TriangleNCT01261247 · OUTCOME
Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of CR or PR patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Every 28 days for up to 2 years
What was measured
The primary endpoint of this phase II trial is the proportion of confirmed responses (complete response (CR) or partial response (PR)) noted as the objective status and will be considered synonymous with "success" for this study.Response will be evaluated using all cycles of treatment. A CR is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as Disappearance of all evidence of disease. A PR is defined as Regression of measurable disease and no new sites with ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.
Analysis population: Patients who completed the study were evaluable for the primary outcome. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
Groups in this outcome
Arm I (LBH589)
Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm I (LBH589) | 39 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (LBH589) | 0.21 | Not reported | 0.07 | 0.38 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.07
- upper Limit
- 0.38
- value
- 0.21
- denoms
- counts
- group Id
- OG000
- value
- 39
- units
- Participants
- description
- The primary endpoint of this phase II trial is the proportion of confirmed responses (complete response (CR) or partial response (PR)) noted as the objective status and will be considered synonymous with "success" for this study.Response will be evaluated using all cycles of treatment. A CR is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as Disappearance of all evidence of disease. A PR is defined as Regression of measurable disease and no new sites with ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm I (LBH589)
- param Type
- NUMBER
- population Description
- Patients who completed the study were evaluable for the primary outcome. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
- reporting Status
- POSTED
- time Frame
- Every 28 days for up to 2 years
- title
- Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status
- type
- PRIMARY
- unit Of Measure
- proportion of CR or PR patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice