TriangleNCT00448357 · OUTCOME
Number of Participants With Dose Limiting Toxicities (DLTs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- DLTs
- Interval / dispersion
- Not reported
- Time frame
- first 6 weeks or 42 days following stem cell infusion
What was measured
Dose limiting toxicity will be defined as any irreversible grade 3 or any grade 4 non-hematologic toxicity that is related to busulfan infusion and not graft vs host disease or late infection after recovery from the initial period of myelosuppression. The maximum tolerated dose (MTD) is defined as the dose with probability of dose limiting toxicity (DLT) of 0.25. The dose of continuous infusion IV busulfan based on blood levels derived from a test dose in conjunction with fludarabine and alemtuzumab plus tacrolimus for GVHD prophylaxis.
Groups in this outcome
Dose Level 1
Target AUC/24 hrs of 4800 micrometer (uM)-min +/-15%
Dose Level 2
Target AUC/24 hrs of 5760 uM-min +/- 15%
Dose Level 3
Target AUC/24 hrs of 6912 uM-min +/- 15%
Dose Level 4
Target AUC/24 hrs of 7603 uM-min+/- 15%
Dose Level 5
Target AUC/24 hrs of 8363 uM-min+/- 15%
| Group | Source count |
|---|---|
| Dose Level 1 | 14 |
| Dose Level 2 | 7 |
| Dose Level 3 | 24 |
| Dose Level 4 | 7 |
| Dose Level 5 | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 5 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 24
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 2
- units
- Participants
- description
- Dose limiting toxicity will be defined as any irreversible grade 3 or any grade 4 non-hematologic toxicity that is related to busulfan infusion and not graft vs host disease or late infection after recovery from the initial period of myelosuppression. The maximum tolerated dose (MTD) is defined as the dose with probability of dose limiting toxicity (DLT) of 0.25. The dose of continuous infusion IV busulfan based on blood levels derived from a test dose in conjunction with fludarabine and alemtuzumab plus tacrolimus for GVHD prophylaxis.
- groups
- description
- Target AUC/24 hrs of 4800 micrometer (uM)-min +/-15%
- id
- OG000
- title
- Dose Level 1
- description
- Target AUC/24 hrs of 5760 uM-min +/- 15%
- id
- OG001
- title
- Dose Level 2
- description
- Target AUC/24 hrs of 6912 uM-min +/- 15%
- id
- OG002
- title
- Dose Level 3
- description
- Target AUC/24 hrs of 7603 uM-min+/- 15%
- id
- OG003
- title
- Dose Level 4
- description
- Target AUC/24 hrs of 8363 uM-min+/- 15%
- id
- OG004
- title
- Dose Level 5
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- first 6 weeks or 42 days following stem cell infusion
- title
- Number of Participants With Dose Limiting Toxicities (DLTs)
- type
- PRIMARY
- unit Of Measure
- DLTs
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice