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NCT02552121 · OUTCOME

Part 2: Number of Participants With Markedly Abnormal Laboratory Values

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline to end of trial (Part 2), up to 36 weeks

What was measured

The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Markedly abnormal laboratory values are defined as any grade \>=3 laboratory abnormality events.

Groups in this outcome

Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian

Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).

Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical

Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).

Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian

Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).

Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical

Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).

Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian

Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.

Part 2: Cohort Expansion: Cohort 6 1q3w Cervical

Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 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 2: Cohort Expansion: Cohort 1 3q4wk Ovarian11
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical3
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian1
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical5
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian1
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical3

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian5Not reportedNot reportedNot reportedNot reported
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical2Not reportedNot reportedNot reportedNot reported
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian0Not reportedNot reportedNot reportedNot reported
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical3Not reportedNot reportedNot reportedNot reported
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian1Not reportedNot reportedNot reportedNot reported
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      3
    units
    Participants
description
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Markedly abnormal laboratory values are defined as any grade \>=3 laboratory abnormality events.
groups
  1. description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
    id
    OG000
    title
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
  2. description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
    id
    OG001
    title
    Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
  3. description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
    id
    OG002
    title
    Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
  4. description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
    id
    OG003
    title
    Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
  5. description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
    id
    OG004
    title
    Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
  6. description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
    id
    OG005
    title
    Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Baseline to end of trial (Part 2), up to 36 weeks
title
Part 2: Number of Participants With Markedly Abnormal Laboratory Values
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice