NCT02453594 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087) · Source last updated 2024-10-29

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: Up to approximately 99 months.
Other-event reporting threshold: 5%

The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1 (First Course) Participants with RRcHL who failed to achieve a response or progressed after auto-stem cell transplant (SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin (BV) post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	15 / 69	68 / 69	21 / 69
Cohort 2 (First Course) Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	18 / 81	76 / 81	28 / 81
Cohort 3 (First Course) Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.	15 / 60	56 / 60	19 / 61
Cohort 1 (Second Course) Eligible participants allocated to the pembrolizumab first course in Cohort 1 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year.	0 / 10	10 / 10	2 / 10
Cohort 2 (Second Course) Eligible participants allocated to the pembrolizumab first course in Cohort 2 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 Q3W for up to 17 cycles up to approximately an additional year.	1 / 7	7 / 7	0 / 7
Cohort 3 (Second Course) Eligible participants allocated to the pembrolizumab first course in Cohort 3 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 Q3W for up to 17 cycles up to approximately an additional year.	0 / 3	3 / 3	0 / 3

Group identifiers: EG000: Cohort 1 (First Course) · EG001: Cohort 2 (First Course) · EG002: Cohort 3 (First Course) · EG003: Cohort 1 (Second Course) · EG004: Cohort 2 (Second Course) · EG005: Cohort 3 (Second Course)

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 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
69
num Events
2
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Stress cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Alcoholic pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Hyperthermia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
3
num At Risk
60
num Events
3
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Autoimmune hepatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Acute graft versus host disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Cytokine release syndrome

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 26.0
stats
group Id
EG000
num Affected
7
num At Risk
69
num Events
8
group Id
EG001
num Affected
8
num At Risk
81
num Events
8
group Id
EG002
num Affected
5
num At Risk
60
num Events
6
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
5
num At Risk
69
num Events
6
group Id
EG001
num Affected
4
num At Risk
81
num Events
6
group Id
EG002
num Affected
4
num At Risk
60
num Events
5
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
69
num Events
5
group Id
EG001
num Affected
3
num At Risk
81
num Events
3
group Id
EG002
num Affected
3
num At Risk
60
num Events
7
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
69
num Events
4
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
3
num At Risk
60
num Events
3
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
69
num Events
2
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Ear congestion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
2
num At Risk
81
num Events
2
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
3
num Events
1
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
8
num At Risk
69
num Events
9
group Id
EG001
num Affected
13
num At Risk
81
num Events
14
group Id
EG002
num Affected
12
num At Risk
60
num Events
15
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
2
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Iritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Scleral hyperaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Visual impairment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Abdominal discomfort

Complete source fields

description

event Groups

deaths Num Affected
21
deaths Num At Risk
69
description
Participants with RRcHL who failed to achieve a response or progressed after auto-stem cell transplant (SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin (BV) post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.
id
EG000
other Num Affected
68
other Num At Risk
69
serious Num Affected
15
serious Num At Risk
69
title
Cohort 1 (First Course)
deaths Num Affected
28
deaths Num At Risk
81
description
Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.
id
EG001
other Num Affected
76
other Num At Risk
81
serious Num Affected
18
serious Num At Risk
81
title
Cohort 2 (First Course)
deaths Num Affected
19
deaths Num At Risk
61
description
Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
id
EG002
other Num Affected
56
other Num At Risk
60
serious Num Affected
15
serious Num At Risk
60
title
Cohort 3 (First Course)
deaths Num Affected
2
deaths Num At Risk
10
description
Eligible participants allocated to the pembrolizumab first course in Cohort 1 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year.
id
EG003
other Num Affected
10
other Num At Risk
10
serious Num Affected
0
serious Num At Risk
10
title
Cohort 1 (Second Course)
deaths Num Affected
0
deaths Num At Risk
7
description
Eligible participants allocated to the pembrolizumab first course in Cohort 2 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 Q3W for up to 17 cycles up to approximately an additional year.
id
EG004
other Num Affected
7
other Num At Risk
7
serious Num Affected
1
serious Num At Risk
7
title
Cohort 2 (Second Course)
deaths Num Affected
0
deaths Num At Risk
3
description
Eligible participants allocated to the pembrolizumab first course in Cohort 3 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 Q3W for up to 17 cycles up to approximately an additional year.
id
EG005
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Cohort 3 (Second Course)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
7
num At Risk
69
num Events
8
group Id
EG001
num Affected
8
num At Risk
81
num Events
8
group Id
EG002
num Affected
5
num At Risk
60
num Events
6
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
5
num At Risk
69
num Events
6
group Id
EG001
num Affected
4
num At Risk
81
num Events
6
group Id
EG002
num Affected
4
num At Risk
60
num Events
5
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
69
num Events
5
group Id
EG001
num Affected
3
num At Risk
81
num Events
3
group Id
EG002
num Affected
3
num At Risk
60
num Events
7
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
69
num Events
4
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
3
num At Risk
60
num Events
3
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
69
num Events
2
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Ear congestion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
2
num At Risk
81
num Events
2
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
3
num Events
1
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
8
num At Risk
69
num Events
9
group Id
EG001
num Affected
13
num At Risk
81
num Events
14
group Id
EG002
num Affected
12
num At Risk
60
num Events
15
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
2
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Iritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Scleral hyperaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Visual impairment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Abdominal discomfort

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
69
num Events
2
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Stress cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Alcoholic pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Hyperthermia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
3
num At Risk
60
num Events
3
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Autoimmune hepatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Acute graft versus host disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
term
Cytokine release syndrome

time Frame

Up to approximately 99 months.

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

Preserved source evidence · Not medical advice