TriangleNCT00602667 · OUTCOME
Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Percentage of scheduled doses received
- Interval / dispersion
- Standard Deviation
- Time frame
- From start of oral maintenance therapy (approximately 6 months after on-study date) to completion of oral maintenance therapy (up to 1 year after on-study date)
What was measured
These data are based on patient diaries. For children \<3 years of age, we will calculate the percentage of total scheduled doses each patient received per course for each of the oral maintenance courses and report the overall average number percentage of doses received per course across patients. If patients received all planned doses, their percentage would be 100%. If the average percentage was less than 75%, then feasibility would be in question.
Analysis population: Eligible patients less than 3 years of age (n=273) constituted the study population for this analysis; 167 of these patients started the first course of maintenance and were included in this analysis (50 low-risk, 87 intermediate-risk, and 30 high-risk patients).
Groups in this outcome
Low-Risk Group
Patients \<3 years of age with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.
Intermediate-Risk Group
Patients \<3 years of age with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.
High-Risk Group
Patients \<3 years of age with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy
| Group | Source count |
|---|---|
| Low-Risk Group | 50 |
| Intermediate-Risk Group | 87 |
| High-Risk Group | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low-Risk Group | 96 | 8 | Not reported | Not reported | Not reported |
| Intermediate-Risk Group | 91 | 23 | Not reported | Not reported | Not reported |
| High-Risk Group | 98 | 4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 8
- value
- 96
- group Id
- OG001
- spread
- 23
- value
- 91
- group Id
- OG002
- spread
- 4
- value
- 98
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 87
- group Id
- OG002
- value
- 30
- units
- Participants
- description
- These data are based on patient diaries. For children \<3 years of age, we will calculate the percentage of total scheduled doses each patient received per course for each of the oral maintenance courses and report the overall average number percentage of doses received per course across patients. If patients received all planned doses, their percentage would be 100%. If the average percentage was less than 75%, then feasibility would be in question.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients \<3 years of age with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.
- id
- OG000
- title
- Low-Risk Group
- description
- Patients \<3 years of age with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.
- id
- OG001
- title
- Intermediate-Risk Group
- description
- Patients \<3 years of age with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy
- id
- OG002
- title
- High-Risk Group
- param Type
- MEAN
- population Description
- Eligible patients less than 3 years of age (n=273) constituted the study population for this analysis; 167 of these patients started the first course of maintenance and were included in this analysis (50 low-risk, 87 intermediate-risk, and 30 high-risk patients).
- reporting Status
- POSTED
- time Frame
- From start of oral maintenance therapy (approximately 6 months after on-study date) to completion of oral maintenance therapy (up to 1 year after on-study date)
- title
- Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received
- type
- SECONDARY
- unit Of Measure
- Percentage of scheduled doses received
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice