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NCT04299048 · OUTCOME

Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities

Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia. · Source last updated 2023-12-14

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 up to Week 24

What was measured

ECG data (PR interval, QRS interval, QT interval, and QTcF) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in ECG, were PR interval: value ≥300 milliseconds (msec), percentage change ≥25/50%; QRS interval: value ≥140 msec, percentage change ≥50%; QT interval: value ≥500 msec; QTcF interval: 470\< value ≤480 msec, 480\< value ≤500 msec, value \>500 msec, and 30\< change ≤60 msec, change \>60 msec.

Analysis population: Overall number of participants analyzed included participants evaluated against pre-defined criteria for ECGs.

Groups in this outcome

PF-06946860 Q3W

During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.

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

Analysis denominator · Participants

GroupSource count
PF-06946860 Q3W8

Reported measurements

Supine PR Interval - Value ≥300 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Supine PR Interval - %Chg ≥25/50%
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Supine QRS Interval - Value ≥140 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Supine QRS Interval - %Chg ≥50%
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Supine QT Interval - Value ≥500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Supine QTcF - 470<Value≤480 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Supine QTcF - 480<Value≤500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Supine QTcF - Value>500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Supine QTcF - 30<Chg≤60 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W2Not reportedNot reportedNot reportedNot reported
Supine QTcF - Chg>60 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine PR Interval - Value ≥300 msec
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine PR Interval - %Chg ≥25/50%
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine QRS Interval - Value ≥140 msec
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine QRS Interval - %Chg ≥50%
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine QT Interval - Value ≥500 msec
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine QTcF - 470<Value≤480 msec
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine QTcF - 480<Value≤500 msec
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine QTcF - Value>500 msec
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Supine QTcF - 30<Chg≤60 msec
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine QTcF - Chg>60 msec
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
ECG data (PR interval, QRS interval, QT interval, and QTcF) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in ECG, were PR interval: value ≥300 milliseconds (msec), percentage change ≥25/50%; QRS interval: value ≥140 msec, percentage change ≥50%; QT interval: value ≥500 msec; QTcF interval: 470\< value ≤480 msec, 480\< value ≤500 msec, value \>500 msec, and 30\< change ≤60 msec, change \>60 msec.
groups
  1. description
    During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
    id
    OG000
    title
    PF-06946860 Q3W
param Type
COUNT_OF_PARTICIPANTS
population Description
Overall number of participants analyzed included participants evaluated against pre-defined criteria for ECGs.
reporting Status
POSTED
time Frame
From Day 1 up to Week 24
title
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice