TriangleNCT00934544 · OUTCOME
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline, Week 24
What was measured
The change in spleen volume from baseline to week 24 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 24 was then calculated by treatment group.
Analysis population: Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. The table included participants with non-missing baseline MRI measurement of spleen volume only.
Groups in this outcome
Ruxolitinib
5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
Best Available Therapy (BAT)
Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.
| Group | Source count |
|---|---|
| Ruxolitinib | 144 |
| Best Available Therapy (BAT) | 72 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 31.9 | Not reported | Not reported | Not reported | Not reported |
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 31.9
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 144
- group Id
- OG001
- value
- 72
- units
- Participants
- description
- The change in spleen volume from baseline to week 24 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 24 was then calculated by treatment group.
- groups
- description
- 5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
- id
- OG000
- title
- Ruxolitinib
- description
- Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.
- id
- OG001
- title
- Best Available Therapy (BAT)
- param Type
- NUMBER
- population Description
- Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. The table included participants with non-missing baseline MRI measurement of spleen volume only.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 24
- title
- Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice