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NCT03438396 · OUTCOME

Number of Participants With Positive Anti-drug Antibodies (ADA) to Tisotumab Vedotin

A Trial of Tisotumab Vedotin in Cervical Cancer · Source last updated 2023-07-25

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
Predose of each treatment cycle (Cycle 1 to 21) and end of treatment visit (approximately 49 months)

What was measured

Number of participants with positive ADA titer to tisotumab vedotin at baseline and post-baseline are reported. Baseline is defined as the latest available measurement made before the first dose of tisotumab vedotin. For post-baseline results, a participant was considered ADA positive if either ADA is negative at baseline and at least one post-baseline result is positive or positive at baseline and at least one positive post-baseline result with a titer higher than baseline.

Analysis population: Participants in FAS (received at least 1 dose of tisotumab vedotin) and who had ADA results at baseline and post-baseline are analyzed for this outcome measure.

Groups in this outcome

Tisotumab Vedotin

Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin93

Reported measurements

ADA positive at Baseline
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin2Not reportedNot reportedNot reportedNot reported
ADA positive at post-baseline
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    ADA positive at Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    ADA positive at post-baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      93
    units
    Participants
description
Number of participants with positive ADA titer to tisotumab vedotin at baseline and post-baseline are reported. Baseline is defined as the latest available measurement made before the first dose of tisotumab vedotin. For post-baseline results, a participant was considered ADA positive if either ADA is negative at baseline and at least one post-baseline result is positive or positive at baseline and at least one positive post-baseline result with a titer higher than baseline.
groups
  1. description
    Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
    id
    OG000
    title
    Tisotumab Vedotin
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants in FAS (received at least 1 dose of tisotumab vedotin) and who had ADA results at baseline and post-baseline are analyzed for this outcome measure.
reporting Status
POSTED
time Frame
Predose of each treatment cycle (Cycle 1 to 21) and end of treatment visit (approximately 49 months)
title
Number of Participants With Positive Anti-drug Antibodies (ADA) to Tisotumab Vedotin
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice