TriangleNCT00789828 · OUTCOME
Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- End of core period (Week 48), and end of extension period (up to 4 years)
What was measured
Participants were assessed for 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 utilized 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 primary analysis was performed in Full Analysis Set (FAS) population, defined as all randomized participants involved in the study.
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.
Placebo (Core Period)
Participants received oral dose of placebo matching to everolimus daily.
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) | 78 |
| Placebo (Core Period) | 39 |
| Everolimus (Extension Period) | 111 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus (Core Period) | 34.6 | Not reported | 24.2 | 46.2 | Not reported |
| Placebo (Core Period) | 0.0 | Not reported | 0.0 | 9.0 | Not reported |
| Everolimus (Extension Period) | 57.7 | Not reported | 47.9 | 67 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.2
- upper Limit
- 46.2
- value
- 34.6
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 9.0
- value
- 0.0
- group Id
- OG002
- lower Limit
- 47.9
- upper Limit
- 67
- value
- 57.7
- denoms
- counts
- group Id
- OG000
- value
- 78
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 111
- units
- Participants
- description
- Participants were assessed for 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 utilized 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 placebo matching to everolimus daily.
- id
- OG001
- title
- Placebo (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
- OG002
- title
- Everolimus (Extension Period)
- param Type
- NUMBER
- population Description
- The primary analysis was performed in Full Analysis Set (FAS) population, defined as all randomized participants involved in the study.
- reporting Status
- POSTED
- time Frame
- End of core period (Week 48), and end of extension period (up to 4 years)
- title
- Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice