NCT03158688 · OUTCOME

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. · Source last updated 2025-05-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks

What was measured

Treatment-emergent adverse events are defined as any adverse event with an onset after the administration of the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurs earlier. The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal. Treatment-related adverse events are treatment-emergent adverse events considered related to at least one study drug by the investigator, including those with unknown relationship.

Analysis population: Safety Population

Groups in this outcome

Kd - Carfilzomib and Dexamethasone

KdD - Carfilzomib, Dexamethasone and Daratumumab

Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Kd - Carfilzomib and Dexamethasone	153
KdD - Carfilzomib, Dexamethasone and Daratumumab	308

Reported measurements

PA DCO: All TEAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	147	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	306	Not reported	Not reported	Not reported	Not reported

PA DCO: TEAEs: Severity Grade >=3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	113	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	253	Not reported	Not reported	Not reported	Not reported

PA DCO: TEAEs: Serious Adverse Events

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	70	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	173	Not reported	Not reported	Not reported	Not reported

PA DCO: TEAEs: Leading to discon of carfilzomib

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	33	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	65	Not reported	Not reported	Not reported	Not reported

PA DCO: TEAEs: Leading to discon of daratumumab

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	NA	Not reported	Not reported	Not reported	not relevant for this treatment arm
KdD - Carfilzomib, Dexamethasone and Daratumumab	28	Not reported	Not reported	Not reported	Not reported

PA DCO: TEAEs: Leading to discon of dexamethasone

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	37	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	33	Not reported	Not reported	Not reported	Not reported

PA DCO: Fatal TEAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	8	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	30	Not reported	Not reported	Not reported	Not reported

PA DCO: Treatment-related TEAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	129	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	260	Not reported	Not reported	Not reported	Not reported

PA DCO: Related TEAEs: Grade >=3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	74	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	187	Not reported	Not reported	Not reported	Not reported

PA DCO: Related and serious TEAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	32	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	84	Not reported	Not reported	Not reported	Not reported

PA DCO: Related TEAEs: discon of carfilzomib

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	21	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	50	Not reported	Not reported	Not reported	Not reported

PA DCO: Related TEAEs: discon of daratumumab

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	NA	Not reported	Not reported	Not reported	not relevant for this treatment arm
KdD - Carfilzomib, Dexamethasone and Daratumumab	15	Not reported	Not reported	Not reported	Not reported

PA DCO: Related TEAEs: discon of dexamethasone

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	24	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	19	Not reported	Not reported	Not reported	Not reported

PA DCO: Related Fatal TEAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	5	Not reported	Not reported	Not reported	Not reported

FA DCO: All TEAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	149	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	306	Not reported	Not reported	Not reported	Not reported

FA DCO: TEAEs: Severity Grade >=3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	120	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	273	Not reported	Not reported	Not reported	Not reported

FA DCO: TEAEs: Serious Adverse Events

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	80	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	211	Not reported	Not reported	Not reported	Not reported

FA DCO: TEAEs: Leading to discontinuation of carfilzomib

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	37	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	98	Not reported	Not reported	Not reported	Not reported

FA DCO: TEAEs: Leading to discontinuation of daratumumab

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	NA	Not reported	Not reported	Not reported	not relevant for this treatment arm
KdD - Carfilzomib, Dexamethasone and Daratumumab	43	Not reported	Not reported	Not reported	Not reported

FA DCO: TEAEs: Leading to discon of dexamethasone

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	40	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	58	Not reported	Not reported	Not reported	Not reported

FA DCO: Fatal TEAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	11	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	39	Not reported	Not reported	Not reported	Not reported

FA DCO: Treatment-related TEAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	131	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	267	Not reported	Not reported	Not reported	Not reported

FA DCO: Related TEAEs: Grade >=3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	82	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	206	Not reported	Not reported	Not reported	Not reported

FA DCO: Related and serious TEAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	34	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	102	Not reported	Not reported	Not reported	Not reported

FA DCO: Related TEAEs: discon of carfilzomib

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	22	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	69	Not reported	Not reported	Not reported	Not reported

FA DCO: Related TEAEs: discon of daratumumab

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	NA	Not reported	Not reported	Not reported	not relevant for this treatment arm
KdD - Carfilzomib, Dexamethasone and Daratumumab	18	Not reported	Not reported	Not reported	Not reported

FA DCO: Related TEAEs: discon of dexamethasone

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	24	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	30	Not reported	Not reported	Not reported	Not reported

FA DCO: Related Fatal TEAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Kd - Carfilzomib and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab	5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
147
group Id
OG001
value
306
title
PA DCO: All TEAEs
categories
measurements
group Id
OG000
value
113
group Id
OG001
value
253
title
PA DCO: TEAEs: Severity Grade >=3
categories
measurements
group Id
OG000
value
70
group Id
OG001
value
173
title
PA DCO: TEAEs: Serious Adverse Events
categories
measurements
group Id
OG000
value
33
group Id
OG001
value
65
title
PA DCO: TEAEs: Leading to discon of carfilzomib
categories
measurements
comment
not relevant for this treatment arm
group Id
OG000
value
NA
group Id
OG001
value
28
title
PA DCO: TEAEs: Leading to discon of daratumumab
categories
measurements
group Id
OG000
value
37
group Id
OG001
value
33
title
PA DCO: TEAEs: Leading to discon of dexamethasone
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
30
title
PA DCO: Fatal TEAEs
categories
measurements
group Id
OG000
value
129
group Id
OG001
value
260
title
PA DCO: Treatment-related TEAEs
categories
measurements
group Id
OG000
value
74
group Id
OG001
value
187
title
PA DCO: Related TEAEs: Grade >=3
categories
measurements
group Id
OG000
value
32
group Id
OG001
value
84
title
PA DCO: Related and serious TEAEs
categories
measurements
group Id
OG000
value
21
group Id
OG001
value
50
title
PA DCO: Related TEAEs: discon of carfilzomib
categories
measurements
comment
not relevant for this treatment arm
group Id
OG000
value
NA
group Id
OG001
value
15
title
PA DCO: Related TEAEs: discon of daratumumab

denoms

counts
group Id
OG000
value
153
group Id
OG001
value
308
units
Participants

description

groups

description
Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.
id
OG000
title
Kd - Carfilzomib and Dexamethasone
description
Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only.
id
OG001
title
KdD - Carfilzomib, Dexamethasone and Daratumumab

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety Population

reporting Status

POSTED

time Frame

PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks

title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice