TriangleNCT03112603 · OUTCOME
Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score
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
- Baseline; Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
What was measured
To assess improvement of symptoms based on the total symptom score (TSS); a responder was defined as having achieved a clinically relevant reduction from Baseline of the TSS. The scale consists of 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). Participants reported their level of symptom "bother" over the previous month on a 5-point likert scale: not at all, slightly, moderately, quite a bit, or extremely. Subscale scores and the summary score range from 0 to 100, with a higher score indicating worse symptoms.
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 | 24.2 | Not reported | 17.9 | 31.5 | Not reported |
| Best Available Therapy | 11.0 | Not reported | 6.6 | 16.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.9
- upper Limit
- 31.5
- value
- 24.2
- group Id
- OG001
- lower Limit
- 6.6
- upper Limit
- 16.8
- value
- 11.0
- denoms
- counts
- group Id
- OG000
- value
- 165
- group Id
- OG001
- value
- 164
- units
- Participants
- description
- To assess improvement of symptoms based on the total symptom score (TSS); a responder was defined as having achieved a clinically relevant reduction from Baseline of the TSS. The scale consists of 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). Participants reported their level of symptom "bother" over the previous month on a 5-point likert scale: not at all, slightly, moderately, quite a bit, or extremely. Subscale scores and the summary score range from 0 to 100, with a higher score indicating worse symptoms.
- 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
- Baseline; Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
- title
- Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice