NCT03221426 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) · Source last updated 2026-03-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Up to approximately 89 months
Other-event reporting threshold: 5%

All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pembrolizumab + XP/FP XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.	174 / 399	392 / 399	200 / 402
Placebo + XP/FP Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.	160 / 400	392 / 400	225 / 402
Pembrolizumab + FLOT Cohort FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m\^2, oxaliplatin 85 mg/m\^2, 5FU 2600 mg/m\^2, and leucovorin 200 mg/m\^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.	66 / 99	99 / 99	40 / 100
Placebo + FLOT Cohort Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.	51 / 103	103 / 103	56 / 103
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Combined Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined	240 / 498	491 / 498	240 / 502
Placebo + XP/FP and Placebo + FLOT Combined Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined	211 / 503	495 / 503	281 / 505

Group identifiers: EG000: Pembrolizumab + XP/FP · EG001: Placebo + XP/FP · EG002: Pembrolizumab + FLOT Cohort · EG003: Placebo + FLOT Cohort · EG004: Pembrolizumab + XP/FP and Pembrolizumab + FLOT Combined · EG005: Placebo + XP/FP and Placebo + FLOT Combined

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
5
num At Risk
399
num Events
5
group Id
EG001
num Affected
6
num At Risk
400
num Events
6
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
5
num At Risk
498
num Events
5
group Id
EG005
num Affected
6
num At Risk
503
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
399
num Events
3
group Id
EG001
num Affected
12
num At Risk
400
num Events
12
group Id
EG002
num Affected
5
num At Risk
99
num Events
5
group Id
EG003
num Affected
6
num At Risk
103
num Events
6
group Id
EG004
num Affected
8
num At Risk
498
num Events
8
group Id
EG005
num Affected
18
num At Risk
503
num Events
18
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
399
num Events
0
group Id
EG001
num Affected
1
num At Risk
400
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
0
num At Risk
498
num Events
0
group Id
EG005
num Affected
1
num At Risk
503
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
399
num Events
1
group Id
EG001
num Affected
3
num At Risk
400
num Events
3
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
1
num At Risk
103
num Events
1
group Id
EG004
num Affected
1
num At Risk
498
num Events
1
group Id
EG005
num Affected
4
num At Risk
503
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
399
num Events
0
group Id
EG001
num Affected
1
num At Risk
400
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
0
num At Risk
498
num Events
0
group Id
EG005
num Affected
1
num At Risk
503
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
399
num Events
1
group Id
EG001
num Affected
0
num At Risk
400
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
1
num At Risk
498
num Events
1
group Id
EG005
num Affected
0
num At Risk
503
num Events
0
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
399
num Events
0
group Id
EG001
num Affected
0
num At Risk
400
num Events
0
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
1
num At Risk
498
num Events
1
group Id
EG005
num Affected
0
num At Risk
503
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
2
num At Risk
399
num Events
2
group Id
EG001
num Affected
0
num At Risk
400
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
2
num At Risk
498
num Events
2
group Id
EG005
num Affected
0
num At Risk
503
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
399
num Events
1
group Id
EG001
num Affected
0
num At Risk
400
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
1
num At Risk
498
num Events
1
group Id
EG005
num Affected
0
num At Risk
503
num Events
0
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
399
num Events
1
group Id
EG001
num Affected
0
num At Risk
400
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
1
num At Risk
103
num Events
1
group Id
EG004
num Affected
1
num At Risk
498
num Events
1
group Id
EG005
num Affected
1
num At Risk
503
num Events
1
term
Arteriospasm coronary
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
399
num Events
0
group Id
EG001
num Affected
1
num At Risk
400
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
2
num At Risk
103
num Events
2
group Id
EG004
num Affected
0
num At Risk
498
num Events
0
group Id
EG005
num Affected
3
num At Risk
503
num Events
3
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
399
num Events
0
group Id
EG001
num Affected
0
num At Risk
400
num Events
0
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
1
num At Risk
498
num Events
1
group Id
EG005
num Affected
0
num At Risk
503
num Events
0
term
Cardiac arrest

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
165
num At Risk
399
num Events
228
group Id
EG001
num Affected
158
num At Risk
400
num Events
210
group Id
EG002
num Affected
25
num At Risk
99
num Events
46
group Id
EG003
num Affected
26
num At Risk
103
num Events
49
group Id
EG004
num Affected
190
num At Risk
498
num Events
274
group Id
EG005
num Affected
184
num At Risk
503
num Events
259
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
16
num At Risk
399
num Events
27
group Id
EG001
num Affected
23
num At Risk
400
num Events
37
group Id
EG002
num Affected
5
num At Risk
99
num Events
5
group Id
EG003
num Affected
5
num At Risk
103
num Events
6
group Id
EG004
num Affected
21
num At Risk
498
num Events
32
group Id
EG005
num Affected
28
num At Risk
503
num Events
43
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
114
num At Risk
399
num Events
198
group Id
EG001
num Affected
111
num At Risk
400
num Events
192
group Id
EG002
num Affected
27
num At Risk
99
num Events
44
group Id
EG003
num Affected
23
num At Risk
103
num Events
36
group Id
EG004
num Affected
141
num At Risk
498
num Events
242
group Id
EG005
num Affected
134
num At Risk
503
num Events
228
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
19
num At Risk
399
num Events
22
group Id
EG001
num Affected
26
num At Risk
400
num Events
32
group Id
EG002
num Affected
4
num At Risk
99
num Events
6
group Id
EG003
num Affected
7
num At Risk
103
num Events
9
group Id
EG004
num Affected
23
num At Risk
498
num Events
28
group Id
EG005
num Affected
33
num At Risk
503
num Events
41
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
399
num Events
3
group Id
EG001
num Affected
2
num At Risk
400
num Events
2
group Id
EG002
num Affected
5
num At Risk
99
num Events
5
group Id
EG003
num Affected
3
num At Risk
103
num Events
4
group Id
EG004
num Affected
8
num At Risk
498
num Events
8
group Id
EG005
num Affected
5
num At Risk
503
num Events
6
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
29
num At Risk
399
num Events
30
group Id
EG001
num Affected
29
num At Risk
400
num Events
36
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
30
num At Risk
498
num Events
31
group Id
EG005
num Affected
29
num At Risk
503
num Events
36
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
14
num At Risk
399
num Events
15
group Id
EG001
num Affected
5
num At Risk
400
num Events
5
group Id
EG002
num Affected
6
num At Risk
99
num Events
7
group Id
EG003
num Affected
4
num At Risk
103
num Events
4
group Id
EG004
num Affected
20
num At Risk
498
num Events
22
group Id
EG005
num Affected
9
num At Risk
503
num Events
9
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
33
num At Risk
399
num Events
35
group Id
EG001
num Affected
10
num At Risk
400
num Events
10
group Id
EG002
num Affected
6
num At Risk
99
num Events
7
group Id
EG003
num Affected
5
num At Risk
103
num Events
5
group Id
EG004
num Affected
39
num At Risk
498
num Events
42
group Id
EG005
num Affected
15
num At Risk
503
num Events
15
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
57
num At Risk
399
num Events
96
group Id
EG001
num Affected
64
num At Risk
400
num Events
87
group Id
EG002
num Affected
24
num At Risk
99
num Events
37
group Id
EG003
num Affected
31
num At Risk
103
num Events
54
group Id
EG004
num Affected
81
num At Risk
498
num Events
133
group Id
EG005
num Affected
95
num At Risk
503
num Events
141
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
21
num At Risk
399
num Events
21
group Id
EG001
num Affected
30
num At Risk
400
num Events
31
group Id
EG002
num Affected
10
num At Risk
99
num Events
13
group Id
EG003
num Affected
15
num At Risk
103
num Events
17
group Id
EG004
num Affected
31
num At Risk
498
num Events
34
group Id
EG005
num Affected
45
num At Risk
503
num Events
48
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
108
num At Risk
399
num Events
151
group Id
EG001
num Affected
111
num At Risk
400
num Events
149
group Id
EG002
num Affected
21
num At Risk
99
num Events
28
group Id
EG003
num Affected
32
num At Risk
103
num Events
43
group Id
EG004
num Affected
129
num At Risk
498
num Events
179
group Id
EG005
num Affected
143
num At Risk
503
num Events
192
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
148
num At Risk
399
num Events
218
group Id
EG001
num Affected
129
num At Risk
400
num Events
203
group Id
EG002
num Affected
68
num At Risk
99
num Events
141
group Id
EG003
num Affected
75
num At Risk
103
num Events
174
group Id
EG004
num Affected
216
num At Risk
498
num Events
359
group Id
EG005
num Affected
204
num At Risk
503
num Events
377
term
Diarrhoea

Complete source fields

description

event Groups

deaths Num Affected
200
deaths Num At Risk
402
description
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
id
EG000
other Num Affected
392
other Num At Risk
399
serious Num Affected
174
serious Num At Risk
399
title
Pembrolizumab + XP/FP
deaths Num Affected
225
deaths Num At Risk
402
description
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
id
EG001
other Num Affected
392
other Num At Risk
400
serious Num Affected
160
serious Num At Risk
400
title
Placebo + XP/FP
deaths Num Affected
40
deaths Num At Risk
100
description
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m\^2, oxaliplatin 85 mg/m\^2, 5FU 2600 mg/m\^2, and leucovorin 200 mg/m\^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
id
EG002
other Num Affected
99
other Num At Risk
99
serious Num Affected
66
serious Num At Risk
99
title
Pembrolizumab + FLOT Cohort
deaths Num Affected
56
deaths Num At Risk
103
description
Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
id
EG003
other Num Affected
103
other Num At Risk
103
serious Num Affected
51
serious Num At Risk
103
title
Placebo + FLOT Cohort
deaths Num Affected
240
deaths Num At Risk
502
description
Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
id
EG004
other Num Affected
491
other Num At Risk
498
serious Num Affected
240
serious Num At Risk
498
title
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Combined
deaths Num Affected
281
deaths Num At Risk
505
description
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
id
EG005
other Num Affected
495
other Num At Risk
503
serious Num Affected
211
serious Num At Risk
503
title
Placebo + XP/FP and Placebo + FLOT Combined

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
165
num At Risk
399
num Events
228
group Id
EG001
num Affected
158
num At Risk
400
num Events
210
group Id
EG002
num Affected
25
num At Risk
99
num Events
46
group Id
EG003
num Affected
26
num At Risk
103
num Events
49
group Id
EG004
num Affected
190
num At Risk
498
num Events
274
group Id
EG005
num Affected
184
num At Risk
503
num Events
259
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
16
num At Risk
399
num Events
27
group Id
EG001
num Affected
23
num At Risk
400
num Events
37
group Id
EG002
num Affected
5
num At Risk
99
num Events
5
group Id
EG003
num Affected
5
num At Risk
103
num Events
6
group Id
EG004
num Affected
21
num At Risk
498
num Events
32
group Id
EG005
num Affected
28
num At Risk
503
num Events
43
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
114
num At Risk
399
num Events
198
group Id
EG001
num Affected
111
num At Risk
400
num Events
192
group Id
EG002
num Affected
27
num At Risk
99
num Events
44
group Id
EG003
num Affected
23
num At Risk
103
num Events
36
group Id
EG004
num Affected
141
num At Risk
498
num Events
242
group Id
EG005
num Affected
134
num At Risk
503
num Events
228
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
19
num At Risk
399
num Events
22
group Id
EG001
num Affected
26
num At Risk
400
num Events
32
group Id
EG002
num Affected
4
num At Risk
99
num Events
6
group Id
EG003
num Affected
7
num At Risk
103
num Events
9
group Id
EG004
num Affected
23
num At Risk
498
num Events
28
group Id
EG005
num Affected
33
num At Risk
503
num Events
41
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
399
num Events
3
group Id
EG001
num Affected
2
num At Risk
400
num Events
2
group Id
EG002
num Affected
5
num At Risk
99
num Events
5
group Id
EG003
num Affected
3
num At Risk
103
num Events
4
group Id
EG004
num Affected
8
num At Risk
498
num Events
8
group Id
EG005
num Affected
5
num At Risk
503
num Events
6
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
29
num At Risk
399
num Events
30
group Id
EG001
num Affected
29
num At Risk
400
num Events
36
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
30
num At Risk
498
num Events
31
group Id
EG005
num Affected
29
num At Risk
503
num Events
36
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
14
num At Risk
399
num Events
15
group Id
EG001
num Affected
5
num At Risk
400
num Events
5
group Id
EG002
num Affected
6
num At Risk
99
num Events
7
group Id
EG003
num Affected
4
num At Risk
103
num Events
4
group Id
EG004
num Affected
20
num At Risk
498
num Events
22
group Id
EG005
num Affected
9
num At Risk
503
num Events
9
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
33
num At Risk
399
num Events
35
group Id
EG001
num Affected
10
num At Risk
400
num Events
10
group Id
EG002
num Affected
6
num At Risk
99
num Events
7
group Id
EG003
num Affected
5
num At Risk
103
num Events
5
group Id
EG004
num Affected
39
num At Risk
498
num Events
42
group Id
EG005
num Affected
15
num At Risk
503
num Events
15
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
57
num At Risk
399
num Events
96
group Id
EG001
num Affected
64
num At Risk
400
num Events
87
group Id
EG002
num Affected
24
num At Risk
99
num Events
37
group Id
EG003
num Affected
31
num At Risk
103
num Events
54
group Id
EG004
num Affected
81
num At Risk
498
num Events
133
group Id
EG005
num Affected
95
num At Risk
503
num Events
141
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
21
num At Risk
399
num Events
21
group Id
EG001
num Affected
30
num At Risk
400
num Events
31
group Id
EG002
num Affected
10
num At Risk
99
num Events
13
group Id
EG003
num Affected
15
num At Risk
103
num Events
17
group Id
EG004
num Affected
31
num At Risk
498
num Events
34
group Id
EG005
num Affected
45
num At Risk
503
num Events
48
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
108
num At Risk
399
num Events
151
group Id
EG001
num Affected
111
num At Risk
400
num Events
149
group Id
EG002
num Affected
21
num At Risk
99
num Events
28
group Id
EG003
num Affected
32
num At Risk
103
num Events
43
group Id
EG004
num Affected
129
num At Risk
498
num Events
179
group Id
EG005
num Affected
143
num At Risk
503
num Events
192
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
148
num At Risk
399
num Events
218
group Id
EG001
num Affected
129
num At Risk
400
num Events
203
group Id
EG002
num Affected
68
num At Risk
99
num Events
141
group Id
EG003
num Affected
75
num At Risk
103
num Events
174
group Id
EG004
num Affected
216
num At Risk
498
num Events
359
group Id
EG005
num Affected
204
num At Risk
503
num Events
377
term
Diarrhoea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
5
num At Risk
399
num Events
5
group Id
EG001
num Affected
6
num At Risk
400
num Events
6
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
5
num At Risk
498
num Events
5
group Id
EG005
num Affected
6
num At Risk
503
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
399
num Events
3
group Id
EG001
num Affected
12
num At Risk
400
num Events
12
group Id
EG002
num Affected
5
num At Risk
99
num Events
5
group Id
EG003
num Affected
6
num At Risk
103
num Events
6
group Id
EG004
num Affected
8
num At Risk
498
num Events
8
group Id
EG005
num Affected
18
num At Risk
503
num Events
18
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
399
num Events
0
group Id
EG001
num Affected
1
num At Risk
400
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
0
num At Risk
498
num Events
0
group Id
EG005
num Affected
1
num At Risk
503
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
399
num Events
1
group Id
EG001
num Affected
3
num At Risk
400
num Events
3
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
1
num At Risk
103
num Events
1
group Id
EG004
num Affected
1
num At Risk
498
num Events
1
group Id
EG005
num Affected
4
num At Risk
503
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
399
num Events
0
group Id
EG001
num Affected
1
num At Risk
400
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
0
num At Risk
498
num Events
0
group Id
EG005
num Affected
1
num At Risk
503
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
399
num Events
1
group Id
EG001
num Affected
0
num At Risk
400
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
1
num At Risk
498
num Events
1
group Id
EG005
num Affected
0
num At Risk
503
num Events
0
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
399
num Events
0
group Id
EG001
num Affected
0
num At Risk
400
num Events
0
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
1
num At Risk
498
num Events
1
group Id
EG005
num Affected
0
num At Risk
503
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
2
num At Risk
399
num Events
2
group Id
EG001
num Affected
0
num At Risk
400
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
2
num At Risk
498
num Events
2
group Id
EG005
num Affected
0
num At Risk
503
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
399
num Events
1
group Id
EG001
num Affected
0
num At Risk
400
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
1
num At Risk
498
num Events
1
group Id
EG005
num Affected
0
num At Risk
503
num Events
0
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
399
num Events
1
group Id
EG001
num Affected
0
num At Risk
400
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
1
num At Risk
103
num Events
1
group Id
EG004
num Affected
1
num At Risk
498
num Events
1
group Id
EG005
num Affected
1
num At Risk
503
num Events
1
term
Arteriospasm coronary
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
399
num Events
0
group Id
EG001
num Affected
1
num At Risk
400
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
group Id
EG003
num Affected
2
num At Risk
103
num Events
2
group Id
EG004
num Affected
0
num At Risk
498
num Events
0
group Id
EG005
num Affected
3
num At Risk
503
num Events
3
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
399
num Events
0
group Id
EG001
num Affected
0
num At Risk
400
num Events
0
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
group Id
EG003
num Affected
0
num At Risk
103
num Events
0
group Id
EG004
num Affected
1
num At Risk
498
num Events
1
group Id
EG005
num Affected
0
num At Risk
503
num Events
0
term
Cardiac arrest

time Frame

Up to approximately 89 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice