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NCT03242590 · ADVERSE EVENTS

Adverse events

Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021). · Source last updated 2019-10-23

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
1 month
Other-event reporting threshold
1%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Oral Testosterone Undecanoate, LPCN 1021

Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate

1 / 956 / 950 / 95

Group identifiers: EG000: Oral Testosterone Undecanoate, LPCN 1021

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
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Gastric Ulcer Hemorrhage

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
    Endocrine disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      95
      num Events
      4
    term
    Blood prolactin increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Blood FSH decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Blood LH decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    PSA increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Weight increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Headache
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    95
    description
    Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    95
    serious Num Affected
    1
    serious Num At Risk
    95
    title
    Oral Testosterone Undecanoate, LPCN 1021
frequency Threshold
1
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      95
      num Events
      4
    term
    Blood prolactin increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Blood FSH decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Blood LH decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    PSA increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Weight increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Headache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Gastric Ulcer Hemorrhage
time Frame
1 month

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

Preserved source evidence · Not medical advice