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NCT02343120 · ADVERSE EVENTS

Adverse events

Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies · Source last updated 2022-04-28

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
Up to 6 years and 7 months
Other-event reporting threshold
3%

One participant in the 320 mg QD group discontinued the study for Other reasons, as shown in the participant flow section, and subsequently died after study discontinuation. That participant is counted under all-cause mortality in this section.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: 40 mg QD

Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up

1 / 33 / 31 / 3
Part 1: 80 mg QD

Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up

2 / 44 / 42 / 4
Part 1: 160 mg QD

Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up

3 / 55 / 52 / 5
Part 1 and Part 2: 160 mg BID

Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.

157 / 278273 / 27876 / 278
Part 1 and Part 2: 320 mg QD

Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.

45 / 9594 / 9519 / 95

Group identifiers: EG000: Part 1: 40 mg QD · EG001: Part 1: 80 mg QD · EG002: Part 1: 160 mg QD · EG003: Part 1 and Part 2: 160 mg BID · EG004: Part 1 and Part 2: 320 mg QD

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      278
      num Events
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      95
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      278
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Hyperviscosity syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      278
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      2
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Lymphocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      278
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Splenomegaly
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      278
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      278
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      95
      num Events
      2
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Atrial flutter

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
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
      num Events
      3
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      278
      num Events
      64
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      95
      num Events
      16
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      278
      num Events
      6
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      95
      num Events
      7
    term
    Increased tendency to bruise
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      3
    4. group Id
      EG003
      num Affected
      44
      num At Risk
      278
      num Events
      107
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      95
      num Events
      29
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      278
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Spontaneous haemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      278
      num Events
      42
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      95
      num Events
      6
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      278
      num Events
      15
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      95
      num Events
      3
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      278
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      95
      num Events
      3
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      278
      num Events
      10
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      95
      num Events
      4
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      278
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      278
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Right ventricular failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      278
      num Events
      6
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      95
      num Events
      3
    term
    Ear pain
Complete source fields
description
One participant in the 320 mg QD group discontinued the study for Other reasons, as shown in the participant flow section, and subsequently died after study discontinuation. That participant is counted under all-cause mortality in this section.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Part 1: 40 mg QD
  2. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Part 1: 80 mg QD
  3. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Part 1: 160 mg QD
  4. deaths Num Affected
    76
    deaths Num At Risk
    278
    description
    Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
    id
    EG003
    other Num Affected
    273
    other Num At Risk
    278
    serious Num Affected
    157
    serious Num At Risk
    278
    title
    Part 1 and Part 2: 160 mg BID
  5. deaths Num Affected
    19
    deaths Num At Risk
    95
    description
    Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
    id
    EG004
    other Num Affected
    94
    other Num At Risk
    95
    serious Num Affected
    45
    serious Num At Risk
    95
    title
    Part 1 and Part 2: 320 mg QD
frequency Threshold
3
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
      num Events
      3
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      278
      num Events
      64
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      95
      num Events
      16
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      278
      num Events
      6
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      95
      num Events
      7
    term
    Increased tendency to bruise
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      3
    4. group Id
      EG003
      num Affected
      44
      num At Risk
      278
      num Events
      107
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      95
      num Events
      29
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      278
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Spontaneous haemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      278
      num Events
      42
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      95
      num Events
      6
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      278
      num Events
      15
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      95
      num Events
      3
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      278
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      95
      num Events
      3
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      278
      num Events
      10
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      95
      num Events
      4
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      278
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      278
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Right ventricular failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      278
      num Events
      6
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      95
      num Events
      3
    term
    Ear pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      278
      num Events
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      95
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      278
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Hyperviscosity syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      278
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      2
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Lymphocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      278
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Splenomegaly
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      278
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      278
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      95
      num Events
      2
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      278
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
      num Events
      1
    term
    Atrial flutter
time Frame
Up to 6 years and 7 months

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Preserved source evidence · Not medical advice