NCT02569242 · ADVERSE EVENTS

Adverse events

Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer · Source last updated 2022-07-06

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: Monitoring for any AEs will be continued until 28 days after the end of the treatment phase. In subjects who, at the time of initiation of the follow-up investigation, have any AE for which a causal relationship to the investigational product cannot be ruled out or which led to discontinuation, investigation of the AE will be continued until the event is judged not to require further follow-up. SAEs are to be collected during the treatment period and for 100 days following the last dose.
Other-event reporting threshold: 5%

For all-cause mortality, the number of adverse events reported as Grade 5 was extracted.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Nivolumab Arm Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends	68 / 209	185 / 209	7 / 209
Active Comparator Arm （Docetaxel/Paclitaxel） Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends	77 / 208	204 / 208	5 / 208

Group identifiers: EG000: Nivolumab Arm · EG001: Active Comparator Arm （Docetaxel/Paclitaxel）

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 21.1
stats
group Id
EG000
num Affected
2
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
209
group Id
EG001
num Affected
16
num At Risk
208
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
209
group Id
EG001
num Affected
1
num At Risk
208
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
209
group Id
EG001
num Affected
1
num At Risk
208
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
209
group Id
EG001
num Affected
1
num At Risk
208
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
209
group Id
EG001
num Affected
1
num At Risk
208
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Tracheo-oesophageal fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Hypopituitarism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Inappropriate antidiuretic hormone secretion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Adrenocorticotropic hormone deficiency

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 21.1
stats
group Id
EG000
num Affected
24
num At Risk
209
group Id
EG001
num Affected
61
num At Risk
208
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
209
group Id
EG001
num Affected
18
num At Risk
208
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
40
num At Risk
208
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
21
num At Risk
209
group Id
EG001
num Affected
3
num At Risk
208
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
12
num At Risk
209
group Id
EG001
num Affected
8
num At Risk
208
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
35
num At Risk
209
group Id
EG001
num Affected
40
num At Risk
208
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
36
num At Risk
209
group Id
EG001
num Affected
34
num At Risk
208
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
13
num At Risk
209
group Id
EG001
num Affected
3
num At Risk
208
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
23
num At Risk
209
group Id
EG001
num Affected
40
num At Risk
208
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
7
num At Risk
209
group Id
EG001
num Affected
26
num At Risk
208
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
12
num At Risk
209
group Id
EG001
num Affected
17
num At Risk
208
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
13
num At Risk
209
group Id
EG001
num Affected
4
num At Risk
208
term
Chest pain

Complete source fields

description

For all-cause mortality, the number of adverse events reported as Grade 5 was extracted.

event Groups

deaths Num Affected
7
deaths Num At Risk
209
description
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
id
EG000
other Num Affected
185
other Num At Risk
209
serious Num Affected
68
serious Num At Risk
209
title
Nivolumab Arm
deaths Num Affected
5
deaths Num At Risk
208
description
Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
id
EG001
other Num Affected
204
other Num At Risk
208
serious Num Affected
77
serious Num At Risk
208
title
Active Comparator Arm （Docetaxel/Paclitaxel）

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
24
num At Risk
209
group Id
EG001
num Affected
61
num At Risk
208
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
209
group Id
EG001
num Affected
18
num At Risk
208
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
40
num At Risk
208
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
21
num At Risk
209
group Id
EG001
num Affected
3
num At Risk
208
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
12
num At Risk
209
group Id
EG001
num Affected
8
num At Risk
208
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
35
num At Risk
209
group Id
EG001
num Affected
40
num At Risk
208
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
36
num At Risk
209
group Id
EG001
num Affected
34
num At Risk
208
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
13
num At Risk
209
group Id
EG001
num Affected
3
num At Risk
208
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
23
num At Risk
209
group Id
EG001
num Affected
40
num At Risk
208
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
7
num At Risk
209
group Id
EG001
num Affected
26
num At Risk
208
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
12
num At Risk
209
group Id
EG001
num Affected
17
num At Risk
208
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
13
num At Risk
209
group Id
EG001
num Affected
4
num At Risk
208
term
Chest pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
2
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
209
group Id
EG001
num Affected
16
num At Risk
208
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
209
group Id
EG001
num Affected
1
num At Risk
208
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
209
group Id
EG001
num Affected
1
num At Risk
208
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
209
group Id
EG001
num Affected
1
num At Risk
208
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
209
group Id
EG001
num Affected
1
num At Risk
208
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Tracheo-oesophageal fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Hypopituitarism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Inappropriate antidiuretic hormone secretion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
209
group Id
EG001
num Affected
0
num At Risk
208
term
Adrenocorticotropic hormone deficiency

time Frame

Monitoring for any AEs will be continued until 28 days after the end of the treatment phase. In subjects who, at the time of initiation of the follow-up investigation, have any AE for which a causal relationship to the investigational product cannot be ruled out or which led to discontinuation, investigation of the AE will be continued until the event is judged not to require further follow-up. SAEs are to be collected during the treatment period and for 100 days following the last dose.

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