NCT02335983 · ADVERSE EVENTS

Adverse events

Phase 1b Study of Weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma · Source last updated 2020-11-06

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: All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
RRMM Dose-evaluation: Carfilzomib 56 mg/m² Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.	4 / 10	10 / 10	0 / 10
RRMM Dose-evaluation: Carfilzomib 70 mg/m² Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.	5 / 12	12 / 12	0 / 12
RRMM Dose-expansion: Carfilzomib 70 mg/m² Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.	10 / 34	33 / 34	2 / 34
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m² Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.	3 / 9	9 / 9	0 / 9
NDMM Dose-expansion: Carfilzomib 70 mg/m² Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.	3 / 9	9 / 9	0 / 9
NDMM Dose-expansion: Carfilzomib 56 mg/m² Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.	11 / 33	33 / 33	0 / 33

Group identifiers: EG000: RRMM Dose-evaluation: Carfilzomib 56 mg/m² · EG001: RRMM Dose-evaluation: Carfilzomib 70 mg/m² · EG002: RRMM Dose-expansion: Carfilzomib 70 mg/m² · EG003: NDMM Dose-evaluation: Carfilzomib 56/70 mg/m² · EG004: NDMM Dose-expansion: Carfilzomib 70 mg/m² · EG005: NDMM Dose-expansion: Carfilzomib 56 mg/m²

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 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
1
num At Risk
33
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
2
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
2
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Vitello-intestinal duct remnant
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
1
num At Risk
33
term
Lower gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
1
num At Risk
33
term
Peripheral swelling

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 22.1
stats
group Id
EG000
num Affected
3
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
9
num At Risk
34
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
2
num At Risk
9
group Id
EG005
num Affected
9
num At Risk
33
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Haemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
3
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
2
num At Risk
10
group Id
EG001
num Affected
3
num At Risk
12
group Id
EG002
num Affected
4
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
1
num At Risk
33
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
5
num At Risk
10
group Id
EG001
num Affected
4
num At Risk
12
group Id
EG002
num Affected
6
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
9
group Id
EG005
num Affected
1
num At Risk
33
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Atrial fibrillation

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
10
description
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
id
EG000
other Num Affected
10
other Num At Risk
10
serious Num Affected
4
serious Num At Risk
10
title
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
deaths Num Affected
0
deaths Num At Risk
12
description
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
id
EG001
other Num Affected
12
other Num At Risk
12
serious Num Affected
5
serious Num At Risk
12
title
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
deaths Num Affected
2
deaths Num At Risk
34
description
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
id
EG002
other Num Affected
33
other Num At Risk
34
serious Num Affected
10
serious Num At Risk
34
title
RRMM Dose-expansion: Carfilzomib 70 mg/m²
deaths Num Affected
0
deaths Num At Risk
9
description
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
id
EG003
other Num Affected
9
other Num At Risk
9
serious Num Affected
3
serious Num At Risk
9
title
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
deaths Num Affected
0
deaths Num At Risk
9
description
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
id
EG004
other Num Affected
9
other Num At Risk
9
serious Num Affected
3
serious Num At Risk
9
title
NDMM Dose-expansion: Carfilzomib 70 mg/m²
deaths Num Affected
0
deaths Num At Risk
33
description
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
id
EG005
other Num Affected
33
other Num At Risk
33
serious Num Affected
11
serious Num At Risk
33
title
NDMM Dose-expansion: Carfilzomib 56 mg/m²

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
3
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
9
num At Risk
34
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
2
num At Risk
9
group Id
EG005
num Affected
9
num At Risk
33
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Haemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
3
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
2
num At Risk
10
group Id
EG001
num Affected
3
num At Risk
12
group Id
EG002
num Affected
4
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
1
num At Risk
33
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
5
num At Risk
10
group Id
EG001
num Affected
4
num At Risk
12
group Id
EG002
num Affected
6
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
9
group Id
EG005
num Affected
1
num At Risk
33
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Atrial fibrillation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
1
num At Risk
33
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
1
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
2
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
1
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
1
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
2
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Vitello-intestinal duct remnant
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
1
num At Risk
33
term
Lower gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
0
num At Risk
33
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
12
group Id
EG002
num Affected
0
num At Risk
34
group Id
EG003
num Affected
0
num At Risk
9
group Id
EG004
num Affected
0
num At Risk
9
group Id
EG005
num Affected
1
num At Risk
33
term
Peripheral swelling

time Frame

All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.

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Preserved source evidence · Not medical advice