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NCT06263582 · ADVERSE EVENTS

Adverse events

Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya · Source last updated 2025-08-19

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
Up to ten days after the study intervention (vaginal insertion of Artesunate pessaries).
Other-event reporting threshold
0%

AEs were collected according to National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0)

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Artesunate Vaginal Inserts/ Pessaries

Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions. Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.

0 / 128 / 120 / 12

Group identifiers: EG000: Artesunate Vaginal Inserts/ Pessaries

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
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        12
      term
      Abdominal Pain
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        12
      term
      Vaginal discharge
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
      term
      Toothache
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
      term
      Vaginal fistula
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
      term
      Pain in the extremity
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
      term
      Vaginal pruritis
    Complete source fields
    description
    AEs were collected according to National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0)
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      12
      description
      Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions. Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
      id
      EG000
      other Num Affected
      8
      other Num At Risk
      12
      serious Num Affected
      0
      serious Num At Risk
      12
      title
      Artesunate Vaginal Inserts/ Pessaries
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        12
      term
      Abdominal Pain
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        12
      term
      Vaginal discharge
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
      term
      Toothache
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
      term
      Vaginal fistula
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
      term
      Pain in the extremity
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
      term
      Vaginal pruritis
    time Frame
    Up to ten days after the study intervention (vaginal insertion of Artesunate pessaries).

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

    Preserved source evidence · Not medical advice