NCT03386513 · ADVERSE EVENTS

Adverse events

Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN · Source last updated 2026-09-04

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 81 months
Other-event reporting threshold: 5%

The safety population included all participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Escalation - Schedule A: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.	2 / 3	3 / 3	2 / 3
Dose Escalation - Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	8 / 12	12 / 12	10 / 12
Dose Escalation - Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.	11 / 13	13 / 13	12 / 13
Dose Escalation - Schedule A: IMGN632 0.18 mg/kg Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.	7 / 7	7 / 7	7 / 7
Dose Escalation - Schedule A: IMGN632 0.3 mg/kg Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.	5 / 5	5 / 5	5 / 5
Dose Escalation - Schedule A: IMGN632 0.45 mg/kg Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.	2 / 2	2 / 2	2 / 2
Dose Escalation - Schedule B: IMGN632 0.015 mg/kg Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	2 / 3	3 / 3	3 / 3
Dose Escalation - Schedule B: IMGN632 0.03 mg/kg Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	6 / 6	5 / 6	6 / 6
Dose Escalation - Schedule B: IMGN632 0.06 mg/kg Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.	12 / 14	12 / 14	12 / 14
Dose Expansion - Schedule A: IMGN632 0.045 mg/kg Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.	66 / 104	102 / 104	76 / 104
Dose Expansion - Schedule A: IMGN632 0.09 mg/kg Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.	10 / 10	10 / 10	9 / 10

Group identifiers: EG000: Dose Escalation - Schedule A: IMGN632 0.015 mg/kg · EG001: Dose Escalation - Schedule A: IMGN632 0.045 mg/kg · EG002: Dose Escalation - Schedule A: IMGN632 0.09 mg/kg · EG003: Dose Escalation - Schedule A: IMGN632 0.18 mg/kg · EG004: Dose Escalation - Schedule A: IMGN632 0.3 mg/kg · EG005: Dose Escalation - Schedule A: IMGN632 0.45 mg/kg · EG006: Dose Escalation - Schedule B: IMGN632 0.015 mg/kg · EG007: Dose Escalation - Schedule B: IMGN632 0.03 mg/kg · EG008: Dose Escalation - Schedule B: IMGN632 0.06 mg/kg · EG009: Dose Expansion - Schedule A: IMGN632 0.045 mg/kg · EG010: Dose Expansion - Schedule A: IMGN632 0.09 mg/kg

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 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
1
num At Risk
5
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
1
num At Risk
104
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
1
num At Risk
104
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
COAGULOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
12
num Events
1
group Id
EG002
num Affected
4
num At Risk
13
num Events
5
group Id
EG003
num Affected
2
num At Risk
7
num Events
3
group Id
EG004
num Affected
2
num At Risk
5
num Events
2
group Id
EG005
num Affected
1
num At Risk
2
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
14
num Events
1
group Id
EG009
num Affected
13
num At Risk
104
num Events
16
group Id
EG010
num Affected
1
num At Risk
10
num Events
1
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
2
num At Risk
104
num Events
3
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
1
num At Risk
5
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
2
num At Risk
104
num Events
2
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
1
num At Risk
104
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
0
num At Risk
104
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
12
num Events
1
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
0
num At Risk
104
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
CARDIAC ARREST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
2
num At Risk
104
num Events
3
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
0
num At Risk
104
num Events
0
group Id
EG010
num Affected
1
num At Risk
10
num Events
1
term
CARDIAC FAILURE CONGESTIVE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
12
num Events
1
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
0
num At Risk
104
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
PERICARDIAL EFFUSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
1
num At Risk
104
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
STRESS 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 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
3
num At Risk
12
num Events
10
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
2
num At Risk
3
num Events
2
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
14
num Events
7
group Id
EG009
num Affected
22
num At Risk
104
num Events
63
group Id
EG010
num Affected
3
num At Risk
10
num Events
11
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
2
num At Risk
13
num Events
2
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
2
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
1
num At Risk
14
num Events
1
group Id
EG009
num Affected
4
num At Risk
104
num Events
4
group Id
EG010
num Affected
2
num At Risk
10
num Events
2
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
12
num Events
1
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
2
num At Risk
14
num Events
2
group Id
EG009
num Affected
8
num At Risk
104
num Events
11
group Id
EG010
num Affected
1
num At Risk
10
num Events
1
term
LEUKOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
6
num At Risk
104
num Events
24
group Id
EG010
num Affected
1
num At Risk
10
num Events
14
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
2
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
1
num At Risk
104
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
LYMPHADENOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
12
num Events
1
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
0
num At Risk
104
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
MYELOSUPPRESSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
1
num At Risk
5
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
14
num Events
1
group Id
EG009
num Affected
13
num At Risk
104
num Events
23
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
12
num Events
1
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
2
num At Risk
104
num Events
2
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
SPLENOMEGALY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
3
num At Risk
12
num Events
14
group Id
EG002
num Affected
1
num At Risk
13
num Events
2
group Id
EG003
num Affected
2
num At Risk
7
num Events
3
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
14
num Events
2
group Id
EG009
num Affected
16
num At Risk
104
num Events
48
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
1
num At Risk
5
num Events
1
group Id
EG005
num Affected
1
num At Risk
2
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
1
num At Risk
104
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
0
num At Risk
104
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
ATRIAL FLUTTER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
14
num Events
1
group Id
EG009
num Affected
2
num At Risk
104
num Events
2
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
BRADYCARDIA

Complete source fields

description

The safety population included all participants who received at least 1 dose of study drug.

event Groups

deaths Num Affected
2
deaths Num At Risk
3
description
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
deaths Num Affected
10
deaths Num At Risk
12
description
Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
id
EG001
other Num Affected
12
other Num At Risk
12
serious Num Affected
8
serious Num At Risk
12
title
Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
deaths Num Affected
12
deaths Num At Risk
13
description
Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
id
EG002
other Num Affected
13
other Num At Risk
13
serious Num Affected
11
serious Num At Risk
13
title
Dose Escalation - Schedule A: IMGN632 0.09 mg/kg
deaths Num Affected
7
deaths Num At Risk
7
description
Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
id
EG003
other Num Affected
7
other Num At Risk
7
serious Num Affected
7
serious Num At Risk
7
title
Dose Escalation - Schedule A: IMGN632 0.18 mg/kg
deaths Num Affected
5
deaths Num At Risk
5
description
Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
id
EG004
other Num Affected
5
other Num At Risk
5
serious Num Affected
5
serious Num At Risk
5
title
Dose Escalation - Schedule A: IMGN632 0.3 mg/kg
deaths Num Affected
2
deaths Num At Risk
2
description
Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
id
EG005
other Num Affected
2
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Dose Escalation - Schedule A: IMGN632 0.45 mg/kg
deaths Num Affected
3
deaths Num At Risk
3
description
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
id
EG006
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Dose Escalation - Schedule B: IMGN632 0.015 mg/kg
deaths Num Affected
6
deaths Num At Risk
6
description
Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
id
EG007
other Num Affected
5
other Num At Risk
6
serious Num Affected
6
serious Num At Risk
6
title
Dose Escalation - Schedule B: IMGN632 0.03 mg/kg
deaths Num Affected
12
deaths Num At Risk
14
description
Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
id
EG008
other Num Affected
12
other Num At Risk
14
serious Num Affected
12
serious Num At Risk
14
title
Dose Escalation - Schedule B: IMGN632 0.06 mg/kg
deaths Num Affected
76
deaths Num At Risk
104
description
Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
id
EG009
other Num Affected
102
other Num At Risk
104
serious Num Affected
66
serious Num At Risk
104
title
Dose Expansion - Schedule A: IMGN632 0.045 mg/kg
deaths Num Affected
9
deaths Num At Risk
10
description
Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
id
EG010
other Num Affected
10
other Num At Risk
10
serious Num Affected
10
serious Num At Risk
10
title
Dose Expansion - Schedule A: IMGN632 0.09 mg/kg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
3
num At Risk
12
num Events
10
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
2
num At Risk
3
num Events
2
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
14
num Events
7
group Id
EG009
num Affected
22
num At Risk
104
num Events
63
group Id
EG010
num Affected
3
num At Risk
10
num Events
11
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
2
num At Risk
13
num Events
2
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
2
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
1
num At Risk
14
num Events
1
group Id
EG009
num Affected
4
num At Risk
104
num Events
4
group Id
EG010
num Affected
2
num At Risk
10
num Events
2
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
12
num Events
1
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
2
num At Risk
14
num Events
2
group Id
EG009
num Affected
8
num At Risk
104
num Events
11
group Id
EG010
num Affected
1
num At Risk
10
num Events
1
term
LEUKOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
6
num At Risk
104
num Events
24
group Id
EG010
num Affected
1
num At Risk
10
num Events
14
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
2
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
1
num At Risk
104
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
LYMPHADENOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
12
num Events
1
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
0
num At Risk
104
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
MYELOSUPPRESSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
1
num At Risk
5
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
14
num Events
1
group Id
EG009
num Affected
13
num At Risk
104
num Events
23
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
12
num Events
1
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
2
num At Risk
104
num Events
2
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
SPLENOMEGALY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
3
num At Risk
12
num Events
14
group Id
EG002
num Affected
1
num At Risk
13
num Events
2
group Id
EG003
num Affected
2
num At Risk
7
num Events
3
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
14
num Events
2
group Id
EG009
num Affected
16
num At Risk
104
num Events
48
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
1
num At Risk
5
num Events
1
group Id
EG005
num Affected
1
num At Risk
2
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
1
num At Risk
104
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
0
num At Risk
104
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
ATRIAL FLUTTER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
14
num Events
1
group Id
EG009
num Affected
2
num At Risk
104
num Events
2
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
BRADYCARDIA

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
1
num At Risk
5
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
1
num At Risk
104
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
1
num At Risk
104
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
COAGULOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
12
num Events
1
group Id
EG002
num Affected
4
num At Risk
13
num Events
5
group Id
EG003
num Affected
2
num At Risk
7
num Events
3
group Id
EG004
num Affected
2
num At Risk
5
num Events
2
group Id
EG005
num Affected
1
num At Risk
2
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
14
num Events
1
group Id
EG009
num Affected
13
num At Risk
104
num Events
16
group Id
EG010
num Affected
1
num At Risk
10
num Events
1
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
2
num At Risk
104
num Events
3
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
1
num At Risk
5
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
2
num At Risk
104
num Events
2
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
BLOOD AND LYMPHATIC SYSTEM DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
7
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
1
num At Risk
104
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
0
num At Risk
104
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
12
num Events
1
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
0
num At Risk
104
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
CARDIAC ARREST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
2
num At Risk
104
num Events
3
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
0
num At Risk
104
num Events
0
group Id
EG010
num Affected
1
num At Risk
10
num Events
1
term
CARDIAC FAILURE CONGESTIVE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
12
num Events
1
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
0
num At Risk
104
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
PERICARDIAL EFFUSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
CARDIAC DISORDERS
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
7
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
14
num Events
0
group Id
EG009
num Affected
1
num At Risk
104
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
term
STRESS CARDIOMYOPATHY

time Frame

Up to approximately 81 months

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

Preserved source evidence · Independent clinical review pending · Not medical advice