TriangleNCT01482962 · OUTCOME
Progression-Free Survival (PFS) Based on IRC Assessment
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
- 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
PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurred first.
Analysis population: Intent-to-treat (ITT) population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.
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 | 138 |
| Pralatrexate, or Romidepsin, or Gemcitabine | 133 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib | 115 | Not reported | 83 | 174 | Not reported |
| Pralatrexate, or Romidepsin, or Gemcitabine | 104 | Not reported | 61 | 114 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.637
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.178
- estimate Comment
- Hazard ratio (HR) was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.177
- param Type
- Hazard Ratio (HR)
- param Value
- 0.87
- statistical Method
- Stratified Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.637
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.178
- estimate Comment
- Hazard ratio (HR) was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.177
- param Type
- Hazard Ratio (HR)
- param Value
- 0.87
- statistical Method
- Stratified Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 83
- upper Limit
- 174
- value
- 115
- group Id
- OG001
- lower Limit
- 61
- upper Limit
- 114
- value
- 104
- denoms
- counts
- group Id
- OG000
- value
- 138
- group Id
- OG001
- value
- 133
- units
- Participants
- description
- PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurred first.
- 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
- Intent-to-treat (ITT) population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.
- reporting Status
- POSTED
- time Frame
- 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
- Progression-Free Survival (PFS) Based on IRC Assessment
- type
- PRIMARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice