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NCT02552121 · OUTCOME

Part 1: Response Evaluation Based on PSA (Prostate Specific Antigen [Prostate Cancer]): Percentage 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: PSA is only assessed for participants with prostate cancer. 2 participants in Part 1 Cohort 1 and 1 participant in Part 1 Cohort 2 had the indication of prostate cancer.

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 percentage of change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg23.4261.686Not reportedNot reportedNot reported
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg12.97NANot reportedNot reportedOnly 1 participant is included in the analysis, therefore Standard deviation cannot be calculated.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        61.686
        value
        23.42
      2. comment
        Only 1 participant is included in the analysis, therefore Standard deviation cannot be calculated.
        group Id
        OG001
        spread
        NA
        value
        12.97
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    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
PSA is only assessed for participants with prostate cancer. 2 participants in Part 1 Cohort 1 and 1 participant in Part 1 Cohort 2 had the indication of prostate cancer.
reporting Status
POSTED
time Frame
Baseline to end of follow-up; maximum follow-up was 24 weeks
title
Part 1: Response Evaluation Based on PSA (Prostate Specific Antigen [Prostate Cancer]): Percentage 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