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NCT01029652 · ADVERSE EVENTS

Adverse events

Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study · Source last updated 2014-01-30

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
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Randomized to Canakinumab

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study. After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.

19 / 11347 / 113Not reported / Not reported
Randomized to Canakinumab :Before Re-treated With Canakinumab

All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab

6 / 6919 / 69Not reported / Not reported
Randomized to Canakinumab :After Re-treated With Canakinumab

All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab

8 / 6919 / 69Not reported / Not reported
All Randomized to Triamcinolone Acetonide (Triam)

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study. Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab

11 / 11522 / 115Not reported / Not reported
Randomized to Triam: Before Switched to Canakinumab

All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab

2 / 397 / 39Not reported / Not reported
Randomized to Triam: After Switched to Canakinumab

All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab

0 / 3912 / 39Not reported / Not reported

Group identifiers: EG000: All Randomized to Canakinumab · EG001: Randomized to Canakinumab :Before Re-treated With Canakinumab · EG002: Randomized to Canakinumab :After Re-treated With Canakinumab · EG003: All Randomized to Triamcinolone Acetonide (Triam) · EG004: Randomized to Triam: Before Switched to Canakinumab · EG005: Randomized to Triam: After Switched to Canakinumab

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
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Acute myocardial infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Angina pectoris
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Angina unstable
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Arrhythmia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Myocardial ischaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Glaucoma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Retinal artery occlusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Diverticulum intestinal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Gastritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Periproctitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Device dislocation

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
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      39
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
    term
    Influenza
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      39
    term
    Nasopharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
    term
    Upper respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Gamma-glutamyltransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      39
    term
    Hyperlipidaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
    term
    Hypertriglyceridaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
    term
    Arthralgia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Osteoarthritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
    term
    Headache
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      39
    term
    Hypertension
Complete source fields
event Groups
  1. description
    Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study. After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.
    id
    EG000
    other Num Affected
    47
    other Num At Risk
    113
    serious Num Affected
    19
    serious Num At Risk
    113
    title
    All Randomized to Canakinumab
  2. description
    All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    69
    serious Num Affected
    6
    serious Num At Risk
    69
    title
    Randomized to Canakinumab :Before Re-treated With Canakinumab
  3. description
    All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab
    id
    EG002
    other Num Affected
    19
    other Num At Risk
    69
    serious Num Affected
    8
    serious Num At Risk
    69
    title
    Randomized to Canakinumab :After Re-treated With Canakinumab
  4. description
    Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study. Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab
    id
    EG003
    other Num Affected
    22
    other Num At Risk
    115
    serious Num Affected
    11
    serious Num At Risk
    115
    title
    All Randomized to Triamcinolone Acetonide (Triam)
  5. description
    All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab
    id
    EG004
    other Num Affected
    7
    other Num At Risk
    39
    serious Num Affected
    2
    serious Num At Risk
    39
    title
    Randomized to Triam: Before Switched to Canakinumab
  6. description
    All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
    id
    EG005
    other Num Affected
    12
    other Num At Risk
    39
    serious Num Affected
    0
    serious Num At Risk
    39
    title
    Randomized to Triam: After Switched to Canakinumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      39
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
    term
    Influenza
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      39
    term
    Nasopharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
    term
    Upper respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Gamma-glutamyltransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      39
    term
    Hyperlipidaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
    term
    Hypertriglyceridaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
    term
    Arthralgia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Osteoarthritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      39
    term
    Headache
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      39
    term
    Hypertension
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Acute myocardial infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Angina pectoris
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Angina unstable
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Arrhythmia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Myocardial ischaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Glaucoma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Retinal artery occlusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Diverticulum intestinal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Gastritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Periproctitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      69
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      115
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      39
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      39
    term
    Device dislocation

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