Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02552121 · OUTCOME

Part 1: Response Evaluation Based on CA125 (Cancer Antigen 125 [Ovarian and Endometrial Cancer]): Percentage of Change From Baseline to End of Study

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
MEAN
Unit
percentage of change
Interval / dispersion
Standard Deviation
Time frame
Baseline to end of follow-up; maximum follow-up was 24 weeks

Analysis population: CA 125 is only assessed for participants with ovarian and endometrial cancer, 1 participant in Cohort 1 and 1 participant in Cohort 2 had the indication of ovarian or endometrial cancer. No participants from Cohort 1 with the indication of ovarian and endometrial Cancer had results at the End of Study visit.

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/kg0
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg1

Reported measurements

Source class 1
Values in percentage of change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg186.21NANot reportedNot reportedOnly 1 participant was included in the analysis, therefore Standard deviation could not calculated.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Only 1 participant was included in the analysis, therefore Standard deviation could not calculated.
        group Id
        OG001
        spread
        NA
        value
        186.21
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      1
    units
    Participants
dispersion Type
Standard Deviation
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
MEAN
population Description
CA 125 is only assessed for participants with ovarian and endometrial cancer, 1 participant in Cohort 1 and 1 participant in Cohort 2 had the indication of ovarian or endometrial cancer. No participants from Cohort 1 with the indication of ovarian and endometrial Cancer had results at the End of Study visit.
reporting Status
POSTED
time Frame
Baseline to end of follow-up; maximum follow-up was 24 weeks
title
Part 1: Response Evaluation Based on CA125 (Cancer Antigen 125 [Ovarian and Endometrial Cancer]): Percentage of Change From Baseline to End of Study
type
SECONDARY
unit Of Measure
percentage of change

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

Preserved source evidence · Not medical advice