TriangleNCT00426764 · OUTCOME
Duration of Objective Disease Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
What was measured
Duration of response was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.
Analysis population: Histopathologically-Confirmed Population with an objective response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.
Groups in this outcome
Romidepsin
Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
| Group | Source count |
|---|---|
| Romidepsin | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romidepsin | NA | Not reported | 353 | NA | The median and the upper limit of the 95% confidence interval were not estimable due to the low number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median and the upper limit of the 95% confidence interval were not estimable due to the low number of events.
- group Id
- OG000
- lower Limit
- 353
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 34
- units
- Participants
- description
- Duration of response was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
- id
- OG000
- title
- Romidepsin
- param Type
- MEDIAN
- population Description
- Histopathologically-Confirmed Population with an objective response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.
- reporting Status
- POSTED
- time Frame
- Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
- title
- Duration of Objective Disease Response
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice