TriangleNCT00789828 · OUTCOME
Duration of Skin Lesion Response in Everolimus Treated Participants
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
Duration of skin lesion response was defined as the time from the first skin lesion response until the first skin lesion progression, defined as worsening of lesion by \> 25% or more from baseline.
Analysis population: The analysis was performed in the FAS population. Here, "Number of participants analysed" signifies everolimus treated responders with best overall skin lesion response during the core and extension period, 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.
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) | 30 |
| Everolimus (Extension Period) | 61 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus (Core Period) | NA | Not reported | NA | NA | Median was not achieved as no case of skin lesion was observed. |
| Everolimus (Extension Period) | NA | Not reported | NA | NA | Median was not achieved as no case of skin lesion was observed. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median was not achieved as no case of skin lesion was observed.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median was not achieved as no case of skin lesion was observed.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 61
- units
- Participants
- description
- Duration of skin lesion response was defined as the time from the first skin lesion response until the first skin lesion progression, defined as worsening of lesion by \> 25% or more from baseline.
- 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 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
- OG001
- title
- Everolimus (Extension Period)
- param Type
- MEDIAN
- population Description
- The analysis was performed in the FAS population. Here, "Number of participants analysed" signifies everolimus treated responders with best overall skin lesion response during the core and extension period, 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
- Duration of Skin Lesion Response in Everolimus Treated Participants
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice