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NCT01245764 · ADVERSE EVENTS

Adverse events

GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046) · Source last updated 2018-11-14

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
Serious adverse events were assessed up to 19 months from study start. Other adverse events were assessed up to 15 days after each vaccination in study Phase A.
Other-event reporting threshold
5%

The analysis included all participants receiving at least one vaccination and had at least one postvaccination follow-up visit.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
GARDASIL 9 to 12 Years Old

GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.

0 / 7961 / 79Not reported / Not reported
GARDASIL 13 to 15 Years Old

GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.

0 / 2922 / 29Not reported / Not reported
GARDASIL 16 to 26 Years Old

GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.

1 / 119103 / 119Not reported / Not reported
Placebo 9 to 12 Years Old

Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B.

0 / 1915 / 19Not reported / Not reported

Group identifiers: EG000: GARDASIL 9 to 12 Years Old · EG001: GARDASIL 13 to 15 Years Old · EG002: GARDASIL 16 to 26 Years Old · EG003: Placebo 9 to 12 Years Old

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Pregnancy, puerperium and perinatal conditions
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      119
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Foetal distress syndrome

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      119
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Eye pain
  2. organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      119
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Myopia
  3. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      79
      num Events
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      29
      num Events
      3
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      119
      num Events
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Abdominal pain
  4. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Dyspepsia
  5. organ System
    General disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      79
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      29
      num Events
      4
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      119
      num Events
      21
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Injection site erythema
  6. organ System
    General disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      79
      num Events
      113
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      29
      num Events
      46
    3. group Id
      EG002
      num Affected
      88
      num At Risk
      119
      num Events
      188
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      19
      num Events
      21
    term
    Injection site pain
  7. organ System
    General disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      79
      num Events
      37
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      29
      num Events
      9
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      119
      num Events
      48
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      19
      num Events
      7
    term
    Injection site swelling
  8. organ System
    General disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      79
      num Events
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      29
      num Events
      7
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      119
      num Events
      10
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      19
      num Events
      8
    term
    Pyrexia
  9. organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      119
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Gastroenteritis
  10. organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      79
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      29
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Malaria
  11. organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      79
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      2
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      119
      num Events
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Nasopharyngitis
  12. organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      119
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Upper respiratory tract infection
Complete source fields
description
The analysis included all participants receiving at least one vaccination and had at least one postvaccination follow-up visit.
event Groups
  1. description
    GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
    id
    EG000
    other Num Affected
    61
    other Num At Risk
    79
    serious Num Affected
    0
    serious Num At Risk
    79
    title
    GARDASIL 9 to 12 Years Old
  2. description
    GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    29
    serious Num Affected
    0
    serious Num At Risk
    29
    title
    GARDASIL 13 to 15 Years Old
  3. description
    GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
    id
    EG002
    other Num Affected
    103
    other Num At Risk
    119
    serious Num Affected
    1
    serious Num At Risk
    119
    title
    GARDASIL 16 to 26 Years Old
  4. description
    Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B.
    id
    EG003
    other Num Affected
    15
    other Num At Risk
    19
    serious Num Affected
    0
    serious Num At Risk
    19
    title
    Placebo 9 to 12 Years Old
frequency Threshold
5
other Events
  1. organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      119
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Eye pain
  2. organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      119
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Myopia
  3. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      79
      num Events
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      29
      num Events
      3
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      119
      num Events
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Abdominal pain
  4. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Dyspepsia
  5. organ System
    General disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      79
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      29
      num Events
      4
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      119
      num Events
      21
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Injection site erythema
  6. organ System
    General disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      79
      num Events
      113
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      29
      num Events
      46
    3. group Id
      EG002
      num Affected
      88
      num At Risk
      119
      num Events
      188
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      19
      num Events
      21
    term
    Injection site pain
  7. organ System
    General disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      79
      num Events
      37
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      29
      num Events
      9
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      119
      num Events
      48
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      19
      num Events
      7
    term
    Injection site swelling
  8. organ System
    General disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      79
      num Events
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      29
      num Events
      7
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      119
      num Events
      10
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      19
      num Events
      8
    term
    Pyrexia
  9. organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      119
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Gastroenteritis
  10. organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      79
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      29
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Malaria
  11. organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      79
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      2
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      119
      num Events
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Nasopharyngitis
  12. organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      119
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Upper respiratory tract infection
serious Events
  1. organ System
    Pregnancy, puerperium and perinatal conditions
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      119
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Foetal distress syndrome
time Frame
Serious adverse events were assessed up to 19 months from study start. Other adverse events were assessed up to 15 days after each vaccination in study Phase A.

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