NCT02488759 · ADVERSE EVENTS

Adverse events

An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors · Source last updated 2023-11-13

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: SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Metastatic Monotherapy Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first	59 / 113	110 / 113	82 / 113
Metastatic Combo A Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first	130 / 195	189 / 195	133 / 195
Metastatic Combo B Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first	99 / 133	129 / 133	86 / 133
Metastatic Combo C Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first	5 / 8	7 / 8	7 / 8
Metastatic Combo D Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first	5 / 6	5 / 6	5 / 6
Neoadjuvant Nivolumab IV over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15	40 / 123	108 / 123	40 / 123

Group identifiers: EG000: Metastatic Monotherapy · EG001: Metastatic Combo A · EG002: Metastatic Combo B · EG003: Metastatic Combo C · EG004: Metastatic Combo D · EG005: Neoadjuvant

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
25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
group Id
EG001
num Affected
1
num At Risk
195
group Id
EG002
num Affected
5
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
123
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
1
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
2
num At Risk
123
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
group Id
EG001
num Affected
0
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
0
num At Risk
195
group Id
EG002
num Affected
1
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
0
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
123
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
0
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
123
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
1
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
1
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
group Id
EG001
num Affected
2
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
1
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Autoimmune pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
0
num At Risk
195
group Id
EG002
num Affected
2
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
2
num At Risk
113
group Id
EG001
num Affected
0
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
1
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Cardiac tamponade

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
25.1
stats
group Id
EG000
num Affected
28
num At Risk
113
group Id
EG001
num Affected
53
num At Risk
195
group Id
EG002
num Affected
42
num At Risk
133
group Id
EG003
num Affected
2
num At Risk
8
group Id
EG004
num Affected
2
num At Risk
6
group Id
EG005
num Affected
11
num At Risk
123
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
3
num At Risk
113
group Id
EG001
num Affected
4
num At Risk
195
group Id
EG002
num Affected
1
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
2
num At Risk
123
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
6
num At Risk
113
group Id
EG001
num Affected
1
num At Risk
195
group Id
EG002
num Affected
1
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
2
num At Risk
113
group Id
EG001
num Affected
9
num At Risk
195
group Id
EG002
num Affected
21
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
4
num At Risk
123
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
17
num At Risk
113
group Id
EG001
num Affected
39
num At Risk
195
group Id
EG002
num Affected
31
num At Risk
133
group Id
EG003
num Affected
2
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
3
num At Risk
123
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
18
num At Risk
113
group Id
EG001
num Affected
28
num At Risk
195
group Id
EG002
num Affected
30
num At Risk
133
group Id
EG003
num Affected
1
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
8
num At Risk
123
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
12
num At Risk
113
group Id
EG001
num Affected
9
num At Risk
195
group Id
EG002
num Affected
5
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
123
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
2
num At Risk
113
group Id
EG001
num Affected
6
num At Risk
195
group Id
EG002
num Affected
7
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
4
num At Risk
123
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
27
num At Risk
113
group Id
EG001
num Affected
51
num At Risk
195
group Id
EG002
num Affected
37
num At Risk
133
group Id
EG003
num Affected
1
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
21
num At Risk
123
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
31
num At Risk
113
group Id
EG001
num Affected
61
num At Risk
195
group Id
EG002
num Affected
54
num At Risk
133
group Id
EG003
num Affected
1
num At Risk
8
group Id
EG004
num Affected
2
num At Risk
6
group Id
EG005
num Affected
22
num At Risk
123
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
8
num At Risk
113
group Id
EG001
num Affected
13
num At Risk
195
group Id
EG002
num Affected
6
num At Risk
133
group Id
EG003
num Affected
1
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
6
num At Risk
123
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
4
num At Risk
113
group Id
EG001
num Affected
11
num At Risk
195
group Id
EG002
num Affected
7
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Dyspepsia

Complete source fields

event Groups

deaths Num Affected
82
deaths Num At Risk
113
description
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
id
EG000
other Num Affected
110
other Num At Risk
113
serious Num Affected
59
serious Num At Risk
113
title
Metastatic Monotherapy
deaths Num Affected
133
deaths Num At Risk
195
description
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
id
EG001
other Num Affected
189
other Num At Risk
195
serious Num Affected
130
serious Num At Risk
195
title
Metastatic Combo A
deaths Num Affected
86
deaths Num At Risk
133
description
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
id
EG002
other Num Affected
129
other Num At Risk
133
serious Num Affected
99
serious Num At Risk
133
title
Metastatic Combo B
deaths Num Affected
7
deaths Num At Risk
8
description
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
id
EG003
other Num Affected
7
other Num At Risk
8
serious Num Affected
5
serious Num At Risk
8
title
Metastatic Combo C
deaths Num Affected
5
deaths Num At Risk
6
description
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
id
EG004
other Num Affected
5
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
Metastatic Combo D
deaths Num Affected
40
deaths Num At Risk
123
description
Nivolumab IV over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
id
EG005
other Num Affected
108
other Num At Risk
123
serious Num Affected
40
serious Num At Risk
123
title
Neoadjuvant

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
28
num At Risk
113
group Id
EG001
num Affected
53
num At Risk
195
group Id
EG002
num Affected
42
num At Risk
133
group Id
EG003
num Affected
2
num At Risk
8
group Id
EG004
num Affected
2
num At Risk
6
group Id
EG005
num Affected
11
num At Risk
123
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
3
num At Risk
113
group Id
EG001
num Affected
4
num At Risk
195
group Id
EG002
num Affected
1
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
2
num At Risk
123
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
6
num At Risk
113
group Id
EG001
num Affected
1
num At Risk
195
group Id
EG002
num Affected
1
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
2
num At Risk
113
group Id
EG001
num Affected
9
num At Risk
195
group Id
EG002
num Affected
21
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
4
num At Risk
123
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
17
num At Risk
113
group Id
EG001
num Affected
39
num At Risk
195
group Id
EG002
num Affected
31
num At Risk
133
group Id
EG003
num Affected
2
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
3
num At Risk
123
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
18
num At Risk
113
group Id
EG001
num Affected
28
num At Risk
195
group Id
EG002
num Affected
30
num At Risk
133
group Id
EG003
num Affected
1
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
8
num At Risk
123
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
12
num At Risk
113
group Id
EG001
num Affected
9
num At Risk
195
group Id
EG002
num Affected
5
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
123
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
2
num At Risk
113
group Id
EG001
num Affected
6
num At Risk
195
group Id
EG002
num Affected
7
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
4
num At Risk
123
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
27
num At Risk
113
group Id
EG001
num Affected
51
num At Risk
195
group Id
EG002
num Affected
37
num At Risk
133
group Id
EG003
num Affected
1
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
21
num At Risk
123
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
31
num At Risk
113
group Id
EG001
num Affected
61
num At Risk
195
group Id
EG002
num Affected
54
num At Risk
133
group Id
EG003
num Affected
1
num At Risk
8
group Id
EG004
num Affected
2
num At Risk
6
group Id
EG005
num Affected
22
num At Risk
123
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
8
num At Risk
113
group Id
EG001
num Affected
13
num At Risk
195
group Id
EG002
num Affected
6
num At Risk
133
group Id
EG003
num Affected
1
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
6
num At Risk
123
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
4
num At Risk
113
group Id
EG001
num Affected
11
num At Risk
195
group Id
EG002
num Affected
7
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Dyspepsia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
group Id
EG001
num Affected
1
num At Risk
195
group Id
EG002
num Affected
5
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
123
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
1
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
2
num At Risk
123
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
group Id
EG001
num Affected
0
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
0
num At Risk
195
group Id
EG002
num Affected
1
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
0
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
123
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
0
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
123
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
1
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
1
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
group Id
EG001
num Affected
2
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
1
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Autoimmune pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
0
num At Risk
195
group Id
EG002
num Affected
2
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
2
num At Risk
113
group Id
EG001
num Affected
0
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
group Id
EG001
num Affected
1
num At Risk
195
group Id
EG002
num Affected
0
num At Risk
133
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
123
term
Cardiac tamponade

time Frame

SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)

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

Preserved source evidence · Not medical advice