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NCT00577317 · ADVERSE EVENTS

Adverse events

Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer · Source last updated 2021-06-23

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
Not reported
Other-event reporting threshold
0%

Two participants enrolled in this study. The study was closed early due to poor accrual.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1

Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks. Management of Therapy Complications: Receive standard home maintenance therapy and perform self-manual lymphatic drainage Quality-of-Life Assessment: Ancillary studies

0 / 00 / 00 / 0
Arm II

Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks Management of Therapy Complications: Receive Flexitouch home maintenance therapy Quality-of-Life Assessment: Ancillary studies

0 / 20 / 20 / 2

Group identifiers: EG000: Arm 1 · EG001: Arm II

Serious adverse events

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

    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
      description
      Two participants enrolled in this study. The study was closed early due to poor accrual.
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        0
        description
        Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks. Management of Therapy Complications: Receive standard home maintenance therapy and perform self-manual lymphatic drainage Quality-of-Life Assessment: Ancillary studies
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        Arm 1
      2. deaths Num Affected
        0
        deaths Num At Risk
        2
        description
        Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks Management of Therapy Complications: Receive Flexitouch home maintenance therapy Quality-of-Life Assessment: Ancillary studies
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        2
        serious Num Affected
        0
        serious Num At Risk
        2
        title
        Arm II
      frequency Threshold
      0

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice