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NCT02145403 · OUTCOME

Phase II: Cumulative Incidence of Chronic GVHD

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 chronic Graft Versus Host Disease (GVHD). 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

cGVHD overall: Day 180
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^22Not reported016Not reported
cGVHD overall: Day 365
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^215Not reported731Not reported
cGVHD overall: Day 1095
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^215Not reported731Not reported
cGVHD Moderate / Severe: Day 180
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^22Not reported016Not reported
cGVHD Moderate / Severe: Day 365
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^210Not reported425Not reported
cGVHD Moderate / Severe: Day 1095
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^210Not reported425Not reported
cGVHD Requiring Systemic Therapy: Day 180
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^22Not reported016Not reported
cGVHD Requiring Systemic Therapy: Day 365
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^27Not reported222Not reported
cGVHD Requiring Systemic Therapy: Day 1095
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^27Not reported222Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        16
        value
        2
    title
    cGVHD overall: Day 180
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7
        upper Limit
        31
        value
        15
    title
    cGVHD overall: Day 365
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7
        upper Limit
        31
        value
        15
    title
    cGVHD overall: Day 1095
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        16
        value
        2
    title
    cGVHD Moderate / Severe: Day 180
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4
        upper Limit
        25
        value
        10
    title
    cGVHD Moderate / Severe: Day 365
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4
        upper Limit
        25
        value
        10
    title
    cGVHD Moderate / Severe: Day 1095
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        16
        value
        2
    title
    cGVHD Requiring Systemic Therapy: Day 180
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        22
        value
        7
    title
    cGVHD Requiring Systemic Therapy: Day 365
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        22
        value
        7
    title
    cGVHD Requiring Systemic Therapy: Day 1095
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
description
The cumulative incidence of chronic Graft Versus Host Disease (GVHD). 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 Chronic GVHD
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice