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NCT01083199 · ADVERSE EVENTS

Adverse events

Global Performance Evaluation of the AMS CONTINUUM™ Device · Source last updated 2016-04-12

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
AMS CONTINUUM™ Device

Not reported

6 / 106 / 10Not reported / Not reported

Group identifiers: EG000: AMS 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
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hemorrhage
  2. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Migration
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      4
    term
    Separation/Distruption of Anastomosis
  4. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Urinary Retention
  5. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Urinary Tract Infection (UTI)

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
      1
      num At Risk
      10
      num Events
      1
    term
    False Passage
  2. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
      num Events
      6
    term
    Hematuria
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Rectal Injury
  4. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      4
    term
    Separation/Disruption of Anastomosis
Complete source fields
event Groups
  1. id
    EG000
    other Num Affected
    6
    other Num At Risk
    10
    serious Num Affected
    6
    serious Num At Risk
    10
    title
    AMS CONTINUUM™ Device
frequency Threshold
5
other Events
  1. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    False Passage
  2. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
      num Events
      6
    term
    Hematuria
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Rectal Injury
  4. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      4
    term
    Separation/Disruption of Anastomosis
serious Events
  1. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hemorrhage
  2. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Migration
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      4
    term
    Separation/Distruption of Anastomosis
  4. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Urinary Retention
  5. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Urinary Tract Infection (UTI)

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Preserved source evidence · Not medical advice