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NCT00851643 · ADVERSE EVENTS

Adverse events

Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002) · Source last updated 2016-02-03

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
All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
qHPV (GARDASIL™) - Phase A and Phase B Controls

Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) combined from Phase A and Phase B.

0 / 3030 / 30Not reported / Not reported
Octavalent HPV With 15 mcg IMX / AAHS

Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 15 mcg IMX.

0 / 3030 / 30Not reported / Not reported
Octavalent HPV With 30 mcg IMX / AAHS

Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 30 mcg IMX.

0 / 3030 / 30Not reported / Not reported
Octavalent HPV With 60 mcg IMX / AAHS

Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 60 mcg IMX.

0 / 3030 / 30Not reported / Not reported
Octavalent With 120 mcg IMX / AAHS

Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 120 mcg IMX.

0 / 3030 / 30Not reported / Not reported

Group identifiers: EG000: qHPV (GARDASIL™) - Phase A and Phase B Controls · EG001: Octavalent HPV With 15 mcg IMX / AAHS · EG002: Octavalent HPV With 30 mcg IMX / AAHS · EG003: Octavalent HPV With 60 mcg IMX / AAHS · EG004: Octavalent With 120 mcg IMX / AAHS

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
      Blood and lymphatic system disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        30
        num Events
        2
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        30
        num Events
        2
      4. group Id
        EG003
        num Affected
        2
        num At Risk
        30
        num Events
        4
      5. group Id
        EG004
        num Affected
        0
        num At Risk
        30
        num Events
        0
      term
      Lymphadenopathy
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        30
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        30
        num Events
        2
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        30
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        30
        num Events
        1
      5. group Id
        EG004
        num Affected
        0
        num At Risk
        30
        num Events
        0
      term
      Abdominal pain lower
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        30
        num Events
        0
      3. group Id
        EG002
        num Affected
        5
        num At Risk
        30
        num Events
        6
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        30
        num Events
        1
      5. group Id
        EG004
        num Affected
        1
        num At Risk
        30
        num Events
        1
      term
      Diarrhoea
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        30
        num Events
        7
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        30
        num Events
        2
      3. group Id
        EG002
        num Affected
        6
        num At Risk
        30
        num Events
        11
      4. group Id
        EG003
        num Affected
        6
        num At Risk
        30
        num Events
        6
      5. group Id
        EG004
        num Affected
        9
        num At Risk
        30
        num Events
        10
      term
      Nausea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        30
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        30
        num Events
        0
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        30
        num Events
        4
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        30
        num Events
        0
      5. group Id
        EG004
        num Affected
        1
        num At Risk
        30
        num Events
        1
      term
      Toothache
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        30
        num Events
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        30
        num Events
        0
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        30
        num Events
        2
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        30
        num Events
        0
      5. group Id
        EG004
        num Affected
        3
        num At Risk
        30
        num Events
        3
      term
      Vomiting
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        30
        num Events
        0
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        30
        num Events
        3
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        30
        num Events
        2
      4. group Id
        EG003
        num Affected
        3
        num At Risk
        30
        num Events
        5
      5. group Id
        EG004
        num Affected
        2
        num At Risk
        30
        num Events
        3
      term
      Axillary pain
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        30
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        30
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        30
        num Events
        1
      5. group Id
        EG004
        num Affected
        2
        num At Risk
        30
        num Events
        2
      term
      Chills
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        1
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        30
        num Events
        4
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        30
        num Events
        1
      4. group Id
        EG003
        num Affected
        3
        num At Risk
        30
        num Events
        4
      5. group Id
        EG004
        num Affected
        1
        num At Risk
        30
        num Events
        1
      term
      Fatigue
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        12
        num At Risk
        30
        num Events
        21
      2. group Id
        EG001
        num Affected
        15
        num At Risk
        30
        num Events
        18
      3. group Id
        EG002
        num Affected
        16
        num At Risk
        30
        num Events
        27
      4. group Id
        EG003
        num Affected
        21
        num At Risk
        30
        num Events
        36
      5. group Id
        EG004
        num Affected
        20
        num At Risk
        30
        num Events
        38
      term
      Injection site erythema
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        1
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        30
        num Events
        3
      3. group Id
        EG002
        num Affected
        7
        num At Risk
        30
        num Events
        7
      4. group Id
        EG003
        num Affected
        3
        num At Risk
        30
        num Events
        3
      5. group Id
        EG004
        num Affected
        4
        num At Risk
        30
        num Events
        5
      term
      Injection site haematoma
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        30
        num Events
        0
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        30
        num Events
        6
      3. group Id
        EG002
        num Affected
        5
        num At Risk
        30
        num Events
        8
      4. group Id
        EG003
        num Affected
        5
        num At Risk
        30
        num Events
        10
      5. group Id
        EG004
        num Affected
        5
        num At Risk
        30
        num Events
        6
      term
      Injection site induration
    Complete source fields
    event Groups
    1. description
      Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) combined from Phase A and Phase B.
      id
      EG000
      other Num Affected
      30
      other Num At Risk
      30
      serious Num Affected
      0
      serious Num At Risk
      30
      title
      qHPV (GARDASIL™) - Phase A and Phase B Controls
    2. description
      Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 15 mcg IMX.
      id
      EG001
      other Num Affected
      30
      other Num At Risk
      30
      serious Num Affected
      0
      serious Num At Risk
      30
      title
      Octavalent HPV With 15 mcg IMX / AAHS
    3. description
      Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 30 mcg IMX.
      id
      EG002
      other Num Affected
      30
      other Num At Risk
      30
      serious Num Affected
      0
      serious Num At Risk
      30
      title
      Octavalent HPV With 30 mcg IMX / AAHS
    4. description
      Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 60 mcg IMX.
      id
      EG003
      other Num Affected
      30
      other Num At Risk
      30
      serious Num Affected
      0
      serious Num At Risk
      30
      title
      Octavalent HPV With 60 mcg IMX / AAHS
    5. description
      Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 120 mcg IMX.
      id
      EG004
      other Num Affected
      30
      other Num At Risk
      30
      serious Num Affected
      0
      serious Num At Risk
      30
      title
      Octavalent With 120 mcg IMX / AAHS
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        30
        num Events
        2
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        30
        num Events
        2
      4. group Id
        EG003
        num Affected
        2
        num At Risk
        30
        num Events
        4
      5. group Id
        EG004
        num Affected
        0
        num At Risk
        30
        num Events
        0
      term
      Lymphadenopathy
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        30
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        30
        num Events
        2
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        30
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        30
        num Events
        1
      5. group Id
        EG004
        num Affected
        0
        num At Risk
        30
        num Events
        0
      term
      Abdominal pain lower
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        30
        num Events
        0
      3. group Id
        EG002
        num Affected
        5
        num At Risk
        30
        num Events
        6
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        30
        num Events
        1
      5. group Id
        EG004
        num Affected
        1
        num At Risk
        30
        num Events
        1
      term
      Diarrhoea
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        30
        num Events
        7
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        30
        num Events
        2
      3. group Id
        EG002
        num Affected
        6
        num At Risk
        30
        num Events
        11
      4. group Id
        EG003
        num Affected
        6
        num At Risk
        30
        num Events
        6
      5. group Id
        EG004
        num Affected
        9
        num At Risk
        30
        num Events
        10
      term
      Nausea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        30
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        30
        num Events
        0
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        30
        num Events
        4
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        30
        num Events
        0
      5. group Id
        EG004
        num Affected
        1
        num At Risk
        30
        num Events
        1
      term
      Toothache
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        30
        num Events
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        30
        num Events
        0
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        30
        num Events
        2
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        30
        num Events
        0
      5. group Id
        EG004
        num Affected
        3
        num At Risk
        30
        num Events
        3
      term
      Vomiting
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        30
        num Events
        0
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        30
        num Events
        3
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        30
        num Events
        2
      4. group Id
        EG003
        num Affected
        3
        num At Risk
        30
        num Events
        5
      5. group Id
        EG004
        num Affected
        2
        num At Risk
        30
        num Events
        3
      term
      Axillary pain
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        30
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        30
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        30
        num Events
        1
      5. group Id
        EG004
        num Affected
        2
        num At Risk
        30
        num Events
        2
      term
      Chills
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        1
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        30
        num Events
        4
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        30
        num Events
        1
      4. group Id
        EG003
        num Affected
        3
        num At Risk
        30
        num Events
        4
      5. group Id
        EG004
        num Affected
        1
        num At Risk
        30
        num Events
        1
      term
      Fatigue
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        12
        num At Risk
        30
        num Events
        21
      2. group Id
        EG001
        num Affected
        15
        num At Risk
        30
        num Events
        18
      3. group Id
        EG002
        num Affected
        16
        num At Risk
        30
        num Events
        27
      4. group Id
        EG003
        num Affected
        21
        num At Risk
        30
        num Events
        36
      5. group Id
        EG004
        num Affected
        20
        num At Risk
        30
        num Events
        38
      term
      Injection site erythema
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        1
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        30
        num Events
        3
      3. group Id
        EG002
        num Affected
        7
        num At Risk
        30
        num Events
        7
      4. group Id
        EG003
        num Affected
        3
        num At Risk
        30
        num Events
        3
      5. group Id
        EG004
        num Affected
        4
        num At Risk
        30
        num Events
        5
      term
      Injection site haematoma
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 12.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        30
        num Events
        0
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        30
        num Events
        6
      3. group Id
        EG002
        num Affected
        5
        num At Risk
        30
        num Events
        8
      4. group Id
        EG003
        num Affected
        5
        num At Risk
        30
        num Events
        10
      5. group Id
        EG004
        num Affected
        5
        num At Risk
        30
        num Events
        6
      term
      Injection site induration
    time Frame
    All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.

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