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NCT00872521 · ADVERSE EVENTS

Adverse events

A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma · Source last updated 2014-05-16

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
2 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
1q21 Amplified

Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.

15 / 2626 / 26Not reported / Not reported
1q21 Not Amplified

Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.

30 / 7272 / 72Not reported / Not reported
Failed/Missing Test

Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.

5 / 99 / 9Not reported / Not reported
Total

Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.

50 / 107107 / 107Not reported / Not reported

Group identifiers: EG000: 1q21 Amplified · EG001: 1q21 Not Amplified · EG002: Failed/Missing Test · EG003: Total

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      107
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      107
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      107
    term
    Atrial Fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Cardiac Amyloidosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Cardiac Failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Cardiac Failure Congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Cardiomyopathy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Ventricular Arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Hyperthyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      107
    term
    Abdominal Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Abdominal Strangulated Hernia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      107
    term
    Constipation

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 Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      107
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      107
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      107
    term
    Vision Blurred
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      107
    term
    Abdominal Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      65
      num At Risk
      107
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      38
      num At Risk
      107
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      107
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      107
    term
    Gastrooesophageal Reflux Disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      51
      num At Risk
      107
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      107
    term
    Reflux Gastritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      107
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      107
    term
    Chest Pain
Complete source fields
event Groups
  1. description
    Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    EG000
    other Num Affected
    26
    other Num At Risk
    26
    serious Num Affected
    15
    serious Num At Risk
    26
    title
    1q21 Amplified
  2. description
    Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    EG001
    other Num Affected
    72
    other Num At Risk
    72
    serious Num Affected
    30
    serious Num At Risk
    72
    title
    1q21 Not Amplified
  3. description
    Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    EG002
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    5
    serious Num At Risk
    9
    title
    Failed/Missing Test
  4. description
    Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    EG003
    other Num Affected
    107
    other Num At Risk
    107
    serious Num Affected
    50
    serious Num At Risk
    107
    title
    Total
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      107
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      107
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      107
    term
    Vision Blurred
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      107
    term
    Abdominal Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      65
      num At Risk
      107
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      38
      num At Risk
      107
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      107
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      107
    term
    Gastrooesophageal Reflux Disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      51
      num At Risk
      107
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      107
    term
    Reflux Gastritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      107
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      107
    term
    Chest Pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      107
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      107
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      107
    term
    Atrial Fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Cardiac Amyloidosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Cardiac Failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Cardiac Failure Congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Cardiomyopathy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Ventricular Arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Hyperthyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      107
    term
    Abdominal Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      107
    term
    Abdominal Strangulated Hernia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      72
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      107
    term
    Constipation
time Frame
2 years

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Preserved source evidence · Not medical advice