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NCT00092521 · ADVERSE EVENTS

Adverse events

Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED) · Source last updated 2015-09-25

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
Not reported
Other-event reporting threshold
1%

Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

50 / 26732458 / 2673Not reported / Not reported
Group 2 - Base Study Monovalent HPV (Type 16) Vaccine

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

4 / 299276 / 299Not reported / Not reported
Group 3 - Base Study Placebo

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

45 / 26722331 / 2672Not reported / Not reported
Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension

This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent \[type 16\] HPV vaccine in the base study, or subjects who received \<=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as "Completed Period" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.

5 / 8010 / 0Not reported / Not reported

Group identifiers: EG000: Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine · EG001: Group 2 - Base Study Monovalent HPV (Type 16) Vaccine · EG002: Group 3 - Base Study Placebo · EG003: Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      801
    term
    Gastric Ulcer
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Cholecystitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Cholelithiasis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      801
    term
    Allergy to vaccine
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Anogenital warts
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Appendicitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Breast abscess
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Endometritis decidual
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Enterocolitis infectious
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      801
    term
    Gastroenteritis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Pelvic inflammatory 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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      81
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Abdominal pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      87
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Abdominal pain upper
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      105
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      96
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Diarrhea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Dyspepsia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Gastritis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      210
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      174
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      40
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Toothache
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      56
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Asthenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      102
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      40
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Malaise
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Pain
Complete source fields
description
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
event Groups
  1. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    EG000
    other Num Affected
    2458
    other Num At Risk
    2673
    serious Num Affected
    50
    serious Num At Risk
    2673
    title
    Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
  2. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    EG001
    other Num Affected
    276
    other Num At Risk
    299
    serious Num Affected
    4
    serious Num At Risk
    299
    title
    Group 2 - Base Study Monovalent HPV (Type 16) Vaccine
  3. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    EG002
    other Num Affected
    2331
    other Num At Risk
    2672
    serious Num Affected
    45
    serious Num At Risk
    2672
    title
    Group 3 - Base Study Placebo
  4. description
    This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent \[type 16\] HPV vaccine in the base study, or subjects who received \<=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as "Completed Period" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    5
    serious Num At Risk
    801
    title
    Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension
frequency Threshold
1
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      81
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Abdominal pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      87
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Abdominal pain upper
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      105
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      96
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Diarrhea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Dyspepsia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Gastritis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      210
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      174
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      40
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Toothache
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      56
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Asthenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      102
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      40
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Malaise
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    term
    Pain
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      801
    term
    Gastric Ulcer
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Cholecystitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Cholelithiasis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      801
    term
    Allergy to vaccine
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Anogenital warts
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Appendicitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Breast abscess
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Endometritis decidual
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Enterocolitis infectious
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      801
    term
    Gastroenteritis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2673
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      299
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2672
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      801
    term
    Pelvic inflammatory disease

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Preserved source evidence · Not medical advice