Skip to content
TriangleGet started
← Full study record

NCT04322539 · OUTCOME

Overall Survival (OS)

A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer · Source last updated 2025-04-04

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 death from any cause (up to 22 months)

What was measured

OS was defined as the time (months) from date of randomization to death from any cause. OS was calculated as (date of death or last known alive - date of randomization + 1)/30.4375. Participants without report of death at the time of analysis will be censored at the date last known alive.

Analysis population: ITT population included all randomized participants.

Groups in this outcome

Fruquintinib + BSC Group

Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).

Placebo + BSC Group

Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group461
Placebo + BSC Group230

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group7.4Not reported6.78.2Not reported
Placebo + BSC Group4.8Not reported4.05.8Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.549
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.800
    estimate Comment
    The HR between 2 treatment groups (fruquintinib vs placebo), together with its 95 percent (%) confidence interval (CI), was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < .001
    p Value Comment
    Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.
    param Type
    Stratified Hazard Ratio
    param Value
    0.662
    statistical Method
    stratified log-rank test
Complete source fields
analyses
  1. ci Lower Limit
    0.549
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.800
    estimate Comment
    The HR between 2 treatment groups (fruquintinib vs placebo), together with its 95 percent (%) confidence interval (CI), was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < .001
    p Value Comment
    Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.
    param Type
    Stratified Hazard Ratio
    param Value
    0.662
    statistical Method
    stratified log-rank test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.7
        upper Limit
        8.2
        value
        7.4
      2. group Id
        OG001
        lower Limit
        4.0
        upper Limit
        5.8
        value
        4.8
denoms
  1. counts
    1. group Id
      OG000
      value
      461
    2. group Id
      OG001
      value
      230
    units
    Participants
description
OS was defined as the time (months) from date of randomization to death from any cause. OS was calculated as (date of death or last known alive - date of randomization + 1)/30.4375. Participants without report of death at the time of analysis will be censored at the date last known alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
    id
    OG000
    title
    Fruquintinib + BSC Group
  2. description
    Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
    id
    OG001
    title
    Placebo + BSC Group
param Type
MEDIAN
population Description
ITT population included all randomized participants.
reporting Status
POSTED
time Frame
From date of randomization to death from any cause (up to 22 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