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NCT02457793 · ADVERSE EVENTS

Adverse events

A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors · Source last updated 2018-11-20

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
15 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Not Assigned

One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.

1 / 11 / 1Not reported / Not reported
COB 20 mg + GDC 200 mg

Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.

2 / 55 / 5Not reported / Not reported
COB 40 mg + GDC 200 mg

Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.

2 / 33 / 3Not reported / Not reported
COB 80 mg + GDC 200 mg

Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.

3 / 55 / 5Not reported / Not reported
COB 80 mg + GDC 400 mg

Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.

2 / 44 / 4Not reported / Not reported
COB 100 mg + GDC 200 mg

Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.

4 / 66 / 6Not reported / Not reported

Group identifiers: EG000: Not Assigned · EG001: COB 20 mg + GDC 200 mg · EG002: COB 40 mg + GDC 200 mg · EG003: COB 80 mg + GDC 200 mg · EG004: COB 80 mg + GDC 400 mg · EG005: COB 100 mg + GDC 200 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
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    DIARRHOEA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    ABDOMINAL PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    COLITIS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    CONSTIPATION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    DYSPHAGIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    GASTRIC ULCER
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    GASTROINTESTINAL HAEMORRHAGE
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    NAUSEA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    CHOLANGITIS INFECTIVE
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    CLOSTRIDIUM DIFFICILE COLITIS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    KLEBSIELLA BACTERAEMIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    PNEUMONIA

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
    Blood and lymphatic system disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    THROMBOCYTOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    ACUTE MYOCARDIAL INFARCTION
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    LEFT VENTRICULAR DYSFUNCTION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    SINUS BRADYCARDIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    SINUS TACHYCARDIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    TACHYCARDIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    DYSACUSIS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    VERTIGO
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    ADRENAL INSUFFICIENCY
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    DETACHMENT OF RETINAL PIGMENT EPITHELIUM
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    EYELID OEDEMA
Complete source fields
event Groups
  1. description
    One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Not Assigned
  2. description
    Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    COB 20 mg + GDC 200 mg
  3. description
    Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    COB 40 mg + GDC 200 mg
  4. description
    Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    EG003
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    COB 80 mg + GDC 200 mg
  5. description
    Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    COB 80 mg + GDC 400 mg
  6. description
    Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    EG005
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    COB 100 mg + GDC 200 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    THROMBOCYTOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    ACUTE MYOCARDIAL INFARCTION
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    LEFT VENTRICULAR DYSFUNCTION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    SINUS BRADYCARDIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    SINUS TACHYCARDIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    TACHYCARDIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    DYSACUSIS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    VERTIGO
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    ADRENAL INSUFFICIENCY
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    DETACHMENT OF RETINAL PIGMENT EPITHELIUM
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    EYELID OEDEMA
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    DIARRHOEA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    ABDOMINAL PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    COLITIS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    CONSTIPATION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    DYSPHAGIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    GASTRIC ULCER
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    GASTROINTESTINAL HAEMORRHAGE
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    NAUSEA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    CHOLANGITIS INFECTIVE
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    CLOSTRIDIUM DIFFICILE COLITIS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    KLEBSIELLA BACTERAEMIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    PNEUMONIA
time Frame
15 months

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Preserved source evidence · Not medical advice