NCT00531284 · ADVERSE EVENTS

Adverse events

Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma · Source last updated 2017-08-15

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 administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
Other-event reporting threshold: 5%

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
P1B ST: CFZ 20 mg/m² Bolus Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	1 / 3	3 / 3	Not reported / Not reported
P1B ST: CFZ 20/27 mg/m² Bolus Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	1 / 4	4 / 4	Not reported / Not reported
P1B ST: CFZ 20/36 mg/m² Bolus Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	4 / 7	7 / 7	Not reported / Not reported
P2 ST: CFZ 20/36 mg/m² Bolus Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	27 / 65	65 / 65	Not reported / Not reported
P1B ST: CFZ 36 mg/m² Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	2 / 6	6 / 6	Not reported / Not reported
P1B ST: CFZ 45 mg/m² Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	4 / 7	7 / 7	Not reported / Not reported
P1B ST: CFZ 20/45 mg/m² Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	5 / 6	6 / 6	Not reported / Not reported
P1B ST: CFZ 20/56 mg/m² Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	5 / 10	10 / 10	Not reported / Not reported
P1B ST: CFZ 20/70 mg/m² Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	6 / 11	11 / 11	Not reported / Not reported
P1B MM: CFZ 20/36 mg/m² Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	2 / 4	4 / 4	Not reported / Not reported
P1B MM: CFZ 20/45 mg/m² Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	0 / 3	3 / 3	Not reported / Not reported
P1B MM: CFZ 20/56 mg/m² Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	11 / 24	24 / 24	Not reported / Not reported
P1B MM: CFZ 20/70 mg/m² Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	2 / 2	2 / 2	Not reported / Not reported
P1B LYM: CFZ 20/56 mg/m² Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	1 / 3	3 / 3	Not reported / Not reported
P1B LYM: CFZ 20/70 mg/m² Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	5 / 7	7 / 7	Not reported / Not reported
P1B MM: CFZ 20/45 mg/m² + Dex Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	5 / 14	14 / 14	Not reported / Not reported
P1B MM: CFZ 20/56 mg/m² + Dex Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.	3 / 8	8 / 8	Not reported / Not reported

Group identifiers: EG000: P1B ST: CFZ 20 mg/m² Bolus · EG001: P1B ST: CFZ 20/27 mg/m² Bolus · EG002: P1B ST: CFZ 20/36 mg/m² Bolus · EG003: P2 ST: CFZ 20/36 mg/m² Bolus · EG004: P1B ST: CFZ 36 mg/m² · EG005: P1B ST: CFZ 45 mg/m² · EG006: P1B ST: CFZ 20/45 mg/m² · EG007: P1B ST: CFZ 20/56 mg/m² · EG008: P1B ST: CFZ 20/70 mg/m² · EG009: P1B MM: CFZ 20/36 mg/m² · EG010: P1B MM: CFZ 20/45 mg/m² · EG011: P1B MM: CFZ 20/56 mg/m² · EG012: P1B MM: CFZ 20/70 mg/m² · EG013: P1B LYM: CFZ 20/56 mg/m² · EG014: P1B LYM: CFZ 20/70 mg/m² · EG015: P1B MM: CFZ 20/45 mg/m² + Dex · EG016: P1B MM: CFZ 20/56 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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
24
term
Thrombotic thrombocytopenic purpura
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
24
term
Cardiac failure
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
24
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
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
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
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Diastolic dysfunction
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Tachycardia
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Abdominal hernia
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
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
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Ascites
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Constipation
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
4
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
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
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
17
num At Risk
65
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
2
num At Risk
6
group Id
EG007
num Affected
4
num At Risk
10
group Id
EG008
num Affected
3
num At Risk
11
group Id
EG009
num Affected
2
num At Risk
4
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
10
num At Risk
24
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Haemolytic 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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
2
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Iron deficiency 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
4
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
24
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
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
24
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Lymphadenopathy
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
4
group Id
EG002
num Affected
3
num At Risk
7
group Id
EG003
num Affected
10
num At Risk
65
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
2
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
8
num At Risk
24
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
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
4
num At Risk
24
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
1
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
1
num At Risk
10
group Id
EG008
num Affected
3
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
4
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
13
num At Risk
24
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
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Angina pectoris
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
4
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Bradycardia

Complete source fields

description

event Groups

description
Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
P1B ST: CFZ 20 mg/m² Bolus
description
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
P1B ST: CFZ 20/27 mg/m² Bolus
description
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
id
EG002
other Num Affected
7
other Num At Risk
7
serious Num Affected
4
serious Num At Risk
7
title
P1B ST: CFZ 20/36 mg/m² Bolus
description
Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
id
EG003
other Num Affected
65
other Num At Risk
65
serious Num Affected
27
serious Num At Risk
65
title
P2 ST: CFZ 20/36 mg/m² Bolus
description
Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
id
EG004
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
P1B ST: CFZ 36 mg/m²
description
Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
id
EG005
other Num Affected
7
other Num At Risk
7
serious Num Affected
4
serious Num At Risk
7
title
P1B ST: CFZ 45 mg/m²
description
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
id
EG006
other Num Affected
6
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
P1B ST: CFZ 20/45 mg/m²
description
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
id
EG007
other Num Affected
10
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
P1B ST: CFZ 20/56 mg/m²
description
Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
id
EG008
other Num Affected
11
other Num At Risk
11
serious Num Affected
6
serious Num At Risk
11
title
P1B ST: CFZ 20/70 mg/m²
description
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
id
EG009
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
P1B MM: CFZ 20/36 mg/m²
description
Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
id
EG010
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
P1B MM: CFZ 20/45 mg/m²
description
Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
id
EG011
other Num Affected
24
other Num At Risk
24
serious Num Affected
11
serious Num At Risk
24
title
P1B MM: CFZ 20/56 mg/m²

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
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
17
num At Risk
65
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
2
num At Risk
6
group Id
EG007
num Affected
4
num At Risk
10
group Id
EG008
num Affected
3
num At Risk
11
group Id
EG009
num Affected
2
num At Risk
4
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
10
num At Risk
24
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Haemolytic 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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
2
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Iron deficiency 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
4
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
24
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
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
24
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Lymphadenopathy
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
4
group Id
EG002
num Affected
3
num At Risk
7
group Id
EG003
num Affected
10
num At Risk
65
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
2
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
8
num At Risk
24
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
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
4
num At Risk
24
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
1
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
1
num At Risk
10
group Id
EG008
num Affected
3
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
4
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
13
num At Risk
24
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
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Angina pectoris
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
4
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Bradycardia

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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
24
term
Thrombotic thrombocytopenic purpura
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
24
term
Cardiac failure
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
24
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
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
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
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Diastolic dysfunction
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Tachycardia
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Abdominal hernia
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
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
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Ascites
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
4
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Constipation
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
4
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
65
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
10
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
24
term
Diarrhoea

time Frame

From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice