TriangleNCT01713946 · OUTCOME
Core Phase: Change From Baseline in the Overall Vineland-II Adaptive Behavior Composite (ABC) Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- scores on a scale
- Interval / dispersion
- Full Range
- Time frame
- Baseline, 18 weeks
What was measured
Comparison of adaptive functioning using the VABS-II composite score in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm. The Vineland II assesses an individual's development of personal independence \& social responsibility. The questionnaire contains 433 items which assess 15 subdomains organized into the five domains of Communication, Daily Living Skills, Socialization, Motor Skills and Maladaptive Behavior. The overall Adaptive Behavior Composite (ABC) score is obtained by summing the standard scores of the first four domain scores for patients aged less than 7 years, or the first 3 domain scores for patients aged 7 or older (the Maladaptive Behavior domain is optional). The ABC standard score ranges from 20 to 160 with a mean of 100 and a standard deviation of 15. Higher scores correspond to improved adaptive level. Note that 2 questionnaires with ABC scores\<20 (data issues) were included in this analysis.
Analysis population: The safety Set comprised all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment in the Core phase (where the statement that a patient had no AE constitutes a safety assessment).
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 | 75 |
| Everolimus HT Target of 9 to 15 ng/mL | 93 |
| Placebo | 76 |
Reported measurements
Baseline
| Group | Source count |
|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | 34 |
| Everolimus HT Target of 9 to 15 ng/mL | 34 |
| Placebo | 32 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | 58.00 | Not reported | 20.0 | 112.0 | Not reported |
| Everolimus HT Target of 9 to 15 ng/mL | 56.50 | Not reported | 20.0 | 102.0 | Not reported |
| Placebo | 55.00 | Not reported | 20.0 | 103.0 | Not reported |
End of Core Phase
| Group | Source count |
|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | 28 |
| Everolimus HT Target of 9 to 15 ng/mL | 39 |
| Placebo | 31 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | 54.00 | Not reported | 6.0 | 121.0 | Not reported |
| Everolimus HT Target of 9 to 15 ng/mL | 55.00 | Not reported | 20.0 | 111.0 | Not reported |
| Placebo | 55.00 | Not reported | 20.0 | 105.0 | Not reported |
Change from Baseline
| Group | Source count |
|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | 18 |
| Everolimus HT Target of 9 to 15 ng/mL | 23 |
| Placebo | 23 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | -1.00 | Not reported | -21.0 | 15.0 | Not reported |
| Everolimus HT Target of 9 to 15 ng/mL | 0.00 | Not reported | -13.0 | 15.0 | Not reported |
| Placebo | 0.00 | Not reported | -12.0 | 10.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.0
- upper Limit
- 112.0
- value
- 58.00
- group Id
- OG001
- lower Limit
- 20.0
- upper Limit
- 102.0
- value
- 56.50
- group Id
- OG002
- lower Limit
- 20.0
- upper Limit
- 103.0
- value
- 55.00
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 34
- group Id
- OG002
- value
- 32
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.0
- upper Limit
- 121.0
- value
- 54.00
- group Id
- OG001
- lower Limit
- 20.0
- upper Limit
- 111.0
- value
- 55.00
- group Id
- OG002
- lower Limit
- 20.0
- upper Limit
- 105.0
- value
- 55.00
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 31
- units
- Participants
- title
- End of Core Phase
- categories
- measurements
- group Id
- OG000
- lower Limit
- -21.0
- upper Limit
- 15.0
- value
- -1.00
- group Id
- OG001
- lower Limit
- -13.0
- upper Limit
- 15.0
- value
- 0.00
- group Id
- OG002
- lower Limit
- -12.0
- upper Limit
- 10.0
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 23
- units
- Participants
- title
- Change from Baseline
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 93
- group Id
- OG002
- value
- 76
- units
- Participants
- description
- Comparison of adaptive functioning using the VABS-II composite score in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm. The Vineland II assesses an individual's development of personal independence \& social responsibility. The questionnaire contains 433 items which assess 15 subdomains organized into the five domains of Communication, Daily Living Skills, Socialization, Motor Skills and Maladaptive Behavior. The overall Adaptive Behavior Composite (ABC) score is obtained by summing the standard scores of the first four domain scores for patients aged less than 7 years, or the first 3 domain scores for patients aged 7 or older (the Maladaptive Behavior domain is optional). The ABC standard score ranges from 20 to 160 with a mean of 100 and a standard deviation of 15. Higher scores correspond to improved adaptive level. Note that 2 questionnaires with ABC scores\<20 (data issues) were included in this analysis.
- dispersion Type
- Full Range
- 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 safety Set comprised all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment in the Core phase (where the statement that a patient had no AE constitutes a safety assessment).
- reporting Status
- POSTED
- time Frame
- Baseline, 18 weeks
- title
- Core Phase: Change From Baseline in the Overall Vineland-II Adaptive Behavior Composite (ABC) Score
- type
- SECONDARY
- unit Of Measure
- scores on a scale
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Preserved source evidence · Not medical advice