TriangleNCT01607957 · OUTCOME
Overall Survival
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
- Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death)
What was measured
Overall survival was defined as the time from the date of randomization to the date of death for participants. If a participant discontinued study medication for reasons other than radiologic disease progression, the participant was followed for tumor response until radiologic disease progression or initiation of new anticancer therapy.
Analysis population: Analysis was performed in ITT population. For participants who were alive as of the overall survival cutoff date, their survival was censored on the cutoff date post consent.
Groups in this outcome
TAS-102
Participants received TAS-102 orally with a starting dose of 35 mg/m\^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
Placebo
Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
| Group | Source count |
|---|---|
| TAS-102 | 534 |
| Placebo | 266 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS-102 | 7.1 | Not reported | 6.5 | 7.8 | Not reported |
| Placebo | 5.3 | Not reported | 4.6 | 6.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.81
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.68
- statistical Method
- Stratified log-rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.81
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.68
- statistical Method
- Stratified log-rank test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.5
- upper Limit
- 7.8
- value
- 7.1
- group Id
- OG001
- lower Limit
- 4.6
- upper Limit
- 6.0
- value
- 5.3
- denoms
- counts
- group Id
- OG000
- value
- 534
- group Id
- OG001
- value
- 266
- units
- Participants
- description
- Overall survival was defined as the time from the date of randomization to the date of death for participants. If a participant discontinued study medication for reasons other than radiologic disease progression, the participant was followed for tumor response until radiologic disease progression or initiation of new anticancer therapy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received TAS-102 orally with a starting dose of 35 mg/m\^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
- id
- OG000
- title
- TAS-102
- description
- Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- Analysis was performed in ITT population. For participants who were alive as of the overall survival cutoff date, their survival was censored on the cutoff date post consent.
- reporting Status
- POSTED
- time Frame
- Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death)
- title
- Overall Survival
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice