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NCT01829711 · OUTCOME

Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs

Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia · Source last updated 2020-04-08

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
From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)

What was measured

An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 30 days after the last dose of study drug (approximately 7 months).

Analysis population: Safety population included participants who received at least 1 dose of moxetumomab pasudotox.

Groups in this outcome

Moxetumomab Pasudotox 40 µg/kg

Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Moxetumomab Pasudotox 40 µg/kg80

Reported measurements

Angina pectoris
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg2Not reportedNot reportedNot reportedNot reported
Atrial fibrillation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg1Not reportedNot reportedNot reportedNot reported
Atrioventricular block first degree
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg3Not reportedNot reportedNot reportedNot reported
Bundle branch block left
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg1Not reportedNot reportedNot reportedNot reported
Left ventricular dysfunction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg1Not reportedNot reportedNot reportedNot reported
Palpitations
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg1Not reportedNot reportedNot reportedNot reported
Pericardial effusion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg1Not reportedNot reportedNot reportedNot reported
Sinus bradycardia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg2Not reportedNot reportedNot reportedNot reported
Sinus tachycardia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg6Not reportedNot reportedNot reportedNot reported
Supraventricular tachycardia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg1Not reportedNot reportedNot reportedNot reported
Tachycardia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg1Not reportedNot reportedNot reportedNot reported
Ventricular arrhythmia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Angina pectoris
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Atrial fibrillation
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Atrioventricular block first degree
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Bundle branch block left
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Left ventricular dysfunction
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Palpitations
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Pericardial effusion
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Sinus bradycardia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Sinus tachycardia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Supraventricular tachycardia
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Tachycardia
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Ventricular arrhythmia
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    units
    Participants
description
An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 30 days after the last dose of study drug (approximately 7 months).
groups
  1. description
    Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
    id
    OG000
    title
    Moxetumomab Pasudotox 40 µg/kg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population included participants who received at least 1 dose of moxetumomab pasudotox.
reporting Status
POSTED
time Frame
From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)
title
Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice