TriangleNCT00602667 · OUTCOME
Methotrexate Clearance in Induction Cycle 4
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 and 6, 23, 42, 66 hours from start of MTX
What was measured
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.
Analysis population: Eligible patients who received methotrexate during induction cycle 4 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 | 34 |
| Intermediate-Risk Group | 80 |
| High-Risk Group | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low-Risk Group | 5.75 | Not reported | 2.14 | 9.65 | Not reported |
| Intermediate-Risk Group | 5.89 | Not reported | 2.95 | 8.84 | Not reported |
| High-Risk Group | 5.79 | Not reported | 2.36 | 9.16 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.14
- upper Limit
- 9.65
- value
- 5.75
- group Id
- OG001
- lower Limit
- 2.95
- upper Limit
- 8.84
- value
- 5.89
- group Id
- OG002
- lower Limit
- 2.36
- upper Limit
- 9.16
- value
- 5.79
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 34
- units
- Participants
- description
- Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate 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 methotrexate during induction cycle 4 and had samples collected for PK analysis.
- reporting Status
- POSTED
- time Frame
- Pre-infusion and 6, 23, 42, 66 hours from start of MTX
- title
- Methotrexate Clearance in Induction Cycle 4
- type
- SECONDARY
- unit Of Measure
- L/h/m^2
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice