Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus... | NCT03221426 | Trialant
NCT03221426
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Mar 9, 2026Actual
Enrollment
1,007Actual
Phase
Phase 3
Conditions
Gastric Cancer
Gastroesophageal Junction Cancer
Interventions
Pembrolizumab
Placebo
Cisplatin
Capecitabine
5-fluorouracil
Docetaxel
Oxaliplatin
Leucovorin
Countries
United States
Belgium
Brazil
Canada
Chile
China
Estonia
France
Germany
Guatemala
Israel
Italy
Japan
Latvia
Lithuania
Malaysia
Philippines
Poland
Russia
Singapore
South Korea
Taiwan
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03221426
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-585
Secondary IDs
ID
Type
Description
Link
MK-3475-585
Other Identifier
MSD
173786
Registry Identifier
JAPIC
KEYNOTE-585
Other Identifier
MSD
PHRR200226-002534
Registry Identifier
PHRR Research Registration
2023-509595-42-00
Registry Identifier
EU CT
2023-509595-42
EudraCT Number
Brief Title
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)
Official Title
A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Feb 2026
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
Oct 9, 2017Actual
Primary Completion Date
Feb 16, 2024Actual
Completion Date
Apr 23, 2025Actual
First Submitted Date
Jul 17, 2017
First Submission Date that Met QC Criteria
Jul 17, 2017
First Posted Date
Jul 18, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jan 28, 2025
Results First Submitted that Met QC Criteria
Jan 28, 2025
Results First Posted Date
Feb 20, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 13, 2026
Last Update Posted Date
Mar 9, 2026Actual
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
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
The primary study hypotheses are that:
Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and
Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.
With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study.
Detailed Description
Not provided
Conditions Module
Conditions
Gastric Cancer
Gastroesophageal Junction Cancer
Keywords
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,007Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Pembrolizumab + XP/FP
Experimental
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of pembrolizumab 200 mg IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg IV infusion on Day 1 Q3W for up to 11 additional cycles.
Biological: Pembrolizumab
Drug: Cisplatin
Drug: Capecitabine
Drug: 5-fluorouracil
Placebo + XP/FP
Placebo Comparator
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Drug: Placebo
Drug: Cisplatin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pembrolizumab
Biological
IV infusion
Pembrolizumab + XP/FP
Pembrolizumab+FLOT Cohort
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
EFS was based on RECIST 1.1 as assessed by the investigator and was defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by computer tomography (CT) scan or biopsy if indicated (for participants who were disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who were confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), were not considered EFS events.
PathCR rate was defined as the percentage of participants having a pathCR based on central review. pathCR was defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes. The percentage of participants having pathCR was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms.
Up to approximately 9 weeks following completion of neoadjuvant treatment (up to Study Week 18)
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
OS was defined as the time from randomization to death due to any cause. OS was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms.
Up to approximately 75 months
Number of Participants Who Experienced One or More Adverse Events (AEs) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE was presented for the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced One or More Adverse Events (AEs) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced at least one AE was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease.
Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.
Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 within 3 days prior to the first dose of study treatment.
Has adequate organ function.
Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.
Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
Has life expectancy of greater than 6 months.
Exclusion Criteria:
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Has an active infection requiring systemic therapy.
Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], necrosis factor receptor superfamily member 9 [CD137]) or has previously participated in a MSD pembrolizumab (MK-3475) clinical study.
Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment.
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded.
Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients, or to any of the study chemotherapy agents and/or to any of their excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has a known history of human immunodeficiency virus (HIV) infection.
Has a known history of Hepatitis B or known active Hepatitis C virus infection.
Has a known history of active tuberculosis (TB).
Female participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
Male participants who are expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy.
Has had an allogenic tissue/solid organ transplant.
Has received a live vaccine within 30 days prior to the first dose of study treatment.
Of the 1007 participants that were randomized to trial, 1001 received treatment.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pembrolizumab + XP/FP
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).
Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m^2, oxaliplatin 85 mg/m^2, 5FU 2600 mg/m^2, and leucovorin 200 mg/m^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Biological: Pembrolizumab
Drug: 5-fluorouracil
Drug: Docetaxel
Drug: Oxaliplatin
Drug: Leucovorin
Placebo+FLOT Cohort
Placebo Comparator
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).
Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Drug: Placebo
Drug: 5-fluorouracil
Drug: Docetaxel
Drug: Oxaliplatin
Drug: Leucovorin
MK-3475
KEYTRUDA®
Placebo
Drug
IV infusion
Placebo + XP/FP
Placebo+FLOT Cohort
Normal saline solution
Cisplatin
Drug
IV infusion
Pembrolizumab + XP/FP
Placebo + XP/FP
PLATINOL®
Capecitabine
Drug
Oral tablets
Pembrolizumab + XP/FP
Placebo + XP/FP
XELODA®
5-fluorouracil
Drug
IV infusion
Pembrolizumab + XP/FP
Pembrolizumab+FLOT Cohort
Placebo + XP/FP
Placebo+FLOT Cohort
ADRUCIL®
5FU
Docetaxel
Drug
IV infusion
Pembrolizumab+FLOT Cohort
Placebo+FLOT Cohort
TAXOTERE®
Oxaliplatin
Drug
IV infusion
Pembrolizumab+FLOT Cohort
Placebo+FLOT Cohort
ELOXATIN®
Leucovorin
Drug
IV infusion
Pembrolizumab+FLOT Cohort
Placebo+FLOT Cohort
WELLCOVORIN®
Up to approximately 70 months
Number of Participants Who Discontinued Study Treatment Due to an AE - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE was presented for the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Up to approximately 17 months
Up to approximately 89 months
Number of Participants Who Discontinued Study Treatment Due to an AE - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Up to approximately 17 months
Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
DFS was defined as the time from post-surgery baseline scan until the first occurrence of local or distant recurrence or death from any cause and was based on RECIST 1.1 as assessed by the investigator.
Up to approximately 75 months
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
OS was defined as the time from randomization to death due to any cause. OS was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Up to approximately 75 months
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
EFS was based on RECIST 1.1 as assessed by the investigator and was defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by CT scan or biopsy if indicated (for participants who were disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who were confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), were not considered EFS events.
Up to approximately 75 months
New Haven
Connecticut
06520
United States
Georgetown University ( Site 0015)
Washington D.C.
District of Columbia
20007
United States
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018)
Chicago
Illinois
60611
United States
The University of Chicago Medical Center ( Site 0004)
Chicago
Illinois
60637
United States
Roswell Park Cancer Institute ( Site 0001)
Buffalo
New York
14263
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019)
New York
New York
10016
United States
Memorial Sloan Kettering ( Site 0024)
New York
New York
10065
United States
Weill Cornell Medical Center ( Site 0023)
New York
New York
10065
United States
University of Rochester ( Site 0011)
Rochester
New York
14642
United States
Fox Chase Cancer Center ( Site 0006)
Philadelphia
Pennsylvania
19111
United States
Temple University Hospital ( Site 0026)
Philadelphia
Pennsylvania
19140
United States
University of Utah, Huntsman Cancer Institute ( Site 0012)
Salt Lake City
Utah
84112
United States
Virginia Cancer Specialists, PC ( Site 0010)
Fairfax
Virginia
22031
United States
Institut Jules Bordet ( Site 0480)
Brussels
Bruxelles-Capitale, Region de
1000
Belgium
Hopital Erasme ULB ( Site 0484)
Brussels
Bruxelles-Capitale, Region de
1070
Belgium
UCL Saint Luc ( Site 0479)
Brussels
Bruxelles-Capitale, Region de
1200
Belgium
Grand Hopital de Charleroi ( Site 0478)
Charleroi
Hainaut
6000
Belgium
CHU de Liege ( Site 0482)
Liège
Liege
4000
Belgium
CHU UCL Namur Site de Godinne ( Site 0485)
Yvoir
Namur
5530
Belgium
UZ Gent ( Site 0486)
Ghent
Oost-Vlaanderen
9000
Belgium
UZ Leuven ( Site 0483)
Leuven
Vlaams-Brabant
3000
Belgium
AZ Groeninge ( Site 0481)
Kortrijk
West-Vlaanderen
8500
Belgium
Instituto do Cancer do Ceara ( Site 0311)
Fortaleza
Ceará
60430-230
Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308)
Porto Alegre
Rio Grande do Sul
90610-000
Brazil
CEPON - Centro de Pesquisas Oncologicas ( Site 0302)
Florianópolis
Santa Catarina
88034-000
Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301)
Barretos
São Paulo
14784-400
Brazil
Hospital de Base de Sao Jose de Rio Preto ( Site 0304)
Sao Jose Rio Preto
São Paulo
15090-000
Brazil
Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307)
Rio de Janeiro
20230-130
Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0305)
São Paulo
01246-000
Brazil
Hospital Israelita Albert Einstein ( Site 0309)
São Paulo
05652-900
Brazil
Cross Cancer Institute ( Site 0033)
Edmonton
Alberta
T6G 1Z2
Canada
Moncton Hospital - Horizon Health Network ( Site 0038)
Moncton
New Brunswick
E1C 6Z8
Canada
Sunnybrook Research Institute ( Site 0032)
Toronto
Ontario
M4N 3M5
Canada
CISSS de la Monteregie-Centre ( Site 0039)
Greenfield Park
Quebec
J4V 2H1
Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040)
Montreal
Quebec
H1T 2M4
Canada
Jewish General Hospital ( Site 0034)
Montreal
Quebec
H3T 1E2
Canada
CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042)
Québec
Quebec
G1R 2J6
Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035)
Sherbrooke
Quebec
J1H 5N4
Canada
Instituto Clinico del Sur. ICOS ( Site 0290)
Temuco
Araucania
4810469
Chile
Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299)
Rancagua
Lbtdr Gen Bernardo O Higgins
2820000
Chile
Fundacion Arturo Lopez Perez FALP ( Site 0286)
Santiago
Region M. de Santiago
7500921
Chile
Pontificia Universidad Catolica de Chile ( Site 0285)
Santiago
Region M. de Santiago
8330032
Chile
Hospital Clinico Universidad de Chile ( Site 0287)
Santiago
Region M. de Santiago
8380456
Chile
Beijing Cancer Hospital ( Site 0221)
Beijing
Beijing Municipality
100142
China
Zhejiang Cancer Hospital ( Site 0231)
Hangzhou
Zhejiang
310022
China
Sir Run Run Shaw Hospital ( Site 0233)
Hangzhou
Zhejiang
430030
China
SA Pohja-Eesti Regionaalhaigla ( Site 0526)
Tallinn
Harju
13419
Estonia
Hopital Prive Jean Mermoz ( Site 0462)
Lyon
Auvergne
69008
France
Institut Paoli Calmettes ( Site 0472)
Marseille
Bouches-du-Rhone
13009
France
CHU Reims - Hopital Robert Debre ( Site 0465)
Reims
Champagne-Ardenne
51092
France
CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474)
Brest
Finistere
29200
France
CHU Toulouse - Hopital Rangueil ( Site 0470)
Toulouse
Haute-Garonne
31059
France
Institut du Cancer de Montpellier ( Site 0473)
Montpellier
Herault
34298
France
Centre Eugene Marquis ( Site 0466)
Rennes
Ille-et-Vilaine
35042
France
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469)
Saint-Herblain
Loire-Atlantique
44805
France
CHRU Lille - Hopital Claude Huriez ( Site 0461)
Lille
Nord
59037
France
CHU Poitiers - Pole Regional de Cancerologie ( Site 0467)
Poitiers
Vienne
86021
France
CHU Hopital Saint Antoine ( Site 0471)
Paris
75012
France
Institut Mutualiste Montsouris ( Site 0463)
Paris
75014
France
Klinikum Esslingen GmbH ( Site 0453)
Esslingen am Neckar
Baden-Wurttemberg
73730
Germany
Universitaetsklinikum Freiburg ( Site 0450)
Freiburg im Breisgau
Baden-Wurttemberg
79106
Germany
Klinikum der Universitaet in Muenchen ( Site 0446)
Munich
Bavaria
81377
Germany
Medizinische Hochschule Hannover ( Site 0449)
Hanover
Lower Saxony
30625
Germany
Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445)
Essen
North Rhine-Westphalia
45136
Germany
Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455)
Mainz
Rhineland-Palatinate
55131
Germany
Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448)
Dresden
Saxony
01307
Germany
Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454)
Hamburg
20249
Germany
Integra Cancer Institute ( Site 0262)
Guatemala City
01010
Guatemala
Grupo Medico Angeles ( Site 0261)
Guatemala City
01015
Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 0260)
Quetzaltenango
09002
Guatemala
Meir medical center ( Site 0386)
Kfar Saba
Central District
4428164
Israel
Soroka University M.C ( Site 0385)
Beersheba
Southern District
8410101
Israel
Sourasky Medical Center. ( Site 0382)
Tel Aviv
Tell Abib
6423906
Israel
Rambam Health Care Campus ( Site 0381)
Haifa
31096
Israel
Hadassah Medical Center. Ein Kerem ( Site 0383)
Jerusalem
9112001
Israel
Rabin-Medical Center ( Site 0384)
Petah Tikva
4941492
Israel
Sheba Medical center ( Site 0387)
Ramat Gan
5265601
Israel
IRCCS Istituto Oncologico Veneto ( Site 0431)
Padova
Abruzzo
35128
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430)
Milan
Lombardy
20133
Italy
Istituto Clinico Humanitas Research Hospital ( Site 0432)
Rozzano
Milano
20089
Italy
IRCCS Policlinico San Donato ( Site 0433)
San Donato Milanese
Milano
20097
Italy
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429)
Modena
41125
Italy
Seconda Universita Napoli ( Site 0436)
Naples
80131
Italy
A.O.U. Santa Maria della Misericordia di Udine ( Site 0434)
Udine
33100
Italy
Aichi Cancer Center Hospital ( Site 0165)
Nagoya
Aichi-ken
464-8681
Japan
National Cancer Center Hospital East ( Site 0178)
Kashiwa
Chiba
277-8577
Japan
National Hospital Organization Shikoku Cancer Center ( Site 0186)
Matsuyama
Ehime
791-0280
Japan
Hokkaido University Hospital ( Site 0160)
Sapporo
Hokkaido
060-8648
Japan
Hyogo Cancer Center ( Site 0182)
Akashi
Hyōgo
673-8558
Japan
Kobe University Hospital ( Site 0188)
Kobe
Hyōgo
650-0017
Japan
Kobe City Medical Center General Hospital ( Site 0181)
Kobe
Hyōgo
650-0047
Japan
Ibaraki Prefectural Central Hospital ( Site 0177)
Kasama
Ibaraki
309-1793
Japan
Iwate Medical University Hospital ( Site 0184)
Shiwa-gun
Iwate
028-3695
Japan
St. Marianna University School of Medicine Hospital ( Site 0187)
Kawasaki
Kanagawa
216-8511
Japan
Kanagawa Cancer Center ( Site 0167)
Yokohama
Kanagawa
241-8515
Japan
Kansai Medical University Hospital ( Site 0190)
Hirakata
Osaka
573-1191
Japan
Osaka University Hospital ( Site 0162)
Suita
Osaka
565-0871
Japan
Osaka Medical College Hospital ( Site 0168)
Takatsuki
Osaka
569-8686
Japan
Saitama Cancer Center ( Site 0170)
Kitaadachi-gun
Saitama
362-0806
Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0176)
Sunto-gun
Shizuoka
411-8777
Japan
Chiba Cancer Center ( Site 0180)
Chiba
260-8717
Japan
National Hospital Organization Kyushu Cancer Center ( Site 0172)
Fukuoka
811-1395
Japan
Kyushu University Hospital ( Site 0173)
Fukuoka
812-8582
Japan
Gifu University Hospital ( Site 0166)
Gifu
501-1194
Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 0171)
Hiroshima
730-8518
Japan
Kochi Health Sciences Center ( Site 0189)
Kochi
781-8555
Japan
Kumamoto University Hospital ( Site 0164)
Kumamoto
860-8556
Japan
Niigata Cancer Center Hospital ( Site 0169)
Niigata
951-8566
Japan
Osaka International Cancer Institute ( Site 0161)
Osaka
541-8567
Japan
Osaka General Medical Center ( Site 0159)
Osaka
558-8558
Japan
National Cancer Center Hospital ( Site 0179)
Tokyo
104-0045
Japan
Tokyo Metropolitan Komagome Hospital ( Site 0183)
Tokyo
113-8677
Japan
The Cancer Institute Hospital of JFCR ( Site 0185)
Tokyo
135-8550
Japan
Toyama Prefectural Central Hospital ( Site 0163)
Toyama
930-8550
Japan
Riga East Clinical University Hospital ( Site 0550)
Riga
1079
Latvia
LSMUL Kauno Klinikos ( Site 0570)
Kaunas
50161
Lithuania
Nacionalinis Vezio Institutas ( Site 0569)
Vilnius
08406
Lithuania
Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568)
Vilnius
08460
Lithuania
Hospital Kuala Lumpur ( Site 0146)
Kuala Lumpur
50586
Malaysia
University Malaya Medical Centre ( Site 0143)
Kuala Lumpur
59100
Malaysia
St. Luke s Medical Center ( Site 0622)
Quezon City
National Capital Region
1102
Philippines
Szpital Uniwersytecki w Krakowie ( Site 0352)
Krakow
Lesser Poland Voivodeship
31-501
Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358)
Wroclaw
Lower Silesian Voivodeship
51-124
Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351)
Lublin
Lublin Voivodeship
20-080
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0349)
Warsaw
Masovian Voivodeship
02-034
Poland
Mazowiecki Szpital Onkologiczny ( Site 0363)
Wieliszew
Masovian Voivodeship
05-135
Poland
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353)
Kościerzyna
Pomeranian Voivodeship
83-400
Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354)
Bielsko-Biala
Silesian Voivodeship
43-300
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0361)
Gliwice
Silesian Voivodeship
44-101
Poland
SPZOZ WSS nr 3 w Rybniku ( Site 0357)
Rybnik
Silesian Voivodeship
44-200
Poland
Kaluga Regional Clinical Oncology Center ( Site 0345)
Kaluga
Kaluzskaja Oblast
248007
Russia
SBHI Leningrad Regional Clinical Hospital ( Site 0496)
Saint Petersburg
Leningradskaya Oblast'
194291
Russia
National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338)
Moscow
Moscow
105203
Russia
Blokhin National Medical Oncology ( Site 0494)
Moscow
Moscow
115478
Russia
Leningrad Regional Oncology Center ( Site 0335)
Saint Petersburg
Sankt-Peterburg
188663
Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344)
Saint Petersburg
Sankt-Peterburg
197758
Russia
City clinical oncological dispensary ( Site 0336)
Saint Petersburg
Sankt-Peterburg
198255
Russia
Tomsk Scientific Research Institute of Oncology ( Site 0337)
Tomsk
Tomsk Oblast
634028
Russia
National University Hospital ( Site 0095)
Singapore
Central Singapore
119074
Singapore
National Cancer Centre Singapore ( Site 0097)
Singapore
Central Singapore
169610
Singapore
Oncocare Cancer Centre ( Site 0096)
Singapore
Central Singapore
258499
Singapore
Chonnam National University Hwasun Hospital ( Site 0083)
Hwasun Gun
Jeonranamdo
58128
South Korea
Seoul National University Bundang Hospital ( Site 0085)
Seongnam-si
Kyonggi-do
13620
South Korea
Kyungpook National University Chilgok Hospital ( Site 0089)
Daegu
Taegu-Kwangyokshi
41404
South Korea
Gachon University Gil Medical Center ( Site 0087)
Incheon
21565
South Korea
Korea University Anam Hospital ( Site 0084)
Seoul
02841
South Korea
Seoul National University Hospital -SNUH- ( Site 0080)
Seoul
03080
South Korea
Severance Hospital Yonsei University Health System ( Site 0081)
Seoul
03722
South Korea
Asan Medical Center ( Site 0082)
Seoul
05505
South Korea
Gangnam Severance Hospital ( Site 0088)
Seoul
06273
South Korea
SMG-SNU BORAMAE Medical Center ( Site 0086)
Seoul
07061
South Korea
Taipei Medical University Shuang Ho Hospital ( Site 0068)
New Taipei City
235
Taiwan
National Cheng Kung University Hospital ( Site 0067)
Tainan
704
Taiwan
National Taiwan University Hospital ( Site 0063)
Taipei
10002
Taiwan
Mackay Memorial Hospital ( Site 0065)
Taipei
104
Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066)
Taipei
11259
Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0064)
Taoyuan
333
Taiwan
City Clinical Hosp.4 of DCC ( Site 0325)
Dnipro
Dnipropetrovsk Oblast
49102
Ukraine
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 0589)
Kryviy Rih
Dnipropetrovsk Oblast
50048
Ukraine
Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321)
Ivano-Frankivsk
Ivano-Frankivsk Oblast
76018
Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 0591)
Kharkiv
Kharkiv Oblast
61070
Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 0319)
Kyiv
Kyivska Oblast
03022
Ukraine
Kyiv City Clinical Oncology Center ( Site 0590)
Kyiv
Kyivska Oblast
03115
Ukraine
University Hospitals Bristol NHS Foundation Trust ( Site 0407)
Bristol
Bristol, City of
BS2 8ED
United Kingdom
Ninewells Hospital and Medical School ( Site 0406)
Dundee
Dundee City
DD1 9SY
United Kingdom
Royal Free London NHS Foundation Trust ( Site 0403)
London
London, City of
NW3 2QG
United Kingdom
The Royal Marsden Foundation Trust ( Site 0405)
London
London, City of
SW3 6JJ
United Kingdom
Imperial College Healthcare NHS Trust ( Site 0402)
London
London, City of
W2 1NY
United Kingdom
Royal Marsden NHS Foundation Trust ( Site 0400)
Sutton
Surrey
SM2 5PT
United Kingdom
The Christie NHS Foundation Trust ( Site 0397)
Manchester
M20 4BX
United Kingdom
Derived
Shitara K, Rha SY, Wyrwicz L, Oshima T, Karaseva N, Osipov M, Yasui H, Yabusaki H, Afanasyev S, Park YK, Al-Batran SE, Yoshikawa T, Yanez P, Pietrantonio F, Lonardi S, Fang X, Guan Y, Valderrama A, Leconte P, Bhagia P, Bang YJ; KEYNOTE-585 Investigators. Pembrolizumab Plus Chemotherapy Versus Chemotherapy as Perioperative Therapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer: Final Analysis of the Randomized, Phase III KEYNOTE-585 Study. J Clin Oncol. 2025 Oct 10;43(29):3152-3159. doi: 10.1200/JCO-25-00486. Epub 2025 Aug 19.
Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
Bang YJ, Van Cutsem E, Fuchs CS, Ohtsu A, Tabernero J, Ilson DH, Hyung WJ, Strong VE, Goetze TO, Yoshikawa T, Tang LH, Hwang PMT, Webb N, Adelberg D, Shitara K. KEYNOTE-585: Phase III study of perioperative chemotherapy with or without pembrolizumab for gastric cancer. Future Oncol. 2019 Mar;15(9):943-952. doi: 10.2217/fon-2018-0581. Epub 2019 Feb 19.
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
FG002
Pembrolizumab + FLOT Cohort
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m^2, oxaliplatin 85 mg/m^2, 5FU 2600 mg/m^2, and leucovorin 200 mg/m^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
FG003
Placebo + FLOT Cohort
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
FG000402 subjects
FG001402 subjects
FG002100 subjects
FG003103 subjects
Treated
FG000399 subjects
FG001400 subjects
FG00299 subjects
FG003103 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG000402 subjects
FG001402 subjects
FG002100 subjects
FG003103 subjects
Type
Comment
Reasons
Sponsor Decision
FG000188 subjects
FG001173 subjects
FG00258 subjects
FG00347 subjects
Withdrawal by Subject
FG00012 subjects
FG0016 subjects
FG0022 subjects
FG0033 subjects
Lost to Follow-up
FG0009 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
Death
FG000193 subjects
FG001221 subjects
FG00239 subjects
FG00353 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pembrolizumab + XP/FP
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
BG001
Placebo + XP/FP
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
BG002
Pembrolizumab + FLOT Cohort
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m^2, oxaliplatin 85 mg/m^2, 5FU 2600 mg/m^2, and leucovorin 200 mg/m^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
BG003
Placebo + FLOT Cohort
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000402
BG001402
BG002100
BG003103
BG0041007
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Adults (between 18 and 64 years)
BG000207
BG001221
BG00258
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000114
BG001115
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00044
BG00154
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Geographic Region
Participants were categorized according to geographic region of site: Asia, Western Europe, United States (US), and Rest of World (ROW).
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asia
BG000190
BG001191
Tumor Staging
Participants were categorized by tumor stage based on American Joint Committee on Cancer (AJCC) staging guidelines. The lower the cancer stage, the less the cancer has spread. Stages can range from I to IVd. 'a' describes less aggressive (slower growing) cancer, while 'd' describes more aggressive (faster growing) cancer within a numeric stage.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Stage II
BG00082
BG001
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
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
EFS was based on RECIST 1.1 as assessed by the investigator and was defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by computer tomography (CT) scan or biopsy if indicated (for participants who were disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who were confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), were not considered EFS events.
The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms, as pre-specified per protocol.
Posted
Median
95% Confidence Interval
Months
Up to approximately 75 months
ID
Title
Description
OG000
Pembrolizumab + XP/FP
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
OG001
Placebo + XP/FP
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Units
Counts
Participants
OG000402
OG001402
Title
Denominators
Categories
Title
Measurements
OG00044.4(33.0 to 69.8)
OG00125.7(20.8 to 36.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.01501
One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)
Hazard Ratio (HR)
0.81
2-Sided
95
0.67
0.98
Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)
PathCR rate was defined as the percentage of participants having a pathCR based on central review. pathCR was defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes. The percentage of participants having pathCR was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms.
The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms, as pre-specified per protocol.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 9 weeks following completion of neoadjuvant treatment (up to Study Week 18)
ID
Title
Description
OG000
Pembrolizumab + XP/FP
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Primary
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
OS was defined as the time from randomization to death due to any cause. OS was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms.
The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms, as pre-specified per protocol.
Posted
Median
95% Confidence Interval
Months
Up to approximately 75 months
ID
Title
Description
OG000
Pembrolizumab + XP/FP
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
OG001
Placebo + XP/FP
Primary
Number of Participants Who Experienced One or More Adverse Events (AEs) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE was presented for the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
The analysis population consisted of all participants who received ≥1 dose of study treatment in the Pembrolizumab+FLOT and Placebo+FLOT Cohort treatment arms, as pre-specified per protocol.
Posted
Count of Participants
Participants
Up to approximately 70 months
ID
Title
Description
OG000
Pembrolizumab + FLOT Cohort
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m^2, oxaliplatin 85 mg/m^2, 5FU 2600 mg/m^2, and leucovorin 200 mg/m^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Primary
Number of Participants Who Discontinued Study Treatment Due to an AE - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE was presented for the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
The analysis population consisted of all participants who received ≥1 dose of study treatment in the Pembrolizumab+FLOT and Placebo+FLOT Cohort treatment arms, as pre-specified per protocol.
Posted
Count of Participants
Participants
Up to approximately 17 months
ID
Title
Description
OG000
Pembrolizumab + FLOT Cohort
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m^2, oxaliplatin 85 mg/m^2, 5FU 2600 mg/m^2, and leucovorin 200 mg/m^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Secondary
Number of Participants Who Experienced One or More Adverse Events (AEs) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced at least one AE was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
The analysis population consisted of all participants who received ≥1 dose of study treatment for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts, as pre-specified per protocol.
Posted
Count of Participants
Participants
Up to approximately 89 months
ID
Title
Description
OG000
Pembrolizumab + XP/FP
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Secondary
Number of Participants Who Discontinued Study Treatment Due to an AE - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
The analysis population consisted of all participants who received ≥1 dose of study treatment for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts, as pre-specified in the protocol.
Posted
Count of Participants
Participants
Up to approximately 17 months
ID
Title
Description
OG000
Pembrolizumab + XP/FP
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Secondary
Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
DFS was defined as the time from post-surgery baseline scan until the first occurrence of local or distant recurrence or death from any cause and was based on RECIST 1.1 as assessed by the investigator.
The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms who had surgery, as pre-specified per protocol.
Posted
Median
95% Confidence Interval
Months
Up to approximately 75 months
ID
Title
Description
OG000
Pembrolizumab + XP/FP
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Secondary
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
OS was defined as the time from randomization to death due to any cause. OS was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts, as pre-specified in the protocol.
Posted
Median
95% Confidence Interval
Months
Up to approximately 75 months
ID
Title
Description
OG000
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
OG001
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
Units
Counts
Participants
Secondary
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
EFS was based on RECIST 1.1 as assessed by the investigator and was defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by CT scan or biopsy if indicated (for participants who were disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who were confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), were not considered EFS events.
The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts, as pre-specified per protocol.
Posted
Median
95% Confidence Interval
Months
Up to approximately 75 months
ID
Title
Description
OG000
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
Neoadjuvant and adjuvant pembrolizumab + XP/FP and neoadjuvant and adjuvant pembrolizumab + FLOT Cohort treatment arms combined
OG001
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Time Frame
Up to approximately 89 months
Description
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Pembrolizumab + XP/FP
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
200
402
174
399
392
399
EG001
Placebo + XP/FP
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
225
402
160
400
392
400
EG002
Pembrolizumab + FLOT Cohort
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m^2, oxaliplatin 85 mg/m^2, 5FU 2600 mg/m^2, and leucovorin 200 mg/m^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
40
100
66
99
99
99
EG003
Placebo + FLOT Cohort
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
56
103
51
103
103
103
EG004
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Combined
Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
240
502
240
498
491
498
EG005
Placebo + XP/FP and Placebo + FLOT Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
281
505
211
503
495
503
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0005 events5 affected399 at risk
EG0016 events6 affected400 at risk
EG0020 events0 affected99 at risk
EG0030 events0 affected103 at risk
EG0045 events5 affected498 at risk
EG0056 events6 affected503 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected399 at risk
EG00112 events12 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0013 events3 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Arteriospasm coronary
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Toxic cardiomyopathy
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Pyloric stenosis
Congenital, familial and genetic disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 28.0
Systematic Assessment
EG0008 events8 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Secondary adrenocortical insufficiency
Endocrine disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0018 events7 affected400 at risk
EG0022 events2 affected99 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0022 events2 affected99 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG00011 events11 affected399 at risk
EG0013 events3 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Diaphragmatic hernia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0022 events2 affected99 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0006 events6 affected399 at risk
EG00112 events10 affected400 at risk
EG0026 events6 affected99 at risk
EG003
Dumping syndrome
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0015 events4 affected400 at risk
EG0023 events3 affected99 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0013 events3 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0012 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Fistula of small intestine
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0012 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0015 events4 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Gastric stenosis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected399 at risk
EG0012 events2 affected400 at risk
EG0022 events2 affected99 at risk
EG003
Gastrointestinal toxicity
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Haemoperitoneum
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0011 events1 affected400 at risk
EG0022 events2 affected99 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 events1 affected399 at risk
EG0012 events2 affected400 at risk
EG0022 events2 affected99 at risk
EG003
Intra-abdominal haematoma
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Mechanical ileus
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0006 events5 affected399 at risk
EG0018 events7 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Neutropenic colitis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0012 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Omental infarction
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Pancreatic fistula
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected399 at risk
EG0010 events0 affected400 at risk
EG0022 events2 affected99 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0012 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Pneumoperitoneum
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Small intestinal stenosis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0013 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Terminal ileitis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0014 events4 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG00011 events9 affected399 at risk
EG00110 events9 affected400 at risk
EG0027 events7 affected99 at risk
EG003
Adverse drug reaction
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Asthenia
General disorders
MedDRA 28.0
Systematic Assessment
EG0005 events3 affected399 at risk
EG0013 events3 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Chest discomfort
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Chest pain
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Fatigue
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0021 events1 affected99 at risk
EG003
General physical health deterioration
General disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0011 events1 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Generalised oedema
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Hernia
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Influenza like illness
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Infusion site reaction
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Malaise
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0015 events5 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Oedema peripheral
General disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Physical deconditioning
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Pyrexia
General disorders
MedDRA 28.0
Systematic Assessment
EG0004 events4 affected399 at risk
EG0016 events5 affected400 at risk
EG00210 events7 affected99 at risk
EG003
Serositis
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Sudden death
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Acute cholecystitis necrotic
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0014 events3 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Hepatic ischaemia
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0004 events4 affected399 at risk
EG0011 events1 affected400 at risk
EG0022 events2 affected99 at risk
EG003
Hepatitis toxic
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Hepatobiliary disease
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Hydrocholecystis
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Anaphylactic shock
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0022 events1 affected99 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0023 events3 affected99 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Abscess soft tissue
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
COVID-19
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0022 events2 affected99 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Cellulitis of male external genital organ
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Clostridial sepsis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Device related infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0002 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Empyema
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0022 events2 affected99 at risk
EG003
Influenza
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Mediastinal abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Meningitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Parotitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0007 events7 affected399 at risk
EG0015 events4 affected400 at risk
EG0026 events5 affected99 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Postoperative abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0022 events2 affected99 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Pyopneumothorax
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Salmonellosis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Sepsis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0004 events4 affected399 at risk
EG0014 events4 affected400 at risk
EG0023 events3 affected99 at risk
EG003
Septic shock
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0012 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Stoma site abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Stoma site infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0024 events4 affected99 at risk
EG003
Wound infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Afferent loop syndrome
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Anastomotic fistula
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Anastomotic haemorrhage
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Anastomotic leak
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0012 events2 affected400 at risk
EG0023 events3 affected99 at risk
EG003
Anastomotic stenosis
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Chemical burn of skin
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Drain site complication
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Failure to anastomose
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Gastrointestinal anastomotic leak
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0004 events4 affected399 at risk
EG0011 events1 affected400 at risk
EG0023 events3 affected99 at risk
EG003
Gastrointestinal anastomotic stenosis
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Glaucoma traumatic
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Incarcerated incisional hernia
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Pancreatic leak
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0012 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Poisoning
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Post procedural inflammation
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Postoperative ileus
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0012 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Stoma obstruction
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Suture rupture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0012 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0005 events5 affected399 at risk
EG0012 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Escherichia test positive
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0005 events4 affected399 at risk
EG0014 events4 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Platelet count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Transaminases increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Weight decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG00010 events9 affected399 at risk
EG00115 events14 affected400 at risk
EG0022 events2 affected99 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected399 at risk
EG0012 events2 affected400 at risk
EG0022 events2 affected99 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Fulminant type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0013 events3 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0004 events4 affected399 at risk
EG0016 events6 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0012 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Steroid diabetes
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Gastrointestinal lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Gastrointestinal tract adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Neuroendocrine carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Neuroendocrine tumour of the lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Oesophageal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Pancreatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Squamous cell carcinoma of the oral cavity
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Thymoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Alcoholic seizure
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Basal ganglia infarction
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Cerebral haematoma
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0012 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Guillain-Barre syndrome
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Headache
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0012 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Seizure
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Syncope
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected399 at risk
EG0012 events2 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Thrombotic cerebral infarction
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Device dislocation
Product Issues
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Device occlusion
Product Issues
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Thrombosis in device
Product Issues
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0004 events4 affected399 at risk
EG0013 events3 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Renal salt-wasting syndrome
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Bronchial haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Chylothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Immune-mediated lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Mediastinal effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Oesophagobronchial fistula
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Pleural fistula
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Pneumomediastinum
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0006 events6 affected399 at risk
EG0011 events1 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0008 events8 affected399 at risk
EG0015 events5 affected400 at risk
EG0022 events2 affected99 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Pulmonary sarcoidosis
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Respiratory depression
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Pemphigoid
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Stevens-Johnson syndrome
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Subcutaneous emphysema
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Toxic epidermal necrolysis
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Arterial haemorrhage
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0013 events3 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Embolism
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0005 events5 affected399 at risk
EG0012 events2 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Hypotension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Iliac artery occlusion
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Internal haemorrhage
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0012 events2 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Peripheral embolism
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0010 events0 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG000228 events165 affected399 at risk
EG001210 events158 affected400 at risk
EG00246 events25 affected99 at risk
EG00349 events26 affected103 at risk
EG004274 events190 affected498 at risk
EG005259 events184 affected503 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG00027 events16 affected399 at risk
EG00137 events23 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG000198 events114 affected399 at risk
EG001192 events111 affected400 at risk
EG00244 events27 affected99 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG00022 events19 affected399 at risk
EG00132 events26 affected400 at risk
EG0026 events4 affected99 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected399 at risk
EG0012 events2 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 28.0
Systematic Assessment
EG00030 events29 affected399 at risk
EG00136 events29 affected400 at risk
EG0021 events1 affected99 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 28.0
Systematic Assessment
EG00015 events14 affected399 at risk
EG0015 events5 affected400 at risk
EG0027 events6 affected99 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 28.0
Systematic Assessment
EG00035 events33 affected399 at risk
EG00110 events10 affected400 at risk
EG0027 events6 affected99 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG00096 events57 affected399 at risk
EG00187 events64 affected400 at risk
EG00237 events24 affected99 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG00021 events21 affected399 at risk
EG00131 events30 affected400 at risk
EG00213 events10 affected99 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG000151 events108 affected399 at risk
EG001149 events111 affected400 at risk
EG00228 events21 affected99 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG000218 events148 affected399 at risk
EG001203 events129 affected400 at risk
EG002141 events68 affected99 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG00013 events11 affected399 at risk
EG00113 events10 affected400 at risk
EG0028 events7 affected99 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG00059 events39 affected399 at risk
EG00138 events30 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG00022 events20 affected399 at risk
EG00119 events18 affected400 at risk
EG00210 events9 affected99 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0006 events6 affected399 at risk
EG0015 events5 affected400 at risk
EG0027 events6 affected99 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG00019 events17 affected399 at risk
EG00116 events16 affected400 at risk
EG0028 events8 affected99 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG000463 events239 affected399 at risk
EG001499 events245 affected400 at risk
EG002108 events58 affected99 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG00082 events63 affected399 at risk
EG00168 events52 affected400 at risk
EG00216 events14 affected99 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG000165 events102 affected399 at risk
EG001175 events108 affected400 at risk
EG00260 events37 affected99 at risk
EG003
Asthenia
General disorders
MedDRA 28.0
Systematic Assessment
EG000154 events86 affected399 at risk
EG001119 events76 affected400 at risk
EG00228 events19 affected99 at risk
EG003
Chills
General disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0016 events5 affected400 at risk
EG00216 events12 affected99 at risk
EG003
Fatigue
General disorders
MedDRA 28.0
Systematic Assessment
EG000133 events88 affected399 at risk
EG001125 events91 affected400 at risk
EG00276 events57 affected99 at risk
EG003
Malaise
General disorders
MedDRA 28.0
Systematic Assessment
EG00052 events36 affected399 at risk
EG00165 events42 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 28.0
Systematic Assessment
EG00032 events25 affected399 at risk
EG00132 events25 affected400 at risk
EG00212 events10 affected99 at risk
EG003
Oedema peripheral
General disorders
MedDRA 28.0
Systematic Assessment
EG00021 events19 affected399 at risk
EG00124 events19 affected400 at risk
EG00212 events9 affected99 at risk
EG003
Pyrexia
General disorders
MedDRA 28.0
Systematic Assessment
EG00073 events62 affected399 at risk
EG00166 events55 affected400 at risk
EG00243 events25 affected99 at risk
EG003
Temperature intolerance
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0010 events0 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0004 events4 affected399 at risk
EG0015 events4 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0006 events6 affected399 at risk
EG00113 events11 affected400 at risk
EG0024 events4 affected99 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0003 events2 affected399 at risk
EG0011 events1 affected400 at risk
EG0026 events6 affected99 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG00037 events37 affected399 at risk
EG00137 events36 affected400 at risk
EG0024 events4 affected99 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG00027 events25 affected399 at risk
EG00126 events25 affected400 at risk
EG0020 events0 affected99 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG00037 events25 affected399 at risk
EG00135 events25 affected400 at risk
EG00220 events16 affected99 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG00039 events29 affected399 at risk
EG00134 events23 affected400 at risk
EG00218 events14 affected99 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0008 events6 affected399 at risk
EG00111 events10 affected400 at risk
EG0028 events7 affected99 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 28.0
Systematic Assessment
EG00069 events50 affected399 at risk
EG00187 events53 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG000297 events146 affected399 at risk
EG001244 events130 affected400 at risk
EG00283 events40 affected99 at risk
EG003
Platelet count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG00081 events45 affected399 at risk
EG00189 events60 affected400 at risk
EG00224 events11 affected99 at risk
EG003
Weight decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG000107 events104 affected399 at risk
EG001111 events104 affected400 at risk
EG00237 events34 affected99 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG000144 events69 affected399 at risk
EG001110 events53 affected400 at risk
EG00232 events18 affected99 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG000256 events158 affected399 at risk
EG001249 events167 affected400 at risk
EG00256 events39 affected99 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG00013 events13 affected399 at risk
EG00112 events11 affected400 at risk
EG0028 events6 affected99 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG00017 events15 affected399 at risk
EG00113 events11 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG00024 events19 affected399 at risk
EG00123 events18 affected400 at risk
EG0029 events8 affected99 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG00010 events7 affected399 at risk
EG0017 events6 affected400 at risk
EG0026 events6 affected99 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG00047 events33 affected399 at risk
EG00158 events47 affected400 at risk
EG00217 events10 affected99 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG00014 events13 affected399 at risk
EG00120 events17 affected400 at risk
EG00213 events11 affected99 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG00013 events12 affected399 at risk
EG0019 events8 affected400 at risk
EG0027 events7 affected99 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG00024 events23 affected399 at risk
EG00118 events17 affected400 at risk
EG00220 events15 affected99 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG00021 events18 affected399 at risk
EG00123 events21 affected400 at risk
EG00212 events9 affected99 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected399 at risk
EG0011 events1 affected400 at risk
EG0029 events8 affected99 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0007 events7 affected399 at risk
EG0015 events5 affected400 at risk
EG0027 events7 affected99 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG00013 events10 affected399 at risk
EG00116 events15 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG00039 events34 affected399 at risk
EG00146 events36 affected400 at risk
EG00212 events9 affected99 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG00052 events45 affected399 at risk
EG00147 events39 affected400 at risk
EG00216 events13 affected99 at risk
EG003
Headache
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG00039 events29 affected399 at risk
EG00139 events31 affected400 at risk
EG00222 events17 affected99 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG00024 events20 affected399 at risk
EG00125 events25 affected400 at risk
EG00221 events20 affected99 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG00010 events9 affected399 at risk
EG00115 events11 affected400 at risk
EG00226 events19 affected99 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG00017 events17 affected399 at risk
EG00120 events20 affected400 at risk
EG00229 events21 affected99 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected399 at risk
EG0011 events1 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0009 events7 affected399 at risk
EG0018 events8 affected400 at risk
EG0027 events7 affected99 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG00048 events45 affected399 at risk
EG00145 events42 affected400 at risk
EG00220 events18 affected99 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG00022 events21 affected399 at risk
EG00122 events22 affected400 at risk
EG00214 events12 affected99 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0014 events3 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG00015 events14 affected399 at risk
EG0017 events7 affected400 at risk
EG00214 events14 affected99 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG00013 events13 affected399 at risk
EG0018 events8 affected400 at risk
EG0028 events7 affected99 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG00055 events28 affected399 at risk
EG00158 events29 affected400 at risk
EG00211 events10 affected99 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0005 events5 affected399 at risk
EG0016 events6 affected400 at risk
EG0029 events9 affected99 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG00011 events11 affected399 at risk
EG0013 events3 affected400 at risk
EG00211 events10 affected99 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected399 at risk
EG0010 events0 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0005 events5 affected399 at risk
EG0019 events7 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG00023 events21 affected399 at risk
EG00117 events16 affected400 at risk
EG00233 events30 affected99 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG00021 events20 affected399 at risk
EG00111 events11 affected400 at risk
EG00214 events13 affected99 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0006 events6 affected399 at risk
EG0014 events4 affected400 at risk
EG00213 events6 affected99 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG00073 events67 affected399 at risk
EG00168 events57 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG00064 events55 affected399 at risk
EG00127 events22 affected400 at risk
EG00222 events16 affected99 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG00051 events45 affected399 at risk
EG00134 events28 affected400 at risk
EG00227 events22 affected99 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0008 events7 affected399 at risk
EG0015 events4 affected400 at risk
EG0028 events6 affected99 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0006 events6 affected399 at risk
EG0018 events8 affected400 at risk
EG0025 events5 affected99 at risk
EG003
Hypertension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG00029 events25 affected399 at risk
EG00137 events30 affected400 at risk
EG0029 events8 affected99 at risk
EG003
Hypotension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG00018 events18 affected399 at risk
EG00110 events9 affected400 at risk
EG0029 events8 affected99 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 investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Units
Counts
Participants
OG000402
OG001402
Title
Denominators
Categories
Title
Measurements
OG00013.4(10.3 to 17.2)
OG0012.0(0.9 to 3.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Stratified Miettinen and Nurminen
Based on Miettinen & Nurminen method stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)
<0.00001
Difference in Percentage
11.4
2-Sided
95
8.0
15.3
Superiority
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Units
Counts
Participants
OG000402
OG001402
Title
Denominators
Categories
Title
Measurements
OG00071.8(52.5 to NA)NA = Upper limit was not reached at time of data cut-off due to insufficient number of participants with an event
OG00155.7(41.7 to NA)NA = Upper limit was not reached at time of data cut-off due to insufficient number of participants with an event
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.07503
One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)
Hazard Ratio (HR)
0.86
2-Sided
95
0.71
1.06
Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)
Superiority
OG001
Placebo + FLOT Cohort
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Units
Counts
Participants
OG00099
OG001103
Title
Denominators
Categories
Title
Measurements
OG00099
OG001103
OG001
Placebo + FLOT Cohort
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Units
Counts
Participants
OG00099
OG001103
Title
Denominators
Categories
Title
Measurements
OG00037
OG00126
OG001
Placebo + XP/FP
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
OG002
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
OG003
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
Units
Counts
Participants
OG000399
OG001400
OG002498
OG003503
Title
Denominators
Categories
Title
Measurements
OG000396
OG001398
OG002495
OG003501
OG001
Placebo + XP/FP
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
OG002
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
OG003
Placebo+ XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
Units
Counts
Participants
OG000399
OG001400
OG002498
OG003503
Title
Denominators
Categories
Title
Measurements
OG000123
OG001103
OG002160
OG003129
OG001
Placebo + XP/FP
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Units
Counts
Participants
OG000320
OG001306
Title
Denominators
Categories
Title
Measurements
OG00066.1(44.9 to NA)Upper limit not reached at time of data cut-off due to insufficient number of participants with an event
OG00144.2(27.6 to NA)Upper limit not reached at time of data cut-off due to insufficient number of participants with an event
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.04125
One-sided p-value based on log-rank test with stratification
Hazard Ratio (HR)
0.82
2-Sided
95
0.65
1.03
Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification
Other
OG000502
OG001505
Title
Denominators
Categories
Title
Measurements
OG000NA(59.2 to NA)NA = Median and upper limit were not reached at the data cut-off due to insufficient number of participants with an event
OG00155.7(42.8 to NA)NA = Upper limit was not reached at the data cut-off due to insufficient number of participants with an event
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.04493
One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)
Hazard Ratio (HR)
0.86
2-Sided
95
0.71
1.03
Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)
Superiority
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
Units
Counts
Participants
OG000502
OG001505
Title
Denominators
Categories
Title
Measurements
OG00047.0(36.2 to NA)NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event
OG00126.9(22.1 to 34.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.00589
One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)
Hazard Ratio (HR)
0.80
2-Sided
95
0.67
0.95
Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)