TriangleNCT00789828 · OUTCOME
Time to SEGA Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)
What was measured
Participants were assessed for time to SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilised to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.
Analysis population: The analysis was performed in the FAS population.
Groups in this outcome
Everolimus (Core Period)
Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
Everolimus (Extension Period)
Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
| Group | Source count |
|---|---|
| Everolimus (Core Period) | 27 |
| Everolimus (Extension Period) | 64 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus (Core Period) | 2.99 | Not reported | 2.79 | 5.36 | Not reported |
| Everolimus (Extension Period) | 5.32 | Not reported | 3.02 | 5.59 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.79
- upper Limit
- 5.36
- value
- 2.99
- group Id
- OG001
- lower Limit
- 3.02
- upper Limit
- 5.59
- value
- 5.32
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 64
- units
- Participants
- description
- Participants were assessed for time to SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilised to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
- id
- OG000
- title
- Everolimus (Core Period)
- description
- Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
- id
- OG001
- title
- Everolimus (Extension Period)
- param Type
- MEDIAN
- population Description
- The analysis was performed in the FAS population.
- reporting Status
- POSTED
- time Frame
- Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)
- title
- Time to SEGA Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice