TriangleNCT02038036 · OUTCOME
Number of Participants Achieving a Complete Hematological Remission at Week 28
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
- Week 28
What was measured
Proportion of patients achieving a complete hematological remission at Week 28 was defined by: * Hct control at Week 28 defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 28, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and * WBC \< 10 x109/L at Week 28, and * Platelets ≤ 400 x 109/L at Week 28
Analysis population: Full Analysis Set (FAS) included all participants to whom study treatment was assigned by randomization and had valid measurements for the outcome measure.
Groups in this outcome
Ruxolitinib
Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid
Best Available Therapy (BAT)
Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib
| Group | Source count |
|---|---|
| Ruxolitinib | 74 |
| Best Available Therapy (BAT) | 75 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 17 | Not reported | Not reported | Not reported | Not reported |
| Best Available Therapy (BAT) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 75
- units
- Participants
- description
- Proportion of patients achieving a complete hematological remission at Week 28 was defined by: * Hct control at Week 28 defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 28, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and * WBC \< 10 x109/L at Week 28, and * Platelets ≤ 400 x 109/L at Week 28
- groups
- description
- Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid
- id
- OG000
- title
- Ruxolitinib
- description
- Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib
- id
- OG001
- title
- Best Available Therapy (BAT)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Full Analysis Set (FAS) included all participants to whom study treatment was assigned by randomization and had valid measurements for the outcome measure.
- reporting Status
- POSTED
- time Frame
- Week 28
- title
- Number of Participants Achieving a Complete Hematological Remission at Week 28
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice