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NCT00973479 · ADVERSE EVENTS

Adverse events

An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy · Source last updated 2013-12-25

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
Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
Other-event reporting threshold
5%

The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16

Participants received placebo only through Week 16 and met early escape criteria or subjects who received first placebo and later inadvertently received Golimumab prior or at Week 16. The follow-up period for this treatment group begins once a participant switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.

11 / 6834 / 68Not reported / Not reported
Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24

Participants received placebo only through Week 24 or subjects who received first placebo and later inadvertently received Golimumab after Week 16 through Week 24. The follow-up period for this treatment group begins once a participants switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.

17 / 12138 / 121Not reported / Not reported
Golimumab 2 mg/kg + MTX

Participants were assigned to Golimumab 2 mg/kg + MTX and received at least one 2 mg/kg Golimumab. The follow-up period for this treatment group begins with the first dose of Golimumab 2 mg/kg. Participants may have missed one or more Golimumab doses.

78 / 395199 / 395Not reported / Not reported
Combined Golimumab

Participants in the reporting groups: Placebo + MTX -\> Golimumab 2 mg/kg + MTX at Week 16, Placebo + MTX -\> Golimumab 2 mg/kg + MTX at Week 24, and Golimumab 2 mg/kg + MTX.

106 / 584271 / 584Not reported / Not reported

Group identifiers: EG000: Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16 · EG001: Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24 · EG002: Golimumab 2 mg/kg + MTX · EG003: Combined Golimumab

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 Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      584
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Angina unstable
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      584
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Cor pulmonale chronic
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      584
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      584
    term
    Myocardial ischaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Sick sinus syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Vertigo

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 Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      584
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      584
    term
    Nasopharyngitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      33
      num At Risk
      584
    term
    Pharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      67
      num At Risk
      584
    term
    Upper respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      36
      num At Risk
      584
    term
    Urinary tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      38
      num At Risk
      584
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      584
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      584
    term
    Hepatic enzyme increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      45
      num At Risk
      584
    term
    Rheumatoid arthritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      34
      num At Risk
      584
    term
    Headache
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      584
    term
    Hypertension
Complete source fields
description
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
event Groups
  1. description
    Participants received placebo only through Week 16 and met early escape criteria or subjects who received first placebo and later inadvertently received Golimumab prior or at Week 16. The follow-up period for this treatment group begins once a participant switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
    id
    EG000
    other Num Affected
    34
    other Num At Risk
    68
    serious Num Affected
    11
    serious Num At Risk
    68
    title
    Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16
  2. description
    Participants received placebo only through Week 24 or subjects who received first placebo and later inadvertently received Golimumab after Week 16 through Week 24. The follow-up period for this treatment group begins once a participants switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
    id
    EG001
    other Num Affected
    38
    other Num At Risk
    121
    serious Num Affected
    17
    serious Num At Risk
    121
    title
    Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24
  3. description
    Participants were assigned to Golimumab 2 mg/kg + MTX and received at least one 2 mg/kg Golimumab. The follow-up period for this treatment group begins with the first dose of Golimumab 2 mg/kg. Participants may have missed one or more Golimumab doses.
    id
    EG002
    other Num Affected
    199
    other Num At Risk
    395
    serious Num Affected
    78
    serious Num At Risk
    395
    title
    Golimumab 2 mg/kg + MTX
  4. description
    Participants in the reporting groups: Placebo + MTX -\> Golimumab 2 mg/kg + MTX at Week 16, Placebo + MTX -\> Golimumab 2 mg/kg + MTX at Week 24, and Golimumab 2 mg/kg + MTX.
    id
    EG003
    other Num Affected
    271
    other Num At Risk
    584
    serious Num Affected
    106
    serious Num At Risk
    584
    title
    Combined Golimumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      584
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      584
    term
    Nasopharyngitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      33
      num At Risk
      584
    term
    Pharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      67
      num At Risk
      584
    term
    Upper respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      36
      num At Risk
      584
    term
    Urinary tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      38
      num At Risk
      584
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      584
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      584
    term
    Hepatic enzyme increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      45
      num At Risk
      584
    term
    Rheumatoid arthritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      34
      num At Risk
      584
    term
    Headache
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      584
    term
    Hypertension
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      584
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Angina unstable
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      584
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Cor pulmonale chronic
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      584
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      584
    term
    Myocardial ischaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Sick sinus syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      395
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      584
    term
    Vertigo
time Frame
Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).

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Preserved source evidence · Not medical advice