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NCT00931528 · ADVERSE EVENTS

Adverse events

Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy · Source last updated 2018-02-14

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
Not reported
Other-event reporting threshold
5%

Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.

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

Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.

3 / 11185 / 111Not reported / Not reported
Placebo

Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.

4 / 10876 / 108Not reported / Not reported

Group identifiers: EG000: Tadalafil · EG001: Placebo

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    term
    Abdominal pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Gastritis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Nausea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    term
    Rectal hemorrhage
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Chills
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Sepsis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Investigations - Other
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Lymphocyte count decreased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Platelet count decreased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Weight loss
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Dehydration

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      108
    term
    Diarrhea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
    term
    Gastrointestinal disorders - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      108
    term
    Fatigue
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      108
    term
    Back pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      108
    term
    Headache
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      108
    term
    Cystitis noninfective
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      108
    term
    Renal and urinary disorders - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      108
    term
    Urinary frequency
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      108
    term
    Urinary retention
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      108
    term
    Urinary tract pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      108
    term
    Urinary urgency
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      108
    term
    Ejaculation disorder
Complete source fields
description
Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
event Groups
  1. description
    Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
    id
    EG000
    other Num Affected
    85
    other Num At Risk
    111
    serious Num Affected
    3
    serious Num At Risk
    111
    title
    Tadalafil
  2. description
    Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
    id
    EG001
    other Num Affected
    76
    other Num At Risk
    108
    serious Num Affected
    4
    serious Num At Risk
    108
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      108
    term
    Diarrhea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
    term
    Gastrointestinal disorders - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      108
    term
    Fatigue
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      108
    term
    Back pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      108
    term
    Headache
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      108
    term
    Cystitis noninfective
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      108
    term
    Renal and urinary disorders - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      108
    term
    Urinary frequency
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      108
    term
    Urinary retention
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      108
    term
    Urinary tract pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      108
    term
    Urinary urgency
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      108
    term
    Ejaculation disorder
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    term
    Abdominal pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Gastritis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Nausea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
    term
    Rectal hemorrhage
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Chills
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Sepsis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Investigations - Other
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Lymphocyte count decreased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Platelet count decreased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Weight loss
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
    term
    Dehydration

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