TriangleNCT03187223 · OUTCOME
Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 60 days
What was measured
Number of Patient experiencing toxicities/adverse events assessed according to the CTCAE 4.0 during the study period
Analysis population: Clinical assessment and documentation of toxicities exceeding grade II during hospitalization were performed until 60 days 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) | 36 | Not reported | Not reported | Not reported | Not reported |
| Arm B (BenMel) | 43 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 43
- denoms
- counts
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 60
- units
- Participants
- description
- Number of Patient experiencing toxicities/adverse events assessed according to the CTCAE 4.0 during the study period
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Clinical assessment and documentation of toxicities exceeding grade II during hospitalization were performed until 60 days after ASCT.
- reporting Status
- POSTED
- time Frame
- 60 days
- title
- Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice