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NCT01953692 · OUTCOME

Neutrophil Response in Cohort 1: Myelodysplastic Syndrome (MDS)

A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013) · Source last updated 2021-08-04

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
Up to approximately 78.5 months

What was measured

Neutrophil response was measured as an evaluation of hematologic improvement and was assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Neutrophil response baseline was based on an average of at least 2 pre-treatment measurements taken ≥1 week apart and not influenced by transfusions. Responses were considered significant if they lasted for ≥8 weeks. Criterion for a neutrophil response was a ≥100% increase in neutrophil count from pre-treatment and an absolute increase of \>0.5 x 10\^9/Liter. The percentage of participants with a neutrophil response as assessed by the investigator is presented.

Analysis population: All participants in Cohort 1 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.

Groups in this outcome

Cohort 1: Myelodysplastic Syndrome (MDS)

Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 1: Myelodysplastic Syndrome (MDS)27

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: Myelodysplastic Syndrome (MDS)3.6Not reported0.216.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.2
        upper Limit
        16.4
        value
        3.6
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
Neutrophil response was measured as an evaluation of hematologic improvement and was assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Neutrophil response baseline was based on an average of at least 2 pre-treatment measurements taken ≥1 week apart and not influenced by transfusions. Responses were considered significant if they lasted for ≥8 weeks. Criterion for a neutrophil response was a ≥100% increase in neutrophil count from pre-treatment and an absolute increase of \>0.5 x 10\^9/Liter. The percentage of participants with a neutrophil response as assessed by the investigator is presented.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
    id
    OG000
    title
    Cohort 1: Myelodysplastic Syndrome (MDS)
param Type
NUMBER
population Description
All participants in Cohort 1 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
reporting Status
POSTED
time Frame
Up to approximately 78.5 months
title
Neutrophil Response in Cohort 1: Myelodysplastic Syndrome (MDS)
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice