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NCT01546038 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events (AEs) at Phase 1B (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 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

Grade 1 AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC1Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Decitabine1Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin0Not reportedNot reportedNot reportedNot reported
Grade 2 AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC2Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Decitabine0Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin3Not reportedNot reportedNot reportedNot reported
Grade 3 AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC3Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Decitabine1Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin8Not reportedNot reportedNot reportedNot reported
Grade 4 AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC10Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Decitabine4Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin10Not reportedNot reportedNot reportedNot reported
Grade 5 AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC7Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Decitabine1Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin1Not reportedNot reportedNot reportedNot reported
Missing or unknown AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC0Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Decitabine0Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Grade 1 AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
    title
    Grade 2 AEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        8
    title
    Grade 3 AEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        10
    title
    Grade 4 AEs
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    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
      23
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      22
    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
    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
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 Adverse Events (AEs) at Phase 1B (All Causality)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice