TriangleNCT00943800 · OUTCOME
Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-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 patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 2 years
What was measured
Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+). Chronic GVHD is assessed by NIH consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria. (See Citation: Filipovich AH et al) The incidence of patients with acute GVHD (Grade II-IV) was determined at 180 days. The incidence of Chronic GVHD by 2 years was reported
Groups in this outcome
Treatment Group
Although the protocol initially had different disease intensities, ultimately, moved to one regimen for all patients. Subjects received 30mg/m\^2 of Fludarabine from Day-7 until Day-3, 140mg/m\^2 of Melphalan on Day-2, and 1.5mg/kg of Rabbit antithymocyte globulin at Day-7,-5,-3 and -1."
| Group | Source count |
|---|---|
| Treatment Group | 87 |
Reported measurements
Acute GVHD (grade II-IV)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Group | 16.1 | Not reported | 9.3 | 24.6 | Not reported |
Chronic GVHD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Group | 3.4 | Not reported | 0.9 | 9.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.3
- upper Limit
- 24.6
- value
- 16.1
- title
- Acute GVHD (grade II-IV)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.9
- upper Limit
- 9.0
- value
- 3.4
- title
- Chronic GVHD
- denoms
- counts
- group Id
- OG000
- value
- 87
- units
- Participants
- description
- Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+). Chronic GVHD is assessed by NIH consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria. (See Citation: Filipovich AH et al) The incidence of patients with acute GVHD (Grade II-IV) was determined at 180 days. The incidence of Chronic GVHD by 2 years was reported
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Although the protocol initially had different disease intensities, ultimately, moved to one regimen for all patients. Subjects received 30mg/m\^2 of Fludarabine from Day-7 until Day-3, 140mg/m\^2 of Melphalan on Day-2, and 1.5mg/kg of Rabbit antithymocyte globulin at Day-7,-5,-3 and -1."
- id
- OG000
- title
- Treatment Group
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice