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NCT00007644 · ADVERSE EVENTS

Adverse events

Prostate Cancer Intervention Versus Observation Trial (PIVOT) · Source last updated 2020-02-24

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Radical Prostatectomy

Surgical removal of the prostate

171 / 3640 / 364Not reported / Not reported
Watchful Waiting

Closely watching, waiting and treating symptoms if and when cancer progresses

183 / 3670 / 367Not reported / Not reported

Group identifiers: EG000: Radical Prostatectomy · EG001: Watchful Waiting

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
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      171
      num At Risk
      364
      num Events
      171
    2. group Id
      EG001
      num Affected
      183
      num At Risk
      367
      num Events
      183
    term
    Death

Other reported adverse events

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

    Complete source fields
    event Groups
    1. description
      Surgical removal of the prostate
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      364
      serious Num Affected
      171
      serious Num At Risk
      364
      title
      Radical Prostatectomy
    2. description
      Closely watching, waiting and treating symptoms if and when cancer progresses
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      367
      serious Num Affected
      183
      serious Num At Risk
      367
      title
      Watchful Waiting
    frequency Threshold
    0
    serious Events
    1. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        171
        num At Risk
        364
        num Events
        171
      2. group Id
        EG001
        num Affected
        183
        num At Risk
        367
        num Events
        183
      term
      Death

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

    Preserved source evidence · Not medical advice