TriangleNCT00426764 · OUTCOME
Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee
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
- 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
Complete Response (CR): \>75% decrease in size aggregate of nodal index lesions (large and small), complete disappearance of extranodal and non-index lesions; total disappearance of clinical disease including skin involvement; disease-related signs and symptoms, normalization of biochemical abnormalities and reduction in size of spleen or liver so no longer palpable. Unconfirmed CR: all above criteria except all nodal index lesions must have regressed \>75% in the sum of the product diameters (SPD) from baseline. Individual nodes previously confluent must have regressed by \>75% in their SPD.
Analysis population: Histologically Confirmed Population, comprised all enrolled patients who received at least 1 dose of study treatment and who had histopathologically confirmed peripheral T-cell lymphoma(s). Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.
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 | 130 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romidepsin | 15.4 | Not reported | 9.7 | 22.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.7
- upper Limit
- 22.8
- value
- 15.4
- denoms
- counts
- group Id
- OG000
- value
- 130
- units
- Participants
- description
- Complete Response (CR): \>75% decrease in size aggregate of nodal index lesions (large and small), complete disappearance of extranodal and non-index lesions; total disappearance of clinical disease including skin involvement; disease-related signs and symptoms, normalization of biochemical abnormalities and reduction in size of spleen or liver so no longer palpable. Unconfirmed CR: all above criteria except all nodal index lesions must have regressed \>75% in the sum of the product diameters (SPD) from baseline. Individual nodes previously confluent must have regressed by \>75% in their SPD.
- 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
- NUMBER
- population Description
- Histologically Confirmed Population, comprised all enrolled patients who received at least 1 dose of study treatment and who had histopathologically confirmed peripheral T-cell lymphoma(s). Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.
- 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
- Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice