TriangleNCT03187223 · OUTCOME
Hematologic Engraftment After High-dose Chemotherapy
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- 30 days
What was measured
Number of days needed to achieve hematologic engraftment after high-dose chemotherapy induced myelosuppression is defined as the first day of neutrophils rising again above 0.5 G/l, and of platelets rising again above 20 G/L in the absence of platelet transfusions in the previous 3 days.
Analysis population: Time to neutrophil engraftment was defined as the duration between day 0 and the first 3 days of neutrophils \>0.5 × 109/L after ASCT.
Groups in this outcome
Arm A (Mel)
Melphalan 100mg/m2/day iv days -2 and -1 Melphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0.
Arm B (BenMel)
Melphalan 100mg/m2/day iv days -2 and -1 Bendamustine 200mg/m2/day iv days -4 and -3 Melphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0. Bendamustine: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive bendamustine at a total dose of 400mg/m2, divided in two doses of 200mg/m2/day on days -4 and -3. Melphalan is given at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day, each on days -2 and -1, with the ASCT at day 0.
| Group | Source count |
|---|---|
| Arm A (Mel) | 60 |
| Arm B (BenMel) | 60 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Mel) | 12 | Not reported | 10 | 18 | Not reported |
| Arm B (BenMel) | 11 | Not reported | 10 | 60 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10
- upper Limit
- 18
- value
- 12
- group Id
- OG001
- lower Limit
- 10
- upper Limit
- 60
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 60
- units
- Participants
- description
- Number of days needed to achieve hematologic engraftment after high-dose chemotherapy induced myelosuppression is defined as the first day of neutrophils rising again above 0.5 G/l, and of platelets rising again above 20 G/L in the absence of platelet transfusions in the previous 3 days.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Melphalan 100mg/m2/day iv days -2 and -1 Melphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0.
- id
- OG000
- title
- Arm A (Mel)
- description
- Melphalan 100mg/m2/day iv days -2 and -1 Bendamustine 200mg/m2/day iv days -4 and -3 Melphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0. Bendamustine: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive bendamustine at a total dose of 400mg/m2, divided in two doses of 200mg/m2/day on days -4 and -3. Melphalan is given at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day, each on days -2 and -1, with the ASCT at day 0.
- id
- OG001
- title
- Arm B (BenMel)
- param Type
- MEDIAN
- population Description
- Time to neutrophil engraftment was defined as the duration between day 0 and the first 3 days of neutrophils \>0.5 × 109/L after ASCT.
- reporting Status
- POSTED
- time Frame
- 30 days
- title
- Hematologic Engraftment After High-dose Chemotherapy
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice