Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02354534 · ADVERSE EVENTS

Adverse events

Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3) · Source last updated 2021-04-28

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
41 weeks
Other-event reporting threshold
0%

All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
50 mg Artesunate Suppositories, 1 Cycle

Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories

0 / 32 / 30 / 3
200 mg Artesunate Suppositories, 1 Cycle

Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories

0 / 99 / 90 / 9
200 mg Artesunate Suppositories,2 Cycles

Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories

0 / 108 / 100 / 10
200 mg Artesunate Suppositories,3 Cycles

Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories

0 / 88 / 80 / 8

Group identifiers: EG000: 50 mg Artesunate Suppositories, 1 Cycle · EG001: 200 mg Artesunate Suppositories, 1 Cycle · EG002: 200 mg Artesunate Suppositories,2 Cycles · EG003: 200 mg Artesunate Suppositories,3 Cycles

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
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        4
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        9
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        10
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Bloating
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Ringing in the ear
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        9
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        2
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Tinnitus
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Abdominal pain
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        9
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        10
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Diarrhea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Loss in appetite
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Nausea
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Change in taste
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Salivary duct inflammation
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        10
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        8
        num Events
        2
      term
      Chills
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Fatigue
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        9
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Fever
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        10
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        8
        num Events
        1
      term
      Flu-like symptoms
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      bacterial or yeast infections
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        9
        num Events
        2
      3. group Id
        EG002
        num Affected
        4
        num At Risk
        10
        num Events
        4
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        8
        num Events
        2
      term
      Vaginal infection
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        1
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        8
        num Events
        1
      term
      Urinary tract infection
    Complete source fields
    description
    All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      3
      description
      Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
      id
      EG000
      other Num Affected
      2
      other Num At Risk
      3
      serious Num Affected
      0
      serious Num At Risk
      3
      title
      50 mg Artesunate Suppositories, 1 Cycle
    2. deaths Num Affected
      0
      deaths Num At Risk
      9
      description
      Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
      id
      EG001
      other Num Affected
      9
      other Num At Risk
      9
      serious Num Affected
      0
      serious Num At Risk
      9
      title
      200 mg Artesunate Suppositories, 1 Cycle
    3. deaths Num Affected
      0
      deaths Num At Risk
      10
      description
      Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
      id
      EG002
      other Num Affected
      8
      other Num At Risk
      10
      serious Num Affected
      0
      serious Num At Risk
      10
      title
      200 mg Artesunate Suppositories,2 Cycles
    4. deaths Num Affected
      0
      deaths Num At Risk
      8
      description
      Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
      id
      EG003
      other Num Affected
      8
      other Num At Risk
      8
      serious Num Affected
      0
      serious Num At Risk
      8
      title
      200 mg Artesunate Suppositories,3 Cycles
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        4
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        9
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        10
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Bloating
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Ringing in the ear
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        9
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        2
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Tinnitus
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Abdominal pain
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        9
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        10
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Diarrhea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Loss in appetite
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Nausea
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Change in taste
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Salivary duct inflammation
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        10
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        8
        num Events
        2
      term
      Chills
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Fatigue
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        9
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        8
        num Events
        0
      term
      Fever
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        10
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        8
        num Events
        1
      term
      Flu-like symptoms
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      bacterial or yeast infections
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        9
        num Events
        2
      3. group Id
        EG002
        num Affected
        4
        num At Risk
        10
        num Events
        4
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        8
        num Events
        2
      term
      Vaginal infection
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        9
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        10
        num Events
        1
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        8
        num Events
        1
      term
      Urinary tract infection
    time Frame
    41 weeks

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

    Preserved source evidence · Not medical advice