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NCT04322539 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From start of study drug administration up to approximately 40 months

What was measured

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE was considered a TEAE if the onset date was on or after the start of study treatment or if the onset date was missing, or if the AE had an onset date before the start of study treatment but worsened in severity after the study treatment until 30 days after the last dose of study treatment or a new treatment of anti-tumor therapy, whichever was earlier. After this period, treatment-related SAEs were also considered as TEAEs. AEs with an unknown/not reported onset date were also included.

Analysis population: SP included all randomized participants who received at least 1 dose of study drug.

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 Group456
Placebo + BSC Group230

Reported measurements

Participants with TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group451Not reportedNot reportedNot reportedNot reported
Placebo + BSC Group214Not reportedNot reportedNot reportedNot reported
Participants with Serious TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group173Not reportedNot reportedNot reportedNot reported
Placebo + BSC Group88Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        451
      2. group Id
        OG001
        value
        214
    title
    Participants with TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        173
      2. group Id
        OG001
        value
        88
    title
    Participants with Serious TEAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      456
    2. group Id
      OG001
      value
      230
    units
    Participants
description
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE was considered a TEAE if the onset date was on or after the start of study treatment or if the onset date was missing, or if the AE had an onset date before the start of study treatment but worsened in severity after the study treatment until 30 days after the last dose of study treatment or a new treatment of anti-tumor therapy, whichever was earlier. After this period, treatment-related SAEs were also considered as TEAEs. AEs with an unknown/not reported onset date were also included.
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
COUNT_OF_PARTICIPANTS
population Description
SP included all randomized participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From start of study drug administration up to approximately 40 months
title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
type
SECONDARY
unit Of Measure
Participants

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

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