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NCT01539083 · ADVERSE EVENTS

Adverse events

Velcade (Bortezomib) Consolidation After Transplant · Source last updated 2025-02-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Not reported
Other-event reporting threshold
5%

Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction)

Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m\^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.

88 / 254233 / 254Not reported / Not reported
Thalidomide + Prednisolone (TP Consolidation)

Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.

22 / 9995 / 99Not reported / Not reported
Bortezomib + Thalidomide + Prednisolone (VTP Consolidation)

Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.

28 / 10396 / 103Not reported / Not reported

Group identifiers: EG000: Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction) · EG001: Thalidomide + Prednisolone (TP Consolidation) · EG002: Bortezomib + Thalidomide + Prednisolone (VTP Consolidation)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Febrile Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Arrhythmia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Atrial Fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
    term
    Atrial Flutter
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Left Ventricular Dysfunction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
    term
    Sinus Bradycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Supraventricular Tachycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Blepharitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Abdominal Pain Lower
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Colitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
    term
    Diarrhoea

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      103
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      103
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      103
    term
    Tinnitus
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      103
    term
    Cushingoid
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      103
    term
    Vision Blurred
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      103
    term
    Visual Impairment
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      103
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      103
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      103
    term
    Dry Mouth
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
    term
    Dyspepsia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      103
    term
    Nausea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      103
    term
    Vomiting
Complete source fields
description
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
event Groups
  1. description
    Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m\^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
    id
    EG000
    other Num Affected
    233
    other Num At Risk
    254
    serious Num Affected
    88
    serious Num At Risk
    254
    title
    Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction)
  2. description
    Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
    id
    EG001
    other Num Affected
    95
    other Num At Risk
    99
    serious Num Affected
    22
    serious Num At Risk
    99
    title
    Thalidomide + Prednisolone (TP Consolidation)
  3. description
    Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
    id
    EG002
    other Num Affected
    96
    other Num At Risk
    103
    serious Num Affected
    28
    serious Num At Risk
    103
    title
    Bortezomib + Thalidomide + Prednisolone (VTP Consolidation)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      103
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      103
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      103
    term
    Tinnitus
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      103
    term
    Cushingoid
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      103
    term
    Vision Blurred
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      103
    term
    Visual Impairment
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      103
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      103
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      103
    term
    Dry Mouth
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
    term
    Dyspepsia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      103
    term
    Nausea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      103
    term
    Vomiting
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Febrile Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Arrhythmia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Atrial Fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
    term
    Atrial Flutter
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Left Ventricular Dysfunction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
    term
    Sinus Bradycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Supraventricular Tachycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Blepharitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Abdominal Pain Lower
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Colitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
    term
    Diarrhoea

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Preserved source evidence · Not medical advice