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NCT02010645 · OUTCOME

Overall Response Rate (ORR)

Eltrombopag With Decitabine in Advanced Myelodysplastic Syndrome (MDS) · Source last updated 2020-01-02

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
28 days

What was measured

The primary endpoint is the overall response rate (ORR) based on the IWG-2006 criteria, which includes complete remission (CR), partial remission (PR), and hematologic improvement (HI).

Analysis population: One participant was not evaluable for response.

Groups in this outcome

Eltrombopag + Decitabine

Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle. Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle. Eltrombopag: Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle. Decitabine: Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 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
Eltrombopag + Decitabine5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag + Decitabine1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
The primary endpoint is the overall response rate (ORR) based on the IWG-2006 criteria, which includes complete remission (CR), partial remission (PR), and hematologic improvement (HI).
groups
  1. description
    Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle. Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle. Eltrombopag: Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle. Decitabine: Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.
    id
    OG000
    title
    Eltrombopag + Decitabine
param Type
COUNT_OF_PARTICIPANTS
population Description
One participant was not evaluable for response.
reporting Status
POSTED
time Frame
28 days
title
Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice