TriangleNCT00602667 · OUTCOME
4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
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-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose
What was measured
4-OH cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of 4-OH 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 maintenance cycle A1 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 | 26 |
| Intermediate-Risk Group | 42 |
| High-Risk Group | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low-Risk Group | 1.98 | Not reported | 0.98 | 3.01 | Not reported |
| Intermediate-Risk Group | 1.96 | Not reported | 1.12 | 3.08 | Not reported |
| High-Risk Group | 1.82 | Not reported | 1.19 | 2.40 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.98
- upper Limit
- 3.01
- value
- 1.98
- group Id
- OG001
- lower Limit
- 1.12
- upper Limit
- 3.08
- value
- 1.96
- group Id
- OG002
- lower Limit
- 1.19
- upper Limit
- 2.40
- value
- 1.82
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 14
- units
- Participants
- description
- 4-OH cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of 4-OH 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 maintenance cycle A1 and had samples collected for PK analysis.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose
- title
- 4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
- type
- SECONDARY
- unit Of Measure
- µmol·h/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice