TriangleNCT00602667 · OUTCOME
4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy
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
4-OH cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. 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 a cycle of induction therapy 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 | 38 |
| Intermediate-Risk Group | 91 |
| High-Risk Group | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low-Risk Group | 116.4 | Not reported | 74.6 | 200.3 | Not reported |
| Intermediate-Risk Group | 111.3 | Not reported | 71.4 | 181.0 | Not reported |
| High-Risk Group | 109.1 | Not reported | 65.0 | 175.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 74.6
- upper Limit
- 200.3
- value
- 116.4
- group Id
- OG001
- lower Limit
- 71.4
- upper Limit
- 181.0
- value
- 111.3
- group Id
- OG002
- lower Limit
- 65.0
- upper Limit
- 175.0
- value
- 109.1
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 91
- group Id
- OG002
- value
- 42
- units
- Participants
- description
- 4-OH cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. 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 a cycle of induction therapy 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
- 4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy
- type
- SECONDARY
- unit Of Measure
- µmol·h/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice