NCT02257567 · ADVERSE EVENTS

Adverse events

A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma · Source last updated 2022-11-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From Baseline up to study completion/discontinuation (up to approximately 84 months)
Other-event reporting threshold: 5%

All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	2 / 6	6 / 6	2 / 6
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	4 / 6	6 / 6	2 / 6
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	4 / 6	6 / 6	2 / 6
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	5 / 6	6 / 6	4 / 6
Arm A (Phase II Randomization): Pola+BR in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	25 / 38	38 / 38	16 / 39
Arm B (Phase II Randomization): BR in FL Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.	12 / 41	39 / 41	11 / 41
Arm C (Phase II Randomization): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	24 / 39	36 / 39	26 / 40
Arm D (Phase II Randomization): BR in DLBCL Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.	27 / 39	37 / 39	30 / 40
Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	8 / 20	20 / 20	3 / 20
Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	13 / 20	19 / 20	18 / 21
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	57 / 106	103 / 106	65 / 106

Group identifiers: EG000: Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL · EG001: Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL · EG002: Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL · EG003: Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL · EG004: Arm A (Phase II Randomization): Pola+BR in FL · EG005: Arm B (Phase II Randomization): BR in FL · EG006: Arm C (Phase II Randomization): Pola+BR in DLBCL · EG007: Arm D (Phase II Randomization): BR in DLBCL · EG008: Arm E (Phase II Expansion): Pola+BG in FL · EG009: Arm F (Phase II Expansion): Pola+BG in DLBCL · EG010: Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL

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 version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
1
group Id
EG007
num Affected
2
num At Risk
39
num Events
2
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
1
num At Risk
106
num Events
1
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
6
num At Risk
38
num Events
9
group Id
EG005
num Affected
1
num At Risk
41
num Events
1
group Id
EG006
num Affected
4
num At Risk
39
num Events
4
group Id
EG007
num Affected
4
num At Risk
39
num Events
4
group Id
EG008
num Affected
2
num At Risk
20
num Events
3
group Id
EG009
num Affected
2
num At Risk
20
num Events
2
group Id
EG010
num Affected
9
num At Risk
106
num Events
11
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
1
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
1
num At Risk
20
num Events
2
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
1
num At Risk
20
num Events
1
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
2
num At Risk
38
num Events
2
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
2
num At Risk
39
num Events
2
group Id
EG007
num Affected
1
num At Risk
39
num Events
1
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
1
num At Risk
106
num Events
1
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
1
num At Risk
39
num Events
1
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
20
num Events
2
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
38
num Events
1
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
1
group Id
EG007
num Affected
2
num At Risk
39
num Events
2
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
1
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
20
num Events
1
group Id
EG010
num Affected
2
num At Risk
106
num Events
2
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
1
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
ATRIAL FLUTTER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
38
num Events
1
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
CARDIAC ARREST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
38
num Events
1
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
1
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
38
num Events
1
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
CARDIOMYOPATHY

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 version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
6
num At Risk
38
num Events
24
group Id
EG005
num Affected
5
num At Risk
41
num Events
5
group Id
EG006
num Affected
10
num At Risk
39
num Events
13
group Id
EG007
num Affected
19
num At Risk
39
num Events
28
group Id
EG008
num Affected
3
num At Risk
20
num Events
7
group Id
EG009
num Affected
5
num At Risk
20
num Events
6
group Id
EG010
num Affected
27
num At Risk
106
num Events
35
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
3
num At Risk
38
num Events
5
group Id
EG005
num Affected
3
num At Risk
41
num Events
4
group Id
EG006
num Affected
4
num At Risk
39
num Events
6
group Id
EG007
num Affected
5
num At Risk
39
num Events
19
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
7
num At Risk
106
num Events
17
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
3
num At Risk
38
num Events
5
group Id
EG005
num Affected
3
num At Risk
41
num Events
4
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
5
num At Risk
39
num Events
6
group Id
EG008
num Affected
2
num At Risk
20
num Events
5
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
5
num At Risk
106
num Events
7
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
4
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
8
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
16
num At Risk
38
num Events
31
group Id
EG005
num Affected
11
num At Risk
41
num Events
18
group Id
EG006
num Affected
14
num At Risk
39
num Events
27
group Id
EG007
num Affected
21
num At Risk
39
num Events
63
group Id
EG008
num Affected
6
num At Risk
20
num Events
10
group Id
EG009
num Affected
6
num At Risk
20
num Events
30
group Id
EG010
num Affected
35
num At Risk
106
num Events
73
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
1
num At Risk
39
num Events
1
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
20
num Events
1
group Id
EG010
num Affected
2
num At Risk
106
num Events
2
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
3
num At Risk
38
num Events
6
group Id
EG005
num Affected
8
num At Risk
41
num Events
13
group Id
EG006
num Affected
11
num At Risk
39
num Events
18
group Id
EG007
num Affected
19
num At Risk
39
num Events
50
group Id
EG008
num Affected
4
num At Risk
20
num Events
4
group Id
EG009
num Affected
7
num At Risk
20
num Events
10
group Id
EG010
num Affected
19
num At Risk
106
num Events
40
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
1
num At Risk
38
num Events
1
group Id
EG005
num Affected
2
num At Risk
41
num Events
2
group Id
EG006
num Affected
3
num At Risk
39
num Events
3
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
1
num At Risk
106
num Events
2
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
1
num At Risk
41
num Events
1
group Id
EG006
num Affected
2
num At Risk
39
num Events
2
group Id
EG007
num Affected
2
num At Risk
39
num Events
3
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
20
num Events
1
group Id
EG010
num Affected
6
num At Risk
106
num Events
6
term
TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
38
num Events
1
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
20
num Events
1
group Id
EG010
num Affected
1
num At Risk
106
num Events
1
term
HYPOACUSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
2
num At Risk
38
num Events
2
group Id
EG005
num Affected
2
num At Risk
41
num Events
2
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
1
num At Risk
39
num Events
1
group Id
EG008
num Affected
1
num At Risk
20
num Events
1
group Id
EG009
num Affected
2
num At Risk
20
num Events
2
group Id
EG010
num Affected
1
num At Risk
106
num Events
1
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
6
num At Risk
38
num Events
6
group Id
EG005
num Affected
5
num At Risk
41
num Events
5
group Id
EG006
num Affected
3
num At Risk
39
num Events
3
group Id
EG007
num Affected
3
num At Risk
39
num Events
3
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
2
num At Risk
20
num Events
2
group Id
EG010
num Affected
12
num At Risk
106
num Events
14
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
2
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
2
num At Risk
20
num Events
2
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
ABDOMINAL PAIN LOWER

Complete source fields

description

event Groups

deaths Num Affected
2
deaths Num At Risk
6
description
Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL
deaths Num Affected
2
deaths Num At Risk
6
description
Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL
deaths Num Affected
2
deaths Num At Risk
6
description
Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
id
EG002
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
deaths Num Affected
4
deaths Num At Risk
6
description
Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
deaths Num Affected
16
deaths Num At Risk
39
description
Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
id
EG004
other Num Affected
38
other Num At Risk
38
serious Num Affected
25
serious Num At Risk
38
title
Arm A (Phase II Randomization): Pola+BR in FL
deaths Num Affected
11
deaths Num At Risk
41
description
Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.
id
EG005
other Num Affected
39
other Num At Risk
41
serious Num Affected
12
serious Num At Risk
41
title
Arm B (Phase II Randomization): BR in FL
deaths Num Affected
26
deaths Num At Risk
40
description
Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
id
EG006
other Num Affected
36
other Num At Risk
39
serious Num Affected
24
serious Num At Risk
39
title
Arm C (Phase II Randomization): Pola+BR in DLBCL
deaths Num Affected
30
deaths Num At Risk
40
description
Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.
id
EG007
other Num Affected
37
other Num At Risk
39
serious Num Affected
27
serious Num At Risk
39
title
Arm D (Phase II Randomization): BR in DLBCL
deaths Num Affected
3
deaths Num At Risk
20
description
Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
id
EG008
other Num Affected
20
other Num At Risk
20
serious Num Affected
8
serious Num At Risk
20
title
Arm E (Phase II Expansion): Pola+BG in FL
deaths Num Affected
18
deaths Num At Risk
21
description
Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
id
EG009
other Num Affected
19
other Num At Risk
20
serious Num Affected
13
serious Num At Risk
20
title
Arm F (Phase II Expansion): Pola+BG in DLBCL
deaths Num Affected
65
deaths Num At Risk
106
description
Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
id
EG010
other Num Affected
103
other Num At Risk
106
serious Num Affected
57
serious Num At Risk
106
title
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
6
num At Risk
38
num Events
24
group Id
EG005
num Affected
5
num At Risk
41
num Events
5
group Id
EG006
num Affected
10
num At Risk
39
num Events
13
group Id
EG007
num Affected
19
num At Risk
39
num Events
28
group Id
EG008
num Affected
3
num At Risk
20
num Events
7
group Id
EG009
num Affected
5
num At Risk
20
num Events
6
group Id
EG010
num Affected
27
num At Risk
106
num Events
35
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
3
num At Risk
38
num Events
5
group Id
EG005
num Affected
3
num At Risk
41
num Events
4
group Id
EG006
num Affected
4
num At Risk
39
num Events
6
group Id
EG007
num Affected
5
num At Risk
39
num Events
19
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
7
num At Risk
106
num Events
17
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
3
num At Risk
38
num Events
5
group Id
EG005
num Affected
3
num At Risk
41
num Events
4
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
5
num At Risk
39
num Events
6
group Id
EG008
num Affected
2
num At Risk
20
num Events
5
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
5
num At Risk
106
num Events
7
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
4
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
8
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
16
num At Risk
38
num Events
31
group Id
EG005
num Affected
11
num At Risk
41
num Events
18
group Id
EG006
num Affected
14
num At Risk
39
num Events
27
group Id
EG007
num Affected
21
num At Risk
39
num Events
63
group Id
EG008
num Affected
6
num At Risk
20
num Events
10
group Id
EG009
num Affected
6
num At Risk
20
num Events
30
group Id
EG010
num Affected
35
num At Risk
106
num Events
73
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
1
num At Risk
39
num Events
1
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
20
num Events
1
group Id
EG010
num Affected
2
num At Risk
106
num Events
2
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
3
num At Risk
38
num Events
6
group Id
EG005
num Affected
8
num At Risk
41
num Events
13
group Id
EG006
num Affected
11
num At Risk
39
num Events
18
group Id
EG007
num Affected
19
num At Risk
39
num Events
50
group Id
EG008
num Affected
4
num At Risk
20
num Events
4
group Id
EG009
num Affected
7
num At Risk
20
num Events
10
group Id
EG010
num Affected
19
num At Risk
106
num Events
40
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
1
num At Risk
38
num Events
1
group Id
EG005
num Affected
2
num At Risk
41
num Events
2
group Id
EG006
num Affected
3
num At Risk
39
num Events
3
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
1
num At Risk
106
num Events
2
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
1
num At Risk
41
num Events
1
group Id
EG006
num Affected
2
num At Risk
39
num Events
2
group Id
EG007
num Affected
2
num At Risk
39
num Events
3
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
20
num Events
1
group Id
EG010
num Affected
6
num At Risk
106
num Events
6
term
TACHYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
38
num Events
1
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
20
num Events
1
group Id
EG010
num Affected
1
num At Risk
106
num Events
1
term
HYPOACUSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
2
num At Risk
38
num Events
2
group Id
EG005
num Affected
2
num At Risk
41
num Events
2
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
1
num At Risk
39
num Events
1
group Id
EG008
num Affected
1
num At Risk
20
num Events
1
group Id
EG009
num Affected
2
num At Risk
20
num Events
2
group Id
EG010
num Affected
1
num At Risk
106
num Events
1
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
6
num At Risk
38
num Events
6
group Id
EG005
num Affected
5
num At Risk
41
num Events
5
group Id
EG006
num Affected
3
num At Risk
39
num Events
3
group Id
EG007
num Affected
3
num At Risk
39
num Events
3
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
2
num At Risk
20
num Events
2
group Id
EG010
num Affected
12
num At Risk
106
num Events
14
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
2
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
2
num At Risk
20
num Events
2
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
ABDOMINAL PAIN LOWER

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
1
group Id
EG007
num Affected
2
num At Risk
39
num Events
2
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
1
num At Risk
106
num Events
1
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
6
num At Risk
38
num Events
9
group Id
EG005
num Affected
1
num At Risk
41
num Events
1
group Id
EG006
num Affected
4
num At Risk
39
num Events
4
group Id
EG007
num Affected
4
num At Risk
39
num Events
4
group Id
EG008
num Affected
2
num At Risk
20
num Events
3
group Id
EG009
num Affected
2
num At Risk
20
num Events
2
group Id
EG010
num Affected
9
num At Risk
106
num Events
11
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
1
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
1
num At Risk
20
num Events
2
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
1
num At Risk
20
num Events
1
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
2
num At Risk
38
num Events
2
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
2
num At Risk
39
num Events
2
group Id
EG007
num Affected
1
num At Risk
39
num Events
1
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
1
num At Risk
106
num Events
1
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
1
num At Risk
39
num Events
1
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
20
num Events
2
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
38
num Events
1
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
1
group Id
EG007
num Affected
2
num At Risk
39
num Events
2
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
1
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
1
num At Risk
20
num Events
1
group Id
EG010
num Affected
2
num At Risk
106
num Events
2
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
38
num Events
0
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
1
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
ATRIAL FLUTTER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
38
num Events
1
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
CARDIAC ARREST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
38
num Events
1
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
1
num At Risk
39
num Events
1
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
38
num Events
1
group Id
EG005
num Affected
0
num At Risk
41
num Events
0
group Id
EG006
num Affected
0
num At Risk
39
num Events
0
group Id
EG007
num Affected
0
num At Risk
39
num Events
0
group Id
EG008
num Affected
0
num At Risk
20
num Events
0
group Id
EG009
num Affected
0
num At Risk
20
num Events
0
group Id
EG010
num Affected
0
num At Risk
106
num Events
0
term
CARDIOMYOPATHY

time Frame

From Baseline up to study completion/discontinuation (up to approximately 84 months)

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

Preserved source evidence · Not medical advice