A Study of Pembrolizumab (MK-3475) in Participants With R... | NCT02335411 | Trialant
NCT02335411
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Aug 8, 2022Actual
Enrollment
318Actual
Phase
Phase 2
Conditions
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Interventions
pembrolizumab
cisplatin
5-FU
capecitabine
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02335411
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-059
Secondary IDs
ID
Type
Description
Link
MK-3475-059
Other Identifier
Merck
KEYNOTE-059
Other Identifier
Merck
2014-003574-16
EudraCT Number
Brief Title
A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059/KEYNOTE-059)
Official Title
A Phase II Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil in Subjects With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE-059)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jul 2022
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
Feb 3, 2015Actual
Primary Completion Date
Jul 23, 2021Actual
Completion Date
Jul 23, 2021Actual
First Submitted Date
Jan 7, 2015
First Submission Date that Met QC Criteria
Jan 7, 2015
First Posted Date
Jan 9, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 13, 2022
Results First Submitted that Met QC Criteria
Jul 13, 2022
Results First Posted Date
Aug 8, 2022Actual
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
Jul 13, 2022
Last Update Posted Date
Aug 8, 2022Actual
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) for advanced gastric or gastroesophageal junction adenocarcinoma; pembrolizumab will be given as monotherapy to participants who have had previous treatment or who are treatment-naïve; pembrolizumab will also be evaluated as combination therapy with cisplatin and 5-Fluorouracil (5-FU) or (Japan only) capecitabine in treatment-naïve participants. The primary study hypothesis is that pembrolizumab will provide a clinically meaningful Overall Response Rate (ORR).
Detailed Description
This study will have 3 cohorts. In Cohort 1, participants who have received at least two prior therapies for their advanced disease will receive monotherapy with pembrolizumab. In Cohort 2, participants who have not received any previous therapy for their disease will receive pembrolizumab in combination with cisplatin and 5-FU or (Japan only) capecitabine. In Cohort 3, participants who have not received any previous therapy and who have programmed death ligand 1 (PD-L1)-positive tumors will receive pembrolizumab monotherapy.
Participants receive pembrolizumab 200 mg IV each 3-week cycle (Q3W) + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-FU 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle
Number of Participants Experiencing Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. The number of participants who experienced at least one AE is presented. Per protocol, the number of participants who experienced at least one AE during first course pembrolizumab treatment is presented.
Up to approximately 65 months
Number of Participants Discontinuing Study Drug Due to AEs
An AE was defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinued study drug due to an AE is presented. Per protocol, the number of participants who discontinued drug during first course pembrolizumab treatment is presented.
Up to approximately 52 months
Objective Response Rate (ORR) For All Participants in Cohorts 1 and 3
The Objective Response Rate (ORR) was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by central radiology review. The percentage of all participants (regardless of programmed death-ligand 1 [PD-L1] tumor status) in Cohorts 1 and 3 who had a CR or PR during first course pembrolizumab treatment per protocol, is presented.
Up to approximately 75 months
Objective Response Rate For PD-L1 Positive Participants in Cohorts 1 and 3
The ORR was defined as the percentage of participants in the analysis population who had a CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, as assessed by central radiology review. The percentage of all participants in Cohorts 1 and 3 with PD-L1+ tumor status who experienced a CR or PR during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) For All Participants in Cohort 2
The Objective Response Rate (ORR) was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by central radiology review. The percentage of all participants (regardless of PD-L1 tumor status) in Cohort 2 who had a CR or PR during first course pembrolizumab treatment per protocol, is presented.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria - Cohort 1:
Received and progressed on ≥2 prior chemotherapy regimens for their advanced disease; prior regimen must have included a cisplatin and a fluoropyridine
Human epidermal growth factor receptor 2 (HER-2/neu) negative, or, if HER2/neu positive, must have previously received treatment with trastuzumab
Inclusion Criteria - Cohort 2 or 3:
HER2/neu negative
Has not received prior systemic anti-cancer therapy for their advanced carcinoma (systemic therapy received in the neoadjuvant and adjuvant setting does not count)
Inclusion Criteria - All Participants:
Histologically- or cytologically-confirmed recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma that is considered incurable by local therapies
Willing to provide tissue for PD-L1 biomarker analysis from newly-obtained and/or archival tissue
Measurable disease based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to first dose of study drug
Life expectancy of at least 3 months
Female participants of childbearing potential should have a negative pregnancy test and be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study drug (180 days for participants receiving cisplatin + 5FU)
Male participants should agree to use an adequate method of contraception starting with the first dose through 120 days after the last dose of study drug (180 days for participants receiving cisplatin + 5FU)
Adequate organ function
Exclusion Criteria - All Participants:
Currently participating and receiving study therapy or participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of study drug
Active autoimmune disease that has required systemic treatment in past 2 years
Immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
Weight loss >10% over 2 months prior to first dose of study drug
Clinical evidence of ascites by physical exam
Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not recovered from AEs due to agents administered more than 4 weeks earlier
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from AEs due to a previously administered agent
Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin or 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
Known history of, or any evidence of active, non-infectious pneumonitis
Active infection requiring systemic therapy
Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug (180 days for participants receiving cisplatin + 5FU)
Prior therapy with an anti-programmed death-1 (PD-1), anti-PD-L1, or anti-PD-L2 agent
Human immunodeficiency virus (HIV)
Hepatitis B or C
Received live vaccine within 30 days of planned start of study drug
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.
318 participants were originally allocated to the study. No study information was collected from 3 participants, who were excluded from all analyses, including disposition.
Per protocol, response/progression or adverse events during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures respectively.
Recruitment Details
Male and female participants of at least 18 years of age with recurrent or metastatic gastric or gastro-esophageal junction (GEJ) adenocarcinoma were enrolled in this study.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Objective Response Rate For PD-L1 Positive Participants in Cohort 2
The ORR was defined as the percentage of participants in the analysis population who had a CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, as assessed by central radiology review. The percentage of participants in Cohort 2 with PD-L1+ tumor status who experienced a CR or PR during first course pembrolizumab treatment per protocol, is presented.
Up to approximately 75 months
Duration of Response (DOR) For All Participants
Duration of Response (DOR) was defined as the time from first documented evidence of CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, based on central imaging vendor assessment, until disease progression (PD) or death, whichever occurred first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. The DOR for all participants (regardless of PD-L1 tumor status) during first course pembrolizumab treatment per protocol, is presented.
Up to approximately 75 months
Duration of Response For PD-L1 Positive Participants
DOR was defined as the time from first documented evidence of CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, based on central imaging vendor assessment, until disease progression (PD) or death, whichever occurred first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. The DOR for only PD-L1 positive participants during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
Up to approximately 75 months
Progression-Free Survival (PFS) For All Participants
Progression-Free Survival (PFS) was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. The PFS for all participants (regardless of PD-L1 tumor status) during first course pembrolizumab treatment per protocol, is presented.
Up to approximately 75 months
Progression-Free Survival For PD-L1 Positive Participants
PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. The PFS for only PD-L1 positive participants during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
Up to approximately 75 months
Overall Survival (OS) For All Participants
Overall Survival (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. The OS for all participants (regardless of PD-L1 tumor status) during first course pembrolizumab treatment per protocol, is presented.
Up to approximately 75 months
Overall Survival For PD-L1 Positive 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. The OS for only PD-L1 positive participants during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
Up to approximately 75 months
Disease Control Rate (DCR) For All Participants
Disease Control Rate (DCR) was defined as the percentage of participants in the analysis population who had a CR or a PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) or stable disease (SD); (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) for ≥6 months, (for Cohort 1 ≥2 months) as assessed by central radiology review. The percentage of all participants (regardless of PD-L1 tumor status) who had a CR or PR or SD during first course pembrolizumab treatment per protocol, is presented.
Up to approximately 75 months
Disease Control Rate For PD-L1 Positive Participants
DCR was defined as the percentage of participants in the analysis population who had a CR or a PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) or stable disease (SD); (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) for ≥6 months, (for Cohort 1 ≥2 months) as assessed by central radiology review. The percentage of participants with PD-L1+ tumor status who experienced a CR or PR or SD during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
Up to approximately 75 months
Derived
Topp BG, Channavazzala M, Mayawala K, De Alwis DP, Rubin E, Snyder A, Wolchok JD, Ribas A. Tumor dynamics in patients with solid tumors treated with pembrolizumab beyond disease progression. Cancer Cell. 2023 Sep 11;41(9):1680-1688.e2. doi: 10.1016/j.ccell.2023.08.004.
Cristescu R, Aurora-Garg D, Albright A, Xu L, Liu XQ, Loboda A, Lang L, Jin F, Rubin EH, Snyder A, Lunceford J. Tumor mutational burden predicts the efficacy of pembrolizumab monotherapy: a pan-tumor retrospective analysis of participants with advanced solid tumors. J Immunother Cancer. 2022 Jan;10(1):e003091. doi: 10.1136/jitc-2021-003091.
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.
Bang YJ, Kang YK, Catenacci DV, Muro K, Fuchs CS, Geva R, Hara H, Golan T, Garrido M, Jalal SI, Borg C, Doi T, Yoon HH, Savage MJ, Wang J, Dalal RP, Shah S, Wainberg ZA, Chung HC. Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study. Gastric Cancer. 2019 Jul;22(4):828-837. doi: 10.1007/s10120-018-00909-5. Epub 2019 Mar 25.
Fuchs CS, Doi T, Jang RW, Muro K, Satoh T, Machado M, Sun W, Jalal SI, Shah MA, Metges JP, Garrido M, Golan T, Mandala M, Wainberg ZA, Catenacci DV, Ohtsu A, Shitara K, Geva R, Bleeker J, Ko AH, Ku G, Philip P, Enzinger PC, Bang YJ, Levitan D, Wang J, Rosales M, Dalal RP, Yoon HH. Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Clinical KEYNOTE-059 Trial. JAMA Oncol. 2018 May 10;4(5):e180013. doi: 10.1001/jamaoncol.2018.0013. Epub 2018 May 10.
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000259
BG00125
BG00231
BG003315
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
BG00061.0± 11.4
BG00158.8± 16.6
BG00260.3± 11.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00061
BG0019
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00017
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Experiencing Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. The number of participants who experienced at least one AE is presented. Per protocol, the number of participants who experienced at least one AE during first course pembrolizumab treatment is presented.
All enrolled participants who received ≥1 dose of study drug.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Units
Counts
Participants
OG000259
OG00125
OG00231
Title
Denominators
Categories
Title
Measurements
OG000248
OG00125
OG00231
Primary
Number of Participants Discontinuing Study Drug Due to AEs
An AE was defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinued study drug due to an AE is presented. Per protocol, the number of participants who discontinued drug during first course pembrolizumab treatment is presented.
All enrolled participants who received ≥1 dose of study drug.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Primary
Objective Response Rate (ORR) For All Participants in Cohorts 1 and 3
The Objective Response Rate (ORR) was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by central radiology review. The percentage of all participants (regardless of programmed death-ligand 1 [PD-L1] tumor status) in Cohorts 1 and 3 who had a CR or PR during first course pembrolizumab treatment per protocol, is presented.
All enrolled participants in Cohorts 1 and 3 who received ≥1 dose of study drug. Per protocol, Cohort 2 was not included in this outcome measure.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Objective Response Rate For PD-L1 Positive Participants in Cohorts 1 and 3
The ORR was defined as the percentage of participants in the analysis population who had a CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, as assessed by central radiology review. The percentage of all participants in Cohorts 1 and 3 with PD-L1+ tumor status who experienced a CR or PR during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
All enrolled participants in Cohorts 1 and 3 with a positive PD-L1 tumor status who received ≥1 dose of study drug. Per protocol, Cohort 2 was not included in this outcome measure.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Secondary
Objective Response Rate (ORR) For All Participants in Cohort 2
The Objective Response Rate (ORR) was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by central radiology review. The percentage of all participants (regardless of PD-L1 tumor status) in Cohort 2 who had a CR or PR during first course pembrolizumab treatment per protocol, is presented.
All enrolled participants in Cohort 2 who received ≥1 dose of study drug. Per protocol, Cohorts 1 and 3 were not included in this outcome measure.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Secondary
Objective Response Rate For PD-L1 Positive Participants in Cohort 2
The ORR was defined as the percentage of participants in the analysis population who had a CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, as assessed by central radiology review. The percentage of participants in Cohort 2 with PD-L1+ tumor status who experienced a CR or PR during first course pembrolizumab treatment per protocol, is presented.
All enrolled participants in Cohort 2 with a positive PD-L1 tumor status who received ≥1 dose of study drug. Per protocol, Cohorts 1 and 3 were not included in this outcome measure.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Secondary
Duration of Response (DOR) For All Participants
Duration of Response (DOR) was defined as the time from first documented evidence of CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, based on central imaging vendor assessment, until disease progression (PD) or death, whichever occurred first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. The DOR for all participants (regardless of PD-L1 tumor status) during first course pembrolizumab treatment per protocol, is presented.
All enrolled participants who received ≥1 dose of study drug and demonstrated a confirmed response (CR or PR).
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
OG001
Secondary
Duration of Response For PD-L1 Positive Participants
DOR was defined as the time from first documented evidence of CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, based on central imaging vendor assessment, until disease progression (PD) or death, whichever occurred first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. The DOR for only PD-L1 positive participants during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
All enrolled participants with a positive PD-L1 tumor status who received ≥1 dose of study drug and demonstrated a confirmed response (CR or PR).
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Secondary
Progression-Free Survival (PFS) For All Participants
Progression-Free Survival (PFS) was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. The PFS for all participants (regardless of PD-L1 tumor status) during first course pembrolizumab treatment per protocol, is presented.
All enrolled participants who received ≥1 dose of study drug.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Secondary
Progression-Free Survival For PD-L1 Positive Participants
PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. The PFS for only PD-L1 positive participants during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
All enrolled participants with a positive PD-L1 tumor status who received ≥1 dose of study drug.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Overall Survival (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. The OS for all participants (regardless of PD-L1 tumor status) during first course pembrolizumab treatment per protocol, is presented.
All enrolled participants who received ≥1 dose of study drug.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Secondary
Overall Survival For PD-L1 Positive 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. The OS for only PD-L1 positive participants during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
All enrolled participants with a positive PD-L1 tumor status who received ≥1 dose of study drug.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Secondary
Disease Control Rate (DCR) For All Participants
Disease Control Rate (DCR) was defined as the percentage of participants in the analysis population who had a CR or a PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) or stable disease (SD); (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) for ≥6 months, (for Cohort 1 ≥2 months) as assessed by central radiology review. The percentage of all participants (regardless of PD-L1 tumor status) who had a CR or PR or SD during first course pembrolizumab treatment per protocol, is presented.
All enrolled participants who received ≥1 dose of study drug.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Secondary
Disease Control Rate For PD-L1 Positive Participants
DCR was defined as the percentage of participants in the analysis population who had a CR or a PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) or stable disease (SD); (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) for ≥6 months, (for Cohort 1 ≥2 months) as assessed by central radiology review. The percentage of participants with PD-L1+ tumor status who experienced a CR or PR or SD during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
All enrolled participants with a positive PD-L1 tumor status who received ≥1 dose of study drug.
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
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
Cohort 1 First Course
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months.
244
259
119
259
237
259
EG001
Cohort 2 First Course
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-FU 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, BID on Days 1-14 of each 3-week cycle.
21
25
11
25
25
25
EG002
Cohort 3 First Course
PD-L1 positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months
26
31
15
31
31
31
EG003
Cohort 1 Second Course
Eligible participants allocated to the pembrolizumab first course in Cohort 1 who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year.
1
3
0
3
0
3
EG004
Cohort 2 Second Course
Eligible participants allocated to the pembrolizumab first course in Cohort 2 who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year.
1
1
0
1
0
1
EG005
Cohort 3 Second Course
Eligible participants allocated to the pembrolizumab first course in Cohort 3 who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year.
1
2
0
2
0
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal lymphadenopathy
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG0030 events0 affected3 at risk
EG004
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0006 events6 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Tracheo-oesophageal fistula
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Diffuse uveal melanocytic proliferation
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected259 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0007 events7 affected259 at risk
EG0011 events1 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Gastric stenosis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0006 events6 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Jejunal perforation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0007 events5 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Oesophageal intramural haematoma
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Oesophageal perforation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0014 events4 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0006 events5 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Asthenia
General disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Death
General disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Gastrointestinal complication associated with device
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Influenza like illness
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG0012 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0011 events1 affected25 at risk
EG0022 events1 affected31 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hepatic haematoma
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Disseminated varicella zoster virus infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Diverticulitis intestinal haemorrhagic
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Encephalitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0006 events4 affected259 at risk
EG0010 events0 affected25 at risk
EG0023 events2 affected31 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Septic shock
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Subdiaphragmatic abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Wound infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Anastomotic stenosis
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Vascular pseudoaneurysm
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Transaminases increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Urine output decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Polymyalgia rheumatica
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Metastases to adrenals
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Oesophageal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Cauda equina syndrome
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Seizure
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Syncope
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Unresponsive to stimuli
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Vertebral artery occlusion
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Depression
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Drug dependence
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0006 events6 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0009 events9 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0006 events6 affected259 at risk
EG0010 events0 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Lichen planus
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Embolism
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Haematoma
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Internal haemorrhage
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG00069 events58 affected259 at risk
EG00113 events11 affected25 at risk
EG0029 events7 affected31 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected2 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0007 events4 affected259 at risk
EG0013 events2 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG00112 events9 affected25 at risk
EG0022 events1 affected31 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG00010 events8 affected259 at risk
EG0015 events3 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0014 events4 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG00010 events10 affected259 at risk
EG0014 events4 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG00024 events24 affected259 at risk
EG0012 events2 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0012 events2 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00015 events15 affected259 at risk
EG0012 events2 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00056 events49 affected259 at risk
EG0013 events3 affected25 at risk
EG00213 events8 affected31 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00025 events19 affected259 at risk
EG0018 events4 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00018 events16 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00057 events52 affected259 at risk
EG00122 events14 affected25 at risk
EG0027 events7 affected31 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00055 events46 affected259 at risk
EG00118 events14 affected25 at risk
EG00213 events8 affected31 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0008 events8 affected259 at risk
EG0014 events2 affected25 at risk
EG0023 events3 affected31 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0009 events9 affected259 at risk
EG0013 events2 affected25 at risk
EG0024 events3 affected31 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00036 events31 affected259 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00012 events10 affected259 at risk
EG0014 events2 affected25 at risk
EG0023 events2 affected31 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00074 events65 affected259 at risk
EG00122 events15 affected25 at risk
EG00210 events8 affected31 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00010 events10 affected259 at risk
EG00129 events17 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00044 events36 affected259 at risk
EG00123 events10 affected25 at risk
EG00212 events6 affected31 at risk
EG003
Asthenia
General disorders
MedDRA 24.0
Systematic Assessment
EG00026 events24 affected259 at risk
EG0017 events4 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Chest discomfort
General disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0010 events0 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG000105 events93 affected259 at risk
EG00113 events10 affected25 at risk
EG00210 events10 affected31 at risk
EG003
Generalised oedema
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0010 events0 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Influenza like illness
General disorders
MedDRA 24.0
Systematic Assessment
EG0005 events4 affected259 at risk
EG0010 events0 affected25 at risk
EG0025 events4 affected31 at risk
EG003
Malaise
General disorders
MedDRA 24.0
Systematic Assessment
EG0007 events7 affected259 at risk
EG00114 events5 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Oedema
General disorders
MedDRA 24.0
Systematic Assessment
EG0009 events9 affected259 at risk
EG00110 events4 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Oedema peripheral
General disorders
MedDRA 24.0
Systematic Assessment
EG00057 events43 affected259 at risk
EG0011 events1 affected25 at risk
EG0026 events4 affected31 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG00035 events25 affected259 at risk
EG0019 events6 affected25 at risk
EG0023 events3 affected31 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0008 events7 affected259 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00010 events8 affected259 at risk
EG0013 events2 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG00019 events14 affected259 at risk
EG0013 events2 affected25 at risk
EG0023 events2 affected31 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG00034 events30 affected259 at risk
EG0012 events2 affected25 at risk
EG0026 events4 affected31 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG00032 events31 affected259 at risk
EG0011 events1 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24.0
Systematic Assessment
EG00015 events13 affected259 at risk
EG0016 events5 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0009 events7 affected259 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected259 at risk
EG0010 events0 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0008 events6 affected259 at risk
EG0010 events0 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected259 at risk
EG00130 events13 affected25 at risk
EG0026 events1 affected31 at risk
EG003
Platelet count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0004 events3 affected259 at risk
EG0017 events5 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Weight decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG00041 events38 affected259 at risk
EG0016 events5 affected25 at risk
EG0024 events4 affected31 at risk
EG003
Weight increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG00113 events3 affected25 at risk
EG0020 events0 affected31 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0019 events4 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG00081 events73 affected259 at risk
EG00122 events13 affected25 at risk
EG00214 events11 affected31 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG00020 events15 affected259 at risk
EG0012 events2 affected25 at risk
EG0024 events2 affected31 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG00029 events23 affected259 at risk
EG0016 events3 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG00024 events24 affected259 at risk
EG0011 events1 affected25 at risk
EG0024 events4 affected31 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG00013 events12 affected259 at risk
EG0013 events3 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG00026 events23 affected259 at risk
EG0012 events1 affected25 at risk
EG0023 events3 affected31 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG00014 events10 affected259 at risk
EG0014 events2 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG00058 events36 affected259 at risk
EG0013 events3 affected25 at risk
EG0028 events5 affected31 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG00038 events34 affected259 at risk
EG0012 events2 affected25 at risk
EG0027 events6 affected31 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected259 at risk
EG0010 events0 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG0010 events0 affected25 at risk
EG0023 events3 affected31 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG0010 events0 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG00010 events8 affected259 at risk
EG0012 events2 affected25 at risk
EG0027 events5 affected31 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG00012 events9 affected259 at risk
EG0010 events0 affected25 at risk
EG0026 events5 affected31 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG00017 events17 affected259 at risk
EG0015 events4 affected25 at risk
EG0026 events4 affected31 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0006 events6 affected259 at risk
EG0019 events6 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG00013 events12 affected259 at risk
EG0015 events5 affected25 at risk
EG0026 events3 affected31 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG0013 events3 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected259 at risk
EG0017 events6 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Syncope
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected259 at risk
EG0013 events2 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG00018 events15 affected259 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG00020 events17 affected259 at risk
EG0019 events9 affected25 at risk
EG0023 events2 affected31 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG00050 events44 affected259 at risk
EG0012 events2 affected25 at risk
EG0028 events6 affected31 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG00043 events40 affected259 at risk
EG0012 events1 affected25 at risk
EG0027 events5 affected31 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected259 at risk
EG00116 events8 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0008 events8 affected259 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG00014 events11 affected259 at risk
EG0012 events2 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected259 at risk
EG0011 events1 affected25 at risk
EG0024 events3 affected31 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG0014 events4 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00018 events17 affected259 at risk
EG0012 events2 affected25 at risk
EG0023 events3 affected31 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0013 events3 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00039 events33 affected259 at risk
EG0017 events4 affected25 at risk
EG00210 events8 affected31 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00033 events31 affected259 at risk
EG0012 events2 affected25 at risk
EG0023 events3 affected31 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected259 at risk
EG0011 events1 affected25 at risk
EG0023 events2 affected31 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0012 events2 affected25 at risk
EG0021 events1 affected31 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected259 at risk
EG0010 events0 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected259 at risk
EG0010 events0 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG00020 events14 affected259 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected31 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG00012 events10 affected259 at risk
EG0010 events0 affected25 at risk
EG0022 events2 affected31 at risk
EG003
Vasculitis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected259 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected31 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.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Units
Counts
Participants
OG000259
OG00125
OG00231
Title
Denominators
Categories
Title
Measurements
OG00018
OG0014
OG0020
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Units
Counts
Participants
OG00030
OG00115
OG0027
Title
Denominators
Categories
Title
Measurements
OG00016.1(2.4 to NA)NA = upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG0014.6(2.6 to NA)NA = upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG00238.0(2.1 to NA)NA = upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Units
Counts
Participants
OG00023
OG00111
OG0027
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA = median, upper and lower limits not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG0014.6(3.2 to NA)NA = upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG00238.0(2.1 to NA)NA = upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Units
Counts
Participants
OG000259
OG00125
OG00231
Title
Denominators
Categories
Title
Measurements
OG0002.0(2.0 to 2.0)
OG0016.6(5.9 to 10.6)
OG0022.9(2.0 to 6.0)
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Units
Counts
Participants
OG000259
OG00125
OG00231
Title
Denominators
Categories
Title
Measurements
OG00027.0(21.7 to 32.9)
OG00180.0(59.3 to 93.2)
OG00232.3(16.7 to 51.4)
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.