NCT00603447 · ADVERSE EVENTS

Adverse events

Phase 1b Multicenter Study of Carfilzomib With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma · Source last updated 2017-05-30

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

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

Collection time frame: From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months.
Other-event reporting threshold: 5%

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
1: CFZ 15 mg/m² + LEN 10 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	3 / 6	6 / 6	Not reported / Not reported
2: CFZ 15 mg/m² + LEN 15 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	3 / 6	6 / 6	Not reported / Not reported
3: CFZ 15 mg/m² + LEN 20 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	4 / 8	8 / 8	Not reported / Not reported
4: CFZ 20 mg/m² + LEN 20 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	4 / 6	6 / 6	Not reported / Not reported
5: CFZ 20 mg/m² + LEN 25 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	3 / 6	6 / 6	Not reported / Not reported
6: CFZ 20/27 mg/m² + LEN 25 mg Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	6 / 8	8 / 8	Not reported / Not reported
7: CFZ 20/27 mg/m² + LEN 25 mg In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	22 / 44	42 / 44	Not reported / Not reported

Group identifiers: EG000: 1: CFZ 15 mg/m² + LEN 10 mg · EG001: 2: CFZ 15 mg/m² + LEN 15 mg · EG002: 3: CFZ 15 mg/m² + LEN 20 mg · EG003: 4: CFZ 20 mg/m² + LEN 20 mg · EG004: 5: CFZ 20 mg/m² + LEN 25 mg · EG005: 6: CFZ 20/27 mg/m² + LEN 25 mg · EG006: 7: CFZ 20/27 mg/m² + LEN 25 mg

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 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Sick sinus syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Colonic stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Diarrhoea

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 8.1
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
6
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
3
num At Risk
6
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
14
num At Risk
44
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
2
num At Risk
44
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
2
num At Risk
8
group Id
EG006
num Affected
9
num At Risk
44
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
5
num At Risk
8
group Id
EG006
num Affected
22
num At Risk
44
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
4
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
6
group Id
EG002
num Affected
4
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
5
num At Risk
6
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
16
num At Risk
44
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
3
num At Risk
6
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
13
num At Risk
44
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Extrasystoles
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
2
num At Risk
44
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
4
num At Risk
44
term
Tachycardia

Complete source fields

description

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

event Groups

description
Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
1: CFZ 15 mg/m² + LEN 10 mg
description
Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
2: CFZ 15 mg/m² + LEN 15 mg
description
Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
id
EG002
other Num Affected
8
other Num At Risk
8
serious Num Affected
4
serious Num At Risk
8
title
3: CFZ 15 mg/m² + LEN 20 mg
description
Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
4: CFZ 20 mg/m² + LEN 20 mg
description
Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
id
EG004
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
5: CFZ 20 mg/m² + LEN 25 mg
description
Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
id
EG005
other Num Affected
8
other Num At Risk
8
serious Num Affected
6
serious Num At Risk
8
title
6: CFZ 20/27 mg/m² + LEN 25 mg
description
In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
id
EG006
other Num Affected
42
other Num At Risk
44
serious Num Affected
22
serious Num At Risk
44
title
7: CFZ 20/27 mg/m² + LEN 25 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
6
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
3
num At Risk
6
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
14
num At Risk
44
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
2
num At Risk
44
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
2
num At Risk
8
group Id
EG006
num Affected
9
num At Risk
44
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
5
num At Risk
8
group Id
EG006
num Affected
22
num At Risk
44
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
4
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
6
group Id
EG002
num Affected
4
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
5
num At Risk
6
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
16
num At Risk
44
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
3
num At Risk
6
group Id
EG005
num Affected
3
num At Risk
8
group Id
EG006
num Affected
13
num At Risk
44
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Extrasystoles
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
2
num At Risk
44
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
4
num At Risk
44
term
Tachycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Sick sinus syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
1
num At Risk
44
term
Colonic stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
8
group Id
EG006
num Affected
0
num At Risk
44
term
Diarrhoea

time Frame

From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months.

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

Preserved source evidence · Not medical advice