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NCT01546038 · OUTCOME

Overall Survival (OS) at Phase 2 Fit

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 2 Fit arm who received at least 1 dose of study medication. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.

Groups in this outcome

Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin

Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.

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 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin69

Reported measurements

Total participants

Analysis denominator · Participants

GroupSource count
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin69
Values in Months · Interval/dispersion: 80% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin14.9Not reported13.419.3Not reported
Participants >= 55 years old

Analysis denominator · Participants

GroupSource count
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin60
Values in Months · Interval/dispersion: 80% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin14.7Not reported13.117.7Not reported
Participants < 55 years old

Analysis denominator · Participants

GroupSource count
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin9
Values in Months · Interval/dispersion: 80% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/DaunorubicinNANot reported11.0NANumber of deaths was 4 until the study completion, not enough for OS calculation.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.4
        upper Limit
        19.3
        value
        14.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      units
      Participants
    title
    Total participants
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.1
        upper Limit
        17.7
        value
        14.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        60
      units
      Participants
    title
    Participants >= 55 years old
  3. categories
    1. measurements
      1. comment
        Number of deaths was 4 until the study completion, not enough for OS calculation.
        group Id
        OG000
        lower Limit
        11.0
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Participants < 55 years old
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    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
    Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
    id
    OG000
    title
    Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin
param Type
MEDIAN
population Description
Full analysis set: all enrolled participants of Phase 2 Fit arm who received at least 1 dose of study medication. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
reporting Status
POSTED
time Frame
First dose to Follow-up (4 years)
title
Overall Survival (OS) at Phase 2 Fit
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice