NCT02332980 · ADVERSE EVENTS

Adverse events

Pembrolizumab Alone or With Idelalisib or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Non-Hodgkin Lymphomas · Source last updated 2026-06-24

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: 5 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A (CLL) Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.	15 / 25	25 / 25	18 / 25
Arm B (NHL) Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.	9 / 23	22 / 23	14 / 23
Arm C (CLL With Richters) Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.	8 / 17	14 / 17	13 / 17
Arm A (Continuation Phase) CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.	3 / 5	5 / 5	3 / 5
Arm C (Continuation Phase) CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.	6 / 13	13 / 13	9 / 13

Group identifiers: EG000: Arm A (CLL) · EG001: Arm B (NHL) · EG002: Arm C (CLL With Richters) · EG003: Arm A (Continuation Phase) · EG004: Arm C (Continuation Phase)

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 12
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
3
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
1
num At Risk
5
num Events
1
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
2
num At Risk
17
num Events
2
group Id
EG003
num Affected
2
num At Risk
5
num Events
2
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Spleen disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
1
num At Risk
23
num Events
2
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Eye disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num Affected
1
num At Risk
23
num Events
2
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Duodenal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Dysphagia

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 12
stats
group Id
EG000
num Affected
23
num At Risk
25
num Events
69
group Id
EG001
num Affected
17
num At Risk
23
num Events
87
group Id
EG002
num Affected
14
num At Risk
17
num Events
41
group Id
EG003
num Affected
4
num At Risk
5
num Events
18
group Id
EG004
num Affected
13
num At Risk
13
num Events
52
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
1
num At Risk
5
num Events
1
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
2
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
4
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Dental caries
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
8
num At Risk
25
num Events
15
group Id
EG001
num Affected
9
num At Risk
23
num Events
21
group Id
EG002
num Affected
5
num At Risk
17
num Events
9
group Id
EG003
num Affected
4
num At Risk
5
num Events
6
group Id
EG004
num Affected
6
num At Risk
13
num Events
22
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
term
Duodenal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
10
num At Risk
25
num Events
15
group Id
EG001
num Affected
9
num At Risk
23
num Events
16
group Id
EG002
num Affected
7
num At Risk
17
num Events
12
group Id
EG003
num Affected
3
num At Risk
5
num Events
5
group Id
EG004
num Affected
2
num At Risk
13
num Events
3
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
5
num At Risk
25
num Events
7
group Id
EG001
num Affected
5
num At Risk
23
num Events
6
group Id
EG002
num Affected
5
num At Risk
17
num Events
5
group Id
EG003
num Affected
1
num At Risk
5
num Events
1
group Id
EG004
num Affected
1
num At Risk
13
num Events
3
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
2
term
Edema limbs

Complete source fields

event Groups

deaths Num Affected
18
deaths Num At Risk
25
description
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
id
EG000
other Num Affected
25
other Num At Risk
25
serious Num Affected
15
serious Num At Risk
25
title
Arm A (CLL)
deaths Num Affected
14
deaths Num At Risk
23
description
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
id
EG001
other Num Affected
22
other Num At Risk
23
serious Num Affected
9
serious Num At Risk
23
title
Arm B (NHL)
deaths Num Affected
13
deaths Num At Risk
17
description
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
id
EG002
other Num Affected
14
other Num At Risk
17
serious Num Affected
8
serious Num At Risk
17
title
Arm C (CLL With Richters)
deaths Num Affected
3
deaths Num At Risk
5
description
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
id
EG003
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
Arm A (Continuation Phase)
deaths Num Affected
9
deaths Num At Risk
13
description
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
id
EG004
other Num Affected
13
other Num At Risk
13
serious Num Affected
6
serious Num At Risk
13
title
Arm C (Continuation Phase)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
23
num At Risk
25
num Events
69
group Id
EG001
num Affected
17
num At Risk
23
num Events
87
group Id
EG002
num Affected
14
num At Risk
17
num Events
41
group Id
EG003
num Affected
4
num At Risk
5
num Events
18
group Id
EG004
num Affected
13
num At Risk
13
num Events
52
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
1
num At Risk
5
num Events
1
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
2
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
4
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Dental caries
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
8
num At Risk
25
num Events
15
group Id
EG001
num Affected
9
num At Risk
23
num Events
21
group Id
EG002
num Affected
5
num At Risk
17
num Events
9
group Id
EG003
num Affected
4
num At Risk
5
num Events
6
group Id
EG004
num Affected
6
num At Risk
13
num Events
22
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
term
Duodenal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
10
num At Risk
25
num Events
15
group Id
EG001
num Affected
9
num At Risk
23
num Events
16
group Id
EG002
num Affected
7
num At Risk
17
num Events
12
group Id
EG003
num Affected
3
num At Risk
5
num Events
5
group Id
EG004
num Affected
2
num At Risk
13
num Events
3
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
5
num At Risk
25
num Events
7
group Id
EG001
num Affected
5
num At Risk
23
num Events
6
group Id
EG002
num Affected
5
num At Risk
17
num Events
5
group Id
EG003
num Affected
1
num At Risk
5
num Events
1
group Id
EG004
num Affected
1
num At Risk
13
num Events
3
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
2
term
Edema limbs

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
3
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
1
num At Risk
5
num Events
1
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
2
num At Risk
17
num Events
2
group Id
EG003
num Affected
2
num At Risk
5
num Events
2
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Spleen disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
1
num At Risk
23
num Events
2
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Eye disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num Affected
1
num At Risk
23
num Events
2
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Duodenal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
25
num Events
0
group Id
EG001
num Affected
1
num At Risk
23
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
term
Dysphagia

time Frame

5 years

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Preserved source evidence · Not medical advice