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NCT03072043 · OUTCOME

Overall Survival (OS)

Phase 1b/2 Safety and Efficacy of APR-246 w/Azacitidine for tx of TP53 Mutant Myeloid Neoplasms · Source last updated 2022-01-24

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
Up to 24 months

What was measured

OS:The length of time from the start of treatment until death by any cause.

Analysis population: All participants who received at least one dose of study drug

Groups in this outcome

Phase 1B Dose Level 1

All participants treated at level 1: APR-246 50mg/kg lean body weight (LBW) + Azacitidine 75mg/m\^2

Phase 1B Dose Level 2

All participants treated at dose level 2: APR-246 75mg/kg lean body weight (LBW) + Azacitidine 75mg/m\^2

Phase 1B: Dose Level 3 / Phase 2 MTD

All participants treated at dose level 3/ Phase 2 MTD : APR-246 100 mg/kg lean body weight (LBW) + Azacitidine 75mg/m\^2

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

Analysis denominator · Participants

GroupSource count
Phase 1B Dose Level 13
Phase 1B Dose Level 23
Phase 1B: Dose Level 3 / Phase 2 MTD49

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B Dose Level 114.6Not reported2.416.0Not reported
Phase 1B Dose Level 211.6Not reported6.313.7Not reported
Phase 1B: Dose Level 3 / Phase 2 MTD10.4Not reported0.717.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.4
        upper Limit
        16.0
        value
        14.6
      2. group Id
        OG001
        lower Limit
        6.3
        upper Limit
        13.7
        value
        11.6
      3. group Id
        OG002
        lower Limit
        0.7
        upper Limit
        17.9
        value
        10.4
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      49
    units
    Participants
description
OS:The length of time from the start of treatment until death by any cause.
dispersion Type
Full Range
groups
  1. description
    All participants treated at level 1: APR-246 50mg/kg lean body weight (LBW) + Azacitidine 75mg/m\^2
    id
    OG000
    title
    Phase 1B Dose Level 1
  2. description
    All participants treated at dose level 2: APR-246 75mg/kg lean body weight (LBW) + Azacitidine 75mg/m\^2
    id
    OG001
    title
    Phase 1B Dose Level 2
  3. description
    All participants treated at dose level 3/ Phase 2 MTD : APR-246 100 mg/kg lean body weight (LBW) + Azacitidine 75mg/m\^2
    id
    OG002
    title
    Phase 1B: Dose Level 3 / Phase 2 MTD
param Type
MEDIAN
population Description
All participants who received at least one dose of study drug
reporting Status
POSTED
time Frame
Up to 24 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice