NCT03601897 · ADVERSE EVENTS

Adverse events

A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors · Source last updated 2024-12-27

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: Baseline up to 2.89 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.	16 / 24	23 / 24	7 / 24
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.	12 / 19	15 / 19	4 / 19
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.	3 / 12	12 / 12	0 / 12
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.	3 / 6	6 / 6	1 / 6
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxelIV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.	2 / 15	15 / 15	1 / 15
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.	3 / 5	5 / 5	0 / 5
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.	9 / 28	28 / 28	0 / 28
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.	5 / 10	10 / 10	2 / 10
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.	10 / 22	22 / 22	2 / 22
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.	9 / 16	16 / 16	0 / 16
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.	9 / 20	20 / 20	3 / 20

Group identifiers: EG000: Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 · EG001: Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 · EG002: Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 · EG003: Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 · EG004: Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 · EG005: Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 · EG006: Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 · EG007: Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 · EG008: Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 · EG009: Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 · EG010: Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2

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
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
16
num Events
1
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
16
num Events
1
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
1
num At Risk
12
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Ischaemic cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
1
num At Risk
12
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
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 v24.1
stats
group Id
EG000
num Affected
5
num At Risk
24
num Events
6
group Id
EG001
num Affected
5
num At Risk
19
num Events
11
group Id
EG002
num Affected
1
num At Risk
12
num Events
3
group Id
EG003
num Affected
3
num At Risk
6
num Events
3
group Id
EG004
num Affected
2
num At Risk
15
num Events
2
group Id
EG005
num Affected
2
num At Risk
5
num Events
3
group Id
EG006
num Affected
5
num At Risk
28
num Events
13
group Id
EG007
num Affected
2
num At Risk
10
num Events
9
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
5
num At Risk
16
num Events
6
group Id
EG010
num Affected
8
num At Risk
20
num Events
28
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
2
num At Risk
12
num Events
7
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
2
num At Risk
28
num Events
7
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
1
num At Risk
12
num Events
2
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
4
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
group Id
EG002
num Affected
1
num At Risk
12
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
2
num At Risk
28
num Events
2
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
2
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
2
num At Risk
28
num Events
2
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
1
num At Risk
22
num Events
2
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
2
num At Risk
20
num Events
2
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Stress cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
1
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
2
num At Risk
16
num Events
2
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
term
Tricuspid valve disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
1
num At Risk
16
num Events
1
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Ear pain

Complete source fields

event Groups

deaths Num Affected
7
deaths Num At Risk
24
description
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
id
EG000
other Num Affected
23
other Num At Risk
24
serious Num Affected
16
serious Num At Risk
24
title
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
deaths Num Affected
4
deaths Num At Risk
19
description
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
id
EG001
other Num Affected
15
other Num At Risk
19
serious Num Affected
12
serious Num At Risk
19
title
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
deaths Num Affected
0
deaths Num At Risk
12
description
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
id
EG002
other Num Affected
12
other Num At Risk
12
serious Num Affected
3
serious Num At Risk
12
title
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
deaths Num Affected
1
deaths Num At Risk
6
description
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
deaths Num Affected
1
deaths Num At Risk
15
description
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxelIV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
id
EG004
other Num Affected
15
other Num At Risk
15
serious Num Affected
2
serious Num At Risk
15
title
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
deaths Num Affected
0
deaths Num At Risk
5
description
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
id
EG005
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
deaths Num Affected
0
deaths Num At Risk
28
description
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
id
EG006
other Num Affected
28
other Num At Risk
28
serious Num Affected
9
serious Num At Risk
28
title
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
deaths Num Affected
2
deaths Num At Risk
10
description
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
id
EG007
other Num Affected
10
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
deaths Num Affected
2
deaths Num At Risk
22
description
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
id
EG008
other Num Affected
22
other Num At Risk
22
serious Num Affected
10
serious Num At Risk
22
title
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
deaths Num Affected
0
deaths Num At Risk
16
description
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
id
EG009
other Num Affected
16
other Num At Risk
16
serious Num Affected
9
serious Num At Risk
16
title
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
deaths Num Affected
3
deaths Num At Risk
20
description
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
id
EG010
other Num Affected
20
other Num At Risk
20
serious Num Affected
9
serious Num At Risk
20
title
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
5
num At Risk
24
num Events
6
group Id
EG001
num Affected
5
num At Risk
19
num Events
11
group Id
EG002
num Affected
1
num At Risk
12
num Events
3
group Id
EG003
num Affected
3
num At Risk
6
num Events
3
group Id
EG004
num Affected
2
num At Risk
15
num Events
2
group Id
EG005
num Affected
2
num At Risk
5
num Events
3
group Id
EG006
num Affected
5
num At Risk
28
num Events
13
group Id
EG007
num Affected
2
num At Risk
10
num Events
9
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
5
num At Risk
16
num Events
6
group Id
EG010
num Affected
8
num At Risk
20
num Events
28
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
2
num At Risk
12
num Events
7
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
2
num At Risk
28
num Events
7
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
1
num At Risk
12
num Events
2
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
4
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
group Id
EG002
num Affected
1
num At Risk
12
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
2
num At Risk
28
num Events
2
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
2
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
2
num At Risk
28
num Events
2
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
1
num At Risk
22
num Events
2
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
2
num At Risk
20
num Events
2
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Stress cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
1
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
2
num At Risk
16
num Events
2
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
term
Tricuspid valve disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
1
num At Risk
16
num Events
1
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Ear pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
16
num Events
1
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
16
num Events
1
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
1
num At Risk
28
num Events
1
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
1
num At Risk
12
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
1
num At Risk
20
num Events
1
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Ischaemic cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
1
num At Risk
12
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v24.1
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
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
15
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
28
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
0
num At Risk
16
num Events
0
group Id
EG010
num Affected
0
num At Risk
20
num Events
0
term
Stress cardiomyopathy

time Frame

Baseline up to 2.89 years

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Preserved source evidence · Not medical advice