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NCT04467697 · ADVERSE EVENTS

Adverse events

Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men · Source last updated 2024-06-28

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
180 days
Other-event reporting threshold
2%

All-Cause Mortality includes all causes; Serious Adverse events includes all causes; Other Adverse Events category includes only AE's judged by clinical investigators to have been treatment-related.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
SOV2012-F1-treated

Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals. SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.

2 / 15530 / 1550 / 155

Group identifiers: EG000: SOV2012-F1-treated

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
    Event judged not treatment related by investigator.
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      155
      num Events
      1
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Event judged not treatment related by investigator.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      155
      num Events
      1
    term
    Diverticular perforation

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
    Vascular disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      155
      num Events
      4
    term
    Hypertension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      155
      num Events
      8
    term
    Upper Respiratory Tract Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      155
      num Events
      5
    term
    Viral upper respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      155
      num Events
      4
    term
    Influenza
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      155
      num Events
      3
    term
    Bronchitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Event judged as treatment related by investigator.
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      155
      num Events
      3
    term
    Hemoglobin increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      155
      num Events
      3
    term
    Headache
Complete source fields
description
All-Cause Mortality includes all causes; Serious Adverse events includes all causes; Other Adverse Events category includes only AE's judged by clinical investigators to have been treatment-related.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    155
    description
    Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals. SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
    id
    EG000
    other Num Affected
    30
    other Num At Risk
    155
    serious Num Affected
    2
    serious Num At Risk
    155
    title
    SOV2012-F1-treated
frequency Threshold
2
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      155
      num Events
      4
    term
    Hypertension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      155
      num Events
      8
    term
    Upper Respiratory Tract Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      155
      num Events
      5
    term
    Viral upper respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      155
      num Events
      4
    term
    Influenza
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      155
      num Events
      3
    term
    Bronchitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Event judged as treatment related by investigator.
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      155
      num Events
      3
    term
    Hemoglobin increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      155
      num Events
      3
    term
    Headache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Event judged not treatment related by investigator.
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      155
      num Events
      1
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Event judged not treatment related by investigator.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      155
      num Events
      1
    term
    Diverticular perforation
time Frame
180 days

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Preserved source evidence · Not medical advice