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NCT02155647 · OUTCOME

Part A: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)

Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200) · Source last updated 2024-03-13

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
Up to 325 weeks

What was measured

A 12-lead ECG was recorded after the participant has been in a supine position breathing quietly for 5 minutes. The ECG results was used to evaluate the heart rate, atrial ventricular conduction, PR interval, QRS, QTcF and QTcB. Number of participants with clinical significant abnormalities in ECG parameter reported here. Clinically Significance was decided by investigator.

Analysis population: Safety analysis set included all participants who received at least 1 dose of study treatment. Here "Number of participants analyzed" signifies those who were evaluable for this outcome measure.

Groups in this outcome

Part A: Avelumab

Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.

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 A: Avelumab81

Reported measurements

PR interval >= 220 ms
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab16Not reportedNot reportedNot reportedNot reported
QRS >= 120 ms
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab12Not reportedNot reportedNot reportedNot reported
QTcF > 30 ms and <= 60 ms
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab20Not reportedNot reportedNot reportedNot reported
QTcF > 60 ms
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
QTcB > 30 ms and <= 60 ms
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab25Not reportedNot reportedNot reportedNot reported
QTcB > 60 ms
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab2Not reportedNot reportedNot reportedNot reported
Heart rate <= 50 bpm
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab3Not reportedNot reportedNot reportedNot reported
Heart rate >= 120 bpm
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    PR interval >= 220 ms
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    QRS >= 120 ms
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    QTcF > 30 ms and <= 60 ms
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    QTcF > 60 ms
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    QTcB > 30 ms and <= 60 ms
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    QTcB > 60 ms
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Heart rate <= 50 bpm
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Heart rate >= 120 bpm
denoms
  1. counts
    1. group Id
      OG000
      value
      81
    units
    Participants
description
A 12-lead ECG was recorded after the participant has been in a supine position breathing quietly for 5 minutes. The ECG results was used to evaluate the heart rate, atrial ventricular conduction, PR interval, QRS, QTcF and QTcB. Number of participants with clinical significant abnormalities in ECG parameter reported here. Clinically Significance was decided by investigator.
groups
  1. description
    Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
    id
    OG000
    title
    Part A: Avelumab
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all participants who received at least 1 dose of study treatment. Here "Number of participants analyzed" signifies those who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Up to 325 weeks
title
Part A: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice