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NCT03072043 · OUTCOME

Phase 2: Complete Response (CR) Rate

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
NUMBER
Unit
percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
Up to 12 months

What was measured

Complete Response Rate as defined by the 2006 International Working Group (IWG) criteria.

Analysis population: 45 participants were evaluable for response

Groups in this outcome

Phase 2: Participants in Dose Level 3/MTD

All participants who received at least one dose at level 3: 100 mg/kg LBW APR-246 + 75 mg Azacitidine

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 2: Participants in Dose Level 3/MTD45

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Participants in Dose Level 3/MTD53Not reported3868Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38
        upper Limit
        68
        value
        53
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    units
    Participants
description
Complete Response Rate as defined by the 2006 International Working Group (IWG) criteria.
dispersion Type
95% Confidence Interval
groups
  1. description
    All participants who received at least one dose at level 3: 100 mg/kg LBW APR-246 + 75 mg Azacitidine
    id
    OG000
    title
    Phase 2: Participants in Dose Level 3/MTD
param Type
NUMBER
population Description
45 participants were evaluable for response
reporting Status
POSTED
time Frame
Up to 12 months
title
Phase 2: Complete Response (CR) Rate
type
PRIMARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice