NCT02412878 · ADVERSE EVENTS

Adverse events

Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma · Source last updated 2022-09-23

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 includes deaths that occurred from randomization until the end of study; median (minimum, maximum) follow-up time was 30.7 (0, 39) and 31.2 (0, 38) months in each treatment group respectively. Adverse events are reported from the first dose of study drug up to 30 days after last dose, as of the end of study; median (minimum, maximum) duration of treatment was 29.1 (0.1, 156.3) weeks and 38.0 (0.1, 158.3) weeks in each treatment group respectively.
Other-event reporting threshold: 5%

All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.	102 / 235	204 / 235	127 / 238
Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.	118 / 238	217 / 238	119 / 240

Group identifiers: EG000: Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone · EG001: Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone

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 21.1
stats
group Id
EG000
num Affected
8
num At Risk
235
group Id
EG001
num Affected
4
num At Risk
238
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
235
group Id
EG001
num Affected
0
num At Risk
238
term
Anaemia folate deficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
235
group Id
EG001
num Affected
0
num At Risk
238
term
Anaemia vitamin B12 deficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
235
group Id
EG001
num Affected
1
num At Risk
238
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
235
group Id
EG001
num Affected
1
num At Risk
238
term
Haemolytic uraemic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
235
group Id
EG001
num Affected
1
num At Risk
238
term
Hyperviscosity syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
3
num At Risk
235
group Id
EG001
num Affected
3
num At Risk
238
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
235
group Id
EG001
num Affected
2
num At Risk
238
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
235
group Id
EG001
num Affected
2
num At Risk
238
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
3
num At Risk
235
group Id
EG001
num Affected
2
num At Risk
238
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
235
group Id
EG001
num Affected
1
num At Risk
238
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
235
group Id
EG001
num Affected
1
num At Risk
238
term
Cardiac arrest

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 21.1
stats
group Id
EG000
num Affected
73
num At Risk
235
group Id
EG001
num Affected
69
num At Risk
238
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
23
num At Risk
235
group Id
EG001
num Affected
20
num At Risk
238
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
19
num At Risk
235
group Id
EG001
num Affected
30
num At Risk
238
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
22
num At Risk
235
group Id
EG001
num Affected
21
num At Risk
238
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
51
num At Risk
235
group Id
EG001
num Affected
53
num At Risk
238
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
30
num At Risk
235
group Id
EG001
num Affected
38
num At Risk
238
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
17
num At Risk
235
group Id
EG001
num Affected
25
num At Risk
238
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
29
num At Risk
235
group Id
EG001
num Affected
29
num At Risk
238
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
47
num At Risk
235
group Id
EG001
num Affected
50
num At Risk
238
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
26
num At Risk
235
group Id
EG001
num Affected
23
num At Risk
238
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
38
num At Risk
235
group Id
EG001
num Affected
55
num At Risk
238
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
25
num At Risk
235
group Id
EG001
num Affected
31
num At Risk
238
term
Bronchitis

Complete source fields

description

event Groups

deaths Num Affected
127
deaths Num At Risk
238
description
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
id
EG000
other Num Affected
204
other Num At Risk
235
serious Num Affected
102
serious Num At Risk
235
title
Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone
deaths Num Affected
119
deaths Num At Risk
240
description
Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
id
EG001
other Num Affected
217
other Num At Risk
238
serious Num Affected
118
serious Num At Risk
238
title
Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
73
num At Risk
235
group Id
EG001
num Affected
69
num At Risk
238
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
23
num At Risk
235
group Id
EG001
num Affected
20
num At Risk
238
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
19
num At Risk
235
group Id
EG001
num Affected
30
num At Risk
238
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
22
num At Risk
235
group Id
EG001
num Affected
21
num At Risk
238
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
51
num At Risk
235
group Id
EG001
num Affected
53
num At Risk
238
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
30
num At Risk
235
group Id
EG001
num Affected
38
num At Risk
238
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
17
num At Risk
235
group Id
EG001
num Affected
25
num At Risk
238
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
29
num At Risk
235
group Id
EG001
num Affected
29
num At Risk
238
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
47
num At Risk
235
group Id
EG001
num Affected
50
num At Risk
238
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
26
num At Risk
235
group Id
EG001
num Affected
23
num At Risk
238
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
38
num At Risk
235
group Id
EG001
num Affected
55
num At Risk
238
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
25
num At Risk
235
group Id
EG001
num Affected
31
num At Risk
238
term
Bronchitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
8
num At Risk
235
group Id
EG001
num Affected
4
num At Risk
238
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
235
group Id
EG001
num Affected
0
num At Risk
238
term
Anaemia folate deficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
235
group Id
EG001
num Affected
0
num At Risk
238
term
Anaemia vitamin B12 deficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
235
group Id
EG001
num Affected
1
num At Risk
238
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
235
group Id
EG001
num Affected
1
num At Risk
238
term
Haemolytic uraemic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
235
group Id
EG001
num Affected
1
num At Risk
238
term
Hyperviscosity syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
3
num At Risk
235
group Id
EG001
num Affected
3
num At Risk
238
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
235
group Id
EG001
num Affected
2
num At Risk
238
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
235
group Id
EG001
num Affected
2
num At Risk
238
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
3
num At Risk
235
group Id
EG001
num Affected
2
num At Risk
238
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
0
num At Risk
235
group Id
EG001
num Affected
1
num At Risk
238
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.1
stats
group Id
EG000
num Affected
1
num At Risk
235
group Id
EG001
num Affected
1
num At Risk
238
term
Cardiac arrest

time Frame

All-cause mortality includes deaths that occurred from randomization until the end of study; median (minimum, maximum) follow-up time was 30.7 (0, 39) and 31.2 (0, 38) months in each treatment group respectively. Adverse events are reported from the first dose of study drug up to 30 days after last dose, as of the end of study; median (minimum, maximum) duration of treatment was 29.1 (0.1, 156.3) weeks and 38.0 (0.1, 158.3) weeks in each treatment group respectively.

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