TriangleNCT01420679 · OUTCOME
Overall Survival (OS)
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
- From randomization until death (up to 76 months)
What was measured
Overall survival was defined as the time in days from randomization to the date of death, regardless of cause (date of death - date of randomization + 1).
Analysis population: ITT population included all randomized participants classified according to the treatment arms into which they were randomized, regardless of the actual study treatment received (or not received).
Groups in this outcome
Pralatrexate Arm
Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \[NaCl\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\^2), could be reduced to 20 mg/m\^2 with potential further reductions to 15 and 10 mg/m\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
Observation Arm
Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
| Group | Source count |
|---|---|
| Pralatrexate Arm | 14 |
| Observation Arm | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pralatrexate Arm | NA | Not reported | NA | NA | Median and 95% CI were not estimable due to low number of participants with events. |
| Observation Arm | NA | Not reported | NA | NA | Median and 95% CI were not estimable due to low number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and 95% CI were not estimable due to low number of participants with events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median and 95% CI were not estimable due to low number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Overall survival was defined as the time in days from randomization to the date of death, regardless of cause (date of death - date of randomization + 1).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \[NaCl\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\^2), could be reduced to 20 mg/m\^2 with potential further reductions to 15 and 10 mg/m\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
- id
- OG000
- title
- Pralatrexate Arm
- description
- Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
- id
- OG001
- title
- Observation Arm
- param Type
- MEDIAN
- population Description
- ITT population included all randomized participants classified according to the treatment arms into which they were randomized, regardless of the actual study treatment received (or not received).
- reporting Status
- POSTED
- time Frame
- From randomization until death (up to 76 months)
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice