TriangleNCT00789828 · OUTCOME
Time to SEGA Progression
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
Time to SEGA progression was defined as time between randomisation to time to first SEGA progression. SEGA progression was defined as either one or more of the following criteria: 1. increase from nadir of ≥ 25% in SEGA volume to a value greater than baseline SEGA volume (where SEGA volume is the sum of the volumes of all target SEGA lesions identified at baseline, and nadir is the lowest SEGA volume obtained for the participant previously in the trial), 2. unequivocal worsening of non-target SEGA lesions, 3. appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, 4. new or worsening hydrocephalus. The median TTSP based on central radiology review was not reached in any treatment arms; Only 6 events of SEGA progressions were observed in the placebo group of core period.
Analysis population: The analysis was performed in the FAS population. Here "Number of participants analysed" signifies the participants assessed for time to SEGA progression during the study for each arm, respectively.
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) | NA | Not reported | NA | NA | Median was not reached as no participant experienced disease progression during core period. |
| Placebo (Core Period) | NA | Not reported | NA | NA | Median was not reached as only 6 participants experienced disease progression during core period. |
| Everolimus (Extension Period) | NA | Not reported | NA | NA | Median was not reached as no participant experienced disease progression during extension period. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median was not reached as no participant experienced disease progression during core period.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median was not reached as only 6 participants experienced disease progression during core period.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median was not reached as no participant experienced disease progression during extension period.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 78
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 111
- units
- Participants
- description
- Time to SEGA progression was defined as time between randomisation to time to first SEGA progression. SEGA progression was defined as either one or more of the following criteria: 1. increase from nadir of ≥ 25% in SEGA volume to a value greater than baseline SEGA volume (where SEGA volume is the sum of the volumes of all target SEGA lesions identified at baseline, and nadir is the lowest SEGA volume obtained for the participant previously in the trial), 2. unequivocal worsening of non-target SEGA lesions, 3. appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, 4. new or worsening hydrocephalus. The median TTSP based on central radiology review was not reached in any treatment arms; Only 6 events of SEGA progressions were observed in the placebo group of core period.
- 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
- MEDIAN
- population Description
- The analysis was performed in the FAS population. Here "Number of participants analysed" signifies the participants assessed for time to SEGA progression during the study for each arm, respectively.
- 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 Progression
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice