TriangleNCT00602667 · OUTCOME
Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- µmol·h/L
- Interval / dispersion
- Full Range
- Time frame
- Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
What was measured
Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.
Analysis population: Eligible patients who received cyclophosphamide during consolidation cycle 2 and had samples collected for PK analysis.
Groups in this outcome
Low-Risk Group
Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma
Intermediate-Risk Group
Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease
High-Risk Group
Patients with central nervous system (CNS) metastatic disease
| Group | Source count |
|---|---|
| Low-Risk Group | 18 |
| Intermediate-Risk Group | 3 |
| High-Risk Group | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low-Risk Group | 1966 | Not reported | 1437 | 2519 | Not reported |
| Intermediate-Risk Group | 799 | Not reported | 740 | 2303 | Not reported |
| High-Risk Group | 899 | Not reported | 700 | 1240 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1437
- upper Limit
- 2519
- value
- 1966
- group Id
- OG001
- lower Limit
- 740
- upper Limit
- 2303
- value
- 799
- group Id
- OG002
- lower Limit
- 700
- upper Limit
- 1240
- value
- 899
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 29
- units
- Participants
- description
- Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.
- dispersion Type
- Full Range
- groups
- description
- Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma
- id
- OG000
- title
- Low-Risk Group
- description
- Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease
- id
- OG001
- title
- Intermediate-Risk Group
- description
- Patients with central nervous system (CNS) metastatic disease
- id
- OG002
- title
- High-Risk Group
- param Type
- MEDIAN
- population Description
- Eligible patients who received cyclophosphamide during consolidation cycle 2 and had samples collected for PK analysis.
- reporting Status
- POSTED
- time Frame
- Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
- title
- Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
- type
- SECONDARY
- unit Of Measure
- µmol·h/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice