NCT00602667 · OUTCOME
Cyclophosphamide Clearance 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
- L/h/m^2
- 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 clearance 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 | 2.48 | Not reported | 1.97 | 3.35 | Not reported |
| Intermediate-Risk Group | 2.55 | Not reported | 2.19 | 2.93 | Not reported |
| High-Risk Group | 2.37 | Not reported | 1.61 | 3.16 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.97
- upper Limit
- 3.35
- value
- 2.48
- group Id
- OG001
- lower Limit
- 2.19
- upper Limit
- 2.93
- value
- 2.55
- group Id
- OG002
- lower Limit
- 1.61
- upper Limit
- 3.16
- value
- 2.37
- 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 clearance 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 Clearance in Consolidation Chemotherapy Cycle 2
- type
- SECONDARY
- unit Of Measure
- L/h/m^2
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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