TriangleNCT00007345 · OUTCOME
Time to Progression
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
- Until disease progression, or 30 days following off study date
What was measured
Time to progression is defined from the first day of therapy until documentation of progressive disease. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the International Working Group (IWG) criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
Groups in this outcome
Peripheral T-cell Lymphoma (PTCL)
Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
Cutaneous T-cell Lymphoma (CTCL)
Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
| Group | Source count |
|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 47 |
| Cutaneous T-cell Lymphoma (CTCL) | 94 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 4.8 | Not reported | 2.0 | 9.3 | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 6.4 | Not reported | 3.9 | 11.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 9.3
- value
- 4.8
- group Id
- OG001
- lower Limit
- 3.9
- upper Limit
- 11.3
- value
- 6.4
- denoms
- counts
- group Id
- OG000
- value
- 47
- group Id
- OG001
- value
- 94
- units
- Participants
- description
- Time to progression is defined from the first day of therapy until documentation of progressive disease. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the International Working Group (IWG) criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- id
- OG000
- title
- Peripheral T-cell Lymphoma (PTCL)
- description
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- id
- OG001
- title
- Cutaneous T-cell Lymphoma (CTCL)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Until disease progression, or 30 days following off study date
- title
- Time to Progression
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice