NCT00918333 · OUTCOME
Overall Survival Time (Phase II)
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
- Time from registration to death due to any cause, assessed up to 2 years post-treatment
What was measured
Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals will be estimated using the method of Kaplan-Meier.
Analysis population: Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
Groups in this outcome
Phase II (Lymphoma Patients Receiving 20 mg LBL589)
Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II (Myeloma Patients Receiving 20 mg LBH589)
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Phase II (Lymphoma Patients Receiving 20 mg LBL589) | 41 |
| Phase II (Myeloma Patients Receiving 20 mg LBH589) | 14 |
| Phase II (Lymphoma Patients Receiving 30/40 mg LBH589) | 20 |
| Phase II (Myeloma Patients Receiving 30/40 mg LBH589) | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II (Lymphoma Patients Receiving 20 mg LBL589) | 17.1 | Not reported | 7.0 | NA | The upper bound of the 95% confidence interval has not yet been reached. |
| Phase II (Myeloma Patients Receiving 20 mg LBH589) | 16.6 | Not reported | 9.7 | NA | The upper bound of the 95% confidence interval has not yet been reached. |
| Phase II (Lymphoma Patients Receiving 30/40 mg LBH589) | 35.4 | Not reported | 11.5 | NA | The upper bound of the 95% confidence interval has not yet been reached. |
| Phase II (Myeloma Patients Receiving 30/40 mg LBH589) | 21.7 | Not reported | 12.1 | 47.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper bound of the 95% confidence interval has not yet been reached.
- group Id
- OG000
- lower Limit
- 7.0
- upper Limit
- NA
- value
- 17.1
- comment
- The upper bound of the 95% confidence interval has not yet been reached.
- group Id
- OG001
- lower Limit
- 9.7
- upper Limit
- NA
- value
- 16.6
- comment
- The upper bound of the 95% confidence interval has not yet been reached.
- group Id
- OG002
- lower Limit
- 11.5
- upper Limit
- NA
- value
- 35.4
- group Id
- OG003
- lower Limit
- 12.1
- upper Limit
- 47.6
- value
- 21.7
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 18
- units
- Participants
- description
- Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals will be estimated using the method of Kaplan-Meier.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Phase II (Lymphoma Patients Receiving 20 mg LBL589)
- description
- Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Phase II (Myeloma Patients Receiving 20 mg LBH589)
- description
- Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
- description
- Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
- param Type
- MEDIAN
- population Description
- Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
- reporting Status
- POSTED
- time Frame
- Time from registration to death due to any cause, assessed up to 2 years post-treatment
- title
- Overall Survival Time (Phase II)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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