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NCT03051516 · ADVERSE EVENTS

Adverse events

HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions · Source last updated 2024-02-28

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
42 months, from enrollment visit (Month 0) to final follow-up at Month 42.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)

Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM

19 / 9160 / 915 / 91
Arm II (Placebo)

Patients receive placebo IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given IM Questionnaire Administration: Ancillary studies

16 / 9458 / 942 / 94

Group identifiers: EG000: Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine) · 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.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Fracture, right femur
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Fracture, right hip
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Fracture, right arm
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Fracture, left leg
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Fracture, broken neck
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Hospitalization due to multiple abscesses
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Acute kidney injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Small bowel obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Pyelonephritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Probable gastroenteritis, 3-day hospitalization
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    COPD exacerbation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Severe migraine requiring overnight hospitalization

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
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Knot on left arm post COVID-19 injection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Sore arm post COVID-19 injection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Fatigue post COVID-19 injection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    High fever (101-102 degrees) post COVID-19 injection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Weakness post COVID-19 injection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      94
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Throbbing in right big toe
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Throbbing in right collar bone
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Pregnancy, puerperium and perinatal conditions
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Spontaneous abortion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      94
    term
    Fever or chills
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      94
    term
    Headache
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      94
    term
    Muscle aches
Complete source fields
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    91
    description
    Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
    id
    EG000
    other Num Affected
    60
    other Num At Risk
    91
    serious Num Affected
    19
    serious Num At Risk
    91
    title
    Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)
  2. deaths Num Affected
    2
    deaths Num At Risk
    94
    description
    Patients receive placebo IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given IM Questionnaire Administration: Ancillary studies
    id
    EG001
    other Num Affected
    58
    other Num At Risk
    94
    serious Num Affected
    16
    serious Num At Risk
    94
    title
    Arm II (Placebo)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Knot on left arm post COVID-19 injection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Sore arm post COVID-19 injection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Fatigue post COVID-19 injection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    High fever (101-102 degrees) post COVID-19 injection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Weakness post COVID-19 injection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      94
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Throbbing in right big toe
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Throbbing in right collar bone
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Pregnancy, puerperium and perinatal conditions
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Spontaneous abortion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      94
    term
    Fever or chills
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      94
    term
    Headache
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      94
    term
    Muscle aches
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Fracture, right femur
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Fracture, right hip
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Fracture, right arm
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Fracture, left leg
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Fracture, broken neck
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Hospitalization due to multiple abscesses
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Acute kidney injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Small bowel obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Pyelonephritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Probable gastroenteritis, 3-day hospitalization
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    COPD exacerbation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Severe migraine requiring overnight hospitalization
time Frame
42 months, from enrollment visit (Month 0) to final follow-up at Month 42.

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Preserved source evidence · Not medical advice