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NCT01842646 · OUTCOME

Median Overall Survival (OS)

Phase II Hedgehog Inhibitor for Myelodysplastic Syndrome (MDS) · Source last updated 2021-06-14

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 2 years, 4 months

What was measured

To estimate the overall survival of patients with refractory/relapsed myelodysplastic Syndrome (MDS) and chronic myelo-monocytic leukemia (CMML) treated with PF-0444913. Overall survival will be defined as the time period between the date of the first dose of drug until the time of death.

Analysis population: All participants

Groups in this outcome

Experimental: PF-04449913 Treatment

Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.

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

Analysis denominator · Participants

GroupSource count
Experimental: PF-04449913 Treatment35

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment10.2Not reported6.813.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.8
        upper Limit
        13.6
        value
        10.2
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
To estimate the overall survival of patients with refractory/relapsed myelodysplastic Syndrome (MDS) and chronic myelo-monocytic leukemia (CMML) treated with PF-0444913. Overall survival will be defined as the time period between the date of the first dose of drug until the time of death.
dispersion Type
95% Confidence Interval
groups
  1. description
    Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
    id
    OG000
    title
    Experimental: PF-04449913 Treatment
param Type
MEDIAN
population Description
All participants
reporting Status
POSTED
time Frame
Up to 2 years, 4 months
title
Median Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice