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NCT04299048 · OUTCOME

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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

An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An AE was considered an TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.

Analysis population: The safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

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 Q3W10

Reported measurements

AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W10Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An AE was considered an TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.
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
The safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
reporting Status
POSTED
time Frame
From Day 1 up to Week 24
title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice