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NCT01776723 · OUTCOME

Duration of Response in Days

A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib · Source last updated 2022-09-22

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

Measure
MEAN
Unit
days
Interval / dispersion
Full Range
Time frame
3.5 years

What was measured

Phase II - To determine the duration of response achieved as in secondary endpoint one. The duration of response is measured from the time measurement criteria are met for major or complete platelet response (which ever is first recorded) until the first date that disease progression defined by the bone marrow response outlined above, progression/relapse following a CR, marrow CR or PR, or progressions/relapse following hematological improvement (HI) as outlined above.

Groups in this outcome

Phase 1, Level 1: Ruxolitinib 10 mg

Phase 1, Level 1: Ruxolitinib 5 mg twice daily

Phase 1, Level 2: Ruxolitinib 20 mg

Phase 1, Level 2: Ruxolitinib 10 mg twice daily

Phase 1, Level 3: Ruxolitinib 30 mg

Phase 1 Level 3: Ruxolitinib 15 mg twice daily

Phase 1, Level 4: Ruxolitinib 40 mg

Phase 1, Level 4: Ruxolitinib 20 mg twice daily

Maximum Tolerated Dose - Ruxolitinib

Treatment at Maximum Tolerated Dose (MTD).

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 1, Level 1: Ruxolitinib 10 mg6
Phase 1, Level 2: Ruxolitinib 20 mg4
Phase 1, Level 3: Ruxolitinib 30 mg5
Phase 1, Level 4: Ruxolitinib 40 mg5
Maximum Tolerated Dose - Ruxolitinib30

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1, Level 1: Ruxolitinib 10 mg104Not reported55172Not reported
Phase 1, Level 2: Ruxolitinib 20 mg446.25Not reported28961Not reported
Phase 1, Level 3: Ruxolitinib 30 mg718Not reported541248Not reported
Phase 1, Level 4: Ruxolitinib 40 mg331.25Not reported60853Not reported
Maximum Tolerated Dose - Ruxolitinib263.5Not reported6874Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        55
        upper Limit
        172
        value
        104
      2. group Id
        OG001
        lower Limit
        28
        upper Limit
        961
        value
        446.25
      3. group Id
        OG002
        lower Limit
        54
        upper Limit
        1248
        value
        718
      4. group Id
        OG003
        lower Limit
        60
        upper Limit
        853
        value
        331.25
      5. group Id
        OG004
        lower Limit
        6
        upper Limit
        874
        value
        263.5
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      30
    units
    Participants
description
Phase II - To determine the duration of response achieved as in secondary endpoint one. The duration of response is measured from the time measurement criteria are met for major or complete platelet response (which ever is first recorded) until the first date that disease progression defined by the bone marrow response outlined above, progression/relapse following a CR, marrow CR or PR, or progressions/relapse following hematological improvement (HI) as outlined above.
dispersion Type
Full Range
groups
  1. description
    Phase 1, Level 1: Ruxolitinib 5 mg twice daily
    id
    OG000
    title
    Phase 1, Level 1: Ruxolitinib 10 mg
  2. description
    Phase 1, Level 2: Ruxolitinib 10 mg twice daily
    id
    OG001
    title
    Phase 1, Level 2: Ruxolitinib 20 mg
  3. description
    Phase 1 Level 3: Ruxolitinib 15 mg twice daily
    id
    OG002
    title
    Phase 1, Level 3: Ruxolitinib 30 mg
  4. description
    Phase 1, Level 4: Ruxolitinib 20 mg twice daily
    id
    OG003
    title
    Phase 1, Level 4: Ruxolitinib 40 mg
  5. description
    Treatment at Maximum Tolerated Dose (MTD).
    id
    OG004
    title
    Maximum Tolerated Dose - Ruxolitinib
param Type
MEAN
reporting Status
POSTED
time Frame
3.5 years
title
Duration of Response in Days
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice