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NCT01546038 · OUTCOME

Number of Participants With Treatment-emergent AEs at Phase 2 Fit and Unfit (All Causality)

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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
4 years

What was measured

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication and occurred within 28 days post last dose. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.

Analysis population: Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.

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.

Phase 2 Unfit: Glasdegib 100 mg + LDAC

Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.

Phase 2 Unfit: LDAC Alone

Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day 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
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin69
Phase 2 Unfit: Glasdegib 100 mg + LDAC84
Phase 2 Unfit: LDAC Alone41

Reported measurements

Grade 1 AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin0Not reportedNot reportedNot reportedNot reported
Phase 2 Unfit: Glasdegib 100 mg + LDAC2Not reportedNot reportedNot reportedNot reported
Phase 2 Unfit: LDAC Alone0Not reportedNot reportedNot reportedNot reported
Grade 2 AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin1Not reportedNot reportedNot reportedNot reported
Phase 2 Unfit: Glasdegib 100 mg + LDAC4Not reportedNot reportedNot reportedNot reported
Phase 2 Unfit: LDAC Alone1Not reportedNot reportedNot reportedNot reported
Grade 3 AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin11Not reportedNot reportedNot reportedNot reported
Phase 2 Unfit: Glasdegib 100 mg + LDAC15Not reportedNot reportedNot reportedNot reported
Phase 2 Unfit: LDAC Alone8Not reportedNot reportedNot reportedNot reported
Grade 4 AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin52Not reportedNot reportedNot reportedNot reported
Phase 2 Unfit: Glasdegib 100 mg + LDAC39Not reportedNot reportedNot reportedNot reported
Phase 2 Unfit: LDAC Alone15Not reportedNot reportedNot reportedNot reported
Grade 5 AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin5Not reportedNot reportedNot reportedNot reported
Phase 2 Unfit: Glasdegib 100 mg + LDAC24Not reportedNot reportedNot reportedNot reported
Phase 2 Unfit: LDAC Alone17Not reportedNot reportedNot reportedNot reported
Missing or unknown AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin0Not reportedNot reportedNot reportedNot reported
Phase 2 Unfit: Glasdegib 100 mg + LDAC0Not reportedNot reportedNot reportedNot reported
Phase 2 Unfit: LDAC Alone0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    title
    Grade 1 AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        1
    title
    Grade 2 AEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        8
    title
    Grade 3 AEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        15
    title
    Grade 4 AEs
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        17
    title
    Grade 5 AEs
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Missing or unknown AEs
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    2. group Id
      OG001
      value
      84
    3. group Id
      OG002
      value
      41
    units
    Participants
description
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication and occurred within 28 days post last dose. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.
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
  2. description
    Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
    id
    OG001
    title
    Phase 2 Unfit: Glasdegib 100 mg + LDAC
  3. description
    Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
    id
    OG002
    title
    Phase 2 Unfit: LDAC Alone
param Type
NUMBER
population Description
Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.
reporting Status
POSTED
time Frame
4 years
title
Number of Participants With Treatment-emergent AEs at Phase 2 Fit and Unfit (All Causality)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice