NCT02145403 · OUTCOME

Number of Regimen Related Toxicities (RRTs)

Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies · Source last updated 2022-01-03

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

Measure: NUMBER
Unit: Regimen related toxicities
Interval / dispersion: Not reported
Time frame: Up to 30 days post treatment

What was measured

An RTT is defined as an adverse event (AE) that occurs within +37 days after transplant or 30 days after the last dose of carfilzomib (day +7), and is considered to be a direct consequence and a related event as a result of the combination of conditioning chemotherapy, GVHD prophylaxis regimen and carfilzomib.

Analysis population: Subjects who have received at least one dose of carfilzomib were evaluable for toxicities

Groups in this outcome

Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2 IV

Participants were administered 20 mg/m\^2 of Carfilzomib on days 1, 2, 6 and 7.

Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2 IV

Participants were administered 20 mg/m\^2 on days 1 and 2; 27 mg/m\^2 of Carfilzomib on days 6 and 7.

Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 IV

Participants were administered 20 mg/m\^2 on days 1 and 2; 36 mg/m\^2 of Carfilzomib on days 6 and 7.

Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2 IV

Participants were administered 20 mg/m\^2 on days 1 and 2; 45 mg/m\^2 of Carfilzomib on days 6 and 7.

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
Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2 IV	3
Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2 IV	3
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 IV	41
Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2 IV	4

Reported measurements

Source class 1

Values in Regimen related toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2 IV	4	Not reported	Not reported	Not reported	Not reported
Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2 IV	1	Not reported	Not reported	Not reported	Not reported
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 IV	15	Not reported	Not reported	Not reported	Not reported
Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2 IV	6	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
4
group Id
OG001
value
1
group Id
OG002
value
15
group Id
OG003
value
6

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
41
group Id
OG003
value
4
units
Participants

description

groups

description
Participants were administered 20 mg/m\^2 of Carfilzomib on days 1, 2, 6 and 7.
id
OG000
title
Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2 IV
description
Participants were administered 20 mg/m\^2 on days 1 and 2; 27 mg/m\^2 of Carfilzomib on days 6 and 7.
id
OG001
title
Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2 IV
description
Participants were administered 20 mg/m\^2 on days 1 and 2; 36 mg/m\^2 of Carfilzomib on days 6 and 7.
id
OG002
title
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 IV
description
Participants were administered 20 mg/m\^2 on days 1 and 2; 45 mg/m\^2 of Carfilzomib on days 6 and 7.
id
OG003
title
Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2 IV

param Type

NUMBER

population Description

Subjects who have received at least one dose of carfilzomib were evaluable for toxicities

reporting Status

POSTED

time Frame

Up to 30 days post treatment

title

Number of Regimen Related Toxicities (RRTs)

type

SECONDARY

unit Of Measure

Regimen related toxicities

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

Preserved source evidence · Not medical advice