My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva... | NCT02091141 | Trialant
NCT02091141
Sponsor
Genentech, Inc.
Status
Completed
Last Update Posted
Jul 23, 2024Actual
Enrollment
673Actual
Phase
Phase 2
Conditions
Neoplasms
Solid Tumors
Biliary Cancer
Salivary Cancer
Bladder Cancer
Interventions
Trastuzumab
Pertuzumab
Erlotinib
Vemurafenib
Cobimetinib
Vismodegib
Alectinib
Atezolizumab
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02091141
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ML28897
Secondary IDs
ID
Type
Description
Link
PRO 02
Other Identifier
Genentech, Inc.
Brief Title
My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors
Official Title
My Pathway: An Open-Label Phase IIa Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents
Acronym
Not provided
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
Jun 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
Apr 14, 2014Actual
Primary Completion Date
May 24, 2023Actual
Completion Date
May 24, 2023Actual
First Submitted Date
Mar 17, 2014
First Submission Date that Met QC Criteria
Mar 17, 2014
First Posted Date
Mar 19, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
May 23, 2024
Results First Submitted that Met QC Criteria
Jun 26, 2024
Results First Posted Date
Jul 23, 2024Actual
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
Jun 26, 2024
Last Update Posted Date
Jul 23, 2024Actual
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 multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Solid Tumors
Biliary Cancer
Salivary Cancer
Bladder Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
673Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Trastuzumab Plus Pertuzumab
Experimental
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
Drug: Trastuzumab
Drug: Pertuzumab
Atezolizumab
Experimental
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
Drug: Atezolizumab
Vemurafenib
Experimental
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
Drug: Vemurafenib
Vemurafenib Plus Cobimetinib
Experimental
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
Drug: Vemurafenib
Drug: Cobimetinib
Vismodegib
Experimental
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Trastuzumab
Drug
Trastuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Trastuzumab Plus Pertuzumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator
The Objective Response Rate (ORR) is defined as the percentage of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for all arms.
From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months)
Percentage of Atezolizumab-Treated Participants With Tissue Tumor Mutational Burden (tTMB) ≥16 Mutations/Mb With Overall Response, as Assessed by the Independent Review Committee (IRC)
The Objective Response Rate (ORR) is defined as the proportion of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
From the date of first study treatment until disease progression or death from any cause, whichever occurs first (68.9 months)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Disease Control
Disease Control Rate (DCR) is defined as the proportion of patients whose best response is CR, PR or stable disease maintained more than 4 months (SD>4 months). Tumor responses were assessed by investigators using RECIST version 1.1 for all arms.
From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
General Inclusion Criteria:
Life expectancy greater than or equal to (≥) 12 weeks
Histologically documented metastatic cancer (solid tumors, not including hematologic malignancies)
Participants who have received standard first-line therapy for metastatic cancer (except for the tumors for which no first-line therapy exists) and in whom a trial of targeted therapy is considered the best available treatment option. Eligible participants should not have available therapies that will convey clinical benefit and/or are not suitable options per the treating physician's judgment
No previous treatment with the specific assigned study drug or any other drug sharing the same target
Measurable disease by RECIST v1.1
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 (For patients enrolling in the atezolizumab arm, ECOG score must be documented within 7 days prior to first treatment and confirmation of ECOG PS must be entered into the interactive web response system [IWRS] prior to initiation of treatment)
Adequate hematologic, renal, and liver function as defined by the protocol
If applicable, use of contraception methods or abstinence as defined by the protocol
Study-Drug Specific Inclusion Criteria:
Trastuzumab plus Pertuzumab
Molecular testing results from clinical laboratory improvement amendments (CLIA)-certified laboratories (using tissue and/or blood) demonstrating HER2 overexpression or amplification. Participants must have one of the following tumor types: biliary cancer, salivary cancer, or bladder cancer
a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)
Left ventricular ejection fraction (LVEF) greater than (>) 50 percent (%) or above the lower limit of the institutional normal range, whichever is lower
Availability of an archival or new pre-treatment tissue sample is required if molecular testing was not performed by Foundation Medicine. Any available tumor tissue sample can be submitted. The tissue sample must be submitted within 4 weeks after enrollment
Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating BRAF V600 mutations a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)
Vismodegib
Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating hedgehog pathway relevant mutation (activating mutation of smoothened [SMO] or loss-of-function mutation of protein patched homolog-1 [PTCH-1])
a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)
All non-hematological adverse events related to any prior chemotherapy, surgery, or radiotherapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade less than or equal to (≤) 2 prior to starting therapy
Alectinib
Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating anaplastic lymphoma kinase (ALK) gene rearrangements, ALK mutations, ALK copy number gain or (for melanoma only) increased ALK expression or presence of ALK-alternative transcription initiation transcript (ALKATI) a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)
For patients where molecular testing was not performed using Foundation Medicine, submission of an archival or new pretreatment tissue sample is mandatory. For patients where molecular testing was performed using Foundation Medicine, submission of an archival or new pretreatment tissue sample is required, if available. The tissue sample must be submitted within 4 weeks after enrollment
General Exclusion Criteria:
Participants with hematologic malignancies
Concurrent administration of any other anti-cancer therapy (except male participants with prostate cancer receiving androgen blockade): Bisphosphonates and denosumab are allowed; Most recent anti-cancer therapy ≤28 days and have not recovered from the side effects, excluding alopecia; Radiation therapy within ≤14 days
Active or untreated brain metastases
History of carcinomatous meningitis
Uncontrolled concurrent malignancy (early stage is allowed if not requiring active therapy or intervention)
Pregnant or breastfeeding women, or intending to become pregnant during the study
Any significant cardiovascular events within 6 months prior to study entry
Pulmonary embolism within 30 days prior to study entry
History or presence of clinically significant ventricular or atrial dysrhythmia >Grade 2 per NCI CTCAE v4.0
Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Study-Drug Specific Exclusion Criteria:
Trastuzumab plus Pertuzumab
Previous treatment with any HER2-targeted therapy
Erlotinib
Non-small cell lung cancer (NSCLC) or pancreatic cancer identified by exon 19 deletions or exon 21 L858R substitution mutations
EGFR amplifications in the absence of EGFR-activating mutations
Cancers with exon 20 mutations
Previous treatment with erlotinib or any other EGFR inhibitor
Inability to swallow pills
Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude absorption of erlotinib
Vemurafenib plus Cobimetinib
Malignant melanoma, papillary thyroid cancer, colorectal cancer, or hematologic malignancy including multiple myeloma
LVEF below institutional lower level of normal (LLN) or below 50%, whichever is lower
History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration
Presence of any of the following conditions, which are risk factors for RVO: Uncontrolled glaucoma with intraocular pressure >21 millimetres of mercury (mm Hg); Serum cholesterol ≥Grade 2; Hypertriglyceridemia ≥Grade 2; Hyperglycemia (fasting) ≥Grade 2; Grade ≥2 uncontrolled hypertension (participants with a history of hypertension controlled with anti-hypertensive medication to Grade \
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Western Regional Medical Center at Cancer Treatment Centers of America
For eligible studies, qualified researchers may request access to individual patient-level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
FG001
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
Dec 17, 2022
May 23, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
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: Vismodegib
Alectinib
Experimental
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
Drug: Alectinib
Erlotinib
Experimental
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
Drug: Erlotinib
Herceptin
Pertuzumab
Drug
Pertuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Trastuzumab Plus Pertuzumab
Perjeta
Erlotinib
Drug
Erlotinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Erlotinib
Tarceva
Vemurafenib
Drug
Vemurafenib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Vemurafenib
Vemurafenib Plus Cobimetinib
Zelboraf
Cobimetinib
Drug
Cobimetinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Vemurafenib Plus Cobimetinib
Cotellic
Vismodegib
Drug
Vismodegib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Vismodegib
Erivedge
Alectinib
Drug
Alectinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Alectinib
Alecensa
Atezolizumab
Drug
Atezolizumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Atezolizumab
Tecentriq
Progression-Free Survival (PFS)
PFS is defined as the time from the start of study treatment to the first occurrence of disease progression, or death, whichever occurs first. Tumor responses were assessed by investigators using RECIST version 1.1 for all arms.
From the date of first study treatment until disease progression as assessed by the investigator, or death from any cause, whichever occurs first (72.1 months)
Overall Survival (OS)
Overall Survival (OS, months) is defined as the time from the date of the first study treatment (Day 1) to the date of death from any cause.
87.5 months
Duration of Response (DoR)
Duration of Response (DoR) is defined as the time from the date of first documented response (CR or PR) to date of first occurrence of disease progression as determined by the investigator, or death from any cause, whichever occurs first.
From the date of first documented response (complete response [CR] or partial response [PR]) to the time of disease progression or death from any cause, whichever occurs first (70.8 months)
Number of Participants With Adverse Events
Incidence, nature, and severity of Adverse Events (AE), per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) for participants enrolled prior to Version 6 of the protocol. The NCI CTCAE (v5.0) grading scale was used for assessing AE severity for participants enrolled under Version 6 of the protocol and subsequent versions.
From first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years)
Mayo Clinic Arizona
Phoenix
Arizona
85259
United States
Highlands Oncology Group
Springdale
Arkansas
72762
United States
Science 37, Inc
Culver City
California
90230
United States
City of Hope Comprehensive Cancer Center
Duarte
California
91010
United States
Moores UCSD Cancer Center; Dept Clinical Trials Office
La Jolla
California
92093-0698
United States
Eisenhower Medical Center
Rancho Mirage
California
92270
United States
Stanford Comprehensive Cancer Center
Stanford
California
94305
United States
Kaiser Permanente - Vallejo
Vallejo
California
94589
United States
University of Colorado
Aurora
Colorado
80045-2517
United States
SCRI Florida Cancer Specialists South
Fort Myers
Florida
33916
United States
Mayo Clinic
Jacksonville
Florida
32224
United States
Florida Hospital Cancer Inst; Memorial System Onc Clin Rsch
Orlando
Florida
32804
United States
Florida Cancer Specialist, North Region
St. Petersburg
Florida
33705
United States
Florida Cancer Specialists, Research Department
West Palm Beach
Florida
33401
United States
University Cancer & Blood Center, LLC; Research
Athens
Georgia
30607
United States
Northeast Georgia Medical Center; Oncology Research Dept-5C
Gainesville
Georgia
30501
United States
Southeastern Regional Medical Center, Inc.
Newnan
Georgia
30265
United States
Northwestern University; Robert H. Lurie Comp Can Ctr; Northwestern Medicine Development Inst
Chicago
Illinois
60611
United States
University Of Chicago Medical Center; Section Of Hematology/Oncology
Chicago
Illinois
60637
United States
Midwestern Regional Med Center
Zion
Illinois
60099
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore
Maryland
21287
United States
Mayo Foundation
Rochester
Minnesota
55905
United States
Research Medical Center - Antibiotic Research Associates, Inc.
Kansas City
Missouri
64132
United States
Memorial Sloan Kettering - Monmouth
Middletown
New Jersey
07748
United States
University of New Mexico Comprehensive Cancer Center
Albuquerque
New Mexico
87102
United States
University of New Mexico Comprehensive Cancer Center - Albuquerque Cedar Street; Drug Shipment
Albuquerque
New Mexico
87106
United States
University of New Mexico Comprehensive Cancer Center - Albuquerque Lang NE; Drug Shipment
Albuquerque
New Mexico
87109
United States
University of New Mexico
Albuquerque
New Mexico
87131
United States
San Juan Oncology Associates
Farmington
New Mexico
87401
United States
Memorial Sloan Kettering Cancer Center at Westchester
Harrison
New York
10604
United States
Weill Cornell Univ Medical Ctr; Breast Cancer Center
New York
New York
10021
United States
Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
New York
New York
10032
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Univ No Carolina School of Med; Physicians Office Bldg
Chapel Hill
North Carolina
27599-7305v
United States
Duke University Medical Center
Durham
North Carolina
27710
United States
Wake Forest Univ Health Svcs; Internal Medicine
Winston-Salem
North Carolina
27157
United States
Sanford Roger Maris Cancer Center
Fargo
North Dakota
58102
United States
Oncology Hematology Care Inc
Cincinnati
Ohio
45242
United States
Cleveland Clinic
Cleveland
Ohio
44106
United States
University Hospitals of Cleveland
Cleveland
Ohio
44106
United States
University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma
73104
United States
Providence Portland Medical Center
Portland
Oregon
97213
United States
Abramson Cancer Center
Philadelphia
Pennsylvania
19104
United States
Thomas Jefferson University Hospital
Philadelphia
Pennsylvania
19107
United States
Eastern Regional Medical Ctr
Philadelphia
Pennsylvania
19124
United States
UPMC - Hillman Cancer Center
Pittsburgh
Pennsylvania
15232
United States
Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins
Willow Grove
Pennsylvania
19090
United States
Sanford Cancer Cnt Onco Clinic
Sioux Falls
South Dakota
57104
United States
Sarah Cannon Research Institute / Tennessee Oncology
Chattanooga
Tennessee
37404
United States
West Clinic
Germantown
Tennessee
38138
United States
Tennessee Cancer Specialists
Knoxville
Tennessee
37920
United States
Tennessee Oncology - Nashville
Nashville
Tennessee
37203
United States
Vanderbilt Ingram Cancer Clinic
Nashville
Tennessee
37232
United States
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth
Texas
76104
United States
MD Anderson
Houston
Texas
77030
United States
Virginia Cancer Institute
Richmond
Virginia
23229
United States
Northwest Medical Specialties
Tacoma
Washington
98405
United States
University of Wisconsin
Madison
Wisconsin
53705
United States
Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
Derived
Narita Y, Yoshimoto T, Namai T, Asakawa T, Kawakami S, Gower-Page C, Reyes-Rivera I, Patel A, Nakamura Y. Pertuzumab Plus Trastuzumab for Treatment-Refractory HER2-Amplified Metastatic Colorectal Cancer: Comparison of the MyPathway Trial With a Real-World External Control Arm. JCO Clin Cancer Inform. 2022 May;6:e2200022. doi: 10.1200/CCI.22.00022.
Friedman CF, Hainsworth JD, Kurzrock R, Spigel DR, Burris HA, Sweeney CJ, Meric-Bernstam F, Wang Y, Levy J, Grindheim J, Shames DS, Schulze K, Patel A, Swanton C. Atezolizumab Treatment of Tumors with High Tumor Mutational Burden from MyPathway, a Multicenter, Open-Label, Phase IIa Multiple Basket Study. Cancer Discov. 2022 Mar 1;12(3):654-669. doi: 10.1158/2159-8290.CD-21-0450.
Hainsworth JD, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel DR, Sweeney C, Burris H, Bose R, Yoo B, Stein A, Beattie M, Kurzrock R. Targeted Therapy for Advanced Solid Tumors on the Basis of Molecular Profiles: Results From MyPathway, an Open-Label, Phase IIa Multiple Basket Study. J Clin Oncol. 2018 Feb 20;36(6):536-542. doi: 10.1200/JCO.2017.75.3780. Epub 2018 Jan 10.
Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
FG002
Vemurafenib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
FG003
Vemurafenib Plus Cobimetinib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
FG004
Vismodegib
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
FG005
Alectinib
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
FG006
Erlotinib
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
FG000357 subjects
FG001175 subjects
FG00255 subjects
FG00315 subjects
FG00437 subjects
FG00521 subjects
FG00613 subjects
COMPLETED
FG00028 subjects
FG00124 subjects
FG0023 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG000329 subjects
FG001151 subjects
FG00252 subjects
FG00315 subjects
FG00434 subjects
FG00521 subjects
FG00613 subjects
Type
Comment
Reasons
Death
FG000280 subjects
FG001118 subjects
FG00246 subjects
FG00313 subjects
FG00431 subjects
FG00516 subjects
FG00612 subjects
Withdrawal by Subject
FG00021 subjects
FG00113 subjects
FG0023 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG00021 subjects
FG0015 subjects
FG0021 subjects
FG0030 subjects
FG004
Reason Not Specified
FG0006 subjects
FG0015 subjects
FG0022 subjects
FG0030 subjects
FG004
Study Ended by Sponsor
FG0001 subjects
FG0019 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrew informed consent before receiving study drug
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Baseline characteristics are provided for the safety population, which includes all participants who received at least one dose of study treatment. One participant who enrolled in the atezolizumab arm withdrew from the study before receiving any treatment and was therefore excluded.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Trastuzumab Plus Pertuzumab
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
BG001
Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
BG002
Vemurafenib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
BG003
Vemurafenib Plus Cobimetinib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
BG004
Vismodegib
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
BG005
Alectinib
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
BG006
Erlotinib
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000357
BG001174
BG00255
BG00315
BG00437
BG00521
BG00613
BG007672
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Customized
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00061.0± 12.06
BG00165.1± 12.33
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000179
BG00198
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00019
BG00115
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0003
BG0013
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
Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator
The Objective Response Rate (ORR) is defined as the percentage of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for all arms.
The efficacy evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. The population includes the treated participants who have baseline tumor measurement and either have a post-baseline tumor measurement or have discontinued treatment for any reason.
Posted
Number
95% Confidence Interval
Percentage of Participants
From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months)
ID
Title
Description
OG000
Trastuzumab Plus Pertuzumab
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
OG001
Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
OG002
Vemurafenib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
OG003
Vemurafenib Plus Cobimetinib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
OG004
Vismodegib
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
OG005
Alectinib
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
OG006
Erlotinib
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
Units
Counts
Participants
OG000357
OG001174
OG00255
OG003
Title
Denominators
Categories
Title
Measurements
OG00021.0(16.9 to 25.6)
OG00119.5(13.9 to 26.2)
OG00225.5(14.7 to 39.0)
OG003
Primary
Percentage of Atezolizumab-Treated Participants With Tissue Tumor Mutational Burden (tTMB) ≥16 Mutations/Mb With Overall Response, as Assessed by the Independent Review Committee (IRC)
The Objective Response Rate (ORR) is defined as the proportion of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The efficacy evaluable population included all atezolizumab-treated participants with tumor mutation burden ≥16 Mutations/Mb and whose tumor responses were assessed by Independent Review Committee (IRC).
Posted
Number
95% Confidence Interval
Percentage of Participants
From the date of first study treatment until disease progression or death from any cause, whichever occurs first (68.9 months)
ID
Title
Description
OG000
Atezolizumab
Atezolizumab-treated participants with tissue TMB ( tTMB) ≥ 16 mutations/Mb (as assessed by FoundationOne or FoundationOne CDx). Participants received atezolizumab 1200 mg IV infusion every 3 weeks.
Units
Counts
Participants
Secondary
Percentage of Participants With Disease Control
Disease Control Rate (DCR) is defined as the proportion of patients whose best response is CR, PR or stable disease maintained more than 4 months (SD>4 months). Tumor responses were assessed by investigators using RECIST version 1.1 for all arms.
The efficacy evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. The population includes the treated participants who have baseline tumor measurement and either have a post-baseline tumor measurement or have discontinued treatment for any reason.
Posted
Number
95% Confidence Interval
Percentage of Participants
From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months)
ID
Title
Description
OG000
Trastuzumab Plus Pertuzumab
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
OG001
Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
OG002
Vemurafenib
Secondary
Progression-Free Survival (PFS)
PFS is defined as the time from the start of study treatment to the first occurrence of disease progression, or death, whichever occurs first. Tumor responses were assessed by investigators using RECIST version 1.1 for all arms.
The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen. The population includes the treated participants who have baseline tumor measurement and either have a post-baseline tumor measurement or have discontinued treatment for any reason.
Posted
Median
95% Confidence Interval
Months
From the date of first study treatment until disease progression as assessed by the investigator, or death from any cause, whichever occurs first (72.1 months)
ID
Title
Description
OG000
Trastuzumab Plus Pertuzumab
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
OG001
Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
OG002
Vemurafenib
Secondary
Overall Survival (OS)
Overall Survival (OS, months) is defined as the time from the date of the first study treatment (Day 1) to the date of death from any cause.
The efficacy evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. The population includes the treated participants who have baseline tumor measurement and either have a post-baseline tumor measurement or have discontinued treatment for any reason.
Posted
Median
95% Confidence Interval
Months
87.5 months
ID
Title
Description
OG000
Trastuzumab Plus Pertuzumab
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
OG001
Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
OG002
Vemurafenib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
OG003
Secondary
Duration of Response (DoR)
Duration of Response (DoR) is defined as the time from the date of first documented response (CR or PR) to date of first occurrence of disease progression as determined by the investigator, or death from any cause, whichever occurs first.
Efficacy evaluable population who have achieved a complete or partial response.
Posted
Median
95% Confidence Interval
Months
From the date of first documented response (complete response [CR] or partial response [PR]) to the time of disease progression or death from any cause, whichever occurs first (70.8 months)
ID
Title
Description
OG000
Trastuzumab Plus Pertuzumab
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
OG001
Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
OG002
Vemurafenib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
Secondary
Number of Participants With Adverse Events
Incidence, nature, and severity of Adverse Events (AE), per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) for participants enrolled prior to Version 6 of the protocol. The NCI CTCAE (v5.0) grading scale was used for assessing AE severity for participants enrolled under Version 6 of the protocol and subsequent versions.
The safety (SAF) population is defined as enrolled patients who receive at least one dose of study medication.
Posted
Number
Participants
From first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years)
ID
Title
Description
OG000
Trastuzumab Plus Pertuzumab
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
OG001
Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
OG002
Vemurafenib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
Time Frame
In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
Description
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Trastuzumab Plus Pertuzumab
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
285
357
95
357
313
357
EG001
Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
118
174
62
174
147
174
EG002
Vemurafenib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
46
55
21
55
50
55
EG003
Vemurafenib Plus Cobimetinib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
13
15
11
15
12
15
EG004
Vismodegib
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
31
37
13
37
30
37
EG005
Alectinib
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
16
21
7
21
20
21
EG006
Erlotinib
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
12
13
3
13
11
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 25.1
Systematic Assessment
EG0005 affected357 at risk
EG0011 affected174 at risk
EG0021 affected55 at risk
EG0030 affected15 at risk
EG0040 affected37 at risk
EG0051 affected21 at risk
EG0060 affected13 at risk
Anaemia of malignant disease
Blood and lymphatic system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0011 affected174 at risk
EG0021 affected55 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Wolff-Parkinson-White syndrome
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0004 affected357 at risk
EG0013 affected174 at risk
EG0020 affected55 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0012 affected174 at risk
EG0020 affected55 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0012 affected174 at risk
EG0020 affected55 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0012 affected174 at risk
EG0020 affected55 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Enterovesical fistula
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0013 affected174 at risk
EG0020 affected55 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0011 affected174 at risk
EG0022 affected55 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0002 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0022 affected55 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0006 affected357 at risk
EG0013 affected174 at risk
EG0020 affected55 at risk
EG003
Superior mesenteric artery syndrome
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0002 affected357 at risk
EG0010 affected174 at risk
EG0022 affected55 at risk
EG003
Asthenia
General disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Chest pain
General disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Chills
General disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Death
General disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Mucosal inflammation
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Pyrexia
General disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0012 affected174 at risk
EG0021 affected55 at risk
EG003
Sudden death
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Appendicitis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Covid-19 pneumonia
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Cholangitis infective
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Clostridium colitis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Device related infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0003 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Gastrointestinal viral
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Influenza
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Kidney infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Liver abscess
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Ophthalmic herpes zoster
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Pelvic infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Peritonitis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0004 affected357 at risk
EG0015 affected174 at risk
EG0022 affected55 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0012 affected174 at risk
EG0020 affected55 at risk
EG003
Sepsis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0005 affected357 at risk
EG0014 affected174 at risk
EG0021 affected55 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Skin infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0005 affected357 at risk
EG0012 affected174 at risk
EG0022 affected55 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Urinary tract infection pseudomonal
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Urosepsis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0002 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Wound infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0002 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0005 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
International Normalised Ratio increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Liver function test increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0003 affected357 at risk
EG0012 affected174 at risk
EG0020 affected55 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0022 affected55 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0003 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Central nervous system lesion
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Cerebrospinal fluid leakage
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Dementia
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Embolic cerebral infarction
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Seizure
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0003 affected357 at risk
EG0012 affected174 at risk
EG0020 affected55 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 25.1
Systematic Assessment
EG0004 affected357 at risk
EG0014 affected174 at risk
EG0021 affected55 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Autoimmune lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0002 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0004 affected357 at risk
EG0012 affected174 at risk
EG0022 affected55 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0002 affected357 at risk
EG0012 affected174 at risk
EG0020 affected55 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0003 affected357 at risk
EG0013 affected174 at risk
EG0021 affected55 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0002 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0012 affected174 at risk
EG0020 affected55 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0021 affected55 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0002 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Embolism
Vascular disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Haematoma
Vascular disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA version 25.1
Systematic Assessment
EG0000 affected357 at risk
EG0010 affected174 at risk
EG0020 affected55 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 25.1
Systematic Assessment
EG0001 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 25.1
Systematic Assessment
EG00063 affected357 at risk
EG00127 affected174 at risk
EG00210 affected55 at risk
EG0032 affected15 at risk
EG0045 affected37 at risk
EG0054 affected21 at risk
EG0063 affected13 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG00018 affected357 at risk
EG0018 affected174 at risk
EG0021 affected55 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG00043 affected357 at risk
EG00125 affected174 at risk
EG0026 affected55 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG00037 affected357 at risk
EG00123 affected174 at risk
EG0029 affected55 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG000129 affected357 at risk
EG00135 affected174 at risk
EG00213 affected55 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG00080 affected357 at risk
EG00140 affected174 at risk
EG00221 affected55 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG00047 affected357 at risk
EG00126 affected174 at risk
EG00213 affected55 at risk
EG003
Chills
General disorders
MedDRA version 25.1
Systematic Assessment
EG00046 affected357 at risk
EG0016 affected174 at risk
EG0022 affected55 at risk
EG003
Fatigue
General disorders
MedDRA version 25.1
Systematic Assessment
EG000105 affected357 at risk
EG00146 affected174 at risk
EG00229 affected55 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 25.1
Systematic Assessment
EG00026 affected357 at risk
EG00114 affected174 at risk
EG0025 affected55 at risk
EG003
Pyrexia
General disorders
MedDRA version 25.1
Systematic Assessment
EG00036 affected357 at risk
EG00116 affected174 at risk
EG0024 affected55 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG00026 affected357 at risk
EG00116 affected174 at risk
EG0021 affected55 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG00051 affected357 at risk
EG00110 affected174 at risk
EG0020 affected55 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG00026 affected357 at risk
EG00110 affected174 at risk
EG0024 affected55 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG00027 affected357 at risk
EG00114 affected174 at risk
EG0028 affected55 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG00037 affected357 at risk
EG00113 affected174 at risk
EG0028 affected55 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG00020 affected357 at risk
EG0018 affected174 at risk
EG0028 affected55 at risk
EG003
Blood creatinine increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG00018 affected357 at risk
EG00115 affected174 at risk
EG0024 affected55 at risk
EG003
Weight decreased
Investigations
MedDRA version 25.1
Systematic Assessment
EG00029 affected357 at risk
EG00118 affected174 at risk
EG0028 affected55 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG00052 affected357 at risk
EG00122 affected174 at risk
EG00210 affected55 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG00012 affected357 at risk
EG00121 affected174 at risk
EG0026 affected55 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG00015 affected357 at risk
EG00113 affected174 at risk
EG0023 affected55 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG00029 affected357 at risk
EG0014 affected174 at risk
EG0025 affected55 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG00021 affected357 at risk
EG00124 affected174 at risk
EG0024 affected55 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG00044 affected357 at risk
EG00122 affected174 at risk
EG00218 affected55 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG00032 affected357 at risk
EG00122 affected174 at risk
EG0027 affected55 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG00023 affected357 at risk
EG0011 affected174 at risk
EG0020 affected55 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG00016 affected357 at risk
EG00116 affected174 at risk
EG0026 affected55 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG00015 affected357 at risk
EG00116 affected174 at risk
EG0022 affected55 at risk
EG003
Headache
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG00027 affected357 at risk
EG00121 affected174 at risk
EG0028 affected55 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 25.1
Systematic Assessment
EG00027 affected357 at risk
EG0016 affected174 at risk
EG0024 affected55 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG00044 affected357 at risk
EG00129 affected174 at risk
EG0026 affected55 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG00041 affected357 at risk
EG00120 affected174 at risk
EG0026 affected55 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG00025 affected357 at risk
EG0015 affected174 at risk
EG0027 affected55 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG00035 affected357 at risk
EG00120 affected174 at risk
EG0024 affected55 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG00038 affected357 at risk
EG0015 affected174 at risk
EG00211 affected55 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG00011 affected357 at risk
EG00111 affected174 at risk
EG00213 affected55 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.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D001745
Urinary Bladder Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068878
Trastuzumab
C485206
pertuzumab
D000069347
Erlotinib Hydrochloride
D000077484
Vemurafenib
C574276
cobimetinib
C538724
HhAntag691
C582670
alectinib
C000594389
atezolizumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
D011799
Quinazolines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D013449
Sulfonamides
D000577
Amides
D009930
Organic Chemicals
D013450
Sulfones
D013457
Sulfur Compounds
D007211
Indoles
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0053 subjects
FG0060 subjects
1 subjects
FG0052 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0061 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG004
0 subjects
FG0050 subjects
FG0060 subjects
0
BG0040
BG0050
BG0060
BG0070
Between 18 and 65 years
BG000201
BG00177
BG00232
BG0036
BG00415
BG00511
BG0066
BG007348
>=65 years
BG000156
BG00197
BG00223
BG0039
BG00422
BG00510
BG0067
BG007324
61.3
± 11.15
BG00363.2± 8.69
BG00463.5± 11.41
BG00563.5± 12.17
BG00664.5± 13.41
BG00762.4± 12.08
29
BG0037
BG00416
BG00512
BG0065
BG007346
Male
BG000178
BG00176
BG00226
BG0038
BG00421
BG0059
BG0068
BG007326
3
BG0031
BG0041
BG0050
BG0061
BG00740
Not Hispanic or Latino
BG000320
BG001152
BG00248
BG00312
BG00436
BG00520
BG00612
BG007600
Unknown or Not Reported
BG00018
BG0017
BG0024
BG0032
BG0040
BG0051
BG0060
BG00732
0
BG0030
BG0040
BG0050
BG0061
BG0077
Asian
BG00021
BG00111
BG0021
BG0030
BG0043
BG0050
BG0061
BG00737
Native Hawaiian or Other Pacific Islander
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
Black or African American
BG00028
BG00120
BG0027
BG0031
BG0042
BG0052
BG0060
BG00760
White
BG000288
BG001131
BG00246
BG00313
BG00431
BG00518
BG00610
BG007537
More than one race
BG0001
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
Unknown or Not Reported
BG00016
BG0018
BG0021
BG0031
BG0041
BG0051
BG0061
BG00729
15
OG00437
OG00521
OG00613
33.3
(11.8 to 61.6)
OG00410.8(3.0 to 25.4)
OG00514.3(3.0 to 36.3)
OG0067.7(0.2 to 36.0)
OG000
44
Title
Denominators
Categories
Title
Measurements
OG00029.5(16.8 to 45.2)
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
OG003
Vemurafenib Plus Cobimetinib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
OG004
Vismodegib
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
OG005
Alectinib
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
OG006
Erlotinib
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
Units
Counts
Participants
OG000357
OG001174
OG00255
OG00315
OG00437
OG00521
OG00613
Title
Denominators
Categories
Title
Measurements
OG00041.5(36.3 to 46.8)
OG00139.1(31.8 to 46.8)
OG00234.5(22.2 to 48.6)
OG00366.7(38.4 to 88.2)
OG00416.2(6.2 to 32.0)
OG00542.9(21.8 to 66.0)
OG00623.1(5.0 to 53.8)
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
OG003
Vemurafenib Plus Cobimetinib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
OG004
Vismodegib
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
OG005
Alectinib
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
OG006
Erlotinib
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
Units
Counts
Participants
OG000357
OG001174
OG00255
OG00315
OG00437
OG00521
OG00613
Title
Denominators
Categories
Title
Measurements
OG0002.8(2.7 to 3.4)
OG0012.7(1.6 to 3.0)
OG0023.1(1.8 to 5.5)
OG0038.2(3.9 to 19.5)
OG0041.8(1.6 to 1.8)
OG0053.2(1.7 to 6.6)
OG0061.8(1.0 to 8.8)
Vemurafenib Plus Cobimetinib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
OG004
Vismodegib
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
OG005
Alectinib
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
OG006
Erlotinib
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
Units
Counts
Participants
OG000357
OG001174
OG00255
OG00315
OG00437
OG00521
OG00613
Title
Denominators
Categories
Title
Measurements
OG00010.1(8.7 to 11.7)
OG00113.5(11.2 to 17.4)
OG00210.6(5.2 to 13.5)
OG00315.6(6.8 to 27.9)
OG0049.8(4.0 to 13.4)
OG00514.1(8.7 to 25.6)
OG0067.7(2.2 to 15.0)
OG003
Vemurafenib Plus Cobimetinib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
OG004
Vismodegib
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
OG005
Alectinib
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
OG006
Erlotinib
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
Units
Counts
Participants
OG00075
OG00134
OG00214
OG0035
OG0044
OG0053
OG0061
Title
Denominators
Categories
Title
Measurements
OG0007.3(5.8 to 9.3)
OG00132.1(6.9 to NA)The upper 95% confidence limit of median is not estimable due to insufficient number of events (disease progression/death) below 50th percentile of Kaplan-Meier curve
OG0026.0(3.7 to 11.1)
OG00317.2(7.4 to NA)The upper 95% confidence limit of median is not estimable due to insufficient number of events (disease progression/death) below 50th percentile of Kaplan-Meier curve
OG00414.1(6.5 to NA)The upper 95% confidence limit of median is not estimable due to insufficient number of events (disease progression/death) below 50th percentile of Kaplan-Meier curve
OG0056.6(6.0 to NA)The upper 95% confidence limit of median is not estimable due to insufficient number of events (disease progression/death) below 50th percentile of Kaplan-Meier curve
OG0068.3(NA to NA)There was only one participant in this arm, therefore there are too few participants to calculate confidence intervals.
OG003
Vemurafenib Plus Cobimetinib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
OG004
Vismodegib
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
OG005
Alectinib
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
OG006
Erlotinib
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
Units
Counts
Participants
OG000357
OG001174
OG00255
OG00315
OG00437
OG00521
OG00613
Title
Denominators
Categories
With at least one AE
Title
Measurements
OG000334
OG001162
OG00254
OG00315
OG00435
OG00521
OG00612
With at least one SAE
Title
Measurements
OG00095
OG00162
OG00221
OG003
With at least one Grade 3-5 AE
Title
Measurements
OG000146
OG00197
OG00237
OG003
With at least one Related AE
Title
Measurements
OG000261
OG001104
OG00249
OG003
With at least one Related SAE
Title
Measurements
OG00017
OG00114
OG0026
OG003
With at least one Grade 3-5 related AE
Title
Measurements
OG00043
OG00125
OG00225
OG003
With at least one non-serious AESI
Title
Measurements
OG0005
OG0019
OG0023
OG003
With at least one AE leading to study drug withdrawn
Title
Measurements
OG00017
OG00115
OG00210
OG003
With at least one AE leading to study drug interruption
Title
Measurements
OG00079
OG00145
OG00227
OG003
With at least one AE leading to study drug reduction