NCT00150462 · ADVERSE EVENTS

Adverse events

Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies · 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 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
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
CFZ 1.2 mg/m² Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.	2 / 3	3 / 3	Not reported / Not reported
CFZ 2.4 mg/m² Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.	1 / 3	3 / 3	Not reported / Not reported
CFZ 4.0 mg/m² Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.	3 / 4	4 / 4	Not reported / Not reported
CFZ 6.0 mg/m² Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.	2 / 3	3 / 3	Not reported / Not reported
CFZ 8.4 mg/m² Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.	2 / 3	3 / 3	Not reported / Not reported
CFZ 11.0 mg/m² Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.	2 / 4	4 / 4	Not reported / Not reported
CFZ 15.0 mg/m² Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.	1 / 3	3 / 3	Not reported / Not reported
CFZ 20.0 mg/m² Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.	3 / 8	8 / 8	Not reported / Not reported
CFZ 27.0 mg/m² Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.	4 / 6	6 / 6	Not reported / Not reported
CFZ 20/27 mg/m² Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.	3 / 7	7 / 7	Not reported / Not reported
CFZ 20/27 mg/m² + DEX Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).	2 / 4	4 / 4	Not reported / Not reported

Group identifiers: EG000: CFZ 1.2 mg/m² · EG001: CFZ 2.4 mg/m² · EG002: CFZ 4.0 mg/m² · EG003: CFZ 6.0 mg/m² · EG004: CFZ 8.4 mg/m² · EG005: CFZ 11.0 mg/m² · EG006: CFZ 15.0 mg/m² · EG007: CFZ 20.0 mg/m² · EG008: CFZ 27.0 mg/m² · EG009: CFZ 20/27 mg/m² · EG010: CFZ 20/27 mg/m² + DEX

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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Hyperviscosity syndrome
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Pyrexia

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
1
num At Risk
3
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
2
num At Risk
3
group Id
EG007
num Affected
4
num At Risk
8
group Id
EG008
num Affected
4
num At Risk
6
group Id
EG009
num Affected
4
num At Risk
7
group Id
EG010
num Affected
4
num At Risk
4
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
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
7
group Id
EG010
num Affected
1
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Lymph node pain
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Lymphopenia
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
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
2
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
7
group Id
EG010
num Affected
2
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Pancytopenia
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
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
3
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
3
num At Risk
8
group Id
EG008
num Affected
3
num At Risk
6
group Id
EG009
num Affected
4
num At Risk
7
group Id
EG010
num Affected
3
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Cardiac flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Cardiomegaly
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Sinus 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
Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
CFZ 1.2 mg/m²
description
Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
CFZ 2.4 mg/m²
description
Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
id
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
CFZ 4.0 mg/m²
description
Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
CFZ 6.0 mg/m²
description
Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
CFZ 8.4 mg/m²
description
Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
id
EG005
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
CFZ 11.0 mg/m²
description
Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
id
EG006
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
CFZ 15.0 mg/m²
description
Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
id
EG007
other Num Affected
8
other Num At Risk
8
serious Num Affected
3
serious Num At Risk
8
title
CFZ 20.0 mg/m²
description
Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
id
EG008
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
CFZ 27.0 mg/m²
description
Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
id
EG009
other Num Affected
7
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
CFZ 20/27 mg/m²
description
Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
id
EG010
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
CFZ 20/27 mg/m² + DEX

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
1
num At Risk
3
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
2
num At Risk
3
group Id
EG007
num Affected
4
num At Risk
8
group Id
EG008
num Affected
4
num At Risk
6
group Id
EG009
num Affected
4
num At Risk
7
group Id
EG010
num Affected
4
num At Risk
4
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
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
7
group Id
EG010
num Affected
1
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Lymph node pain
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Lymphopenia
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
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
2
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
7
group Id
EG010
num Affected
2
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Pancytopenia
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
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
3
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
3
num At Risk
8
group Id
EG008
num Affected
3
num At Risk
6
group Id
EG009
num Affected
4
num At Risk
7
group Id
EG010
num Affected
3
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Cardiac flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Cardiomegaly
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Sinus 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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Hyperviscosity syndrome
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
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
7
group Id
EG010
num Affected
0
num At Risk
4
term
Pyrexia

time Frame

From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.

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

Preserved source evidence · Not medical advice