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NCT01444911 · ADVERSE EVENTS

Adverse events

Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction · Source last updated 2019-12-09

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 event data were collected for 1 year, 8 months.
Other-event reporting threshold
0%

Participants were assessed for toxicity at each study visit. All events at least possibly related to the study intervention will be collected. Participants were instructed to call the study team for adverse events that occurred between visits. The study team or an on-call physician were available 24 hours a day.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Vaginal Renewal Program

Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.

0 / 164 / 16Not reported / Not reported
Standard of Care

This will consist of still vaginal dilator and/or lubricant. Vaginal Dilator: Still vaginal dilator with lubricant.

0 / 133 / 13Not reported / Not reported

Group identifiers: EG000: Vaginal Renewal Program · EG001: Standard of Care

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.

    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        13
      term
      Bladder irritation
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        13
      term
      Bladder pressure
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        13
        num Events
        3
      term
      Urinary tract infections (UTI)
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Yeast
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        13
      term
      Vaginal infection
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        13
      term
      Vaginal irritation
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        13
      term
      Vulvar fissures
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        13
        num Events
        1
      term
      Wrist pain
    Complete source fields
    description
    Participants were assessed for toxicity at each study visit. All events at least possibly related to the study intervention will be collected. Participants were instructed to call the study team for adverse events that occurred between visits. The study team or an on-call physician were available 24 hours a day.
    event Groups
    1. description
      Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
      id
      EG000
      other Num Affected
      4
      other Num At Risk
      16
      serious Num Affected
      0
      serious Num At Risk
      16
      title
      Vaginal Renewal Program
    2. description
      This will consist of still vaginal dilator and/or lubricant. Vaginal Dilator: Still vaginal dilator with lubricant.
      id
      EG001
      other Num Affected
      3
      other Num At Risk
      13
      serious Num Affected
      0
      serious Num At Risk
      13
      title
      Standard of Care
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        13
      term
      Bladder irritation
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        13
      term
      Bladder pressure
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        13
        num Events
        3
      term
      Urinary tract infections (UTI)
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Yeast
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        13
      term
      Vaginal infection
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        13
      term
      Vaginal irritation
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        13
      term
      Vulvar fissures
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        13
        num Events
        1
      term
      Wrist pain
    time Frame
    Adverse event data were collected for 1 year, 8 months.

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

    Preserved source evidence · Not medical advice