TriangleNCT01713946 · OUTCOME
Core Phase: Food & Drug Administration (FDA): Percentage Change From Baseline in Partial Onset-seizure Frequency
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Percentage change from baseline
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)
What was measured
Comparison of median percent change from baseline in weekly seizure frequency in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase. Percentage change from baseline in average weekly seizure frequency during the maintenance period of the Core phase (SFcfb) = 100 × (SFB - SFM) ÷ SFB where: SFB is the average weekly seizure frequency in the Baseline phase SFM is the average weekly seizure frequency in the maintenance period of the Core phase A positive percentage change from baseline (SFcfb) means a reduction in seizure frequency whereas a negative percentage change from baseline (SFcfb) means an increase in seizure frequency.
Analysis population: The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization
Groups in this outcome
Everolimus LT Target of 3 to 7 ng/mL
Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL
Everolimus HT Target of 9 to 15 ng/mL
Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL
Placebo
Participants were randomized to receive placebo dispersible tablets for oral suspension.
| Group | Source count |
|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | 117 |
| Everolimus HT Target of 9 to 15 ng/mL | 130 |
| Placebo | 119 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | 29.29 | Not reported | 18.82 | 41.88 | Not reported |
| Everolimus HT Target of 9 to 15 ng/mL | 39.55 | Not reported | 35.03 | 48.74 | Not reported |
| Placebo | 14.86 | Not reported | 0.11 | 21.71 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.98
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 31.68
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.003
- param Type
- Median Difference (Final Values)
- param Value
- 15.96
- statistical Method
- Bonferroni-Holm
- ci Lower Limit
- 16.36
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 43.36
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 27.46
- statistical Method
- Bonferroni-Holm
Complete source fields
- analyses
- ci Lower Limit
- 1.98
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 31.68
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.003
- param Type
- Median Difference (Final Values)
- param Value
- 15.96
- statistical Method
- Bonferroni-Holm
- ci Lower Limit
- 16.36
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 43.36
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 27.46
- statistical Method
- Bonferroni-Holm
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.82
- upper Limit
- 41.88
- value
- 29.29
- group Id
- OG001
- lower Limit
- 35.03
- upper Limit
- 48.74
- value
- 39.55
- group Id
- OG002
- lower Limit
- 0.11
- upper Limit
- 21.71
- value
- 14.86
- denoms
- counts
- group Id
- OG000
- value
- 117
- group Id
- OG001
- value
- 130
- group Id
- OG002
- value
- 119
- units
- Participants
- description
- Comparison of median percent change from baseline in weekly seizure frequency in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase. Percentage change from baseline in average weekly seizure frequency during the maintenance period of the Core phase (SFcfb) = 100 × (SFB - SFM) ÷ SFB where: SFB is the average weekly seizure frequency in the Baseline phase SFM is the average weekly seizure frequency in the maintenance period of the Core phase A positive percentage change from baseline (SFcfb) means a reduction in seizure frequency whereas a negative percentage change from baseline (SFcfb) means an increase in seizure frequency.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL
- id
- OG000
- title
- Everolimus LT Target of 3 to 7 ng/mL
- description
- Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL
- id
- OG001
- title
- Everolimus HT Target of 9 to 15 ng/mL
- description
- Participants were randomized to receive placebo dispersible tablets for oral suspension.
- id
- OG002
- title
- Placebo
- param Type
- MEDIAN
- population Description
- The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization
- reporting Status
- POSTED
- time Frame
- Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)
- title
- Core Phase: Food & Drug Administration (FDA): Percentage Change From Baseline in Partial Onset-seizure Frequency
- type
- PRIMARY
- unit Of Measure
- Percentage change from baseline
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice