NCT02743494 · ADVERSE EVENTS

Adverse events

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer · Source last updated 2025-11-18

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 collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months).
Other-event reporting threshold: 5%

All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Nivolumab Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.	196 / 532	470 / 532	299 / 532
Placebo Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles	99 / 260	216 / 260	162 / 262

Group identifiers: EG000: Nivolumab · EG001: Placebo

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
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Autoimmune haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
2
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
4
num At Risk
532
group Id
EG001
num Affected
1
num At Risk
260
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
1
num At Risk
260
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
2
num At Risk
532
group Id
EG001
num Affected
2
num At Risk
260
term
Myocardial infarction

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
27.1
stats
group Id
EG000
num Affected
50
num At Risk
532
group Id
EG001
num Affected
22
num At Risk
260
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
44
num At Risk
532
group Id
EG001
num Affected
2
num At Risk
260
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
67
num At Risk
532
group Id
EG001
num Affected
7
num At Risk
260
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
71
num At Risk
532
group Id
EG001
num Affected
39
num At Risk
260
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
21
num At Risk
532
group Id
EG001
num Affected
19
num At Risk
260
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
65
num At Risk
532
group Id
EG001
num Affected
36
num At Risk
260
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
165
num At Risk
532
group Id
EG001
num Affected
84
num At Risk
260
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
28
num At Risk
532
group Id
EG001
num Affected
10
num At Risk
260
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
68
num At Risk
532
group Id
EG001
num Affected
42
num At Risk
260
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
48
num At Risk
532
group Id
EG001
num Affected
36
num At Risk
260
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
129
num At Risk
532
group Id
EG001
num Affected
62
num At Risk
260
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
86
num At Risk
532
group Id
EG001
num Affected
42
num At Risk
260
term
Vomiting

Complete source fields

description

All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.

event Groups

deaths Num Affected
299
deaths Num At Risk
532
description
Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.
id
EG000
other Num Affected
470
other Num At Risk
532
serious Num Affected
196
serious Num At Risk
532
title
Nivolumab
deaths Num Affected
162
deaths Num At Risk
262
description
Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
id
EG001
other Num Affected
216
other Num At Risk
260
serious Num Affected
99
serious Num At Risk
260
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
50
num At Risk
532
group Id
EG001
num Affected
22
num At Risk
260
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
44
num At Risk
532
group Id
EG001
num Affected
2
num At Risk
260
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
67
num At Risk
532
group Id
EG001
num Affected
7
num At Risk
260
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
71
num At Risk
532
group Id
EG001
num Affected
39
num At Risk
260
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
21
num At Risk
532
group Id
EG001
num Affected
19
num At Risk
260
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
65
num At Risk
532
group Id
EG001
num Affected
36
num At Risk
260
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
165
num At Risk
532
group Id
EG001
num Affected
84
num At Risk
260
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
28
num At Risk
532
group Id
EG001
num Affected
10
num At Risk
260
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
68
num At Risk
532
group Id
EG001
num Affected
42
num At Risk
260
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
48
num At Risk
532
group Id
EG001
num Affected
36
num At Risk
260
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
129
num At Risk
532
group Id
EG001
num Affected
62
num At Risk
260
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
86
num At Risk
532
group Id
EG001
num Affected
42
num At Risk
260
term
Vomiting

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Autoimmune haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
2
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
4
num At Risk
532
group Id
EG001
num Affected
1
num At Risk
260
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
1
num At Risk
260
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
532
group Id
EG001
num Affected
0
num At Risk
260
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
2
num At Risk
532
group Id
EG001
num Affected
2
num At Risk
260
term
Myocardial infarction

time Frame

All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months).

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