NCT01776723 · OUTCOME
Duration of Response in Days
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 | Source count |
|---|---|
| Phase 1, Level 1: Ruxolitinib 10 mg | 6 |
| Phase 1, Level 2: Ruxolitinib 20 mg | 4 |
| Phase 1, Level 3: Ruxolitinib 30 mg | 5 |
| Phase 1, Level 4: Ruxolitinib 40 mg | 5 |
| Maximum Tolerated Dose - Ruxolitinib | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Level 1: Ruxolitinib 10 mg | 104 | Not reported | 55 | 172 | Not reported |
| Phase 1, Level 2: Ruxolitinib 20 mg | 446.25 | Not reported | 28 | 961 | Not reported |
| Phase 1, Level 3: Ruxolitinib 30 mg | 718 | Not reported | 54 | 1248 | Not reported |
| Phase 1, Level 4: Ruxolitinib 40 mg | 331.25 | Not reported | 60 | 853 | Not reported |
| Maximum Tolerated Dose - Ruxolitinib | 263.5 | Not reported | 6 | 874 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 55
- upper Limit
- 172
- value
- 104
- group Id
- OG001
- lower Limit
- 28
- upper Limit
- 961
- value
- 446.25
- group Id
- OG002
- lower Limit
- 54
- upper Limit
- 1248
- value
- 718
- group Id
- OG003
- lower Limit
- 60
- upper Limit
- 853
- value
- 331.25
- group Id
- OG004
- lower Limit
- 6
- upper Limit
- 874
- value
- 263.5
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 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
- description
- Phase 1, Level 1: Ruxolitinib 5 mg twice daily
- id
- OG000
- title
- Phase 1, Level 1: Ruxolitinib 10 mg
- description
- Phase 1, Level 2: Ruxolitinib 10 mg twice daily
- id
- OG001
- title
- Phase 1, Level 2: Ruxolitinib 20 mg
- description
- Phase 1 Level 3: Ruxolitinib 15 mg twice daily
- id
- OG002
- title
- Phase 1, Level 3: Ruxolitinib 30 mg
- description
- Phase 1, Level 4: Ruxolitinib 20 mg twice daily
- id
- OG003
- title
- Phase 1, Level 4: Ruxolitinib 40 mg
- 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
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