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NCT00096122 · OUTCOME

Number of Participants With Complete Response

Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia · Source last updated 2014-05-26

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
21 Day Cycle

What was measured

Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1\*10\^9/L or more and platelet count of 100\*10\^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20\*10\^9/L to less than 100\*10\^9/L.

Analysis population: Analysis was per protocol.

Groups in this outcome

Idarubicin, Cytarabine + Tipifarnib

Cytarabine 1.5 g/m\^2 and Idarubicin 12 mg/m\^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.

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

Analysis denominator · Participants

GroupSource count
Idarubicin, Cytarabine + Tipifarnib95

Reported measurements

CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Idarubicin, Cytarabine + Tipifarnib61Not reportedNot reportedNot reportedNot reported
CRp
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Idarubicin, Cytarabine + Tipifarnib9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        61
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    CRp
denoms
  1. counts
    1. group Id
      OG000
      value
      95
    units
    Participants
description
Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1\*10\^9/L or more and platelet count of 100\*10\^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20\*10\^9/L to less than 100\*10\^9/L.
groups
  1. description
    Cytarabine 1.5 g/m\^2 and Idarubicin 12 mg/m\^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
    id
    OG000
    title
    Idarubicin, Cytarabine + Tipifarnib
param Type
NUMBER
population Description
Analysis was per protocol.
reporting Status
POSTED
time Frame
21 Day Cycle
title
Number of Participants With Complete Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice