TriangleNCT01303965 · OUTCOME
Phase II - Percent of Patients With Acute Graft Versus Host Disease (GvHD)
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
- Day 0 through 1 year post transplantation
What was measured
Percent of patients and the 95% Binomial Confidence interval who had any stage I-IV acute GvHD based on the modified Keystone Grading Scale for skin, liver and gastrointestinal symptoms for patients in Phase II. Zero means no acute GvHD was reported, and higher stages are worse outcomes (range of 0-4). For skin: 0=no rash; 1=erthematous macular rash over \<25% body surface; 2=over 25-50% of body surface; 4=bullae, exfoliation ulcerative dermatitis. For liver (bilirubin (mg/dL)): 0= \<2.0; 1= 2-\<2.9; 3= 3-\<5.9; 4= \>=15 . For gut changes (diarrhea\[ml/day\]): 0=none; 1= \>500-1000; 2= \>1000-1500; 3= \>1500; 4=severe abdominal pain with or without ileus. Overall grade 0: Skin=0; liver=0; gut changes=0. Overall grade 1: Skin with 1 or 2; liver=0; gut changes=0. Overall grade 2: Skin with 1, 2, or 3; liver=1; gut changes=1. Overall grade 3: Skin with 2 or 3; liver with 2 or 3; gut changes with 2 or 3. Overall grade 4: Patients with grade 4 toxicity in any organ system.
Analysis population: All patients who received treatment and were followed after transplant
Groups in this outcome
Phase II
Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
| Group | Source count |
|---|---|
| Phase II | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II | 36.4 | Not reported | 10.9 | 69.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.9
- upper Limit
- 69.2
- value
- 36.4
- denoms
- counts
- group Id
- OG000
- value
- 11
- units
- Participants
- description
- Percent of patients and the 95% Binomial Confidence interval who had any stage I-IV acute GvHD based on the modified Keystone Grading Scale for skin, liver and gastrointestinal symptoms for patients in Phase II. Zero means no acute GvHD was reported, and higher stages are worse outcomes (range of 0-4). For skin: 0=no rash; 1=erthematous macular rash over \<25% body surface; 2=over 25-50% of body surface; 4=bullae, exfoliation ulcerative dermatitis. For liver (bilirubin (mg/dL)): 0= \<2.0; 1= 2-\<2.9; 3= 3-\<5.9; 4= \>=15 . For gut changes (diarrhea\[ml/day\]): 0=none; 1= \>500-1000; 2= \>1000-1500; 3= \>1500; 4=severe abdominal pain with or without ileus. Overall grade 0: Skin=0; liver=0; gut changes=0. Overall grade 1: Skin with 1 or 2; liver=0; gut changes=0. Overall grade 2: Skin with 1, 2, or 3; liver=1; gut changes=1. Overall grade 3: Skin with 2 or 3; liver with 2 or 3; gut changes with 2 or 3. Overall grade 4: Patients with grade 4 toxicity in any organ system.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
- id
- OG000
- title
- Phase II
- param Type
- NUMBER
- population Description
- All patients who received treatment and were followed after transplant
- reporting Status
- POSTED
- time Frame
- Day 0 through 1 year post transplantation
- title
- Phase II - Percent of Patients With Acute Graft Versus Host Disease (GvHD)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice