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NCT04803305 · OUTCOME

Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A

Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia · Source last updated 2024-01-12

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
Day 1 through Week 6 (for a period of 6 weeks)

What was measured

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs are events between first dose of study drug and up to discharge from study that are absent before treatment or that worsen relative to pretreatment state. An SAE is any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.

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

Groups in this outcome

Placebo

Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.

PF-06946860 200mg Q3W

Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.

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

Analysis denominator · Participants

GroupSource count
Placebo6
PF-06946860 200mg Q3W12

Reported measurements

Participants With All-Causality TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo4Not reportedNot reportedNot reportedNot reported
PF-06946860 200mg Q3W7Not reportedNot reportedNot reportedNot reported
Participants With All-Causality SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo1Not reportedNot reportedNot reportedNot reported
PF-06946860 200mg Q3W3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        7
    title
    Participants With All-Causality TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
    title
    Participants With All-Causality SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      12
    units
    Participants
description
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs are events between first dose of study drug and up to discharge from study that are absent before treatment or that worsen relative to pretreatment state. An SAE is any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.
groups
  1. description
    Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.
    id
    OG000
    title
    Placebo
  2. description
    Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.
    id
    OG001
    title
    PF-06946860 200mg Q3W
param Type
COUNT_OF_PARTICIPANTS
population Description
The 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
Day 1 through Week 6 (for a period of 6 weeks)
title
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice