TriangleNCT01482962 · OUTCOME
Duration of Response (DOR)
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
- At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years
What was measured
DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease (PD)/relapse for responders as assessed by the IRC using IWG criteria. Responders without documentation of PD/relapse were censored at the date of last response assessment that was stable disease (SD) or better.
Analysis population: All responders in response-evaluable population defined as participants with peripheral T-cell lymphoma confirmed by independent hematopathology central review with measurable disease at baseline who receive at least 1 dose of alisertib or comparator drug and 1 postbaseline response assessment of CR, PR, SD or PD by independent radiology committee.
Groups in this outcome
Alisertib
Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
Pralatrexate, or Romidepsin, or Gemcitabine
Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
| Group | Source count |
|---|---|
| Alisertib | 34 |
| Pralatrexate, or Romidepsin, or Gemcitabine | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib | 225 | Not reported | 125 | NA | Upper Limit Confidence Interval was not estimable due to the insufficient number of participants with the event. |
| Pralatrexate, or Romidepsin, or Gemcitabine | 172 | Not reported | 119 | NA | Upper Limit Confidence Interval was not estimable due to the insufficient number of participants with the event. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper Limit Confidence Interval was not estimable due to the insufficient number of participants with the event.
- group Id
- OG000
- lower Limit
- 125
- upper Limit
- NA
- value
- 225
- comment
- Upper Limit Confidence Interval was not estimable due to the insufficient number of participants with the event.
- group Id
- OG001
- lower Limit
- 119
- upper Limit
- NA
- value
- 172
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 41
- units
- Participants
- description
- DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease (PD)/relapse for responders as assessed by the IRC using IWG criteria. Responders without documentation of PD/relapse were censored at the date of last response assessment that was stable disease (SD) or better.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
- id
- OG000
- title
- Alisertib
- description
- Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
- id
- OG001
- title
- Pralatrexate, or Romidepsin, or Gemcitabine
- param Type
- MEDIAN
- population Description
- All responders in response-evaluable population defined as participants with peripheral T-cell lymphoma confirmed by independent hematopathology central review with measurable disease at baseline who receive at least 1 dose of alisertib or comparator drug and 1 postbaseline response assessment of CR, PR, SD or PD by independent radiology committee.
- reporting Status
- POSTED
- time Frame
- At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice