TriangleNCT00934544 · OUTCOME
Duration of Maintenance of Spleen Volume Reduction (Median)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- years
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline, up to Year 5
What was measured
DoMSR is defined as the interval between the first spleen volume measurement that is \>=35% reduction from baseline and the first scan that is no longer = 35% reduction AND that is a \>25% increase over nadir. It was evaluated using the Kaplan-Meier estimate for each treatment arm. The analysis was performed only for subjects who achieved greater than 35% reduction in spleen volume.
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. Treatment groups were defined according to the treatment assignment at the time of randomization.
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 | 78 |
| Best Available Therapy (BAT) | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 3.22 | Not reported | 1.65 | NA | Upper limit is not estimable |
| Best Available Therapy (BAT) | NA | Not reported | NA | NA | There was only one BAT patient responder (≥ 35% reduction in spleen volume) but no consecutive readings to determine any value for duration of response - no Median or CI possible to calculate |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit is not estimable
- group Id
- OG000
- lower Limit
- 1.65
- upper Limit
- NA
- value
- 3.22
- comment
- There was only one BAT patient responder (≥ 35% reduction in spleen volume) but no consecutive readings to determine any value for duration of response - no Median or CI possible to calculate
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 78
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- DoMSR is defined as the interval between the first spleen volume measurement that is \>=35% reduction from baseline and the first scan that is no longer = 35% reduction AND that is a \>25% increase over nadir. It was evaluated using the Kaplan-Meier estimate for each treatment arm. The analysis was performed only for subjects who achieved greater than 35% reduction in spleen volume.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- 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. Treatment groups were defined according to the treatment assignment at the time of randomization.
- reporting Status
- POSTED
- time Frame
- Baseline, up to Year 5
- title
- Duration of Maintenance of Spleen Volume Reduction (Median)
- type
- SECONDARY
- unit Of Measure
- years
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice