Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo... | NCT03675737

ID	Type	Description
MK-3475-859	Other Identifier	MSD
KEYNOTE-859	Other Identifier	MSD
JAPIC-CTI	Registry Identifier	194649
2023-508890-10-00	Registry Identifier	EU CT
U1111-1299-1405	Registry Identifier	UTN
2018-001757-27	EudraCT Number

Label	Type	Description	Intervention Names
Pembrolizumab + Chemotherapy (FP or CAPOX regimen)	Experimental	Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who complete up to 35 administrations of pembrolizumab (approximately 2 years) or achieve a complete response (CR) but experience progression of disease (PD), can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).	Biological: Pembrolizumab Drug: Cisplatin Drug: 5-fluorouracil Drug: oxaliplatin Drug: capecitabine
Placebo + Chemotherapy (FP or CAPOX regimen)	Active Comparator	Participants receive placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5FU 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).	Drug: Cisplatin Drug: 5-fluorouracil Drug: oxaliplatin Drug: capecitabine Drug: Placebo for Pembrolizumab

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Biological	Administered as an IV infusion on Day 1 Q3W	Pembrolizumab + Chemotherapy (FP or CAPOX regimen)

Measure	Description	Time Frame
Overall Survival (OS) in All Participants	OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.	Up to 45.9 months
Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1	OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.	Up to 45.9 months
Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10	OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.	Up to 45.9 months

Measure	Description	Time Frame
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants	PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status
Has human epidermal growth factor receptor 2 (HER2) negative cancer
Male participants must agree to use contraception during the treatment period and through 95 days after the last dose of chemotherapy, refrain from donating sperm, and be abstinent from heterosexual intercourse, as their preferred and usual lifestyle, and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period
Female participants who are not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) OR is a WOCBP who agrees to use contraception or be abstinent from heterosexual intercourse, as their preferred and usual lifestyle, during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last, and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period
Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator assessment
Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Has provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis
Has provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the start of study intervention
Has adequate organ function as demonstrated by laboratory testing within 10 days prior to the start of study treatment

Exclusion Criteria

Has squamous cell or undifferentiated gastric cancer
Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of the need for major surgery during the course of study intervention, or has not recovered adequately from the toxicity and/or complications from previous surgery
Has preexisting peripheral neuropathy >Grade 1
Is a WOCBP who has a positive urine pregnancy test within 24 hours for urine or within 72 hours for serum prior to randomization or treatment allocation
Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer. Participants may have received prior neoadjuvant and/or adjuvant therapy as long as it was completed ≥6 months prior to randomization
Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1 or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX- 40, CD137)
Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization or has not recovered from all adverse events (AEs) due to any previous therapies to ≤Grade 1 or baseline
Has received prior radiotherapy within 2 weeks prior to study start or has not recovered from all previous radiation-related toxicities, required corticosteroids, and have not had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy
Has known active CNS metastases and/or carcinomatous meningitis
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as Hepatitis C virus [HCV] ribonucleic acid [RNA] detected qualitatively) infection
Has a known history of active tuberculosis
Has hypokalemia (serum potassium less than the lower limit of normal)
Has hypomagnesemia (serum magnesium less than the lower limit of normal)
Has hypocalcemia (serum calcium less than the lower limit of normal)
Has a history or current evidence of any condition (eg, known deficiency of the enzyme dihydropyrimidine dehydrogenase), therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last
Has had an allogenic tissue/solid organ transplant
Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents (including, but not limited to, infusional 5-fluorouracil or oral capecitabine) and/or to any of their excipients
For participants taking cisplatin: has Grade ≥2 audiometric hearing loss

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

Facility	Status	City	State	ZIP	Country	Contacts
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0124)		Los Angeles	California	90095	United States

PubMed Identifier	Type	Citation	Retractions
37875143	Result	Rha SY, Oh DY, Yanez P, Bai Y, Ryu MH, Lee J, Rivera F, Alves GV, Garrido M, Shiu KK, Fernandez MG, Li J, Lowery MA, Cil T, Cruz FM, Qin S, Luo S, Pan H, Wainberg ZA, Yin L, Bordia S, Bhagia P, Wyrwicz LS; KEYNOTE-859 investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Nov;24(11):1181-1195. doi: 10.1016/S1470-2045(23)00515-6. Epub 2023 Oct 21.
40025394

Label	URL
Merck Clinical Trials Information	View source

ID	Title	Description
FG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 28, 2022

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

Overall Survival (OS) in All Participants

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population included all randomized participants.

Posted

Median

95% Confidence Interval

Months

Up to 45.9 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
OG001	Placebo + Chemotherapy (FP or CAPOX Regimen)	Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5FU 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).

Units	Counts
Participants	OG000790 OG001789

Title

Denominators

Categories

Title	Measurements
	OG00012.9(11.9 to 14.0) OG00111.5(10.6 to 12.1)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		<0.0001	One-sided p-value based on log-rank test stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score [CPS] <1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.	Hazard Ratio (HR)	0.78			2-Sided	95	0.70	0.87			Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (CPS <1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.		Superiority

Primary

Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1

The analysis population included randomized participants with a PD-L1 CPS of ≥1.

Posted

Median

95% Confidence Interval

Months

Up to 45.9 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
OG001	Placebo + Chemotherapy (FP or CAPOX Regimen)	Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5FU 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).

Primary

Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10

The analysis population included randomized participants with a PD-L1 CPS of ≥10.

Posted

Median

95% Confidence Interval

Months

Up to 45.9 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
OG001	Placebo + Chemotherapy (FP or CAPOX Regimen)	Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5FU 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).

Secondary

Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population included all randomized participants.

Posted

Median

95% Confidence Interval

Months

Up to 49.5 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).

Secondary

Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1

The analysis population included randomized participants with a PD-L1 CPS ≥1.

Posted

Median

95% Confidence Interval

Months

Up to 49.5 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).

Secondary

The analysis population included randomized participants with a PD-L1 CPS ≥10.

Posted

Median

95% Confidence Interval

Months

Up to 49.5 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).

Secondary

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants

ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.

The analysis population included all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 49.5 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
OG001	Placebo + Chemotherapy (FP or CAPOX Regimen)

Secondary

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1

The analysis population included randomized participants with a PD-L1 CPS ≥1.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 49.5 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
OG001	Placebo + Chemotherapy (FP or CAPOX Regimen)

Secondary

The analysis population included randomized participants with a PD-L1 CPS ≥10.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 49.5 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
OG001	Placebo + Chemotherapy (FP or CAPOX Regimen)

Secondary

Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants

DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as ≥20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population included all randomized participants who experienced a confirmed CR or PR.

Posted

Median

95% Confidence Interval

Months

Up to 49.5 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).

Secondary

Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1

The analysis population included randomized participants, with a PD-L1 CPS ≥1, who experienced a confirmed CR or PR.

Posted

Median

95% Confidence Interval

Months

Up to 49.5 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).

Secondary

The analysis population included randomized participants, with a PD-L1 CPS ≥10, who experienced a confirmed CR or PR.

Posted

Median

95% Confidence Interval

Months

Up to 49.5 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).

Secondary

Number of Participants Who Experienced an Adverse Event (AE)

An AE was defined as any untoward medical occurrence, in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE is presented.

The analysis population included all participants who received at least one dose of study treatment.

Posted

Count of Participants

Participants

Up to approximately 49.3 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
OG001	Placebo + Chemotherapy (FP or CAPOX Regimen)

Secondary

Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.

The analysis population included all participants who received at least one dose of study treatment.

Posted

Count of Participants

Participants

Up to approximately 46.3 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
OG001

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00010 events8 affected785 at risk EG00110 events8 affected787 at risk EG0020 events0 affected12 at risk
Aplastic anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0017 events7 affected787 at risk EG0020 events0 affected12 at risk
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0004 events3 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0014 events4 affected787 at risk EG0020 events0 affected12 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0015 events5 affected787 at risk EG0020 events0 affected12 at risk
Angina unstable	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Arrhythmia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0013 events3 affected787 at risk EG0020 events0 affected12 at risk
Atrial flutter	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Bradycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Cardiac arrest	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Cardiac failure	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Coronary artery disease	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Immune-mediated myocarditis	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Pericardial effusion	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Tachycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Ventricular dysfunction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Hypopituitarism	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Cataract	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Diabetic retinopathy	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Retinal artery occlusion	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00012 events12 affected785 at risk EG0019 events9 affected787 at risk EG0020 events0 affected12 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0014 events4 affected787 at risk EG0020 events0 affected12 at risk
Ascites	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0006 events5 affected785 at risk EG00111 events9 affected787 at risk EG0020 events0 affected12 at risk
Colitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00016 events16 affected785 at risk EG0015 events4 affected787 at risk EG0020 events0 affected12 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0016 events5 affected787 at risk EG0020 events0 affected12 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00035 events32 affected785 at risk EG00126 events25 affected787 at risk EG0020 events0 affected12 at risk
Duodenal stenosis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0009 events9 affected785 at risk EG00115 events15 affected787 at risk EG0020 events0 affected12 at risk
Enteritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0014 events4 affected787 at risk EG0020 events0 affected12 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected785 at risk EG0017 events7 affected787 at risk EG0020 events0 affected12 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0014 events4 affected787 at risk EG0020 events0 affected12 at risk
Gastritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0013 events3 affected787 at risk EG0020 events0 affected12 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00012 events9 affected785 at risk EG00112 events8 affected787 at risk EG0020 events0 affected12 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 events2 affected785 at risk EG0013 events2 affected787 at risk EG0020 events0 affected12 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Ileus	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0009 events7 affected785 at risk EG0016 events5 affected787 at risk EG0020 events0 affected12 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0008 events8 affected785 at risk EG0016 events6 affected787 at risk EG0020 events0 affected12 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Malignant ascites	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Melaena	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00014 events14 affected785 at risk EG00112 events11 affected787 at risk EG0020 events0 affected12 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0019 events9 affected787 at risk EG0020 events0 affected12 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Oral pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Subileus	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0012 events1 affected787 at risk EG0020 events0 affected12 at risk
Terminal ileitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0009 events9 affected785 at risk EG0018 events8 affected787 at risk EG0021 events1 affected12 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00020 events19 affected785 at risk EG00124 events23 affected787 at risk EG0020 events0 affected12 at risk
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected785 at risk EG0015 events5 affected787 at risk EG0020 events0 affected12 at risk
Chest discomfort	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Complication associated with device	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Death	General disorders	MedDRA 27.1	Systematic Assessment	EG00011 events11 affected785 at risk EG0014 events4 affected787 at risk EG0020 events0 affected12 at risk
Face oedema	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected785 at risk EG0016 events6 affected787 at risk EG0020 events0 affected12 at risk
General physical health deterioration	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Hyperthermia	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Injection site discolouration	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Localised oedema	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Malaise	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0013 events2 affected787 at risk EG0020 events0 affected12 at risk
Mucosal inflammation	General disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0015 events5 affected787 at risk EG0020 events0 affected12 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG00016 events12 affected785 at risk EG00114 events9 affected787 at risk EG0020 events0 affected12 at risk
Sudden death	General disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Ulcer haemorrhage	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Biliary fistula	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Biliary obstruction	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected785 at risk EG0013 events2 affected787 at risk EG0020 events0 affected12 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG00012 events3 affected785 at risk EG0013 events3 affected787 at risk EG0020 events0 affected12 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Jaundice	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Liver injury	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Vanishing bile duct syndrome	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Hypersensitivity	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Abdominal abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Abdominal infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Anal abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Appendicitis perforated	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Bacteraemia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Biliary sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Biliary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Bronchitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0006 events6 affected785 at risk EG0014 events4 affected787 at risk EG0020 events0 affected12 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected785 at risk EG0013 events3 affected787 at risk EG0020 events0 affected12 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Campylobacter infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Cellulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0012 events1 affected787 at risk EG0020 events0 affected12 at risk
Chlamydial infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Cholangitis infective	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Device related infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Diverticulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Endocarditis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Epiglottitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Erysipelas	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Febrile infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Hepatic infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Influenza	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Liver abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Lymph node abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Pleural infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00030 events30 affected785 at risk EG00114 events14 affected787 at risk EG0020 events0 affected12 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Pneumonia fungal	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Postoperative wound infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Pyelonephritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0008 events7 affected785 at risk EG0018 events7 affected787 at risk EG0020 events0 affected12 at risk
Septic encephalopathy	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Septic shock	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected785 at risk EG0015 events5 affected787 at risk EG0020 events0 affected12 at risk
Sinusitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Skin infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Streptococcal infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Tinea manuum	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Tinea pedis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Tuberculosis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0004 events3 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Urosepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Wound infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Gastrointestinal anastomotic stenosis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Peripheral nerve injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Unintentional medical device removal	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Alanine aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Blood bilirubin increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Blood creatinine increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Ejection fraction decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
False positive investigation result	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0012 events1 affected787 at risk EG0020 events0 affected12 at risk
Lipase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Neutrophil count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Platelet count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected785 at risk EG0019 events7 affected787 at risk EG0020 events0 affected12 at risk
SARS-CoV-2 test positive	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Transaminases increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Weight decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
White blood cell count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0009 events9 affected785 at risk EG00111 events10 affected787 at risk EG0020 events0 affected12 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected785 at risk EG0014 events4 affected787 at risk EG0020 events0 affected12 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0008 events8 affected785 at risk EG0017 events6 affected787 at risk EG0020 events0 affected12 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0007 events4 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0013 events3 affected787 at risk EG0020 events0 affected12 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Paraneoplastic dermatomyositis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0012 events1 affected787 at risk EG0020 events0 affected12 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Sacral pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Acoustic neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Pharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0014 events3 affected787 at risk EG0020 events0 affected12 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Amnesia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Cerebral infarction	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0014 events4 affected787 at risk EG0020 events0 affected12 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Dizziness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Dysarthria	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Lacunar stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Loss of consciousness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Neuralgia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Neurotoxicity	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Optic neuritis	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Paraneoplastic encephalomyelitis	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Seizure	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Spinal cord compression	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Syncope	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0014 events4 affected787 at risk EG0020 events0 affected12 at risk
Device breakage	Product Issues	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Device dislocation	Product Issues	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Device occlusion	Product Issues	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0013 events1 affected787 at risk EG0020 events0 affected12 at risk
Stent malfunction	Product Issues	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0012 events1 affected787 at risk EG0020 events0 affected12 at risk
Completed suicide	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Substance-induced psychotic disorder	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG00013 events12 affected785 at risk EG00111 events11 affected787 at risk EG0020 events0 affected12 at risk
Haematuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0013 events3 affected787 at risk EG0020 events0 affected12 at risk
Immune-mediated nephritis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Nephritis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Renal failure	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Oropharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0008 events8 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0008 events8 affected785 at risk EG0012 events2 affected787 at risk EG0020 events0 affected12 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00015 events15 affected785 at risk EG0016 events6 affected787 at risk EG0020 events0 affected12 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0013 events3 affected787 at risk EG0020 events0 affected12 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Aortic dissection	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Aortic thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Arteriosclerosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Embolism	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Hypotension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0013 events3 affected787 at risk EG0020 events0 affected12 at risk
Jugular vein embolism	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Peripheral embolism	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0020 events0 affected12 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk
Venous thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0011 events1 affected787 at risk EG0020 events0 affected12 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG000512 events325 affected785 at risk EG001413 events282 affected787 at risk EG0024 events3 affected12 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00076 events47 affected785 at risk EG00179 events42 affected787 at risk EG0023 events2 affected12 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00038 events28 affected785 at risk EG00125 events16 affected787 at risk EG0023 events3 affected12 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG000309 events146 affected785 at risk EG001294 events141 affected787 at risk EG0024 events2 affected12 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG000147 events95 affected785 at risk EG001137 events83 affected787 at risk EG0022 events2 affected12 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG00023 events20 affected785 at risk EG00116 events15 affected787 at risk EG0021 events1 affected12 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG00044 events43 affected785 at risk EG00115 events13 affected787 at risk EG0020 events0 affected12 at risk
Hypothyroidism	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG000139 events121 affected785 at risk EG00140 events34 affected787 at risk EG0020 events0 affected12 at risk
Erythema of eyelid	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0010 events0 affected787 at risk EG0021 events1 affected12 at risk
Eye swelling	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0010 events0 affected787 at risk EG0021 events1 affected12 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00043 events39 affected785 at risk EG00142 events40 affected787 at risk EG0022 events1 affected12 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000165 events130 affected785 at risk EG001137 events111 affected787 at risk EG0020 events0 affected12 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00072 events63 affected785 at risk EG00168 events62 affected787 at risk EG0020 events0 affected12 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000207 events169 affected785 at risk EG001209 events161 affected787 at risk EG0020 events0 affected12 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000443 events255 affected785 at risk EG001357 events238 affected787 at risk EG0023 events2 affected12 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00052 events48 affected785 at risk EG00145 events39 affected787 at risk EG0020 events0 affected12 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00050 events48 affected785 at risk EG00139 events35 affected787 at risk EG0020 events0 affected12 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000626 events359 affected785 at risk EG001612 events359 affected787 at risk EG0021 events1 affected12 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0012 events2 affected787 at risk EG0021 events1 affected12 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00072 events56 affected785 at risk EG00153 events48 affected787 at risk EG0020 events0 affected12 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000423 events252 affected785 at risk EG001312 events192 affected787 at risk EG0022 events1 affected12 at risk
Vomiting projectile	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0010 events0 affected787 at risk EG0021 events1 affected12 at risk
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG000196 events125 affected785 at risk EG001164 events119 affected787 at risk EG0023 events3 affected12 at risk
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG000255 events195 affected785 at risk EG001262 events191 affected787 at risk EG0020 events0 affected12 at risk
Mucosal inflammation	General disorders	MedDRA 27.1	Systematic Assessment	EG00064 events49 affected785 at risk EG00150 events38 affected787 at risk EG0020 events0 affected12 at risk
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG00073 events59 affected785 at risk EG00161 events55 affected787 at risk EG0020 events0 affected12 at risk
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG000132 events86 affected785 at risk EG00163 events51 affected787 at risk EG0020 events0 affected12 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG00112 events7 affected787 at risk EG0021 events1 affected12 at risk
Abscess oral	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected785 at risk EG0010 events0 affected787 at risk EG0021 events1 affected12 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected785 at risk EG0011 events1 affected787 at risk EG0021 events1 affected12 at risk
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00014 events12 affected785 at risk EG00112 events12 affected787 at risk EG0021 events1 affected12 at risk
Oral fungal infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected785 at risk EG0011 events1 affected787 at risk EG0021 events1 affected12 at risk
Periodontitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0022 events1 affected12 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG00031 events24 affected785 at risk EG00128 events23 affected787 at risk EG0021 events1 affected12 at risk
Alanine aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG000179 events133 affected785 at risk EG001124 events96 affected787 at risk EG0020 events0 affected12 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG000287 events183 affected785 at risk EG001194 events139 affected787 at risk EG0021 events1 affected12 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG000103 events82 affected785 at risk EG00178 events68 affected787 at risk EG0021 events1 affected12 at risk
Blood bilirubin increased	Investigations	MedDRA 27.1	Systematic Assessment	EG000195 events108 affected785 at risk EG001133 events71 affected787 at risk EG0020 events0 affected12 at risk
Blood creatinine increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00062 events47 affected785 at risk EG00146 events40 affected787 at risk EG0020 events0 affected12 at risk
Lipase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0009 events9 affected785 at risk EG0014 events4 affected787 at risk EG0021 events1 affected12 at risk
Neutrophil count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG000554 events199 affected785 at risk EG001509 events175 affected787 at risk EG0021 events1 affected12 at risk
Platelet count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG000424 events207 affected785 at risk EG001319 events187 affected787 at risk EG0022 events2 affected12 at risk
Weight decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG000178 events158 affected785 at risk EG001161 events147 affected787 at risk EG0021 events1 affected12 at risk
White blood cell count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG000336 events108 affected785 at risk EG001292 events93 affected787 at risk EG0021 events1 affected12 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG000302 events227 affected785 at risk EG001293 events217 affected787 at risk EG0021 events1 affected12 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG000110 events63 affected785 at risk EG00154 events43 affected787 at risk EG0021 events1 affected12 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG000213 events146 affected785 at risk EG001152 events105 affected787 at risk EG0020 events0 affected12 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00072 events49 affected785 at risk EG00152 events46 affected787 at risk EG0020 events0 affected12 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG000162 events116 affected785 at risk EG001113 events84 affected787 at risk EG0022 events1 affected12 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00068 events55 affected785 at risk EG00148 events39 affected787 at risk EG0020 events0 affected12 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00090 events73 affected785 at risk EG00168 events57 affected787 at risk EG0021 events1 affected12 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00052 events50 affected785 at risk EG00145 events45 affected787 at risk EG0020 events0 affected12 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0010 events0 affected787 at risk EG0021 events1 affected12 at risk
Dizziness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00058 events52 affected785 at risk EG00144 events38 affected787 at risk EG0020 events0 affected12 at risk
Dysgeusia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00055 events48 affected785 at risk EG00144 events37 affected787 at risk EG0020 events0 affected12 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG000215 events157 affected785 at risk EG001231 events175 affected787 at risk EG0021 events1 affected12 at risk
Paraesthesia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00074 events47 affected785 at risk EG00161 events32 affected787 at risk EG0020 events0 affected12 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG000189 events139 affected785 at risk EG001184 events136 affected787 at risk EG0020 events0 affected12 at risk
Tremor	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected785 at risk EG0013 events3 affected787 at risk EG0021 events1 affected12 at risk
Anxiety	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG00023 events21 affected785 at risk EG00112 events12 affected787 at risk EG0021 events1 affected12 at risk
Insomnia	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG00047 events43 affected785 at risk EG00155 events52 affected787 at risk EG0020 events0 affected12 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00044 events41 affected785 at risk EG00132 events30 affected787 at risk EG0020 events0 affected12 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG000225 events195 affected785 at risk EG001188 events172 affected787 at risk EG0021 events1 affected12 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00091 events65 affected785 at risk EG00130 events21 affected787 at risk EG0021 events1 affected12 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00098 events72 affected785 at risk EG00144 events39 affected787 at risk EG0020 events0 affected12 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
D002945	Cisplatin
D005472	Fluorouracil
D000077150	Oxaliplatin
D000069287	Capecitabine

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Title	Description
BG000	Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
BG001	Placebo + Chemotherapy (FP or CAPOX Regimen)	Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5FU 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
BG002	Total	Total of all reporting 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 + Chemotherapy (FP or CAPOX Regimen)	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).	689	790	358	785	755	785
EG001	Placebo + Chemotherapy (FP or CAPOX Regimen)	Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5FU 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).	733	789	317	787	751	787
EG002	Pembrolizumab Second Course	Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule of 200 mg IV on Day 1 Q3W for up to 17 cycles (up to approximately 1 year).	8	12	1	12	10	12