Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus... | NCT04882241

ID	Type	Description
MK-3475-585	Other Identifier	MSD
173786	Registry Identifier	JAPIC
KEYNOTE-585	Other Identifier	MSD
PHRR200226-002534	Registry Identifier	PHRR Research Registration

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 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.	Drug: Placebo Drug: Cisplatin Drug: Capecitabine Drug: 5-fluorouracil
Pembrolizumab+FLOT Cohort

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Biological	IV infusion	Pembrolizumab+FLOT Cohort Pembrolizumab+XP/FP

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 is based on RECIST 1.1 as assessed by the investigator and is 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 are disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who are 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), are not considered EFS events.	Up to approximately 42 months
Pathological Complete Response (pathCR) Rate - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms	PathCR rate is defined as the percentage of participants having a pathCR. pathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.	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 is defined as the time from randomization to death due to any cause. OS is presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms.	Up to approximately 42 months
Number of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts	An AE is 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 FLOT cohort was not enrolled in China per specifications in the protocol Supplemental Statistical Analysis Plan (sSAP) amendment and no data were collected for the FLOT cohort in China.

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Who Experience 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 is 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 is presented for Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms. The FLOT cohort was not enrolled in China per specifications in the protocol Supplemental Statistical Analysis Plan (sSAP) amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has previously untreated localized gastric or gastroesophageal junction (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.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Afflilated Hospital of Bengbu Medical College-Surgical Oncology (Site 0638)		Bengbu	Anhui	233004	China

Label	URL
Merck Clinical Trials Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pembrolizumab + XP/FP	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 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 20, 2023	Feb 11, 2026

Arm/Group Information

ID	Title	Description
BG000	Pembrolizumab + XP/FP	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 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
BG001	Placebo + XP/FP	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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
BG002	Pembrolizumab + FLOT Cohort	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 pembrolizumab 200 mg via IV infusion Day 1 Q3W for up to 11 cycles 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.
BG003	Placebo + FLOT Cohort	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 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.
BG004	Total	Total of all reporting groups

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 is based on RECIST 1.1 as assessed by the investigator and is 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 are disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who are 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), are 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 42 months

ID	Title	Description
OG000	Pembrolizumab + XP/FP	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 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
OG001	Placebo + XP/FP	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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.

Units	Counts
Participants	OG00059 OG00161

Title

Denominators

Categories

Title	Measurements
	OG000NA(15.2 to NA)NA = Median and upper limit were not reached at time of data cut-off due to insufficient number of participants with an event OG00136.5(15.5 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		0.39528	One-sided p-value based on log-rank test	Hazard Ratio (HR)	0.92			2-Sided	95	0.50	1.70			Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.		Other

Primary

Pathological Complete Response (pathCR) Rate - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms

PathCR rate is defined as the percentage of participants having a pathCR. pathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.

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 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 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
OG001

Primary

Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms

OS is defined as the time from randomization to death due to any cause. OS is 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 42 months

ID	Title	Description
OG000	Pembrolizumab + XP/FP	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 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
OG001	Placebo + XP/FP	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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.

Primary

Number of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts

An AE is 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 FLOT cohort was not enrolled in China per specifications in the protocol Supplemental Statistical Analysis Plan (sSAP) amendment and no data were collected for the FLOT cohort in China.

The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China.

Posted

Up to approximately 42 months

ID	Title	Description
OG000	Pembrolizumab + FLOT Cohort	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 pembrolizumab 200 mg via IV infusion Day 1 Q3W for up to 11 cycles 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.
OG001	Placebo + FLOT Cohort

Primary

Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts

An AE is 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 FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China.

The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China.

Posted

Up to approximately 17 months

ID	Title	Description
OG000	Pembrolizumab + FLOT Cohort	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 pembrolizumab 200 mg via IV infusion Day 1 Q3W for up to 11 cycles 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.
OG001	Placebo + FLOT Cohort

Secondary

Number of Participants Who Experience 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 is 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 is presented for Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms. The FLOT cohort was not enrolled in China per specifications in the protocol Supplemental Statistical Analysis Plan (sSAP) amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.

The analysis population consisted of all participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.

Posted

Count of Participants

Participants

Up to approximately 42 months

ID	Title	Description
OG000	Pembrolizumab + XP/FP	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 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.

Secondary

Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts

An AE is 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 discontinue study treatment due to an AE will be presented for Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.

Posted

Count of Participants

Participants

Up to approximately 23 months

ID	Title	Description
OG000	Pembrolizumab + XP/FP	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 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 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 is defined as the time from post-surgery baseline scan until the first occurrence of local/distant recurrence or death from any cause and is 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 42 months

ID	Title	Description
OG000	Pembrolizumab + XP/FP	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 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
OG001	Placebo + XP/FP

Secondary

Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts

OS is defined as the time from randomization to death due to any cause. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.

The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.

Posted

Up to approximately 42 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 is based on RECIST 1.1 as assessed by the investigator and is 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 are disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who are 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), are not considered EFS events. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.

Posted

Up to approximately 42 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

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 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 1000mg/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) via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.	22	59	32	59	59	59
EG001	Placebo + XP/FP	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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.	22	61	30	61	61	61

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected59 at risk EG0013 events3 affected61 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0012 events2 affected61 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Cardiac failure	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Hypopituitarism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0013 events3 affected61 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Enteritis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected59 at risk EG0010 events0 affected61 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected59 at risk EG0010 events0 affected61 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected61 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Intussusception	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Nausea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected61 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected59 at risk EG0010 events0 affected61 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0012 events2 affected61 at risk
Volvulus	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected61 at risk
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected59 at risk EG0019 events8 affected61 at risk
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected61 at risk
Ulcer	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Abdominal infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0013 events3 affected61 at risk
Abdominal sepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected61 at risk
Device related infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Haematological infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Influenza	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected59 at risk EG0013 events3 affected61 at risk
Sepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Urinary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Anastomotic stenosis	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Gastrointestinal anastomotic stenosis	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Blood creatinine increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Neutrophil count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0005 events4 affected59 at risk EG0011 events1 affected61 at risk
Platelet count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected59 at risk EG0014 events3 affected61 at risk
Weight decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
White blood cell count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0007 events6 affected59 at risk EG0011 events1 affected61 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected61 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected59 at risk EG0010 events0 affected61 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Myofascial pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Cerebral infarction	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected59 at risk EG0010 events0 affected61 at risk
Epilepsy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected61 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Renal failure	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk
Renal impairment	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected61 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected61 at risk
Phlebitis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected61 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG00083 events44 affected59 at risk EG00183 events47 affected61 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected59 at risk EG0014 events3 affected61 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0009 events6 affected59 at risk EG0018 events3 affected61 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0008 events4 affected59 at risk EG0010 events0 affected61 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0006 events3 affected59 at risk EG0010 events0 affected61 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected59 at risk EG0011 events1 affected61 at risk
Hypothyroidism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG00014 events10 affected59 at risk EG0013 events3 affected61 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0007 events6 affected59 at risk EG0013 events2 affected61 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00010 events8 affected59 at risk EG00111 events10 affected61 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0014 events4 affected61 at risk
Constipation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00018 events15 affected59 at risk EG00117 events17 affected61 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00025 events20 affected59 at risk EG00110 events7 affected61 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0008 events6 affected59 at risk EG0017 events5 affected61 at risk
Nausea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00099 events45 affected59 at risk EG001120 events49 affected61 at risk
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00071 events37 affected59 at risk EG00165 events30 affected61 at risk
Asthenia	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected59 at risk EG0016 events5 affected61 at risk
Fatigue	General disorders	MedDRA 28.0	Systematic Assessment	EG00010 events9 affected59 at risk EG0017 events5 affected61 at risk
Malaise	General disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected59 at risk EG0014 events3 affected61 at risk
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG00018 events15 affected59 at risk EG00115 events10 affected61 at risk
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00015 events14 affected59 at risk EG00110 events8 affected61 at risk
Pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected59 at risk EG0017 events7 affected61 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00014 events8 affected59 at risk EG0012 events2 affected61 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG00012 events12 affected59 at risk EG00113 events13 affected61 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected59 at risk EG0013 events3 affected61 at risk
Alanine aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG00025 events17 affected59 at risk EG00116 events12 affected61 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG00026 events17 affected59 at risk EG00115 events13 affected61 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0006 events6 affected59 at risk EG0010 events0 affected61 at risk
Blood bilirubin increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0007 events6 affected59 at risk EG0014 events3 affected61 at risk
Blood creatinine increased	Investigations	MedDRA 28.0	Systematic Assessment	EG00012 events8 affected59 at risk EG0014 events4 affected61 at risk
Blood urea increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0004 events2 affected59 at risk EG0018 events4 affected61 at risk
C-reactive protein increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0005 events4 affected59 at risk EG0011 events1 affected61 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0006 events5 affected59 at risk EG0010 events0 affected61 at risk
Lymphocyte count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG00033 events17 affected59 at risk EG00117 events9 affected61 at risk
Neutrophil count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG000125 events47 affected59 at risk EG001168 events50 affected61 at risk
Platelet count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG00080 events31 affected59 at risk EG00174 events35 affected61 at risk
SARS-CoV-2 test positive	Investigations	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected59 at risk EG0014 events4 affected61 at risk
Weight decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG00024 events23 affected59 at risk EG00136 events34 affected61 at risk
White blood cell count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG000138 events45 affected59 at risk EG001166 events46 affected61 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00031 events25 affected59 at risk EG00139 events29 affected61 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00010 events9 affected59 at risk EG0018 events6 affected61 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0008 events4 affected59 at risk EG0015 events3 affected61 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00010 events6 affected59 at risk EG0012 events2 affected61 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0009 events4 affected59 at risk EG0017 events3 affected61 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00048 events28 affected59 at risk EG00123 events18 affected61 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00019 events13 affected59 at risk EG00112 events9 affected61 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00035 events15 affected59 at risk EG00120 events12 affected61 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00012 events7 affected59 at risk EG0017 events4 affected61 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00030 events14 affected59 at risk EG00113 events9 affected61 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00010 events7 affected59 at risk EG0014 events2 affected61 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00016 events10 affected59 at risk EG00116 events11 affected61 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected59 at risk EG0011 events1 affected61 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected59 at risk EG0012 events2 affected61 at risk
Dizziness	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0009 events7 affected59 at risk EG0018 events5 affected61 at risk
Headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0006 events3 affected59 at risk EG0013 events2 affected61 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected59 at risk EG0011 events1 affected61 at risk
Insomnia	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected59 at risk EG0014 events4 affected61 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected59 at risk EG0011 events1 affected61 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected59 at risk EG0013 events2 affected61 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected59 at risk EG0014 events4 affected61 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected59 at risk EG0010 events0 affected61 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0007 events7 affected59 at risk EG0015 events5 affected61 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected59 at risk EG0012 events1 affected61 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG00012 events11 affected59 at risk EG0013 events3 affected61 at risk
Hypertension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected59 at risk EG0017 events4 affected61 at risk

ID	Term
D013274	Stomach Neoplasms
C565324	Parkinson Disease 4, Autosomal Dominant Lewy Body

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases

ID	Term
C582435	pembrolizumab
D000077330	Saline Solution
D002945	Cisplatin
D000069287	Capecitabine
D005472	Fluorouracil
D000077143	Docetaxel
D000077150	Oxaliplatin
D002955	Leucovorin

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D056831	Coordination Complexes
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003067	Coenzymes
D045762	Enzymes and Coenzymes