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NCT03267680 · ADVERSE EVENTS

Adverse events

IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3 · Source last updated 2025-04-13

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
30 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (IRX-2)

Patients receive cyclophosphamide IV on day 1 and IRX-2 via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. Cyclophosphamide: Given IV Indomethacin: Given PO IRX-2: Given via submucosal injection or SC Laboratory Biomarker Analysis: Correlative studies Multivitamin: Given zinc-containing multivitamin PO Omeprazole: Given PO Therapeutic Conventional Surgery: Undergo surgical resection

0 / 77 / 70 / 7
Arm II (Placebo)

Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. Cyclophosphamide: Given IV Indomethacin: Given PO Laboratory Biomarker Analysis: Correlative studies Multivitamin: Given zinc-containing multivitamin PO Omeprazole: Given PO Placebo: Given via submucosal injections or SC Therapeutic Conventional Surgery: Undergo surgical resection

0 / 33 / 30 / 3

Group identifiers: EG000: Arm I (IRX-2) · EG001: Arm II (Placebo)

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
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        3
      term
      Vertigo
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        3
      term
      Abdominal Pain
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        3
      term
      Constipation
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        3
      term
      Mucositis Oral
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        3
      term
      Diarrhea
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        3
      term
      Nausea
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        3
      term
      Vomiting
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        3
      term
      Chills
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        3
      term
      Fatigue
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        3
      term
      Injection Site Reaction
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        3
      term
      Pain
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        3
      term
      Neutrophil Count Decreased
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      7
      description
      Patients receive cyclophosphamide IV on day 1 and IRX-2 via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. Cyclophosphamide: Given IV Indomethacin: Given PO IRX-2: Given via submucosal injection or SC Laboratory Biomarker Analysis: Correlative studies Multivitamin: Given zinc-containing multivitamin PO Omeprazole: Given PO Therapeutic Conventional Surgery: Undergo surgical resection
      id
      EG000
      other Num Affected
      7
      other Num At Risk
      7
      serious Num Affected
      0
      serious Num At Risk
      7
      title
      Arm I (IRX-2)
    2. deaths Num Affected
      0
      deaths Num At Risk
      3
      description
      Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. Cyclophosphamide: Given IV Indomethacin: Given PO Laboratory Biomarker Analysis: Correlative studies Multivitamin: Given zinc-containing multivitamin PO Omeprazole: Given PO Placebo: Given via submucosal injections or SC Therapeutic Conventional Surgery: Undergo surgical resection
      id
      EG001
      other Num Affected
      3
      other Num At Risk
      3
      serious Num Affected
      0
      serious Num At Risk
      3
      title
      Arm II (Placebo)
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        3
      term
      Vertigo
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        3
      term
      Abdominal Pain
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        3
      term
      Constipation
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        3
      term
      Mucositis Oral
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        3
      term
      Diarrhea
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        3
      term
      Nausea
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        3
      term
      Vomiting
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        3
      term
      Chills
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        3
      term
      Fatigue
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        3
      term
      Injection Site Reaction
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        3
      term
      Pain
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        3
      term
      Neutrophil Count Decreased
    time Frame
    30 months

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

    Preserved source evidence · Not medical advice