TriangleNCT00602667 · OUTCOME
Methotrexate AUC0-66h in Induction 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 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 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.
Analysis population: Eligible patients who received methotrexate during induction 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 | 37 |
| Intermediate-Risk Group | 94 |
| High-Risk Group | 44 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low-Risk Group | 1797 | Not reported | 993 | 5029 | Not reported |
| Intermediate-Risk Group | 1813 | Not reported | 1029 | 3584 | Not reported |
| High-Risk Group | 1821 | Not reported | 1053 | 3631 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 993
- upper Limit
- 5029
- value
- 1797
- group Id
- OG001
- lower Limit
- 1029
- upper Limit
- 3584
- value
- 1813
- group Id
- OG002
- lower Limit
- 1053
- upper Limit
- 3631
- value
- 1821
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 94
- group Id
- OG002
- value
- 44
- units
- Participants
- description
- Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 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 methotrexate during induction cycle 1 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 AUC0-66h in Induction Cycle 1
- type
- SECONDARY
- unit Of Measure
- µmol·h/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice