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NCT03158220 · ADVERSE EVENTS

Adverse events

Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) · Source last updated 2019-11-21

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 1 month post vaccination 3 (up to 7 months)
Other-event reporting threshold
5%

Population included all participants that received at least 1 vaccination.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Women 16-26 Years of Age

Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.

6 / 570518 / 5700 / 570
Women 27-45 Years of Age

Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.

8 / 640574 / 6400 / 640

Group identifiers: EG000: Women 16-26 Years of Age · EG001: Women 27-45 Years of Age

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      570
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      640
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      570
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      640
      num Events
      0
    term
    Rectal abscess
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      570
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Tonsillitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Cervical vertebral fracture
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      570
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      640
      num Events
      0
    term
    Head injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Ligament injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Meniscus injury
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Rotator cuff syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Basilar migraine
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Pregnancy, puerperium and perinatal conditions
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Foetal death
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      570
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Abortion induced

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
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      570
      num Events
      35
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      640
      num Events
      32
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      570
      num Events
      36
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      640
      num Events
      42
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      570
      num Events
      166
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      640
      num Events
      163
    term
    Injection site erythema
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      492
      num At Risk
      570
      num Events
      1246
    2. group Id
      EG001
      num Affected
      532
      num At Risk
      640
      num Events
      1244
    term
    Injection site pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      137
      num At Risk
      570
      num Events
      206
    2. group Id
      EG001
      num Affected
      152
      num At Risk
      640
      num Events
      224
    term
    Injection site swelling
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      570
      num Events
      40
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      640
      num Events
      31
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      570
      num Events
      57
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      640
      num Events
      69
    term
    Nasopharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      570
      num Events
      297
    2. group Id
      EG001
      num Affected
      200
      num At Risk
      640
      num Events
      320
    term
    Headache
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      570
      num Events
      65
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      640
      num Events
      27
    term
    Dysmenorrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      570
      num Events
      44
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      640
      num Events
      53
    term
    Oropharyngeal pain
Complete source fields
description
Population included all participants that received at least 1 vaccination.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    570
    description
    Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
    id
    EG000
    other Num Affected
    518
    other Num At Risk
    570
    serious Num Affected
    6
    serious Num At Risk
    570
    title
    Women 16-26 Years of Age
  2. deaths Num Affected
    0
    deaths Num At Risk
    640
    description
    Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
    id
    EG001
    other Num Affected
    574
    other Num At Risk
    640
    serious Num Affected
    8
    serious Num At Risk
    640
    title
    Women 27-45 Years of Age
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      570
      num Events
      35
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      640
      num Events
      32
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      570
      num Events
      36
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      640
      num Events
      42
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      570
      num Events
      166
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      640
      num Events
      163
    term
    Injection site erythema
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      492
      num At Risk
      570
      num Events
      1246
    2. group Id
      EG001
      num Affected
      532
      num At Risk
      640
      num Events
      1244
    term
    Injection site pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      137
      num At Risk
      570
      num Events
      206
    2. group Id
      EG001
      num Affected
      152
      num At Risk
      640
      num Events
      224
    term
    Injection site swelling
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      570
      num Events
      40
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      640
      num Events
      31
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      570
      num Events
      57
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      640
      num Events
      69
    term
    Nasopharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      570
      num Events
      297
    2. group Id
      EG001
      num Affected
      200
      num At Risk
      640
      num Events
      320
    term
    Headache
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      570
      num Events
      65
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      640
      num Events
      27
    term
    Dysmenorrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      570
      num Events
      44
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      640
      num Events
      53
    term
    Oropharyngeal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      570
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      640
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      570
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      640
      num Events
      0
    term
    Rectal abscess
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      570
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Tonsillitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Cervical vertebral fracture
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      570
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      640
      num Events
      0
    term
    Head injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Ligament injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Meniscus injury
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Rotator cuff syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Basilar migraine
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Pregnancy, puerperium and perinatal conditions
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      570
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Foetal death
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      570
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      640
      num Events
      1
    term
    Abortion induced
time Frame
Up to 1 month post vaccination 3 (up to 7 months)

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