TriangleNCT01499147 · OUTCOME
Number of Participants With Moderate to Severe (Grade 2-4) 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
- participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 100 days post-transplant (acute GVHD).
What was measured
Acute GVHD grade 2-4 was assessed in patients in the FluBU and FluMel groups up to 100 days after transplant.
Groups in this outcome
Fludarabine/Busulfan + ATG
All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor. fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.
Fludarabine/Melphalan +ATG
All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG. fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl).
| Group | Source count |
|---|---|
| Fludarabine/Busulfan + ATG | 18 |
| Fludarabine/Melphalan +ATG | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fludarabine/Busulfan + ATG | 2 | Not reported | Not reported | Not reported | Not reported |
| Fludarabine/Melphalan +ATG | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- Acute GVHD grade 2-4 was assessed in patients in the FluBU and FluMel groups up to 100 days after transplant.
- groups
- description
- All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor. fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.
- id
- OG000
- title
- Fludarabine/Busulfan + ATG
- description
- All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG. fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl).
- id
- OG001
- title
- Fludarabine/Melphalan +ATG
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 100 days post-transplant (acute GVHD).
- title
- Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice