NCT02872116 · ADVERSE EVENTS

Adverse events

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer · Source last updated 2025-08-07

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: All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
Other-event reporting threshold: 5%

All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Nivo + Chemo Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks	529 / 782	763 / 782	691 / 782
Chemo Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This chemotherapy group consists of the two comparison chemotherapy sub-groups. Arm 2a (792 participants) is the comparison group to Arm 1 and Arm 2b (404 participants) is the comparison group to Arm 3. Some participants were counted in both Arm 2a and Arm 2b.	474 / 806	756 / 806	741 / 806
Nivo + Ipi 1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.	307 / 403	369 / 403	361 / 403

Group identifiers: EG000: Nivo + Chemo · EG001: Chemo · EG002: Nivo + Ipi

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
24.0
stats
group Id
EG000
num Affected
28
num At Risk
782
group Id
EG001
num Affected
17
num At Risk
806
group Id
EG002
num Affected
13
num At Risk
403
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
782
group Id
EG001
num Affected
1
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
782
group Id
EG001
num Affected
0
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
782
group Id
EG001
num Affected
0
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
2
num At Risk
782
group Id
EG001
num Affected
0
num At Risk
806
group Id
EG002
num Affected
1
num At Risk
403
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
20
num At Risk
782
group Id
EG001
num Affected
10
num At Risk
806
group Id
EG002
num Affected
1
num At Risk
403
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
782
group Id
EG001
num Affected
1
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
782
group Id
EG001
num Affected
0
num At Risk
806
group Id
EG002
num Affected
1
num At Risk
403
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
782
group Id
EG001
num Affected
2
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
782
group Id
EG001
num Affected
0
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
4
num At Risk
782
group Id
EG001
num Affected
2
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
4
num At Risk
782
group Id
EG001
num Affected
3
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Neutropenia

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
24.0
stats
group Id
EG000
num Affected
312
num At Risk
782
group Id
EG001
num Affected
276
num At Risk
806
group Id
EG002
num Affected
132
num At Risk
403
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
75
num At Risk
782
group Id
EG001
num Affected
64
num At Risk
806
group Id
EG002
num Affected
9
num At Risk
403
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
218
num At Risk
782
group Id
EG001
num Affected
203
num At Risk
806
group Id
EG002
num Affected
18
num At Risk
403
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
173
num At Risk
782
group Id
EG001
num Affected
160
num At Risk
806
group Id
EG002
num Affected
10
num At Risk
403
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
30
num At Risk
782
group Id
EG001
num Affected
2
num At Risk
806
group Id
EG002
num Affected
26
num At Risk
403
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
82
num At Risk
782
group Id
EG001
num Affected
13
num At Risk
806
group Id
EG002
num Affected
54
num At Risk
403
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
56
num At Risk
782
group Id
EG001
num Affected
43
num At Risk
806
group Id
EG002
num Affected
26
num At Risk
403
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
159
num At Risk
782
group Id
EG001
num Affected
134
num At Risk
806
group Id
EG002
num Affected
66
num At Risk
403
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
73
num At Risk
782
group Id
EG001
num Affected
75
num At Risk
806
group Id
EG002
num Affected
36
num At Risk
403
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
201
num At Risk
782
group Id
EG001
num Affected
177
num At Risk
806
group Id
EG002
num Affected
77
num At Risk
403
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
309
num At Risk
782
group Id
EG001
num Affected
286
num At Risk
806
group Id
EG002
num Affected
111
num At Risk
403
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
64
num At Risk
782
group Id
EG001
num Affected
64
num At Risk
806
group Id
EG002
num Affected
32
num At Risk
403
term
Dysphagia

Complete source fields

description

All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants

event Groups

deaths Num Affected
691
deaths Num At Risk
782
description
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
id
EG000
other Num Affected
763
other Num At Risk
782
serious Num Affected
529
serious Num At Risk
782
title
Nivo + Chemo
deaths Num Affected
741
deaths Num At Risk
806
description
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This chemotherapy group consists of the two comparison chemotherapy sub-groups. Arm 2a (792 participants) is the comparison group to Arm 1 and Arm 2b (404 participants) is the comparison group to Arm 3. Some participants were counted in both Arm 2a and Arm 2b.
id
EG001
other Num Affected
756
other Num At Risk
806
serious Num Affected
474
serious Num At Risk
806
title
Chemo
deaths Num Affected
361
deaths Num At Risk
403
description
1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
id
EG002
other Num Affected
369
other Num At Risk
403
serious Num Affected
307
serious Num At Risk
403
title
Nivo + Ipi

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
312
num At Risk
782
group Id
EG001
num Affected
276
num At Risk
806
group Id
EG002
num Affected
132
num At Risk
403
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
75
num At Risk
782
group Id
EG001
num Affected
64
num At Risk
806
group Id
EG002
num Affected
9
num At Risk
403
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
218
num At Risk
782
group Id
EG001
num Affected
203
num At Risk
806
group Id
EG002
num Affected
18
num At Risk
403
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
173
num At Risk
782
group Id
EG001
num Affected
160
num At Risk
806
group Id
EG002
num Affected
10
num At Risk
403
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
30
num At Risk
782
group Id
EG001
num Affected
2
num At Risk
806
group Id
EG002
num Affected
26
num At Risk
403
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
82
num At Risk
782
group Id
EG001
num Affected
13
num At Risk
806
group Id
EG002
num Affected
54
num At Risk
403
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
56
num At Risk
782
group Id
EG001
num Affected
43
num At Risk
806
group Id
EG002
num Affected
26
num At Risk
403
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
159
num At Risk
782
group Id
EG001
num Affected
134
num At Risk
806
group Id
EG002
num Affected
66
num At Risk
403
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
73
num At Risk
782
group Id
EG001
num Affected
75
num At Risk
806
group Id
EG002
num Affected
36
num At Risk
403
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
201
num At Risk
782
group Id
EG001
num Affected
177
num At Risk
806
group Id
EG002
num Affected
77
num At Risk
403
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
309
num At Risk
782
group Id
EG001
num Affected
286
num At Risk
806
group Id
EG002
num Affected
111
num At Risk
403
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
64
num At Risk
782
group Id
EG001
num Affected
64
num At Risk
806
group Id
EG002
num Affected
32
num At Risk
403
term
Dysphagia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
28
num At Risk
782
group Id
EG001
num Affected
17
num At Risk
806
group Id
EG002
num Affected
13
num At Risk
403
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
782
group Id
EG001
num Affected
1
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
782
group Id
EG001
num Affected
0
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
782
group Id
EG001
num Affected
0
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
2
num At Risk
782
group Id
EG001
num Affected
0
num At Risk
806
group Id
EG002
num Affected
1
num At Risk
403
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
20
num At Risk
782
group Id
EG001
num Affected
10
num At Risk
806
group Id
EG002
num Affected
1
num At Risk
403
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
782
group Id
EG001
num Affected
1
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
782
group Id
EG001
num Affected
0
num At Risk
806
group Id
EG002
num Affected
1
num At Risk
403
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
782
group Id
EG001
num Affected
2
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
782
group Id
EG001
num Affected
0
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
4
num At Risk
782
group Id
EG001
num Affected
2
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
4
num At Risk
782
group Id
EG001
num Affected
3
num At Risk
806
group Id
EG002
num Affected
0
num At Risk
403
term
Neutropenia

time Frame

All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).

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