NCT02314169 · ADVERSE EVENTS

Adverse events

Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer · Source last updated 2026-07-31

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: Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part A (Nivolumab) Patients receive nivolumab IV over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV	14 / 37	36 / 37	16 / 37
Part B1 (Nivolumab) Patients receive nivolumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Ipilimumab: Given IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV	25 / 52	48 / 52	28 / 52
Part B2 (Nivolumab + Ipilimumab) Patients receive nivolumab +/- ipilimumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Ipilimumab: Given IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV	19 / 48	46 / 48	30 / 48

Group identifiers: EG000: Part A (Nivolumab) · EG001: Part B1 (Nivolumab) · EG002: Part B2 (Nivolumab + Ipilimumab)

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
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
1
num At Risk
52
num Events
1
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
37
num Events
3
group Id
EG001
num Affected
2
num At Risk
52
num Events
2
group Id
EG002
num Affected
3
num At Risk
48
num Events
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
1
num At Risk
52
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Acute renal failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
37
num Events
2
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
2
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
37
num Events
1
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
37
num Events
1
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
1
num At Risk
52
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Anorectal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
1
num At Risk
52
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Aphasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
3
term
Aspartate aminotransferase increased

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
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
37
num Events
10
group Id
EG001
num Affected
11
num At Risk
52
num Events
17
group Id
EG002
num Affected
10
num At Risk
48
num Events
20
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
37
num Events
1
group Id
EG001
num Affected
2
num At Risk
52
num Events
5
group Id
EG002
num Affected
5
num At Risk
48
num Events
11
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
37
num Events
1
group Id
EG001
num Affected
9
num At Risk
52
num Events
16
group Id
EG002
num Affected
5
num At Risk
48
num Events
11
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
16
num At Risk
37
num Events
69
group Id
EG001
num Affected
15
num At Risk
52
num Events
85
group Id
EG002
num Affected
16
num At Risk
48
num Events
36
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
8
num At Risk
37
num Events
41
group Id
EG001
num Affected
11
num At Risk
52
num Events
29
group Id
EG002
num Affected
11
num At Risk
48
num Events
20
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
4
num At Risk
52
num Events
4
group Id
EG002
num Affected
3
num At Risk
48
num Events
7
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
5
num At Risk
37
num Events
25
group Id
EG001
num Affected
4
num At Risk
52
num Events
65
group Id
EG002
num Affected
5
num At Risk
48
num Events
8
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
3
num At Risk
52
num Events
9
group Id
EG002
num Affected
2
num At Risk
48
num Events
2
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
7
num At Risk
37
num Events
33
group Id
EG001
num Affected
4
num At Risk
52
num Events
16
group Id
EG002
num Affected
6
num At Risk
48
num Events
10
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
6
num At Risk
37
num Events
70
group Id
EG001
num Affected
3
num At Risk
52
num Events
39
group Id
EG002
num Affected
5
num At Risk
48
num Events
5
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
37
num Events
68
group Id
EG001
num Affected
7
num At Risk
52
num Events
16
group Id
EG002
num Affected
7
num At Risk
48
num Events
9
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
11
num At Risk
37
num Events
61
group Id
EG001
num Affected
9
num At Risk
52
num Events
51
group Id
EG002
num Affected
6
num At Risk
48
num Events
12
term
Constipation

Complete source fields

event Groups

deaths Num Affected
16
deaths Num At Risk
37
description
Patients receive nivolumab IV over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
id
EG000
other Num Affected
36
other Num At Risk
37
serious Num Affected
14
serious Num At Risk
37
title
Part A (Nivolumab)
deaths Num Affected
28
deaths Num At Risk
52
description
Patients receive nivolumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Ipilimumab: Given IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
id
EG001
other Num Affected
48
other Num At Risk
52
serious Num Affected
25
serious Num At Risk
52
title
Part B1 (Nivolumab)
deaths Num Affected
30
deaths Num At Risk
48
description
Patients receive nivolumab +/- ipilimumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Ipilimumab: Given IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
id
EG002
other Num Affected
46
other Num At Risk
48
serious Num Affected
19
serious Num At Risk
48
title
Part B2 (Nivolumab + Ipilimumab)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
37
num Events
10
group Id
EG001
num Affected
11
num At Risk
52
num Events
17
group Id
EG002
num Affected
10
num At Risk
48
num Events
20
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
37
num Events
1
group Id
EG001
num Affected
2
num At Risk
52
num Events
5
group Id
EG002
num Affected
5
num At Risk
48
num Events
11
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
37
num Events
1
group Id
EG001
num Affected
9
num At Risk
52
num Events
16
group Id
EG002
num Affected
5
num At Risk
48
num Events
11
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
16
num At Risk
37
num Events
69
group Id
EG001
num Affected
15
num At Risk
52
num Events
85
group Id
EG002
num Affected
16
num At Risk
48
num Events
36
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
8
num At Risk
37
num Events
41
group Id
EG001
num Affected
11
num At Risk
52
num Events
29
group Id
EG002
num Affected
11
num At Risk
48
num Events
20
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
4
num At Risk
52
num Events
4
group Id
EG002
num Affected
3
num At Risk
48
num Events
7
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
5
num At Risk
37
num Events
25
group Id
EG001
num Affected
4
num At Risk
52
num Events
65
group Id
EG002
num Affected
5
num At Risk
48
num Events
8
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
3
num At Risk
52
num Events
9
group Id
EG002
num Affected
2
num At Risk
48
num Events
2
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
7
num At Risk
37
num Events
33
group Id
EG001
num Affected
4
num At Risk
52
num Events
16
group Id
EG002
num Affected
6
num At Risk
48
num Events
10
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
6
num At Risk
37
num Events
70
group Id
EG001
num Affected
3
num At Risk
52
num Events
39
group Id
EG002
num Affected
5
num At Risk
48
num Events
5
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
37
num Events
68
group Id
EG001
num Affected
7
num At Risk
52
num Events
16
group Id
EG002
num Affected
7
num At Risk
48
num Events
9
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
11
num At Risk
37
num Events
61
group Id
EG001
num Affected
9
num At Risk
52
num Events
51
group Id
EG002
num Affected
6
num At Risk
48
num Events
12
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
1
num At Risk
52
num Events
1
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
37
num Events
3
group Id
EG001
num Affected
2
num At Risk
52
num Events
2
group Id
EG002
num Affected
3
num At Risk
48
num Events
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
1
num At Risk
52
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Acute renal failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
37
num Events
2
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
2
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
37
num Events
1
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
37
num Events
1
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
1
num At Risk
52
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Anorectal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
1
num At Risk
52
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Aphasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
37
num Events
0
group Id
EG001
num Affected
0
num At Risk
52
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
3
term
Aspartate aminotransferase increased

time Frame

Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment

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

Preserved source evidence · Not medical advice