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NCT02159469 · OUTCOME

Safety and Tolerability

Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism · Source last updated 2018-02-07

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
52 weeks

What was measured

* Incidence of adverse events throughout the study * Incidence and severity of injection site reactions throughout the study

Analysis population: TEAE (Treatment-emergent adverse event)s were defined as any event that started on or after the first dosing of IP (Investigational Product), or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. The Population consisted of all patients who received at least 1 dose of the investigational product.

Groups in this outcome

Testosterone Enanthate Auto-injector

Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study. Testosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg

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

Analysis denominator · Participants

GroupSource count
Testosterone Enanthate Auto-injector150

Reported measurements

Patients with any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Testosterone Enanthate Auto-injector125Not reportedNot reportedNot reportedNot reported
Patients with any TEAE related to IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Testosterone Enanthate Auto-injector66Not reportedNot reportedNot reportedNot reported
Patients with any SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Testosterone Enanthate Auto-injector3Not reportedNot reportedNot reportedNot reported
Patients with TEAE leading to discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Testosterone Enanthate Auto-injector30Not reportedNot reportedNot reportedNot reported
Patients discontinued due to IP related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Testosterone Enanthate Auto-injector1Not reportedNot reportedNot reportedNot reported
Patients with any adverse event leading to death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Testosterone Enanthate Auto-injector1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        125
    title
    Patients with any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        66
    title
    Patients with any TEAE related to IP
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Patients with any SAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        30
    title
    Patients with TEAE leading to discontinuation
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Patients discontinued due to IP related TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Patients with any adverse event leading to death
denoms
  1. counts
    1. group Id
      OG000
      value
      150
    units
    Participants
description
* Incidence of adverse events throughout the study * Incidence and severity of injection site reactions throughout the study
groups
  1. description
    Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study. Testosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg
    id
    OG000
    title
    Testosterone Enanthate Auto-injector
param Type
COUNT_OF_PARTICIPANTS
population Description
TEAE (Treatment-emergent adverse event)s were defined as any event that started on or after the first dosing of IP (Investigational Product), or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. The Population consisted of all patients who received at least 1 dose of the investigational product.
reporting Status
POSTED
time Frame
52 weeks
title
Safety and Tolerability
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice