NCT00721734 · ADVERSE EVENTS

Adverse events

Study of the Safety and Pharmacokinetics of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function · Source last updated 2017-05-02

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. Median duration of treatment was 121 days.
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
Carfilzomib - Normal RF Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.	5 / 12	12 / 12	Not reported / Not reported
Carfilzomib - Mild RI Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.	8 / 12	12 / 12	Not reported / Not reported
Carfilzomib - Moderate RI Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.	10 / 10	10 / 10	Not reported / Not reported
Carfilzomib - Severe RI Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.	6 / 8	8 / 8	Not reported / Not reported
Carfilzomib - Dialysis Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.	8 / 8	8 / 8	Not reported / Not reported

Group identifiers: EG000: Carfilzomib - Normal RF · EG001: Carfilzomib - Mild RI · EG002: Carfilzomib - Moderate RI · EG003: Carfilzomib - Severe RI · EG004: Carfilzomib - Dialysis

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
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
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
12
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
2
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Right ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Hiatus hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
term
Small intestinal obstruction

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
6
num At Risk
12
group Id
EG001
num Affected
7
num At Risk
12
group Id
EG002
num Affected
7
num At Risk
10
group Id
EG003
num Affected
5
num At Risk
8
group Id
EG004
num Affected
5
num At Risk
8
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
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
term
Hypocoagulable state
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
12
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
2
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
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
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Lymphadenopathy
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
12
group Id
EG001
num Affected
4
num At Risk
12
group Id
EG002
num Affected
2
num At Risk
10
group Id
EG003
num Affected
2
num At Risk
8
group Id
EG004
num Affected
4
num At Risk
8
term
Lymphopenia
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
12
group Id
EG001
num Affected
2
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
term
Neutropenia
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
12
group Id
EG001
num Affected
6
num At Risk
12
group Id
EG002
num Affected
5
num At Risk
10
group Id
EG003
num Affected
3
num At Risk
8
group Id
EG004
num Affected
5
num At Risk
8
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
2
num At Risk
8
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
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
2
num At Risk
8
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
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Cardiac failure acute

Complete source fields

description

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

event Groups

description
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
id
EG000
other Num Affected
12
other Num At Risk
12
serious Num Affected
5
serious Num At Risk
12
title
Carfilzomib - Normal RF
description
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
id
EG001
other Num Affected
12
other Num At Risk
12
serious Num Affected
8
serious Num At Risk
12
title
Carfilzomib - Mild RI
description
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
id
EG002
other Num Affected
10
other Num At Risk
10
serious Num Affected
10
serious Num At Risk
10
title
Carfilzomib - Moderate RI
description
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
id
EG003
other Num Affected
8
other Num At Risk
8
serious Num Affected
6
serious Num At Risk
8
title
Carfilzomib - Severe RI
description
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
id
EG004
other Num Affected
8
other Num At Risk
8
serious Num Affected
8
serious Num At Risk
8
title
Carfilzomib - Dialysis

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
6
num At Risk
12
group Id
EG001
num Affected
7
num At Risk
12
group Id
EG002
num Affected
7
num At Risk
10
group Id
EG003
num Affected
5
num At Risk
8
group Id
EG004
num Affected
5
num At Risk
8
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
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
term
Hypocoagulable state
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
12
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
2
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
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
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Lymphadenopathy
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
12
group Id
EG001
num Affected
4
num At Risk
12
group Id
EG002
num Affected
2
num At Risk
10
group Id
EG003
num Affected
2
num At Risk
8
group Id
EG004
num Affected
4
num At Risk
8
term
Lymphopenia
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
12
group Id
EG001
num Affected
2
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
term
Neutropenia
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
12
group Id
EG001
num Affected
6
num At Risk
12
group Id
EG002
num Affected
5
num At Risk
10
group Id
EG003
num Affected
3
num At Risk
8
group Id
EG004
num Affected
5
num At Risk
8
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
2
num At Risk
8
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
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
2
num At Risk
8
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
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Cardiac failure acute

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
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
1
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
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
12
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
2
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Right ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
0
num At Risk
8
term
Hiatus hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
10
group Id
EG003
num Affected
0
num At Risk
8
group Id
EG004
num Affected
1
num At Risk
8
term
Small intestinal obstruction

time Frame

From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.

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

Preserved source evidence · Not medical advice