TriangleNCT00790400 · OUTCOME
Skin Lesion Response Rate as Per Investigator (Only Patients With at Least One Skin Lesion at Baseline)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- 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
Skin lesion response rate in the double-blind period was determined only among patients with at least one skin lesion at baseline, and is the percentage of this group of patients with a best overall skin lesion response on the Physician's Global Assessment of Clinical Condition (PGA) of either complete clinical response (CCR) or partial response (PR). A complete clinical response (CCR) requires a grading of 0 indicating the absence of disease (histological confirmation is not required). Grades 1, 2, and 3 constitute partial response, indicating improvement of at least 50 percent, but less than 100 percent improvement. For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus.
Analysis population: The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. Only patients with at least one skin lesion at baseline are included in the analysis.
Groups in this outcome
Everolimus Randomized (Core Period)
Study drug was given by continuous oral daily dosing of two 5 mg tablets.
Placebo Randomized (Core Period)
Placebo 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) | 77 |
| Placebo Randomized (Core Period) | 37 |
| Everolimus (Core and/or Extension Period) | 112 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus Randomized (Core Period) | 26 | Not reported | 16.6 | 37.2 | Not reported |
| Placebo Randomized (Core Period) | 0 | Not reported | 0.0 | 9.5 | Not reported |
| Everolimus (Core and/or Extension Period) | 68.2 | Not reported | 58.5 | 76.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.6
- upper Limit
- 37.2
- value
- 26
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 9.5
- value
- 0
- group Id
- OG002
- lower Limit
- 58.5
- upper Limit
- 76.9
- value
- 68.2
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 112
- units
- Participants
- description
- Skin lesion response rate in the double-blind period was determined only among patients with at least one skin lesion at baseline, and is the percentage of this group of patients with a best overall skin lesion response on the Physician's Global Assessment of Clinical Condition (PGA) of either complete clinical response (CCR) or partial response (PR). A complete clinical response (CCR) requires a grading of 0 indicating the absence of disease (histological confirmation is not required). Grades 1, 2, and 3 constitute partial response, indicating improvement of at least 50 percent, but less than 100 percent improvement. For the everolimus (core/extension periods) treatment group, the baseline 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
- Placebo was given by continuous oral daily dosing of two 5 mg tablets.
- id
- OG001
- title
- Placebo Randomized (Core Period)
- description
- Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
- id
- OG002
- title
- Everolimus (Core and/or Extension Period)
- param Type
- NUMBER
- population Description
- The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. Only patients with at least one skin lesion at baseline are included in the analysis.
- 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
- Skin Lesion Response Rate as Per Investigator (Only Patients With at Least One Skin Lesion at Baseline)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice