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NCT03438396 · OUTCOME

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Day 1 through 30 days after the last dose of study drug (approximately 49 months)

What was measured

Laboratory abnormalities that induced clinical signs or symptoms, required concomitant therapy or required changes during treatment emergent period were reported as TEAEs. Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.

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

Anaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin34Not reportedNot reportedNot reportedNot reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin4Not reportedNot reportedNot reportedNot reported
Iron deficiency anaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin3Not reportedNot reportedNot reportedNot reported
Leukocytosis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Leukopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Thrombocytosis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Hypokalaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin6Not reportedNot reportedNot reportedNot reported
Hypomagnesaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin6Not reportedNot reportedNot reportedNot reported
Hypocalcaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin4Not reportedNot reportedNot reportedNot reported
Hyperglycaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin3Not reportedNot reportedNot reportedNot reported
Hypercreatininaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin2Not reportedNot reportedNot reportedNot reported
Hyperuricaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin2Not reportedNot reportedNot reportedNot reported
Hypercalcaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Hypernatraemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Hypoalbuminaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Hyponatraemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Activated partial thromboplastin time prolonged
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin3Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin3Not reportedNot reportedNot reportedNot reported
Blood creatinine increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin2Not reportedNot reportedNot reportedNot reported
C-reactive protein increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin2Not reportedNot reportedNot reportedNot reported
International normalised ratio increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin2Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin2Not reportedNot reportedNot reportedNot reported
Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Blood alkaline phosphatase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Blood bicarbonate decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Blood creatine phosphokinase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin2Not reportedNot reportedNot reportedNot reported
Blood potassium decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Creatinine renal clearance decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin2Not reportedNot reportedNot reportedNot reported
Prothrombin time prolonged
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
White blood cell count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Hyperthyroidism
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Hypothyroidism
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Hypertransaminasaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin3Not reportedNot reportedNot reportedNot reported
Hyperbilirubinaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin1Not reportedNot reportedNot reportedNot reported
Haematuria
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        34
    title
    Anaemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Neutropenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Iron deficiency anaemia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Leukocytosis
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Leukopenia
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Thrombocytopenia
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Thrombocytosis
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Hypokalaemia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Hypomagnesaemia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Hypocalcaemia
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Hyperglycaemia
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Hypercreatininaemia
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    units
    Participants
description
Laboratory abnormalities that induced clinical signs or symptoms, required concomitant therapy or required changes during treatment emergent period were reported as TEAEs. Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.
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
COUNT_OF_PARTICIPANTS
population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin.
reporting Status
POSTED
time Frame
From Day 1 through 30 days after the last dose of study drug (approximately 49 months)
title
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice