TriangleNCT00602667 · OUTCOME
CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1
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
Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of CEPM 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 1 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 | 20 |
| Intermediate-Risk Group | 4 |
| High-Risk Group | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low-Risk Group | 128.9 | Not reported | 90.8 | 272.9 | Not reported |
| Intermediate-Risk Group | 62.2 | Not reported | 48.8 | 193.9 | Not reported |
| High-Risk Group | 51.8 | Not reported | 18.9 | 97.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 90.8
- upper Limit
- 272.9
- value
- 128.9
- group Id
- OG001
- lower Limit
- 48.8
- upper Limit
- 193.9
- value
- 62.2
- group Id
- OG002
- lower Limit
- 18.9
- upper Limit
- 97.0
- value
- 51.8
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 28
- units
- Participants
- description
- Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of CEPM 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 1 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
- CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1
- type
- SECONDARY
- unit Of Measure
- µmol·h/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice