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NCT01842646 · OUTCOME

Median Time to Transformation to Acute Myeloid Leukemia (AML)

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 2 years, 4 months

What was measured

To estimate the time to transformation to AML in patients with \<20% blasts. In patients with less than 20% blasts, the time to transformation to AML will be defined as the date of the first dose of drug until either the percentage of bone marrow blasts or the percentage of peripheral blasts exceeds 20%, whichever is first.

Analysis population: NA- The median time to AML was not reached due to insufficient number of participants with events.

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 Treatment0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
To estimate the time to transformation to AML in patients with \<20% blasts. In patients with less than 20% blasts, the time to transformation to AML will be defined as the date of the first dose of drug until either the percentage of bone marrow blasts or the percentage of peripheral blasts exceeds 20%, whichever is first.
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
population Description
NA- The median time to AML was not reached due to insufficient number of participants with events.
reporting Status
POSTED
time Frame
Up to 2 years, 4 months
title
Median Time to Transformation to Acute Myeloid Leukemia (AML)
type
SECONDARY

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

Preserved source evidence · Not medical advice