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NCT02159469 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 weeks
Other-event reporting threshold
2%

Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator. In total, 125 (83.3%) patients had TEAEs during the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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

3 / 150125 / 1501 / 150

Group identifiers: EG000: Testosterone Enanthate Auto-injector

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Worsening depressive disorder
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Depression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    SUICIDE, METHOD UNKNOWN
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Suicide
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Vertigo
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Vertigo

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      150
      num Events
      21
    term
    Hematocrit increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      150
      num Events
      18
    term
    Prostatic specific antigen increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
      num Events
      5
    term
    Blood creatine phosphokinase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      150
      num Events
      4
    term
    Blood testosterone increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      150
      num Events
      12
    term
    Upper respiratory tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      150
      num Events
      11
    term
    Sinusitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      150
      num Events
      6
    term
    Nasopharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
      num Events
      5
    term
    Bronchitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      150
      num Events
      4
    term
    Influenza
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      150
      num Events
      4
    term
    Urinary tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      150
      num Events
      10
    term
    Injection site bruising
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
      num Events
      5
    term
    Injection site hemorrhage
Complete source fields
description
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator. In total, 125 (83.3%) patients had TEAEs during the study.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    150
    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
    EG000
    other Num Affected
    125
    other Num At Risk
    150
    serious Num Affected
    3
    serious Num At Risk
    150
    title
    Testosterone Enanthate Auto-injector
frequency Threshold
2
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      150
      num Events
      21
    term
    Hematocrit increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      150
      num Events
      18
    term
    Prostatic specific antigen increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
      num Events
      5
    term
    Blood creatine phosphokinase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      150
      num Events
      4
    term
    Blood testosterone increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      150
      num Events
      12
    term
    Upper respiratory tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      150
      num Events
      11
    term
    Sinusitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      150
      num Events
      6
    term
    Nasopharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
      num Events
      5
    term
    Bronchitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      150
      num Events
      4
    term
    Influenza
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      150
      num Events
      4
    term
    Urinary tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      150
      num Events
      10
    term
    Injection site bruising
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
      num Events
      5
    term
    Injection site hemorrhage
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Worsening depressive disorder
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Depression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    SUICIDE, METHOD UNKNOWN
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Suicide
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Vertigo
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Vertigo
time Frame
Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 weeks

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