NCT00934544 · OUTCOME
Duration of Maintenance of Spleen Volume Reduction (Kaplan-Meier Estimates)
Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial · Source last updated 2019-08-19
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- probability of response
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline, up to Year 5
What was measured
This is defined as the interval between randomization and date of the first MRI showing a 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Ruxolitinib | 78 |
|---|
| Best Available Therapy (BAT) | 1 |
|---|
Reported measurements
1.0 year
Values in probability of response · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0.72 | Not reported | .60 | .81 | Not reported |
|---|
| 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 |
|---|
1.5 years
Values in probability of response · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0.67 | Not reported | 0.55 | 0.77 | Not reported |
|---|
| 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 |
|---|
2.0 years
Values in probability of response · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0.63 | Not reported | 0.50 | 0.73 | Not reported |
|---|
| 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 |
|---|
2.5 years
Values in probability of response · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0.54 | Not reported | 0.41 | 0.65 | Not reported |
|---|
| 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 |
|---|
3.0 years
Values in probability of response · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0.51 | Not reported | 0.38 | 0.62 | Not reported |
|---|
| 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 |
|---|
3.5 years
Values in probability of response · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0.48 | Not reported | 0.35 | 0.60 | Not reported |
|---|
| 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 |
|---|
4.0 years
Values in probability of response · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0.48 | Not reported | 0.35 | 0.60 | Not reported |
|---|
| 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 |
|---|
4.5 years
Values in probability of response · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0.48 | Not reported | 0.35 | 0.60 | Not reported |
|---|
| 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 |
|---|
5.0 years
Values in probability of response · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0.48 | Not reported | 0.35 | 0.60 | Not reported |
|---|
| 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
- group Id
- OG000
- lower Limit
- .60
- upper Limit
- .81
- value
- 0.72
- 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
- title
- 1.0 year
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.55
- upper Limit
- 0.77
- value
- 0.67
- 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
- title
- 1.5 years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.50
- upper Limit
- 0.73
- value
- 0.63
- 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
- title
- 2.0 years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.41
- upper Limit
- 0.65
- value
- 0.54
- 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
- title
- 2.5 years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.38
- upper Limit
- 0.62
- value
- 0.51
- 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
- title
- 3.0 years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.35
- upper Limit
- 0.60
- value
- 0.48
- 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
- title
- 3.5 years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.35
- upper Limit
- 0.60
- value
- 0.48
- 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
- title
- 4.0 years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.35
- upper Limit
- 0.60
- value
- 0.48
- 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
- title
- 4.5 years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.35
- upper Limit
- 0.60
- value
- 0.48
- 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
- title
- 5.0 years
- denoms
- counts
- group Id
- OG000
- value
- 78
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- This is defined as the interval between randomization and date of the first MRI showing a 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 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
- 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. 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 (Kaplan-Meier Estimates)
- type
- SECONDARY
- unit Of Measure
- probability of response
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