TriangleNCT01408563 · OUTCOME
Rates of Grade II-IV and Grade III-IV Acute Graft Versus Host Disease (GVHD) at 100 Days
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
- 100 Days
What was measured
Acute GVHD is assessed using Consensus Criteria: Organ Classifications: * 0: No rash due to GVHD; Bilirubin \< 2 mg/dL; \< 500 mL diarrhea/ day * 1: Maculopapular rash \< 25% of body surface; Bilirubin 2-3 mg/dL; 500 to 999 mL diarrhea/ day or persistent nausea with histologic evidence of GVHD in stomach/ duodenum * 2: Maculopapular rash 25-50% of body surface; Bilirubin 3.1-6 mg/dL; 1,000 to 1,499 mL diarrhea/ day * 3: Maculopapular rash \> 50% of body surface; Bilirubin 6.1-15 mg/dL; 1,500 or more mL diarrhea/ day * 4: Generalized erythroderma with bullous formation; Bilirubin \> 15 mg/dL; Severe abdominal pain with or without ileus Overall Clinical Grade: * 0: No Stage 1-4 of any organ * I: Stage 1-2 rash and no liver or gut involvement * II: Stage 3 rash, or Stage 1 liver involvement, or Stage 1 gut involvement * III: None to Stage 3 skin rash with Stage 2-3 liver involvement, or Stage 2-4 gut involvement * IV: Stage 4 skin rash, or Stage 4 liver involvement
Analysis population: The two participants found to be ineligible after being consented and registered were excluded from the analysis.
Groups in this outcome
Fludarabine/Melphalan/TBI
All patients receive same therapy Fludarabine: 30 mg/m2/day IV x 6 days Melphalan: 100 mg/m2/day IV x 1 day Total Body Radiation: 200 cGy on Day 0 Cord Blood: 2 cord blood units IV
| Group | Source count |
|---|---|
| Fludarabine/Melphalan/TBI | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fludarabine/Melphalan/TBI | 16 | Not reported | 5.7 | 31 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.7
- upper Limit
- 31
- value
- 16
- denoms
- counts
- group Id
- OG000
- value
- 31
- units
- Participants
- description
- Acute GVHD is assessed using Consensus Criteria: Organ Classifications: * 0: No rash due to GVHD; Bilirubin \< 2 mg/dL; \< 500 mL diarrhea/ day * 1: Maculopapular rash \< 25% of body surface; Bilirubin 2-3 mg/dL; 500 to 999 mL diarrhea/ day or persistent nausea with histologic evidence of GVHD in stomach/ duodenum * 2: Maculopapular rash 25-50% of body surface; Bilirubin 3.1-6 mg/dL; 1,000 to 1,499 mL diarrhea/ day * 3: Maculopapular rash \> 50% of body surface; Bilirubin 6.1-15 mg/dL; 1,500 or more mL diarrhea/ day * 4: Generalized erythroderma with bullous formation; Bilirubin \> 15 mg/dL; Severe abdominal pain with or without ileus Overall Clinical Grade: * 0: No Stage 1-4 of any organ * I: Stage 1-2 rash and no liver or gut involvement * II: Stage 3 rash, or Stage 1 liver involvement, or Stage 1 gut involvement * III: None to Stage 3 skin rash with Stage 2-3 liver involvement, or Stage 2-4 gut involvement * IV: Stage 4 skin rash, or Stage 4 liver involvement
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All patients receive same therapy Fludarabine: 30 mg/m2/day IV x 6 days Melphalan: 100 mg/m2/day IV x 1 day Total Body Radiation: 200 cGy on Day 0 Cord Blood: 2 cord blood units IV
- id
- OG000
- title
- Fludarabine/Melphalan/TBI
- param Type
- NUMBER
- population Description
- The two participants found to be ineligible after being consented and registered were excluded from the analysis.
- reporting Status
- POSTED
- time Frame
- 100 Days
- title
- Rates of Grade II-IV and Grade III-IV Acute Graft Versus Host Disease (GVHD) at 100 Days
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice