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NCT00543543 · ADVERSE EVENTS

Adverse events

Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) · Source last updated 2018-11-27

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
Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
Other-event reporting threshold
5%

The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Base Study: Low-Dose V503

V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.

4 / 310278 / 310Not reported / Not reported
Base Study: Mid-dose V503

V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) will receive a fourth V503 mid-dose vaccination in the extension study.

233 / 70716551 / 7071Not reported / Not reported
Base Study: High-dose V503

V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.

5 / 305280 / 305Not reported / Not reported
Base Study: Gardasil

Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) will be offered the V503 mid-dose 3-dose regimen in the extension study.

184 / 70786268 / 7078Not reported / Not reported
Extension Study: Mid-dose V503 (Cohort 1)

V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL fourth dose administration in Base Study participants who were randomized to receive a 3-dose regimen of V503 (9-Valent HPV) mid-dose 0.5 mL (Cohort 1).

1 / 150130 / 150Not reported / Not reported
Extension Study: Mid-dose V503 (Cohort 2)

V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL 3-dose regimen administration on Base Study participants who were randomized to receive a 3-dose regimen of Gardasil (4-Valent HPV Vaccine) (Cohort 2).

25 / 304989 / 3049Not reported / Not reported

Group identifiers: EG000: Base Study: Low-Dose V503 · EG001: Base Study: Mid-dose V503 · EG002: Base Study: High-dose V503 · EG003: Base Study: Gardasil · EG004: Extension Study: Mid-dose V503 (Cohort 1) · EG005: Extension Study: Mid-dose V503 (Cohort 2)

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7078
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7078
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Aortic valve incompetence
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7078
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Postural orthostatic tachycardia syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7071
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7078
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Cleft lip and palate
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7071
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7078
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Diverticulitis Meckel's
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7078
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Vertigo positional
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7071
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7078
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7071
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7078
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Abdominal pain lower
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7078
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Anal fistula
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7078
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Coeliac disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7071
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7078
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Colitis ulcerative
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7078
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Crohn's disease

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 17.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      310
      num Events
      23
    2. group Id
      EG001
      num Affected
      513
      num At Risk
      7071
      num Events
      617
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      305
      num Events
      20
    4. group Id
      EG003
      num Affected
      459
      num At Risk
      7078
      num Events
      551
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      150
      num Events
      2
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      3049
      num Events
      4
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      100
      num At Risk
      310
      num Events
      157
    2. group Id
      EG001
      num Affected
      2411
      num At Risk
      7071
      num Events
      3597
    3. group Id
      EG002
      num Affected
      91
      num At Risk
      305
      num Events
      140
    4. group Id
      EG003
      num Affected
      1810
      num At Risk
      7078
      num Events
      2564
    5. group Id
      EG004
      num Affected
      33
      num At Risk
      150
      num Events
      34
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      3049
      num Events
      9
    term
    Injection site erythema
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      267
      num At Risk
      310
      num Events
      684
    2. group Id
      EG001
      num Affected
      6360
      num At Risk
      7071
      num Events
      15383
    3. group Id
      EG002
      num Affected
      273
      num At Risk
      305
      num Events
      672
    4. group Id
      EG003
      num Affected
      5911
      num At Risk
      7078
      num Events
      13001
    5. group Id
      EG004
      num Affected
      124
      num At Risk
      150
      num Events
      128
    6. group Id
      EG005
      num Affected
      59
      num At Risk
      3049
      num Events
      94
    term
    Injection site pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      310
      num Events
      21
    2. group Id
      EG001
      num Affected
      389
      num At Risk
      7071
      num Events
      494
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      305
      num Events
      16
    4. group Id
      EG003
      num Affected
      282
      num At Risk
      7078
      num Events
      341
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      150
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3049
      num Events
      1
    term
    Injection site pruritus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      100
      num At Risk
      310
      num Events
      154
    2. group Id
      EG001
      num Affected
      2836
      num At Risk
      7071
      num Events
      4527
    3. group Id
      EG002
      num Affected
      103
      num At Risk
      305
      num Events
      168
    4. group Id
      EG003
      num Affected
      2035
      num At Risk
      7078
      num Events
      2988
    5. group Id
      EG004
      num Affected
      49
      num At Risk
      150
      num Events
      51
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      3049
      num Events
      12
    term
    Injection site swelling
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      310
      num Events
      35
    2. group Id
      EG001
      num Affected
      469
      num At Risk
      7071
      num Events
      563
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      305
      num Events
      19
    4. group Id
      EG003
      num Affected
      463
      num At Risk
      7078
      num Events
      550
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      150
      num Events
      6
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      3049
      num Events
      7
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      310
      num Events
      22
    2. group Id
      EG001
      num Affected
      312
      num At Risk
      7071
      num Events
      343
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      305
      num Events
      12
    4. group Id
      EG003
      num Affected
      296
      num At Risk
      7078
      num Events
      314
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      150
      num Events
      5
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      3049
      num Events
      5
    term
    Influenza
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      310
      num Events
      11
    2. group Id
      EG001
      num Affected
      376
      num At Risk
      7071
      num Events
      412
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      305
      num Events
      13
    4. group Id
      EG003
      num Affected
      389
      num At Risk
      7078
      num Events
      420
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      150
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Nasopharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      310
      num Events
      20
    2. group Id
      EG001
      num Affected
      346
      num At Risk
      7071
      num Events
      405
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      305
      num Events
      13
    4. group Id
      EG003
      num Affected
      307
      num At Risk
      7078
      num Events
      368
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      3049
      num Events
      2
    term
    Dizziness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      310
      num Events
      100
    2. group Id
      EG001
      num Affected
      1879
      num At Risk
      7071
      num Events
      3071
    3. group Id
      EG002
      num Affected
      66
      num At Risk
      305
      num Events
      106
    4. group Id
      EG003
      num Affected
      1756
      num At Risk
      7078
      num Events
      2788
    5. group Id
      EG004
      num Affected
      32
      num At Risk
      150
      num Events
      41
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      3049
      num Events
      13
    term
    Headache
Complete source fields
description
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
event Groups
  1. description
    V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
    id
    EG000
    other Num Affected
    278
    other Num At Risk
    310
    serious Num Affected
    4
    serious Num At Risk
    310
    title
    Base Study: Low-Dose V503
  2. description
    V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) will receive a fourth V503 mid-dose vaccination in the extension study.
    id
    EG001
    other Num Affected
    6551
    other Num At Risk
    7071
    serious Num Affected
    233
    serious Num At Risk
    7071
    title
    Base Study: Mid-dose V503
  3. description
    V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
    id
    EG002
    other Num Affected
    280
    other Num At Risk
    305
    serious Num Affected
    5
    serious Num At Risk
    305
    title
    Base Study: High-dose V503
  4. description
    Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) will be offered the V503 mid-dose 3-dose regimen in the extension study.
    id
    EG003
    other Num Affected
    6268
    other Num At Risk
    7078
    serious Num Affected
    184
    serious Num At Risk
    7078
    title
    Base Study: Gardasil
  5. description
    V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL fourth dose administration in Base Study participants who were randomized to receive a 3-dose regimen of V503 (9-Valent HPV) mid-dose 0.5 mL (Cohort 1).
    id
    EG004
    other Num Affected
    130
    other Num At Risk
    150
    serious Num Affected
    1
    serious Num At Risk
    150
    title
    Extension Study: Mid-dose V503 (Cohort 1)
  6. description
    V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL 3-dose regimen administration on Base Study participants who were randomized to receive a 3-dose regimen of Gardasil (4-Valent HPV Vaccine) (Cohort 2).
    id
    EG005
    other Num Affected
    89
    other Num At Risk
    3049
    serious Num Affected
    25
    serious Num At Risk
    3049
    title
    Extension Study: Mid-dose V503 (Cohort 2)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      310
      num Events
      23
    2. group Id
      EG001
      num Affected
      513
      num At Risk
      7071
      num Events
      617
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      305
      num Events
      20
    4. group Id
      EG003
      num Affected
      459
      num At Risk
      7078
      num Events
      551
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      150
      num Events
      2
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      3049
      num Events
      4
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      100
      num At Risk
      310
      num Events
      157
    2. group Id
      EG001
      num Affected
      2411
      num At Risk
      7071
      num Events
      3597
    3. group Id
      EG002
      num Affected
      91
      num At Risk
      305
      num Events
      140
    4. group Id
      EG003
      num Affected
      1810
      num At Risk
      7078
      num Events
      2564
    5. group Id
      EG004
      num Affected
      33
      num At Risk
      150
      num Events
      34
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      3049
      num Events
      9
    term
    Injection site erythema
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      267
      num At Risk
      310
      num Events
      684
    2. group Id
      EG001
      num Affected
      6360
      num At Risk
      7071
      num Events
      15383
    3. group Id
      EG002
      num Affected
      273
      num At Risk
      305
      num Events
      672
    4. group Id
      EG003
      num Affected
      5911
      num At Risk
      7078
      num Events
      13001
    5. group Id
      EG004
      num Affected
      124
      num At Risk
      150
      num Events
      128
    6. group Id
      EG005
      num Affected
      59
      num At Risk
      3049
      num Events
      94
    term
    Injection site pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      310
      num Events
      21
    2. group Id
      EG001
      num Affected
      389
      num At Risk
      7071
      num Events
      494
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      305
      num Events
      16
    4. group Id
      EG003
      num Affected
      282
      num At Risk
      7078
      num Events
      341
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      150
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3049
      num Events
      1
    term
    Injection site pruritus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      100
      num At Risk
      310
      num Events
      154
    2. group Id
      EG001
      num Affected
      2836
      num At Risk
      7071
      num Events
      4527
    3. group Id
      EG002
      num Affected
      103
      num At Risk
      305
      num Events
      168
    4. group Id
      EG003
      num Affected
      2035
      num At Risk
      7078
      num Events
      2988
    5. group Id
      EG004
      num Affected
      49
      num At Risk
      150
      num Events
      51
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      3049
      num Events
      12
    term
    Injection site swelling
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      310
      num Events
      35
    2. group Id
      EG001
      num Affected
      469
      num At Risk
      7071
      num Events
      563
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      305
      num Events
      19
    4. group Id
      EG003
      num Affected
      463
      num At Risk
      7078
      num Events
      550
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      150
      num Events
      6
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      3049
      num Events
      7
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      310
      num Events
      22
    2. group Id
      EG001
      num Affected
      312
      num At Risk
      7071
      num Events
      343
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      305
      num Events
      12
    4. group Id
      EG003
      num Affected
      296
      num At Risk
      7078
      num Events
      314
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      150
      num Events
      5
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      3049
      num Events
      5
    term
    Influenza
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      310
      num Events
      11
    2. group Id
      EG001
      num Affected
      376
      num At Risk
      7071
      num Events
      412
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      305
      num Events
      13
    4. group Id
      EG003
      num Affected
      389
      num At Risk
      7078
      num Events
      420
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      150
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Nasopharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      310
      num Events
      20
    2. group Id
      EG001
      num Affected
      346
      num At Risk
      7071
      num Events
      405
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      305
      num Events
      13
    4. group Id
      EG003
      num Affected
      307
      num At Risk
      7078
      num Events
      368
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      3049
      num Events
      2
    term
    Dizziness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      310
      num Events
      100
    2. group Id
      EG001
      num Affected
      1879
      num At Risk
      7071
      num Events
      3071
    3. group Id
      EG002
      num Affected
      66
      num At Risk
      305
      num Events
      106
    4. group Id
      EG003
      num Affected
      1756
      num At Risk
      7078
      num Events
      2788
    5. group Id
      EG004
      num Affected
      32
      num At Risk
      150
      num Events
      41
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      3049
      num Events
      13
    term
    Headache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7078
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7078
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Aortic valve incompetence
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7078
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Postural orthostatic tachycardia syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7071
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7078
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Cleft lip and palate
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7071
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7078
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Diverticulitis Meckel's
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7078
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Vertigo positional
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7071
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7078
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7071
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7078
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Abdominal pain lower
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7078
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Anal fistula
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7078
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Coeliac disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7071
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7078
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Colitis ulcerative
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      310
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7071
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      305
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7078
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      150
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3049
      num Events
      0
    term
    Crohn's disease
time Frame
Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.

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