TriangleNCT04737187 · OUTCOME
Probability of Participants With Progression Free Survival at 3, 6, 9 and 12 Months
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- probability of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until 3, 6, 9, and 12 months post treatment
What was measured
PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. In this outcome measure, data of PFS at 3 months was reported.
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
At 3 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trifluridine/Tipiracil + Bevacizumab | 0.73 | Not reported | 0.67 | 0.78 | Not reported |
| Trifluridine/Tipiracil | 0.45 | Not reported | 0.39 | 0.51 | Not reported |
At 6 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trifluridine/Tipiracil + Bevacizumab | 0.43 | Not reported | 0.37 | 0.49 | Not reported |
| Trifluridine/Tipiracil | 0.16 | Not reported | 0.11 | 0.21 | Not reported |
At 9 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trifluridine/Tipiracil + Bevacizumab | 0.28 | Not reported | 0.22 | 0.34 | Not reported |
| Trifluridine/Tipiracil | 0.05 | Not reported | 0.03 | 0.09 | Not reported |
At 12 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trifluridine/Tipiracil + Bevacizumab | 0.16 | Not reported | 0.12 | 0.21 | Not reported |
| Trifluridine/Tipiracil | 0.01 | Not reported | 0.00 | 0.03 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.67
- upper Limit
- 0.78
- value
- 0.73
- group Id
- OG001
- lower Limit
- 0.39
- upper Limit
- 0.51
- value
- 0.45
- title
- At 3 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.37
- upper Limit
- 0.49
- value
- 0.43
- group Id
- OG001
- lower Limit
- 0.11
- upper Limit
- 0.21
- value
- 0.16
- title
- At 6 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.22
- upper Limit
- 0.34
- value
- 0.28
- group Id
- OG001
- lower Limit
- 0.03
- upper Limit
- 0.09
- value
- 0.05
- title
- At 9 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.12
- upper Limit
- 0.21
- value
- 0.16
- group Id
- OG001
- lower Limit
- 0.00
- upper Limit
- 0.03
- value
- 0.01
- title
- At 12 Months
- denoms
- counts
- group Id
- OG000
- value
- 246
- group Id
- OG001
- value
- 246
- units
- Participants
- description
- PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. In this outcome measure, data of PFS at 3 months was reported.
- 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
- NUMBER
- population Description
- Analysis was performed on FAS population.
- reporting Status
- POSTED
- time Frame
- From randomization until 3, 6, 9, and 12 months post treatment
- title
- Probability of Participants With Progression Free Survival at 3, 6, 9 and 12 Months
- type
- SECONDARY
- unit Of Measure
- probability of participants
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Preserved source evidence · Independent clinical review pending · Not medical advice