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NCT04737187 · OUTCOME

Survival Probability at 12 Months

Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients · Source last updated 2024-09-24

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 date of randomization until 12 months post treatment

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. In this outcome measure, data of survival probability at 12 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab246
Trifluridine/Tipiracil246

Reported measurements

Source class 1
Values in probability of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab0.43Not reported0.360.49Not reported
Trifluridine/Tipiracil0.30Not reported0.240.36Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.36
        upper Limit
        0.49
        value
        0.43
      2. group Id
        OG001
        lower Limit
        0.24
        upper Limit
        0.36
        value
        0.30
denoms
  1. counts
    1. group Id
      OG000
      value
      246
    2. 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. In this outcome measure, data of survival probability at 12 months was reported.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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 date of randomization until 12 months post treatment
title
Survival Probability at 12 Months
type
PRIMARY
unit Of Measure
probability of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice