TriangleNCT03112603 · OUTCOME
Best Overall Response (BOR) at Cycle 7 Day 1
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
- 95% Confidence Interval
- Time frame
- up to Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
What was measured
BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. This analysis was based on the primary cutoff date (May 2020).
Analysis population: FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).
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 | 76.4 | Not reported | 69.1 | 82.6 | Not reported |
| Best Available Therapy | 60.4 | Not reported | 52.4 | 67.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.34
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.52
- estimate Comment
- The odds ratio and 95% confidence interval (CI) were calculated using a stratified Cochran-Mantel-Haenszel test.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0011
- p Value Comment
- The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel test.
- param Type
- Odds Ratio (OR)
- param Value
- 2.17
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.34
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.52
- estimate Comment
- The odds ratio and 95% confidence interval (CI) were calculated using a stratified Cochran-Mantel-Haenszel test.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0011
- p Value Comment
- The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel test.
- param Type
- Odds Ratio (OR)
- param Value
- 2.17
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 69.1
- upper Limit
- 82.6
- value
- 76.4
- group Id
- OG001
- lower Limit
- 52.4
- upper Limit
- 67.9
- value
- 60.4
- denoms
- counts
- group Id
- OG000
- value
- 165
- group Id
- OG001
- value
- 164
- units
- Participants
- description
- BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. This analysis was based on the primary cutoff date (May 2020).
- 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
- NUMBER
- population Description
- FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).
- reporting Status
- POSTED
- time Frame
- up to Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
- title
- Best Overall Response (BOR) at Cycle 7 Day 1
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice