TriangleNCT03112603 · OUTCOME
Rate of FFS at Study Completion
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From Baseline to Last Participant Last Visit (LPLV) (approximately 5 years)
What was measured
Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD.
Analysis population: FAS
Groups in this outcome
Ruxolitinib
Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
Best Available Therapy
Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.
| Group | Source count |
|---|---|
| Ruxolitinib | 165 |
| Best Available Therapy | 164 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 38.4 | Not reported | 22.1 | NA | The upper limit of the confidence interval was not estimable due to an insufficient number of participants with events. |
| Best Available Therapy | 5.7 | Not reported | 5.6 | 6.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.268
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.485
- estimate Comment
- The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.361
Complete source fields
- analyses
- ci Lower Limit
- 0.268
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.485
- estimate Comment
- The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.361
- classes
- categories
- measurements
- comment
- The upper limit of the confidence interval was not estimable due to an insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 22.1
- upper Limit
- NA
- value
- 38.4
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 6.5
- value
- 5.7
- denoms
- counts
- group Id
- OG000
- value
- 165
- group Id
- OG001
- value
- 164
- units
- Participants
- description
- Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
- id
- OG000
- title
- Ruxolitinib
- description
- Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.
- id
- OG001
- title
- Best Available Therapy
- param Type
- MEDIAN
- population Description
- FAS
- reporting Status
- POSTED
- time Frame
- From Baseline to Last Participant Last Visit (LPLV) (approximately 5 years)
- title
- Rate of FFS at Study Completion
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice