0025.5(3.7 to NA)The upper limit of the 95% CI was not estimable because there was an insufficient number of events.
OG003NA(7.4 to NA)The median and upper limit of the 95% CI was not estimable because there was an insufficient number of events.
OG00420.0(NA to NA)The 95% CI was not estimable because there was an insufficient number of events.
OG0077.6(3.7 to NA)The upper limit of the 95% CI was not estimable because there was an insufficient number of events.
OG0115.5(4.0 to NA)The upper limit of the 95% CI was not estimable because there was an insufficient number of events.
OG012NA(3.6 to NA)The median and upper limit of the 95% CI was not estimable because there was an insufficient number of events.
OG013NA(NA to NA)The median and 95% CI were not estimable because only one participant had confirmed response and the participant had not experienced an event (i.e., censored).
OG001
Arm C: Alectinib
Participants with a positive tumor biomarker result for ALK gene fusion self-administered alectinib, 600 mg, orally, BID until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG002
Arm D: Ipatasertib
Participants with a positive tumor biomarker result for phosphatase and tensin homolog (PTEN) loss/loss-of-function or protein kinase B (AKT) activating mutation self-administered ipatasertib, 400 mg orally, QD until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG003
Arm E: Atezolizumab + Chemotherapy
Participants with a positive tumor biomarker result for TMB-H or MSI-H or dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine) until disease progression, loss of clinical benefit, or unacceptable toxicity whichever occurs first.
OG004
Arm F: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for human epidermal growth factor receptor 2 (HER2) gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 milligrams/kilograms (mg/kg), as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG005
Arm G: PH FDC SC
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as subcutaneous (SC) injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2.
OG006
Arm H: PH FDC SC + Chemotherapy
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2 in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine).
OG007
Arm I: Trastuzumab Emtansine + Tucatinib
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received trastuzumab emtansine, 3.6 mg/kg as IV infusion, every 21 days in combination with tucatinib, 300 mg, orally, BID starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity, whichever occurs first.
OG008
Arm J: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation plus TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 mg/kg, as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG009
Arm K: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PIK3CA activating mutation received ipatasertib, 400 mg, orally QD in combination with atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG010
Arm L: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD and received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or intolerable toxicity, whichever occurs first.
OG011
Arm M: Ipatasertib + Paclitaxel
Participants with a positive tumor biomarker result for co-mutations in PIK3CA activating mutations and PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD on Days 1 to 21 of 28-day cycles and received paclitaxel, 80 mg/m^2, as IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG012
Arm N: Atezolizumab + Tiragolumab
Participants with a positive tumor biomarker result for TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG013
Arm O: Pralsetinib
Participants with a positive tumor biomarker result for RET gene fusion self-administered pralsetinib, 400 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
Units
Counts
Participants
OG00026
OG0015
OG00226
OG00325
OG00425
OG00513
OG0068
OG00723
OG00819
OG00928
OG01025
OG0113
OG01223
OG0133
Title
Denominators
Categories
3 months
ParticipantsOG00015
ParticipantsOG0012
ParticipantsOG00213
ParticipantsOG00312
ParticipantsOG00416
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG00710
ParticipantsOG0085
ParticipantsOG0099
ParticipantsOG01015
ParticipantsOG0112
ParticipantsOG01213
ParticipantsOG0132
Title
Measurements
OG00057.69(38.7 to 76.68)
OG00150.00(1.00 to 99.00)
OG00252.00(32.42 to 71.58)
OG003
6 months
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0037
9 months
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0036
12 months
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0034
OG001
Arm C: Alectinib
Participants with a positive tumor biomarker result for ALK gene fusion self-administered alectinib, 600 mg, orally, BID until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG002
Arm D: Ipatasertib
Participants with a positive tumor biomarker result for phosphatase and tensin homolog (PTEN) loss/loss-of-function or protein kinase B (AKT) activating mutation self-administered ipatasertib, 400 mg orally, QD until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG003
Arm E: Atezolizumab + Chemotherapy
Participants with a positive tumor biomarker result for TMB-H or MSI-H or dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine) until disease progression, loss of clinical benefit, or unacceptable toxicity whichever occurs first.
OG004
Arm F: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for human epidermal growth factor receptor 2 (HER2) gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 milligrams/kilograms (mg/kg), as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG005
Arm G: PH FDC SC
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as subcutaneous (SC) injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2.
OG006
Arm H: PH FDC SC + Chemotherapy
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2 in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine).
OG007
Arm I: Trastuzumab Emtansine + Tucatinib
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received trastuzumab emtansine, 3.6 mg/kg as IV infusion, every 21 days in combination with tucatinib, 300 mg, orally, BID starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity, whichever occurs first.
OG008
Arm J: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation plus TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 mg/kg, as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG009
Arm K: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PIK3CA activating mutation received ipatasertib, 400 mg, orally QD in combination with atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG010
Arm L: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD and received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or intolerable toxicity, whichever occurs first.
OG011
Arm M: Ipatasertib + Paclitaxel
Participants with a positive tumor biomarker result for co-mutations in PIK3CA activating mutations and PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD on Days 1 to 21 of 28-day cycles and received paclitaxel, 80 mg/m^2, as IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG012
Arm N: Atezolizumab + Tiragolumab
Participants with a positive tumor biomarker result for TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG013
Arm O: Pralsetinib
Participants with a positive tumor biomarker result for RET gene fusion self-administered pralsetinib, 400 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.
Units
Counts
Participants
OG00026
OG0015
OG00226
OG00325
OG00425
OG00513
OG0068
OG00723
OG00819
OG00928
OG01025
OG0113
OG01223
OG0133
Title
Denominators
Categories
Title
Measurements
OG00057.7(36.9 to 76.6)
OG00140.0(5.3 to 85.3)
OG00234.6(17.2 to 55.7)
OG00332.0(14.9 to 53.5)
OG00452.0(31.3 to 72.2)
OG00523.1(5.0 to 53.8)
OG00637.5(8.5 to 75.5)
OG00726.1(10.2 to 48.4)
OG00815.8(3.4 to 39.6)
OG00910.7(2.3 to 28.2)
OG01032.0(14.9 to 53.5)
OG01166.7(9.4 to 99.2)
OG01247.8(26.8 to 69.4)
OG01366.7(9.4 to 99.2)
OG001
Arm C: Alectinib
Participants with a positive tumor biomarker result for ALK gene fusion self-administered alectinib, 600 mg, orally, BID until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG002
Arm D: Ipatasertib
Participants with a positive tumor biomarker result for phosphatase and tensin homolog (PTEN) loss/loss-of-function or protein kinase B (AKT) activating mutation self-administered ipatasertib, 400 mg orally, QD until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG003
Arm E: Atezolizumab + Chemotherapy
Participants with a positive tumor biomarker result for TMB-H or MSI-H or dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine) until disease progression, loss of clinical benefit, or unacceptable toxicity whichever occurs first.
OG004
Arm F: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for human epidermal growth factor receptor 2 (HER2) gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 milligrams/kilograms (mg/kg), as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG005
Arm G: PH FDC SC
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as subcutaneous (SC) injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2.
OG006
Arm H: PH FDC SC + Chemotherapy
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received PH FDC SC, a loading dose of 1200 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of Cycle 1 followed by a maintenance dose of 600 mg pertuzumab + 600 mg trastuzumab as a SC injection on Day 1 of each 21-day cycle, starting at Cycle 2 in combination with investigators choice of chemotherapy (docetaxel, paclitaxel, or capecitabine).
OG007
Arm I: Trastuzumab Emtansine + Tucatinib
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation without known TMB-H/ MSI-H/ dMMR received trastuzumab emtansine, 3.6 mg/kg as IV infusion, every 21 days in combination with tucatinib, 300 mg, orally, BID starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity, whichever occurs first.
OG008
Arm J: Trastuzumab Emtansine + Atezolizumab
Participants with a positive tumor biomarker result for HER2 gene amplification or mutation plus TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by trastuzumab emtansine, 3.6 mg/kg, as IV infusion, every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG009
Arm K: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PIK3CA activating mutation received ipatasertib, 400 mg, orally QD in combination with atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG010
Arm L: Ipatasertib + Atezolizumab
Participants with a positive tumor biomarker result for PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD and received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or intolerable toxicity, whichever occurs first.
OG011
Arm M: Ipatasertib + Paclitaxel
Participants with a positive tumor biomarker result for co-mutations in PIK3CA activating mutations and PTEN loss/loss-of-function or AKT-activating mutation self-administered ipatasertib, 400 mg, orally, QD on Days 1 to 21 of 28-day cycles and received paclitaxel, 80 mg/m^2, as IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, or consent withdrawal, whichever occurs first.
OG012
Arm N: Atezolizumab + Tiragolumab
Participants with a positive tumor biomarker result for TMB-H/ MSI-H/ dMMR received atezolizumab, 1200 mg, as IV infusion, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as IV infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity, whichever occurs first.
OG013
Arm O: Pralsetinib
Participants with a positive tumor biomarker result for RET gene fusion self-administered pralsetinib, 400 mg, orally, QD until disease progression, intolerable toxicity, or consent withdrawal whichever occurs first.