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NCT02145403 · OUTCOME

Phase II: Cumulative Incidence of Non-relapse Mortality

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
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 3 years

What was measured

The cumulative incidence of non-relapse mortality. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis.

Analysis population: Subjects who received all 4 doses of carfilzomib at the maximum tolerated dose (MTD) level (dose level 3, 36 mg/m\^2): 39 subjects total. Note: three subjects who completed 4 doses of carfilzomib at the MTD during the phase 1 portion of the study were included in phase 2 analysis.

Groups in this outcome

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

Participants were administered 20 mg/m\^2 on days 1 and 2; 36 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

GroupSource count
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^239

Reported measurements

Day 180
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^215Not reported729Not reported
Day 365
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^217Not reported931Not reported
Day 1095
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^223Not reported1439Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7
        upper Limit
        29
        value
        15
    title
    Day 180
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9
        upper Limit
        31
        value
        17
    title
    Day 365
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14
        upper Limit
        39
        value
        23
    title
    Day 1095
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
description
The cumulative incidence of non-relapse mortality. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis.
dispersion Type
95% Confidence Interval
groups
  1. 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
    OG000
    title
    Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2
param Type
NUMBER
population Description
Subjects who received all 4 doses of carfilzomib at the maximum tolerated dose (MTD) level (dose level 3, 36 mg/m\^2): 39 subjects total. Note: three subjects who completed 4 doses of carfilzomib at the MTD during the phase 1 portion of the study were included in phase 2 analysis.
reporting Status
POSTED
time Frame
Up to 3 years
title
Phase II: Cumulative Incidence of Non-relapse Mortality
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice