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NCT02552121 · OUTCOME

Part 1: Progression Free Survival (PFS)

Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors · Source last updated 2021-04-08

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

Measure
MEDIAN
Unit
weeks
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to end of follow-up; maximum time of follow-up was 24 weeks

What was measured

Progression-free survival was defined as the time in weeks from date of first dose until the date of disease progression or death, whichever is earliest.

Groups in this outcome

Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg

Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).

Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg

Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).

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

Analysis denominator · Participants

GroupSource count
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg2
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg1

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg11.3Not reported7.315.3Not reported
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kgNANot reported7.1NACould not be estimated due to the low number of events disease progression or death.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.3
        upper Limit
        15.3
        value
        11.3
      2. comment
        Could not be estimated due to the low number of events disease progression or death.
        group Id
        OG001
        lower Limit
        7.1
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Progression-free survival was defined as the time in weeks from date of first dose until the date of disease progression or death, whichever is earliest.
dispersion Type
95% Confidence Interval
groups
  1. description
    Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
    id
    OG000
    title
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
  2. description
    Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
    id
    OG001
    title
    Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
param Type
MEDIAN
reporting Status
POSTED
time Frame
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
title
Part 1: Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice