NCT02320058 · ADVERSE EVENTS

Adverse events

An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipilimumab, Followed by Nivolumab by Itself · Source last updated 2021-10-05

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: From first dose to 100 days post last dose (Up to 68 months)
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort A Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.	50 / 101	97 / 101	29 / 101
Cohort B Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.	14 / 18	18 / 18	10 / 18

Group identifiers: EG000: Cohort A · EG001: Cohort B

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 23.1
stats
group Id
EG000
num Affected
1
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
WARM TYPE HAEMOLYTIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
ACUTE CORONARY SYNDROME
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
ANGINA PECTORIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
3
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
MYOCARDITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
4
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
ADRENAL INSUFFICIENCY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
3
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
HYPERTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
6
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
HYPOPHYSITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
VISION BLURRED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
5
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
COLITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
6
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
DIARRHOEA

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 23.1
stats
group Id
EG000
num Affected
16
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
6
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
SINUS TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
4
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
101
group Id
EG001
num Affected
2
num At Risk
18
term
EAR PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
3
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
TINNITUS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
10
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
ADRENAL INSUFFICIENCY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
14
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
HYPERTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
HYPOGONADISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
11
num At Risk
101
group Id
EG001
num Affected
2
num At Risk
18
term
HYPOPHYSITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
26
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
HYPOTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
4
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
THYROIDITIS

Complete source fields

event Groups

deaths Num Affected
29
deaths Num At Risk
101
description
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
id
EG000
other Num Affected
97
other Num At Risk
101
serious Num Affected
50
serious Num At Risk
101
title
Cohort A
deaths Num Affected
10
deaths Num At Risk
18
description
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
id
EG001
other Num Affected
18
other Num At Risk
18
serious Num Affected
14
serious Num At Risk
18
title
Cohort B

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
16
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
6
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
SINUS TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
4
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
101
group Id
EG001
num Affected
2
num At Risk
18
term
EAR PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
3
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
TINNITUS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
10
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
ADRENAL INSUFFICIENCY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
14
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
HYPERTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
HYPOGONADISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
11
num At Risk
101
group Id
EG001
num Affected
2
num At Risk
18
term
HYPOPHYSITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
26
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
HYPOTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
4
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
THYROIDITIS

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
WARM TYPE HAEMOLYTIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
ACUTE CORONARY SYNDROME
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
ANGINA PECTORIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
3
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
MYOCARDITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
4
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
ADRENAL INSUFFICIENCY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
3
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
HYPERTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
6
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
HYPOPHYSITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
VISION BLURRED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
101
group Id
EG001
num Affected
0
num At Risk
18
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
5
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
COLITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
6
num At Risk
101
group Id
EG001
num Affected
1
num At Risk
18
term
DIARRHOEA

time Frame

From first dose to 100 days post last dose (Up to 68 months)

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

Preserved source evidence · Not medical advice