Study of Pembrolizumab (MK-3475) as First-Line Monotherap... | NCT02494583 | Trialant
NCT02494583
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Apr 13, 2023Actual
Enrollment
763Actual
Phase
Phase 3
Conditions
Gastric Adenocarcinoma
Interventions
Pembrolizumab
Cisplatin
5-FU
Capecitabine
Placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02494583
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-062
Secondary IDs
ID
Type
Description
Link
163187
Registry Identifier
JAPIC-CTI
MK-3475-062
Other Identifier
Merck Protocol Number
KEYNOTE-062
Other Identifier
Merck
2015-000972-88
EudraCT Number
Brief Title
Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)
Official Title
A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil Versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects With Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Mar 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 31, 2015Actual
Primary Completion Date
Mar 26, 2019Actual
Completion Date
Jun 6, 2022Actual
First Submitted Date
Jul 8, 2015
First Submission Date that Met QC Criteria
Jul 8, 2015
First Posted Date
Jul 10, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 28, 2020
Results First Submitted that Met QC Criteria
Feb 28, 2020
Results First Posted Date
Mar 13, 2020Actual
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
Mar 17, 2023
Last Update Posted Date
Apr 13, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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 study of pembrolizumab (MK-3475) as first-line treatment for participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Participants whose tumors express programmed death-ligand 1 (PD-L1) will be randomly assigned to one of the three treatment arms of the study: pembrolizumab as monotherapy [pembro mono], pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin plus 5-fluorouracil (5-FU) or capecitabine [pembro combo], or placebo plus SOC chemotherapy with cisplatin plus 5-fluorouracil (5-FU) or capecitabine [SOC].
The primary study hypotheses are that pembrolizumab in combination with SOC chemotherapy is superior to SOC chemotherapy alone in terms of Progression-free Survival (PFS) and Overall Survival (OS) in participants with PD-L1 Combined Positive Score (CPS) ≥1, pembrolizumab in combination with SOC chemotherapy is superior to SOC chemotherapy alone in terms of OS in participants with PD-L1 CPS ≥10, pembrolizumab monotherapy is non-inferior to SOC chemotherapy alone in terms of OS in participants with PD-L1 CPS ≥1, and pembrolizumab monotherapy is superior to SOC chemotherapy alone in terms of OS in participants with PD-L1 CPS ≥1 and in participants with PD-L1 CPS ≥10.
Detailed Description
As specified by the protocol, primary and secondary efficacy analyses will be evaluated in gastric cancer participants with PD-L1 CPS ≥1 (all participants) and PD-L1 CPS ≥10 (OS) by comparing the pembro mono arm or pembro combo arm separately to the SOC arm.
Conditions Module
Conditions
Gastric Adenocarcinoma
Keywords
Gastric carcinoma
Gastric cancer
Gastroesophageal junction cancer
Gastroesophageal junction carcinoma
Programmed Cell Death-1 (PD1, PD-1),
Programmed Death-Ligand 1 (PDL1, PD-L1)
Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
763Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Pembrolizumab Monotherapy (Pembro Mono)
Experimental
Participants will receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). Eligible participants who stop pembrolizumab with Stable Disease (SD) or better but progress after discontinuation may be able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Biological: Pembrolizumab
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Experimental
Participants will receive pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W may be substituted for 5-FU per local guidelines. Eligible participants who stop pembrolizumab with Stable Disease (SD) or better but progress after discontinuation may be able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Biological: Pembrolizumab
Drug: Cisplatin
Drug: 5-FU
Drug: Capecitabine
Placebo + SOC Chemotherapy (SOC)
Placebo Comparator
Participants receive placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W may be substituted for 5-FU per local guidelines.
Drug: Cisplatin
Drug: 5-FU
Drug: Capecitabine
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pembrolizumab
Biological
Pembrolizumab 200 mg IV on Day 1 of each week in 3-week cycles for up to 35 cycles (approximately 2 years).
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Pembro Combo vs SOC: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 (All Participants)
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Per protocol, PFS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population. PFS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record.
Up to approximately 36 months
Pembro Combo vs SOC: Overall Survival (OS) in Participants With PD-L1 CPS ≥1 (All Participants)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record.
Up to approximately 42 months
Pembro Combo vs SOC: OS in Participants With PD-L1 CPS ≥10
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥10. Per protocol, OS was compared separately between CPS ≥10 participants of the pembro mono arm and SOC arm and is presented later in the record.
Secondary Outcomes
Measure
Description
Time Frame
Pembro Combo vs SOC: Objective Response Rate (ORR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro combo arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to first dose of study medication
Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma
Human epidermal growth factor receptor 2- (HER2/neu-) negative and programmed cell death ligand 1 (PD-L1)-positive
Has measurable disease
Female participants of childbearing potential must be willing to use adequate contraception or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
Male participants of childbearing potential should agree to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study medication
Adequate organ function
Exclusion Criteria:
Squamous cell or undifferentiated gastric cancer
Previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer. Participant may have received prior neoadjuvant or adjuvant therapy as long as it was completed at least 6 months prior to randomization
Major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment.
Radiotherapy within 14 days of randomization
Known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Active autoimmune disease that has required systemic treatment in past 2 years
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
History of non-infectious pneumonitis that required steroids or current pneumonitis
Active infection requiring systemic therapy
Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study medication
Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, or anti-PD-L2 agent
Known history of human immunodeficiency virus (HIV)
Known active Hepatitis B or C
Currently participating in and receiving study therapy or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study medication
Received a live vaccine within 30 days prior to the first dose of study medication
Janjigian YY, Cecchini M, Shitara K, Enzinger PC, Wainberg ZA, Chau I, Satoh T, Lee J, Nebozhyn M, Loboda A, Kobie J, Vajdi A, Shih CS, Cristescu R, Cao ZA. Genomic Landscape of Late-Stage Gastric Cancer: Analysis From KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 Studies. JCO Precis Oncol. 2025 Mar;9:e2400456. doi: 10.1200/PO-24-00456. Epub 2025 Mar 21.
Of 1,787 screened, 763 were randomized 1:1:1 to the pembrolizumab monotherapy (pembro mono) arm, pembrolizumab plus standard of care (SOC) chemotherapy (pembro combo) arm, or placebo plus SOC chemotherapy (SOC) arm. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures, respectively.
Recruitment Details
Participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who were programmed death-ligand 1 (PD-L1)-positive (Combined Positive Score [CPS]≥1) and human epidermal growth factor receptor 2 (HER2/neu)-negative were recruited to the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jan 23, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Australia
Austria
Belgium
Brazil
Chile
Colombia
Czechia
Germany
Guatemala
Hong Kong
Hungary
Italy
Japan
Latvia
Lithuania
Mexico
Netherlands
New Zealand
Poland
Puerto Rico
Russia
South Africa
South Korea
Spain
Switzerland
Taiwan
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
This study is partially blinded. The participant, study site personnel, and the sponsor will be blinded in the pembrolizumab plus SOC chemotherapy (pembro combo) arm and the placebo plus SOC chemotherapy (SOC) arm, but not in the pembro monotherapy (mono arm) since only one type of study medication will be administered.
Cisplatin 80 mg/m^2 IV on Day 1 of each week in 3-week cycles (6 cycle maximum per local country guidelines).
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Placebo + SOC Chemotherapy (SOC)
5-FU
Drug
5-FU 800 mg/m^2/day IV continuous from Day 1-5 of each 3-week cycle.
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Placebo + SOC Chemotherapy (SOC)
Capecitabine
Drug
Capecitabine 1000 mg/m^2 twice daily by oral tablet on Day 1-14 of each 3-week cycle.
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Placebo + SOC Chemotherapy (SOC)
Placebo
Drug
Normal saline IV on Day 1 of each week in 3-week cycles for up to 35 cycles (approximately 2 years).
Placebo + SOC Chemotherapy (SOC)
Up to approximately 42 months
Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥1 (All Participants)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
Up to approximately 42 months
Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥10
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥10. Per protocol, OS was compared separately between CPS ≥10 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
Up to approximately 42 months
Up to approximately 42 months
Pembro Combo vs SOC: Duration of Response (DOR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro mono arm and SOC arm and is presented later in the record.
Up to approximately 42 months
Pembro Mono vs SOC: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
Up to approximately 42 months
Pembro Mono vs SOC: DOR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro combo arm and SOC arm and is presented earlier in the record.
Up to approximately 42 months
Pembro Mono vs SOC: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Per protocol, PFS in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. PFS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
Up to approximately 42 months
Pembro Mono vs SOC: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro mono arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and SOC arm and is presented later in the record.
Baseline, Week 18
Pembro Combo vs SOC: Change From Baseline to Week 18 in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro combo arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro mono arm and SOC arm and is presented earlier in the record.
Baseline, Week 18
Pembro Mono vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-Module for Gastric Cancer (STO22) Pain Symptom Subscale Score
EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales that assess dysphagia (3 items), dietary restriction (4 items), pain (4 items), upper gastro-esophageal symptoms (3 items), and emotional problems (3 items), and questions on dry mouth, taste, body image, and hair loss. Participant responses to the Pain symptom subscale (Items 34-37) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Per protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared between the pembro mono arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared separately between the pembro combo arm and SOC arm and is presented later in the record.
Baseline, Week 18
Pembro Combo vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-STO22 Pain Symptom Subscale Score
EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales that assess dysphagia (3 items), dietary restriction (4 items), pain (4 items), upper gastro-esophageal symptoms (3 items), and emotional problems (3 items), and questions on dry mouth, taste, body image, and hair loss. Participant responses to the Pain symptom subscale (Items 34-37) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Per protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared between the pembro combo arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared separately between the pembro mono arm and SOC arm and is presented earlier in the record.
Baseline, Week 18
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received.
Up to approximately 33 months
Number of Participants Discontinuing Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who discontinued study treatment due to an AE was reported for each arm according to the treatment received.
Up to approximately 30 months
Derived
Muro K, Shitara K, Yamaguchi K, Yoshikawa T, Satake H, Hara H, Sugimoto N, Machida N, Goto M, Kawakami H, Amagai K, Omuro Y, Esaki T, Hironaka S, Nishina T, Komatsu Y, Matsubara H, Shiratori S, Han S, Satoh T, Ohtsu A. Efficacy of Pembrolizumab Monotherapy in Japanese Patients with Advanced Gastric or Gastroesophageal Junction Cancer. J Gastrointest Cancer. 2023 Sep;54(3):951-961. doi: 10.1007/s12029-023-00920-9. Epub 2023 Apr 10.
Satake H, Lee KW, Chung HC, Lee J, Yamaguchi K, Chen JS, Yoshikawa T, Amagai K, Yeh KH, Goto M, Chao Y, Lam KO, Han SR, Shiratori S, Shah S, Shitara K. Pembrolizumab or pembrolizumab plus chemotherapy versus standard of care chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Asian subgroup analysis of KEYNOTE-062. Jpn J Clin Oncol. 2023 Mar 7;53(3):221-229. doi: 10.1093/jjco/hyac188.
Lee KW, Van Cutsem E, Bang YJ, Fuchs CS, Kudaba I, Garrido M, Chung HC, Lee J, Castro HR, Chao J, Wainberg ZA, Cao ZA, Aurora-Garg D, Kobie J, Cristescu R, Bhagia P, Shah S, Tabernero J, Shitara K, Wyrwicz L. Association of Tumor Mutational Burden with Efficacy of Pembrolizumab+/-Chemotherapy as First-Line Therapy for Gastric Cancer in the Phase III KEYNOTE-062 Study. Clin Cancer Res. 2022 Aug 15;28(16):3489-3498. doi: 10.1158/1078-0432.CCR-22-0121.
Chao J, Fuchs CS, Shitara K, Tabernero J, Muro K, Van Cutsem E, Bang YJ, De Vita F, Landers G, Yen CJ, Chau I, Elme A, Lee J, Ozguroglu M, Catenacci D, Yoon HH, Chen E, Adelberg D, Shih CS, Shah S, Bhagia P, Wainberg ZA. Assessment of Pembrolizumab Therapy for the Treatment of Microsatellite Instability-High Gastric or Gastroesophageal Junction Cancer Among Patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 Clinical Trials. JAMA Oncol. 2021 Jun 1;7(6):895-902. doi: 10.1001/jamaoncol.2021.0275.
Shitara K, Van Cutsem E, Bang YJ, Fuchs C, Wyrwicz L, Lee KW, Kudaba I, Garrido M, Chung HC, Lee J, Castro HR, Mansoor W, Braghiroli MI, Karaseva N, Caglevic C, Villanueva L, Goekkurt E, Satake H, Enzinger P, Alsina M, Benson A, Chao J, Ko AH, Wainberg ZA, Kher U, Shah S, Kang SP, Tabernero J. Efficacy and Safety of Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy Alone for Patients With First-line, Advanced Gastric Cancer: The KEYNOTE-062 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Oct 1;6(10):1571-1580. doi: 10.1001/jamaoncol.2020.3370.
FG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-fluorouracil (5-FU) 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
FG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
FG000256 subjects
FG001257 subjects
FG002250 subjects
Received First Course of Pembrolizumab
FG000254 subjects1 participant randomized to the pembro combo arm received pembrolizumab monotherapy by mistake.
FG001250 subjects
FG002244 subjects
Received Second Course of Pembrolizumab
FG0004 subjects
FG0015 subjects
FG0020 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG000256 subjects
FG001257 subjects
FG002250 subjects
Type
Comment
Reasons
Death
FG000224 subjects
FG001214 subjects
FG002225 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
Protocol Violation
FG0001 subjects
FG0012 subjects
FG0020 subjects
Screen Failure
FG0000 subjects
FG0011 subjects
FG0020 subjects
Transferred to Extension Study
FG00015 subjects
FG00115 subjects
FG0026 subjects
Did Not Continue on Extension Study
FG0008 subjects
FG00110 subjects
FG0024 subjects
Withdrawal by Subject
FG0007 subjects
FG00115 subjects
FG00215 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
BG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-fluorouracil (5-FU) 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
BG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000256
BG001257
BG002250
BG003763
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
BG00059.9± 11.6
BG00160.9± 11.6
BG00260.7± 12.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00076
BG00162
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00045
BG00154
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0009
BG0017
BG002
Region of Enrollment
Participants were stratified according to geographic region of enrolling site:
Europe (including Israel)/North America/Australia, Asia (including East Asia [South Korea, Hong Kong, Taiwan], South East Asia [Malaysia], Thailand, Singapore, Japan), or Rest of the World (including South America).
Number
Participants
Title
Denominators
Categories
Europe/North America/Australia
Title
Measurements
BG000148
BG001
Disease Status
Participants were stratified according to gastric cancer disease status as either locally advanced unresectable or metastatic disease.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Locally advanced
BG00010
BG00112
Fluoropyrimidine Treatment
Participants receiving SOC chemotherapy were stratified according to fluoropyrimidine treatment (5-FU or capecitabine).
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
5-FU
BG00097
BG00198
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
Pembro Combo vs SOC: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 (All Participants)
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Per protocol, PFS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population. PFS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record.
All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 36 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
OG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG0000
OG001257
OG002250
Title
Denominators
Categories
Title
Measurements
OG0016.9(5.7 to 7.3)
OG0026.4(5.7 to 7.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the SOC arm to address the first primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.
Regression, Cox
0.03918
One-sided p-value based on log-rank test with stratification.
Hazard Ratio (HR)
0.84
2-Sided
95
0.70
1.02
Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
Primary
Pembro Combo vs SOC: Overall Survival (OS) in Participants With PD-L1 CPS ≥1 (All Participants)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record.
All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Primary
Pembro Combo vs SOC: OS in Participants With PD-L1 CPS ≥10
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥10. Per protocol, OS was compared separately between CPS ≥10 participants of the pembro mono arm and SOC arm and is presented later in the record.
All CPS ≥10 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
OG002
Primary
Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥1 (All Participants)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Primary
Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥10
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥10. Per protocol, OS was compared separately between CPS ≥10 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
All CPS ≥10 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
OG002
Secondary
Pembro Combo vs SOC: Objective Response Rate (ORR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro combo arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record.
All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Secondary
Pembro Combo vs SOC: Duration of Response (DOR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro mono arm and SOC arm and is presented later in the record.
All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm and who demonstrated a confirmed CR or PR were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
Posted
Median
Full Range
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Secondary
Pembro Mono vs SOC: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Secondary
Pembro Mono vs SOC: DOR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro combo arm and SOC arm and is presented earlier in the record.
All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm and who demonstrated a confirmed CR or PR were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
Posted
Median
Full Range
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Secondary
Pembro Mono vs SOC: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Per protocol, PFS in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. PFS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Secondary
Pembro Mono vs SOC: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro mono arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and SOC arm and is presented later in the record.
Participants in the pembro mono arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline, Week 18
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
Secondary
Pembro Combo vs SOC: Change From Baseline to Week 18 in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro combo arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro mono arm and SOC arm and is presented earlier in the record.
Participants in the pembro combo arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline, Week 18
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Secondary
Pembro Mono vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-Module for Gastric Cancer (STO22) Pain Symptom Subscale Score
EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales that assess dysphagia (3 items), dietary restriction (4 items), pain (4 items), upper gastro-esophageal symptoms (3 items), and emotional problems (3 items), and questions on dry mouth, taste, body image, and hair loss. Participant responses to the Pain symptom subscale (Items 34-37) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Per protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared between the pembro mono arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared separately between the pembro combo arm and SOC arm and is presented later in the record.
Participants in the pembro mono arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-STO22 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline, Week 18
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
Secondary
Pembro Combo vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-STO22 Pain Symptom Subscale Score
EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales that assess dysphagia (3 items), dietary restriction (4 items), pain (4 items), upper gastro-esophageal symptoms (3 items), and emotional problems (3 items), and questions on dry mouth, taste, body image, and hair loss. Participant responses to the Pain symptom subscale (Items 34-37) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Per protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared between the pembro combo arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared separately between the pembro mono arm and SOC arm and is presented earlier in the record.
Participants in the pembro combo arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-STO22 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline, Week 18
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Secondary
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received.
All randomized participants who received at least 1 dose of trial treatment were analyzed.
Posted
Count of Participants
Participants
Up to approximately 33 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
OG002
Secondary
Number of Participants Discontinuing Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who discontinued study treatment due to an AE was reported for each arm according to the treatment received.
All randomized participants who received at least 1 dose of trial treatment were analyzed.
Posted
Count of Participants
Participants
Up to approximately 30 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
OG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Time Frame
Up to approximately 78 months
Description
All-Cause Mortality reported for all randomized participants.
Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
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
Pembrolizumab Monotherapy (Pembro Mono) First Course
Participants received pembrolizumab 200 mg IV Q3W.
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
232
257
122
250
239
250
EG002
Placebo + SOC Chemotherapy (SOC)-First Course
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
240
250
117
244
234
244
EG003
Pembrolizumab Monotherapy Second Course
Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments [approximately 2 years]) with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).
2
4
1
4
3
4
EG004
Pembrolizumab + SOC Chemotherapy-Second Course
Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments [approximately 2 years]) administered in combination with SOC chemotherapy, and experienced Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).
1
5
0
5
5
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected254 at risk
EG00114 events12 affected250 at risk
EG00213 events10 affected244 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected5 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0019 events9 affected250 at risk
EG0028 events7 affected244 at risk
EG003
Hypochromic anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0013 events3 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0012 events2 affected250 at risk
EG0024 events3 affected244 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Addison's disease
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0012 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0013 events3 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0015 events4 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0016 events6 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0012 events2 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0017 events7 affected250 at risk
EG0029 events9 affected244 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0013 events3 affected250 at risk
EG0026 events5 affected244 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0006 events5 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0011 events1 affected250 at risk
EG0023 events3 affected244 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Incarcerated hiatus hernia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Mechanical ileus
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0017 events5 affected250 at risk
EG0025 events5 affected244 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0012 events2 affected250 at risk
EG0023 events3 affected244 at risk
EG003
Oesophageal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0013 events2 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Peritoneocutaneous fistula
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0004 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0012 events2 affected250 at risk
EG0023 events3 affected244 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected254 at risk
EG0012 events2 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected254 at risk
EG0017 events6 affected250 at risk
EG00215 events12 affected244 at risk
EG003
Asthenia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0013 events3 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Death
General disorders
MedDRA 25.0
Systematic Assessment
EG0006 events6 affected254 at risk
EG0013 events3 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0013 events3 affected250 at risk
EG0020 events0 affected244 at risk
EG003
General physical health deterioration
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Malaise
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0013 events2 affected250 at risk
EG0023 events3 affected244 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Peripheral swelling
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0015 events5 affected250 at risk
EG0026 events5 affected244 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0012 events2 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Abdominal sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Amoebiasis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Candida sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Device related infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Lower respiratory tract infection bacterial
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Meningitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Meningitis tuberculous
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Pharyngitis bacterial
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0005 events5 affected254 at risk
EG0017 events7 affected250 at risk
EG00210 events8 affected244 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0022 events1 affected244 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Pneumonia klebsiella
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Prostate infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0025 events4 affected244 at risk
EG003
Septic shock
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0011 events1 affected250 at risk
EG0023 events3 affected244 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0012 events2 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0025 events5 affected244 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0012 events2 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Wound infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Anastomotic stenosis
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0022 events1 affected244 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Blood calcium decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Transaminases increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected254 at risk
EG0012 events2 affected250 at risk
EG0025 events5 affected244 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0018 events7 affected250 at risk
EG0027 events7 affected244 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0012 events2 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0012 events2 affected250 at risk
EG0023 events3 affected244 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0013 events3 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0005 events5 affected254 at risk
EG0011 events1 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Refeeding syndrome
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0011 events1 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Compartment syndrome
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Oncologic complication
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0012 events2 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0022 events1 affected244 at risk
EG003
Cerebral thrombosis
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Cerebral venous sinus thrombosis
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0012 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Seizure
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Syncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0012 events2 affected250 at risk
EG0023 events3 affected244 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Device dislocation
Product Issues
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0013 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Depression
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0004 events4 affected254 at risk
EG0018 events8 affected250 at risk
EG0028 events8 affected244 at risk
EG003
Autoimmune nephritis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Prerenal failure
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0013 events3 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Renal injury
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected254 at risk
EG0012 events2 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0019 events8 affected250 at risk
EG00213 events13 affected244 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Stevens-Johnson syndrome
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0012 events2 affected250 at risk
EG0023 events3 affected244 at risk
EG003
Embolism
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0011 events1 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG0010 events0 affected250 at risk
EG0020 events0 affected244 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG00073 events61 affected254 at risk
EG001150 events112 affected250 at risk
EG002144 events108 affected244 at risk
EG0033 events3 affected4 at risk
EG0040 events0 affected5 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG00152 events21 affected250 at risk
EG00251 events26 affected244 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected254 at risk
EG001201 events95 affected250 at risk
EG002222 events102 affected244 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0005 events2 affected254 at risk
EG00138 events27 affected250 at risk
EG00233 events26 affected244 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG00124 events22 affected250 at risk
EG00220 events20 affected244 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG00021 events21 affected254 at risk
EG00129 events28 affected250 at risk
EG00211 events10 affected244 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0017 events6 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00021 events13 affected254 at risk
EG00111 events9 affected250 at risk
EG00210 events10 affected244 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00056 events46 affected254 at risk
EG00149 events41 affected250 at risk
EG00254 events41 affected244 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00026 events23 affected254 at risk
EG00127 events24 affected250 at risk
EG00225 events23 affected244 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0007 events6 affected254 at risk
EG0018 events8 affected250 at risk
EG00215 events14 affected244 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00043 events36 affected254 at risk
EG001108 events71 affected250 at risk
EG00283 events68 affected244 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00060 events35 affected254 at risk
EG001153 events83 affected250 at risk
EG002106 events71 affected244 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00018 events16 affected254 at risk
EG00118 events13 affected250 at risk
EG00213 events11 affected244 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00011 events11 affected254 at risk
EG00117 events15 affected250 at risk
EG00220 events16 affected244 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0008 events8 affected254 at risk
EG0017 events6 affected250 at risk
EG00214 events13 affected244 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00059 events49 affected254 at risk
EG001295 events162 affected250 at risk
EG002236 events129 affected244 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0006 events5 affected254 at risk
EG00149 events33 affected250 at risk
EG00239 events35 affected244 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00064 events49 affected254 at risk
EG001148 events84 affected250 at risk
EG002142 events79 affected244 at risk
EG003
Asthenia
General disorders
MedDRA 25.0
Systematic Assessment
EG00033 events30 affected254 at risk
EG00153 events41 affected250 at risk
EG00281 events47 affected244 at risk
EG003
Chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0006 events4 affected254 at risk
EG00116 events14 affected250 at risk
EG0027 events7 affected244 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG00063 events49 affected254 at risk
EG001156 events105 affected250 at risk
EG002112 events75 affected244 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 25.0
Systematic Assessment
EG0005 events3 affected254 at risk
EG00157 events41 affected250 at risk
EG00262 events34 affected244 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG00014 events13 affected254 at risk
EG00116 events16 affected250 at risk
EG00222 events19 affected244 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG00033 events25 affected254 at risk
EG00138 events32 affected250 at risk
EG00226 events25 affected244 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0008 events8 affected254 at risk
EG00113 events13 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG00016 events13 affected254 at risk
EG0018 events7 affected250 at risk
EG0029 events9 affected244 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG00022 events18 affected254 at risk
EG00110 events9 affected250 at risk
EG00212 events11 affected244 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0008 events8 affected254 at risk
EG00152 events30 affected250 at risk
EG00259 events34 affected244 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG0010 events0 affected250 at risk
EG0021 events1 affected244 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG00015 events4 affected254 at risk
EG001120 events59 affected250 at risk
EG00279 events40 affected244 at risk
EG003
Platelet count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected254 at risk
EG00138 events23 affected250 at risk
EG00221 events17 affected244 at risk
EG003
Weight decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG00028 events28 affected254 at risk
EG00163 events54 affected250 at risk
EG00233 events33 affected244 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0006 events4 affected254 at risk
EG00171 events30 affected250 at risk
EG00252 events25 affected244 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG00053 events48 affected254 at risk
EG001135 events94 affected250 at risk
EG002127 events90 affected244 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0007 events7 affected254 at risk
EG00114 events11 affected250 at risk
EG00219 events16 affected244 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG00021 events18 affected254 at risk
EG00121 events17 affected250 at risk
EG00228 events23 affected244 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG00010 events9 affected254 at risk
EG00120 events14 affected250 at risk
EG00216 events14 affected244 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG00016 events11 affected254 at risk
EG00149 events35 affected250 at risk
EG00261 events42 affected244 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG00011 events3 affected254 at risk
EG00143 events34 affected250 at risk
EG00248 events32 affected244 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG00016 events15 affected254 at risk
EG00121 events12 affected250 at risk
EG00226 events20 affected244 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG00121 events15 affected250 at risk
EG00216 events9 affected244 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG00020 events19 affected254 at risk
EG00125 events22 affected250 at risk
EG0027 events7 affected244 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG00032 events30 affected254 at risk
EG00114 events13 affected250 at risk
EG00215 events14 affected244 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0004 events4 affected254 at risk
EG00123 events17 affected250 at risk
EG0029 events8 affected244 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG00018 events14 affected254 at risk
EG00121 events20 affected250 at risk
EG00222 events15 affected244 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0004 events4 affected254 at risk
EG00118 events16 affected250 at risk
EG00221 events20 affected244 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG00018 events16 affected254 at risk
EG00126 events24 affected250 at risk
EG00222 events16 affected244 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG00136 events31 affected250 at risk
EG00217 events16 affected244 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected254 at risk
EG00137 events34 affected250 at risk
EG00218 events16 affected244 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG00021 events21 affected254 at risk
EG00119 events18 affected250 at risk
EG00224 events22 affected244 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0013 events3 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG00023 events19 affected254 at risk
EG00126 events24 affected250 at risk
EG00226 events23 affected244 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected254 at risk
EG0011 events1 affected250 at risk
EG0022 events2 affected244 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG00016 events11 affected254 at risk
EG00123 events19 affected250 at risk
EG00211 events9 affected244 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG0015 events5 affected250 at risk
EG00212 events10 affected244 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected254 at risk
EG00120 events16 affected250 at risk
EG00221 events12 affected244 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected254 at risk
EG00119 events19 affected250 at risk
EG00211 events11 affected244 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0006 events6 affected254 at risk
EG00116 events15 affected250 at risk
EG00215 events15 affected244 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected254 at risk
EG00169 events60 affected250 at risk
EG00257 events46 affected244 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG00027 events22 affected254 at risk
EG00125 events21 affected250 at risk
EG00211 events8 affected244 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG00023 events20 affected254 at risk
EG00141 events31 affected250 at risk
EG00218 events15 affected244 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG00012 events11 affected254 at risk
EG00113 events10 affected250 at risk
EG00217 events12 affected244 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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG0000
OG001257
OG002250
Title
Denominators
Categories
Title
Measurements
OG00112.5(10.8 to 13.9)
OG00211.1(9.2 to 12.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the SOC arm to address the second primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.
Regression, Cox
0.04611
One-sided p-value based on log-rank test with stratification.
Hazard Ratio (HR)
0.85
2-Sided
95
0.70
1.03
Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
Superiority
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG0000
OG00199
OG00290
Title
Denominators
Categories
Title
Measurements
OG00112.3(9.5 to 14.8)
OG00210.8(8.5 to 13.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
OS in CPS ≥10 participants of the pembro combo arm was compared to OS in CPS ≥10 participants of the SOC arm to address the third primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.
Regression, Cox
0.15804
One-sided p-value based on log-rank test with stratification.
Hazard Ratio (HR)
0.85
2-Sided
95
0.62
1.17
Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
Superiority
OG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG000256
OG0010
OG002250
Title
Denominators
Categories
Title
Measurements
OG00010.6(7.7 to 13.8)
OG00211.1(9.2 to 12.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fourth primary hypothesis (non-inferiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.
Hazard Ratio (HR)
0.91
2-Sided
99.2
0.69
1.18
Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
Non-Inferiority
Pre-specified non-inferiority margin: if the upper bound of the confidence interval (based on the alpha level allocated to the analysis) for the hazard ratio ([HR], pembro mono arm vs SOC) is < 1.2, the pembro mono arm could be considered as non-inferior to the SOC arm in terms of OS.
OG000
OG002
OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fifth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.
Regression, Cox
0.16205
One-sided p-value based on log-rank test with stratification.
Hazard Ratio (HR)
0.91
2-Sided
95
0.74
1.10
Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
Superiority
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG00092
OG0010
OG00290
Title
Denominators
Categories
Title
Measurements
OG00017.4(9.1 to 23.1)
OG00210.8(8.5 to 13.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
OS in CPS ≥10 participants of the pembro mono arm was compared to OS in CPS ≥10 participants of the SOC arm to address the sixth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.
Regression, Cox
0.01491
One-sided p-value based on log-rank test with stratification.
Hazard Ratio (HR)
0.69
2-Sided
95
0.49
0.97
Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
Superiority
OG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG0000
OG001257
OG002250
Title
Denominators
Categories
Title
Measurements
OG00148.6(42.4 to 54.9)
OG00237.2(31.2 to 43.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen & Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.
Miettinen & Nurminen method
0.00447
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in ORR Percentage
11.5
2-Sided
95
2.9
20.0
Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
Other
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
OG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG0000
OG001125
OG00293
Title
Denominators
Categories
Title
Measurements
OG001NA(NA to NA)NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)
OG002NA(NA to NA)NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)
OG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG000256
OG0010
OG002250
Title
Denominators
Categories
Title
Measurements
OG00014.8(10.7 to 19.8)
OG00237.2(31.2 to 43.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen & Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.
Miettinen & Nurminen method
>0.99999
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in ORR Percentage
-22.3
2-Sided
95
-29.6
-14.9
Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
Other
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
OG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG00038
OG0010
OG00293
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)
OG002NA(NA to NA)NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)
OG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG000256
OG0010
OG002250
Title
Denominators
Categories
Title
Measurements
OG0002.0(1.5 to 2.8)
OG0026.4(5.7 to 7.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.
Regression, Cox
1.00000
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Hazard Ratio (HR)
1.64
2-Sided
95
1.36
1.98
Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
Other
OG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
OG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG000251
OG0010
OG002243
Title
Denominators
Categories
Title
Measurements
OG000-1.91(-5.81 to 1.98)
OG002-1.75(-5.17 to 1.66)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.
cLDA
0.948
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in LS Means
-0.16
2-Sided
95
-5.01
4.69
Stratified analyses could be based on collapsing strata with insufficient number of participants or events; strata were pooled in some cases based on clinical judgement and actual counts.
Other
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
OG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG0000
OG001245
OG002243
Title
Denominators
Categories
Title
Measurements
OG001-0.09(-3.36 to 3.19)
OG002-2.07(-5.43 to 1.29)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.
cLDA
0.368
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in LS Means
1.98
2-Sided
95
-2.34
6.31
Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
Other
OG001
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
OG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG000251
OG0010
OG002243
Title
Denominators
Categories
Title
Measurements
OG000-1.14(-4.67 to 2.39)
OG002-3.49(-6.60 to -0.38)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.
cLDA
0.308
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in LS Means
2.35
2-Sided
95
-2.18
6.89
Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
Other
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
OG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG0000
OG001245
OG002243
Title
Denominators
Categories
Title
Measurements
OG001-10.12(-13.08 to -7.17)
OG002-3.56(-6.61 to -0.51)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.
cLDA
0.001
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in LS Means
-6.56
2-Sided
95
-10.55
-2.58
Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
Other
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Units
Counts
Participants
OG000254
OG001250
OG002244
Title
Denominators
Categories
Title
Measurements
OG000242
OG001244
OG002240
OG002
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.