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NCT01546038 · OUTCOME

Overall Survival (OS) at Phase 1B

A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome · Source last updated 2020-03-03

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
80% Confidence Interval
Time frame
First dose to Follow-up (4 years)

What was measured

OS was defined as duration from the date of randomization to the date of death from any cause. Kaplan-Meier (KM) method was used to estimate median OS. In this method, every participant had a follow-up time which was associated with an indicator, 1=event (death in our case), and 0 =censored. If the participants were not known to have died, time to date of last known to be alive was used as to calculate the follow-up time and indicator was 0 for these participants. KM method estimates the median OS based on the K-M curve. The K-M curve only drops when we had an event and censor data are the ticks in the graph. To estimate median OS, the K-M curve usually will be smoothed first and a line will be drawn at 50%. The median OS is the point when K-M curve and the horizontal hit. Survival status was collected every month for the first 2 months after discontinuation of study treatment and thereafter every 2 months until death or 4 years from each participant's first dose.

Analysis population: Full analysis set: all enrolled participants of Phase 1B portion who received at least 1 dose of study medication.

Groups in this outcome

Phase 1B: Glasdegib + LDAC

Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.

Phase 1B: Glasdegib + Decitabine

Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.

Phase 1B: Glasdegib + Cytarabine/Daunorubicin

Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.

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: Glasdegib + LDAC23
Phase 1B: Glasdegib + Decitabine7
Phase 1B: Glasdegib + Cytarabine/Daunorubicin22

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 80% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC4.4Not reported2.56.6Not reported
Phase 1B: Glasdegib + Decitabine11.5Not reported4.517.4Not reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin37.8Not reported14.5NAThe upper bound of 80% CI was not estimable, as 10 (45.5%) participants were censored for no longer being followed for survival
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.5
        upper Limit
        6.6
        value
        4.4
      2. group Id
        OG001
        lower Limit
        4.5
        upper Limit
        17.4
        value
        11.5
      3. comment
        The upper bound of 80% CI was not estimable, as 10 (45.5%) participants were censored for no longer being followed for survival
        group Id
        OG002
        lower Limit
        14.5
        upper Limit
        NA
        value
        37.8
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      22
    units
    Participants
description
OS was defined as duration from the date of randomization to the date of death from any cause. Kaplan-Meier (KM) method was used to estimate median OS. In this method, every participant had a follow-up time which was associated with an indicator, 1=event (death in our case), and 0 =censored. If the participants were not known to have died, time to date of last known to be alive was used as to calculate the follow-up time and indicator was 0 for these participants. KM method estimates the median OS based on the K-M curve. The K-M curve only drops when we had an event and censor data are the ticks in the graph. To estimate median OS, the K-M curve usually will be smoothed first and a line will be drawn at 50%. The median OS is the point when K-M curve and the horizontal hit. Survival status was collected every month for the first 2 months after discontinuation of study treatment and thereafter every 2 months until death or 4 years from each participant's first dose.
dispersion Type
80% Confidence Interval
groups
  1. description
    Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.
    id
    OG000
    title
    Phase 1B: Glasdegib + LDAC
  2. description
    Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.
    id
    OG001
    title
    Phase 1B: Glasdegib + Decitabine
  3. description
    Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
    id
    OG002
    title
    Phase 1B: Glasdegib + Cytarabine/Daunorubicin
param Type
MEDIAN
population Description
Full analysis set: all enrolled participants of Phase 1B portion who received at least 1 dose of study medication.
reporting Status
POSTED
time Frame
First dose to Follow-up (4 years)
title
Overall Survival (OS) at Phase 1B
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice