TriangleNCT02038036 · OUTCOME
Number of Participants Achieving a Complete Hematological Remission at Week 104, Week 156, Week 208 and Week 260
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
- From Week 8 to Week 104, 156, 208 and 260
What was measured
Proportion of patients achieving a complete hematological remission at Week 104 as defined by Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and * WBC \< 10 x10\^9/L at Week 104, and * Platelets ≤ 400 x 10\^9/L at Week 104 Endpoint for Week 156, Week 208 and Week 260 were defined, similarly.
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. Data after crossover for participants randomized to BAT were not collected.
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
| Group | Source count |
|---|---|
| Ruxolitinib | 74 |
Reported measurements
Week 104
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 15 | Not reported | Not reported | Not reported | Not reported |
Week 156
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 19 | Not reported | Not reported | Not reported | Not reported |
Week 208
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 11 | Not reported | Not reported | Not reported | Not reported |
Week 260
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 15
- title
- Week 104
- categories
- measurements
- group Id
- OG000
- value
- 19
- title
- Week 156
- categories
- measurements
- group Id
- OG000
- value
- 11
- title
- Week 208
- categories
- measurements
- group Id
- OG000
- value
- 9
- title
- Week 260
- denoms
- counts
- group Id
- OG000
- value
- 74
- units
- Participants
- description
- Proportion of patients achieving a complete hematological remission at Week 104 as defined by Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and * WBC \< 10 x10\^9/L at Week 104, and * Platelets ≤ 400 x 10\^9/L at Week 104 Endpoint for Week 156, Week 208 and Week 260 were defined, similarly.
- 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
- 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. Data after crossover for participants randomized to BAT were not collected.
- reporting Status
- POSTED
- time Frame
- From Week 8 to Week 104, 156, 208 and 260
- title
- Number of Participants Achieving a Complete Hematological Remission at Week 104, Week 156, Week 208 and Week 260
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice