NCT01010126 · ADVERSE EVENTS

Adverse events

Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer · Source last updated 2019-01-25

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: Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Other-event reporting threshold: 0%

Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Endometrial Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	16 / 26	26 / 26	2 / 26
Ovarian Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	34 / 58	58 / 58	1 / 58
Hepatocellular Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	13 / 27	27 / 27	3 / 27
Carcinoid Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	36 / 57	56 / 57	3 / 57
Islet Cell (Double Agent) Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	27 / 55	55 / 55	0 / 55
Islet Cell (Bevacizumab-only) Cohort Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	6 / 24	24 / 24	0 / 24

Group identifiers: EG000: Endometrial Cohort · EG001: Ovarian Cohort · EG002: Hepatocellular Cohort · EG003: Carcinoid Cohort · EG004: Islet Cell (Double Agent) Cohort · EG005: Islet Cell (Bevacizumab-only) Cohort

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 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
4
num At Risk
57
num Events
5
group Id
EG004
num Affected
2
num At Risk
55
num Events
3
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
2
num At Risk
55
num Events
2
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Cardiac pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
1
num At Risk
55
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
2
num At Risk
58
num Events
2
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
1
num At Risk
55
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
group Id
EG001
num Affected
5
num At Risk
58
num Events
7
group Id
EG002
num Affected
3
num At Risk
27
num Events
3
group Id
EG003
num Affected
8
num At Risk
57
num Events
10
group Id
EG004
num Affected
6
num At Risk
55
num Events
6
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Abdominal pain

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 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
2
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
20
num At Risk
26
num Events
79
group Id
EG001
num Affected
48
num At Risk
58
num Events
212
group Id
EG002
num Affected
23
num At Risk
27
num Events
122
group Id
EG003
num Affected
49
num At Risk
57
num Events
382
group Id
EG004
num Affected
49
num At Risk
55
num Events
556
group Id
EG005
num Affected
8
num At Risk
24
num Events
82
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
9
group Id
EG004
num Affected
1
num At Risk
55
num Events
10
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
3
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
group Id
EG004
num Affected
1
num At Risk
55
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
1
num At Risk
55
num Events
13
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
1
num At Risk
55
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
7
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Atrioventricular block complete
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
1
num At Risk
55
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
2
num At Risk
58
num Events
2
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Cardiac pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Palpitations

Complete source fields

description

Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.

event Groups

deaths Num Affected
2
deaths Num At Risk
26
description
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
26
other Num At Risk
26
serious Num Affected
16
serious Num At Risk
26
title
Endometrial Cohort
deaths Num Affected
1
deaths Num At Risk
58
description
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
58
other Num At Risk
58
serious Num Affected
34
serious Num At Risk
58
title
Ovarian Cohort
deaths Num Affected
3
deaths Num At Risk
27
description
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG002
other Num Affected
27
other Num At Risk
27
serious Num Affected
13
serious Num At Risk
27
title
Hepatocellular Cohort
deaths Num Affected
3
deaths Num At Risk
57
description
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG003
other Num Affected
56
other Num At Risk
57
serious Num Affected
36
serious Num At Risk
57
title
Carcinoid Cohort
deaths Num Affected
0
deaths Num At Risk
55
description
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG004
other Num Affected
55
other Num At Risk
55
serious Num Affected
27
serious Num At Risk
55
title
Islet Cell (Double Agent) Cohort
deaths Num Affected
0
deaths Num At Risk
24
description
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG005
other Num Affected
24
other Num At Risk
24
serious Num Affected
6
serious Num At Risk
24
title
Islet Cell (Bevacizumab-only) Cohort

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
2
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
20
num At Risk
26
num Events
79
group Id
EG001
num Affected
48
num At Risk
58
num Events
212
group Id
EG002
num Affected
23
num At Risk
27
num Events
122
group Id
EG003
num Affected
49
num At Risk
57
num Events
382
group Id
EG004
num Affected
49
num At Risk
55
num Events
556
group Id
EG005
num Affected
8
num At Risk
24
num Events
82
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
9
group Id
EG004
num Affected
1
num At Risk
55
num Events
10
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
3
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
group Id
EG004
num Affected
1
num At Risk
55
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
1
num At Risk
55
num Events
13
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
1
num At Risk
55
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
7
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Atrioventricular block complete
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
1
num At Risk
55
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
2
num At Risk
58
num Events
2
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Cardiac pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Palpitations

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
4
num At Risk
57
num Events
5
group Id
EG004
num Affected
2
num At Risk
55
num Events
3
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
2
num At Risk
55
num Events
2
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Cardiac pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
1
num At Risk
55
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
2
num At Risk
58
num Events
2
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
0
num At Risk
58
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
0
num At Risk
55
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
58
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
group Id
EG004
num Affected
1
num At Risk
55
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
group Id
EG001
num Affected
5
num At Risk
58
num Events
7
group Id
EG002
num Affected
3
num At Risk
27
num Events
3
group Id
EG003
num Affected
8
num At Risk
57
num Events
10
group Id
EG004
num Affected
6
num At Risk
55
num Events
6
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Abdominal pain

time Frame

Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice