NCT02181738 · ADVERSE EVENTS

Adverse events

Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational) · Source last updated 2023-11-28

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: Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
Other-event reporting threshold: 5%

All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019). Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin- Nivolumab 3 mg/kg Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.	10 / 46	46 / 46	14 / 46
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 240 mg Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.	3 / 9	9 / 9	3 / 9
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 480 mg Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.	1 / 8	8 / 8	0 / 8
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 3 mg/kg Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.	30 / 75	75 / 75	25 / 75
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 240 mg Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.	0 / 3	3 / 3	0 / 3
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant- Nivolumab 480 mg Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.	1 / 2	2 / 2	0 / 2
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/or Post-SC Transplant - Nivolumab 3 mg/kg Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.	33 / 84	80 / 84	31 / 84
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 240 mg Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.	8 / 13	13 / 13	4 / 13
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 480 mg Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.	3 / 3	3 / 3	0 / 3
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).	12 / 51	50 / 51	5 / 51

Group identifiers: EG000: Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin- Nivolumab 3 mg/kg · EG001: Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 240 mg · EG002: Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 480 mg · EG003: Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 3 mg/kg · EG004: Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 240 mg · EG005: Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant- Nivolumab 480 mg · EG006: Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/or Post-SC Transplant - Nivolumab 3 mg/kg · EG007: Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 240 mg · EG008: Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 480 mg · EG009: Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)

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
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
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
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
51
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
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
46
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
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
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
51
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
1
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Tracheo-oesophageal fistula

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
4
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
12
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
18
num At Risk
84
group Id
EG007
num Affected
2
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
9
num At Risk
51
term
Anaemia
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
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Eosinophilia
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
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
4
num At Risk
51
term
Febrile neutropenia
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
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
3
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
1
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
51
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
4
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
7
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
9
num At Risk
84
group Id
EG007
num Affected
2
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
28
num At Risk
51
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
3
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
3
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
14
num At Risk
84
group Id
EG007
num Affected
1
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
3
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
3
num At Risk
84
group Id
EG007
num Affected
1
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
51
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
7
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
51
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
4
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
51
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
3
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
2
group Id
EG006
num Affected
2
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
51
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
51
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
3
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
3
num At Risk
51
term
Hyperthyroidism

Complete source fields

description

event Groups

deaths Num Affected
14
deaths Num At Risk
46
description
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
id
EG000
other Num Affected
46
other Num At Risk
46
serious Num Affected
10
serious Num At Risk
46
title
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin- Nivolumab 3 mg/kg
deaths Num Affected
3
deaths Num At Risk
9
description
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
id
EG001
other Num Affected
9
other Num At Risk
9
serious Num Affected
3
serious Num At Risk
9
title
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 240 mg
deaths Num Affected
0
deaths Num At Risk
8
description
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
id
EG002
other Num Affected
8
other Num At Risk
8
serious Num Affected
1
serious Num At Risk
8
title
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 480 mg
deaths Num Affected
25
deaths Num At Risk
75
description
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
id
EG003
other Num Affected
75
other Num At Risk
75
serious Num Affected
30
serious Num At Risk
75
title
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 3 mg/kg
deaths Num Affected
0
deaths Num At Risk
3
description
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 240 mg
deaths Num Affected
0
deaths Num At Risk
2
description
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
id
EG005
other Num Affected
2
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant- Nivolumab 480 mg
deaths Num Affected
31
deaths Num At Risk
84
description
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
id
EG006
other Num Affected
80
other Num At Risk
84
serious Num Affected
33
serious Num At Risk
84
title
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/or Post-SC Transplant - Nivolumab 3 mg/kg
deaths Num Affected
4
deaths Num At Risk
13
description
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
id
EG007
other Num Affected
13
other Num At Risk
13
serious Num Affected
8
serious Num At Risk
13
title
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 240 mg
deaths Num Affected
0
deaths Num At Risk
3
description
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
id
EG008
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Cohort C: Post Transplant, Brentuximab Vedotin Pre-and/Post-Stem Cell Transplant - Nivolumab 480 mg
deaths Num Affected
5
deaths Num At Risk
51
description
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
id
EG009
other Num Affected
50
other Num At Risk
51
serious Num Affected
12
serious Num At Risk
51
title
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)

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
4
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
12
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
18
num At Risk
84
group Id
EG007
num Affected
2
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
9
num At Risk
51
term
Anaemia
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
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Eosinophilia
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
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
4
num At Risk
51
term
Febrile neutropenia
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
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
3
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
1
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
51
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
4
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
7
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
9
num At Risk
84
group Id
EG007
num Affected
2
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
28
num At Risk
51
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
3
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
3
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
14
num At Risk
84
group Id
EG007
num Affected
1
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
3
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
3
num At Risk
84
group Id
EG007
num Affected
1
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
51
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
7
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
51
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
4
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
51
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
3
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
2
group Id
EG006
num Affected
2
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
51
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
51
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
3
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
3
num At Risk
51
term
Hyperthyroidism

serious Events

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
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
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
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
51
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
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
46
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
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
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
51
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
84
group Id
EG007
num Affected
0
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
25.1
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
75
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
84
group Id
EG007
num Affected
1
num At Risk
13
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
51
term
Tracheo-oesophageal fistula

time Frame

Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).

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Preserved source evidence · Not medical advice