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NCT01546038 · OUTCOME

Serum Levels of Circulating Protein Analytes at Phase 1B - Induction Cycle 1/Day 3

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
pg/mL
Interval / dispersion
Full Range
Time frame
Induction Cycle 1/Day 3, 1 Hour Post dose

What was measured

Serum levels were determined for 38 circulating proteins. Values showing statistically significant, ≥2-fold difference compared with baseline are reported here. Statistically significant, \>=2-fold baseline difference was only seen for MMP-3 (Matrix metalloproteinase-3) at Induction Cycle 1/Day 3.

Analysis population: Pharmacodynamic (PD) analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.

Groups in this outcome

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 + Cytarabine/Daunorubicin21

Reported measurements

Source class 1
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin20000Not reported1600111000Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1600
        upper Limit
        111000
        value
        20000
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
Serum levels were determined for 38 circulating proteins. Values showing statistically significant, ≥2-fold difference compared with baseline are reported here. Statistically significant, \>=2-fold baseline difference was only seen for MMP-3 (Matrix metalloproteinase-3) at Induction Cycle 1/Day 3.
dispersion Type
Full Range
groups
  1. description
    Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
    id
    OG000
    title
    Phase 1B: Glasdegib + Cytarabine/Daunorubicin
param Type
MEDIAN
population Description
Pharmacodynamic (PD) analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.
reporting Status
POSTED
time Frame
Induction Cycle 1/Day 3, 1 Hour Post dose
title
Serum Levels of Circulating Protein Analytes at Phase 1B - Induction Cycle 1/Day 3
type
SECONDARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice