TriangleNCT00790400 · OUTCOME
Duration of Skin Lesion Response - Only Everolimus Patients With Best Overall Skin Lesion Response of Complete Clinical Response (CCR) or Partial Response (PR)
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 about 5.7 years
What was measured
Duration of skin lesion response is defined as the time from the date of the first skin lesion response until the date of the first skin lesion progression, according to the PGA (physician's global assessment of clinical condition). A progression is when the disease is worse than at baseline evaluation by \>=25% or more.
Analysis population: The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced a best overall skin lesion response CCR or PR.
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) | 20 |
| Everolimus (Core and/or Extension Period) | 73 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus Randomized (Core Period) | NA | Not reported | NA | NA | N/A = Median not reached since no patients progressed |
| Everolimus (Core and/or Extension Period) | NA | Not reported | NA | NA | N/A = Median not reached since no patients progressed |
Complete source fields
- classes
- categories
- measurements
- comment
- N/A = Median not reached since no patients progressed
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- N/A = Median not reached since no patients progressed
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 73
- units
- Participants
- description
- Duration of skin lesion response is defined as the time from the date of the first skin lesion response until the date of the first skin lesion progression, according to the PGA (physician's global assessment of clinical condition). A progression is when the disease is worse than at baseline evaluation by \>=25% or more.
- 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 a best overall skin lesion response CCR or PR.
- 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 about 5.7 years
- title
- Duration of Skin Lesion Response - Only Everolimus Patients With Best Overall Skin Lesion Response of Complete Clinical Response (CCR) or Partial Response (PR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice