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NCT00894933 · ADVERSE EVENTS

Adverse events

Performance Evaluation of the AMS CONTINUUM™ Device · Source last updated 2018-02-22

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
Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Continuum Device

Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy

3 / 3130 / 31Not reported / Not reported

Group identifiers: EG000: Continuum Device

Serious adverse events

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

  1. organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Excessive bleeding
  2. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Bladder Neck Contracture/Outlet Obstruct
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Separation/Disruption of Anastomosis
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Syncope

Other reported adverse events

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

  1. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      31
      num Events
      26
    term
    Urinary Incontinence - De Novo
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      31
      num Events
      12
    term
    Pain/Discomfort
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      31
      num Events
      13
    term
    Pain/Discomfort - Other
  4. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      31
      num Events
      8
    term
    Hematuria
  5. organ System
    Reproductive system and breast disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      31
      num Events
      18
    term
    Erectile Dysfunction - De Novo
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      31
      num Events
      8
    term
    Pain/Discomfort - Abdominal
  7. organ System
    Reproductive system and breast disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Erectile Dysfunction - Worsening
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Infection
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Urinary Tract Infection (UTI)
  10. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Urinary Retention
  11. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Dysuria
  12. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    False Passage
Complete source fields
event Groups
  1. description
    Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
    id
    EG000
    other Num Affected
    30
    other Num At Risk
    31
    serious Num Affected
    3
    serious Num At Risk
    31
    title
    Continuum Device
frequency Threshold
0
other Events
  1. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      31
      num Events
      26
    term
    Urinary Incontinence - De Novo
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      31
      num Events
      12
    term
    Pain/Discomfort
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      31
      num Events
      13
    term
    Pain/Discomfort - Other
  4. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      31
      num Events
      8
    term
    Hematuria
  5. organ System
    Reproductive system and breast disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      31
      num Events
      18
    term
    Erectile Dysfunction - De Novo
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      31
      num Events
      8
    term
    Pain/Discomfort - Abdominal
  7. organ System
    Reproductive system and breast disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Erectile Dysfunction - Worsening
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Infection
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Urinary Tract Infection (UTI)
  10. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Urinary Retention
  11. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Dysuria
  12. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    False Passage
serious Events
  1. organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Excessive bleeding
  2. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Bladder Neck Contracture/Outlet Obstruct
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Separation/Disruption of Anastomosis
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Syncope
time Frame
Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up

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Preserved source evidence · Not medical advice