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NCT03438396 · OUTCOME

Percentage of Participants With Confirmed Objective Response (OR) as Assessed by the Independent Review Committee (IRC)

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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 20 months)

What was measured

The confirmed OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based upon RECIST v1.1, assessed by the IRC. The CR is disappearance of all target and non-target lesions and no new lesions. A confirmed CR is 2 CRs (CR-CR sequence) that were separated by at least 4 weeks with no evidence of progression in-between. The PR is ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion. A confirmed PR is PR-PR sequence or PR-CR sequence that were separated by at least 4 weeks. The intermediate missing (Not Evaluable \[NE\]) scan evaluations between response scan and confirmation scan were allowed, eg, PR-NE-PR and PR-NE-NE-PR was considered PR confirmed (a repeat scan not earlier than 4 weeks after initial scan documenting response). 95% CI was calculated using the Clopper-Pearson method.

Analysis population: FAS included all participants who received at least 1 dose of tisotumab vedotin.

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 Vedotin101

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin23.8Not reported15.933.3Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    non Inferiority Comment
    The statistical hypotheses was tested to address ORR \<= 11% vs. ORR \> 11%.
    non Inferiority Type
    OTHER
    p Value
    0.0002
    statistical Method
    one-sided exact test
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Comment
    The statistical hypotheses was tested to address ORR \<= 11% vs. ORR \> 11%.
    non Inferiority Type
    OTHER
    p Value
    0.0002
    statistical Method
    one-sided exact test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.9
        upper Limit
        33.3
        value
        23.8
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    units
    Participants
description
The confirmed OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based upon RECIST v1.1, assessed by the IRC. The CR is disappearance of all target and non-target lesions and no new lesions. A confirmed CR is 2 CRs (CR-CR sequence) that were separated by at least 4 weeks with no evidence of progression in-between. The PR is ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion. A confirmed PR is PR-PR sequence or PR-CR sequence that were separated by at least 4 weeks. The intermediate missing (Not Evaluable \[NE\]) scan evaluations between response scan and confirmation scan were allowed, eg, PR-NE-PR and PR-NE-NE-PR was considered PR confirmed (a repeat scan not earlier than 4 weeks after initial scan documenting response). 95% CI was calculated using the Clopper-Pearson method.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin.
reporting Status
POSTED
time Frame
From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 20 months)
title
Percentage of Participants With Confirmed Objective Response (OR) as Assessed by the Independent Review Committee (IRC)
type
PRIMARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice