TriangleNCT00790400 · OUTCOME
Time to Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma 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
- From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years
What was measured
Time to angiomyolipoma response was defined as the time from the date of randomization until the date of the first documented angiomyolipoma response. Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; no kidney increases in volume \> 20% from nadir; no angiomyolipoma-related bleeding of ≥ grade 2. For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma response is from the start of everolimus. The baseline in the response definition means the latest value on or before starting everolimus.
Analysis population: The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.
Groups in this outcome
Everolimus Randomized (Core Period)
Study drug was given by continuous oral daily dosing of two 5 mg tablets.
Everolimus (Core and/or Extension Period)
Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
| Group | Source count |
|---|---|
| Everolimus Randomized (Core Period) | 33 |
| Everolimus (Core and/or Extension Period) | 65 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus Randomized (Core Period) | 2.86 | Not reported | 2.79 | 3.02 | Not reported |
| Everolimus (Core and/or Extension Period) | 2.89 | Not reported | 2.79 | 3.19 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.79
- upper Limit
- 3.02
- value
- 2.86
- group Id
- OG001
- lower Limit
- 2.79
- upper Limit
- 3.19
- value
- 2.89
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 65
- units
- Participants
- description
- Time to angiomyolipoma response was defined as the time from the date of randomization until the date of the first documented angiomyolipoma response. Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; no kidney increases in volume \> 20% from nadir; no angiomyolipoma-related bleeding of ≥ grade 2. For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma response is from the start of everolimus. The baseline in the response definition means the latest value on or before starting everolimus.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Study drug was given by continuous oral daily dosing of two 5 mg tablets.
- id
- OG000
- title
- Everolimus Randomized (Core Period)
- description
- Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
- id
- OG001
- title
- Everolimus (Core and/or Extension Period)
- param Type
- MEDIAN
- population Description
- The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.
- reporting Status
- POSTED
- time Frame
- From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years
- title
- Time to Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice