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NCT00295750 · ADVERSE EVENTS

Adverse events

The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer · Source last updated 2012-12-19

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
Degarelix 240/160 mg

Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.

24 / Not reported165 / Not reportedNot reported / Not reported
Degarelix 240/80 mg

Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.

21 / Not reported162 / Not reportedNot reported / Not reported
Leuprolide 7.5 mg

Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

28 / Not reported153 / Not reportedNot reported / Not reported

Group identifiers: EG000: Degarelix 240/160 mg · EG001: Degarelix 240/80 mg · EG002: Leuprolide 7.5 mg

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 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      202
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      201
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Iron deficiency anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      207
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Angina unstable
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Cardiopulmonary failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      207
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Coronary artery disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      207
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      201
      num Events
      2
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Cardiac disorder

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      202
      num Events
      15
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      207
      num Events
      10
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      201
      num Events
      9
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      202
      num Events
      6
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      207
      num Events
      12
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      201
      num Events
      11
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      202
      num Events
      108
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      207
      num Events
      114
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Injection site pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      202
      num Events
      63
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      207
      num Events
      56
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Injection site erythema
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      202
      num Events
      23
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      207
      num Events
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Injection site swelling
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      202
      num Events
      14
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      207
      num Events
      11
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      201
      num Events
      14
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      202
      num Events
      14
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      207
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Injection site induration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      202
      num Events
      24
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      207
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Injection site nodule
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      202
      num Events
      9
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      207
      num Events
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Chills
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      202
      num Events
      3
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      207
      num Events
      14
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      201
      num Events
      25
    term
    Urinary tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      202
      num Events
      22
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      207
      num Events
      18
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      201
      num Events
      24
    term
    Weight increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      202
      num Events
      17
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      207
      num Events
      22
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      201
      num Events
      11
    term
    Alanine aminotransferase increased
Complete source fields
event Groups
  1. description
    Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
    id
    EG000
    other Num Affected
    165
    serious Num Affected
    24
    title
    Degarelix 240/160 mg
  2. description
    Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
    id
    EG001
    other Num Affected
    162
    serious Num Affected
    21
    title
    Degarelix 240/80 mg
  3. description
    Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
    id
    EG002
    other Num Affected
    153
    serious Num Affected
    28
    title
    Leuprolide 7.5 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      202
      num Events
      15
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      207
      num Events
      10
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      201
      num Events
      9
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      202
      num Events
      6
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      207
      num Events
      12
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      201
      num Events
      11
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      202
      num Events
      108
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      207
      num Events
      114
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Injection site pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      202
      num Events
      63
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      207
      num Events
      56
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Injection site erythema
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      202
      num Events
      23
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      207
      num Events
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Injection site swelling
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      202
      num Events
      14
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      207
      num Events
      11
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      201
      num Events
      14
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      202
      num Events
      14
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      207
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Injection site induration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      202
      num Events
      24
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      207
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Injection site nodule
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      202
      num Events
      9
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      207
      num Events
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Chills
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      202
      num Events
      3
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      207
      num Events
      14
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      201
      num Events
      25
    term
    Urinary tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      202
      num Events
      22
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      207
      num Events
      18
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      201
      num Events
      24
    term
    Weight increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      202
      num Events
      17
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      207
      num Events
      22
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      201
      num Events
      11
    term
    Alanine aminotransferase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      202
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      201
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Iron deficiency anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      207
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Angina unstable
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
      num Events
      0
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Cardiopulmonary failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      207
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Coronary artery disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      207
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      201
      num Events
      2
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      207
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
      num Events
      1
    term
    Cardiac disorder

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Preserved source evidence · Not medical advice