TriangleNCT01969838 · OUTCOME
RBC Transfusion Dependence Rate at Week 24. (Defined as Having Had at Least 4 Units of RBC Transfusions, or a Hemoglobin Level Below 8 g/dL in 8 Weeks Prior to Week 24 (Excluding Cases Associated With Clinically Overt Bleeding)).
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 24
What was measured
RBC transfusion dependence is the percentage of participants who are transfusion dependent at Week 24, defined as having had at least 4 units of RBC transfusions, or a hemoglobin level below 8 g/dL in 8 weeks prior to Week 24 (excluding cases associated with clinically overt bleeding). Participants with the last double-blind phase participation date prior to Day 162 (ie. missing at Week 24) were considered transfusion dependent at Week 24.
Groups in this outcome
Momelotinib (MMB)
Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
Ruxolitinib (RUX)
Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
| Group | Source count |
|---|---|
| Momelotinib (MMB) | 215 |
| Ruxolitinib (RUX) | 217 |
Reported measurements
Source class 1
Dependent
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Momelotinib (MMB) | 65 | Not reported | Not reported | Not reported | Not reported |
| Ruxolitinib (RUX) | 87 | Not reported | Not reported | Not reported | Not reported |
Nondependent
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Momelotinib (MMB) | 150 | Not reported | Not reported | Not reported | Not reported |
| Ruxolitinib (RUX) | 130 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.19
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.02
- estimate Comment
- A smaller proportion represents larger benefit.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.019
- param Type
- Proportion Difference - Stratified CMH
- param Value
- -0.10
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -0.19
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.02
- estimate Comment
- A smaller proportion represents larger benefit.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.019
- param Type
- Proportion Difference - Stratified CMH
- param Value
- -0.10
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 87
- title
- Dependent
- measurements
- group Id
- OG000
- value
- 150
- group Id
- OG001
- value
- 130
- title
- Nondependent
- denoms
- counts
- group Id
- OG000
- value
- 215
- group Id
- OG001
- value
- 217
- units
- Participants
- description
- RBC transfusion dependence is the percentage of participants who are transfusion dependent at Week 24, defined as having had at least 4 units of RBC transfusions, or a hemoglobin level below 8 g/dL in 8 weeks prior to Week 24 (excluding cases associated with clinically overt bleeding). Participants with the last double-blind phase participation date prior to Day 162 (ie. missing at Week 24) were considered transfusion dependent at Week 24.
- groups
- description
- Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
- id
- OG000
- title
- Momelotinib (MMB)
- description
- Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
- id
- OG001
- title
- Ruxolitinib (RUX)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Week 24
- title
- RBC Transfusion Dependence Rate at Week 24. (Defined as Having Had at Least 4 Units of RBC Transfusions, or a Hemoglobin Level Below 8 g/dL in 8 Weeks Prior to Week 24 (Excluding Cases Associated With Clinically Overt Bleeding)).
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice