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NCT03438396 · OUTCOME

Overall Survival (OS)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From Day 1 until death or withdrawal from the study, whichever occurred first (approximately 49 months)

What was measured

The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier 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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin12.3Not reported9.614.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.6
        upper Limit
        14.1
        value
        12.3
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    units
    Participants
description
The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier 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
MEDIAN
population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin.
reporting Status
POSTED
time Frame
From Day 1 until death or withdrawal from the study, whichever occurred first (approximately 49 months)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice