TriangleNCT04737187 · 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 date of randomization to the death due to any cause or cut-off date, whichever comes first (maximum duration: up to 20 months)
What was measured
Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method.
Analysis population: Analysis was performed on FAS population.
Groups in this outcome
Trifluridine/Tipiracil + Bevacizumab
Participants were administered 35 mg/m²/dose FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.
Trifluridine/Tipiracil
Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.
| Group | Source count |
|---|---|
| Trifluridine/Tipiracil + Bevacizumab | 246 |
| Trifluridine/Tipiracil | 246 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trifluridine/Tipiracil + Bevacizumab | 10.78 | Not reported | 9.36 | 11.83 | Not reported |
| Trifluridine/Tipiracil | 7.46 | Not reported | 6.34 | 8.57 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.77
- estimate Comment
- Hazard ratio and 95% confidence interval was estimated with stratified Cox proportional hazard model.
- group Description
- Overall Survival Median analysis: The primary estimand was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- p Value Comment
- Stratified log-rank test, with a target p-value \< 0.025 for level of significance.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.61
- statistical Method
- Stratified log-rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.77
- estimate Comment
- Hazard ratio and 95% confidence interval was estimated with stratified Cox proportional hazard model.
- group Description
- Overall Survival Median analysis: The primary estimand was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- p Value Comment
- Stratified log-rank test, with a target p-value \< 0.025 for level of significance.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.61
- statistical Method
- Stratified log-rank test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.36
- upper Limit
- 11.83
- value
- 10.78
- group Id
- OG001
- lower Limit
- 6.34
- upper Limit
- 8.57
- value
- 7.46
- denoms
- counts
- group Id
- OG000
- value
- 246
- group Id
- OG001
- value
- 246
- units
- Participants
- description
- Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were administered 35 mg/m²/dose FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.
- id
- OG000
- title
- Trifluridine/Tipiracil + Bevacizumab
- description
- Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.
- id
- OG001
- title
- Trifluridine/Tipiracil
- param Type
- MEDIAN
- population Description
- Analysis was performed on FAS population.
- reporting Status
- POSTED
- time Frame
- From date of randomization to the death due to any cause or cut-off date, whichever comes first (maximum duration: up to 20 months)
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice