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NCT01178411 · OUTCOME

Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)

An Extension Protocol for Subjects Who Were Previously Enrolled in Other Tivantinib (ARQ 197) Protocols · Source last updated 2021-03-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 3021 days

What was measured

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Analysis population: All participants who received ≥1 dose of study drug are included.

Groups in this outcome

Tivantinib (Monotherapy or Combination)

Participants received tivantinib 360 mg twice daily by mouth as monotherapy or combination therapy.

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

Analysis denominator · Participants

GroupSource count
Tivantinib (Monotherapy or Combination)60

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib (Monotherapy or Combination)56Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        56
denoms
  1. counts
    1. group Id
      OG000
      value
      60
    units
    Participants
description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
groups
  1. description
    Participants received tivantinib 360 mg twice daily by mouth as monotherapy or combination therapy.
    id
    OG000
    title
    Tivantinib (Monotherapy or Combination)
param Type
NUMBER
population Description
All participants who received ≥1 dose of study drug are included.
reporting Status
POSTED
time Frame
Up to 3021 days
title
Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice