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NCT00123474 · ADVERSE EVENTS

Adverse events

Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML · Source last updated 2016-08-25

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
Baseline to 30 days post last dose, up to 7 years (study closure July 2014)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
100mg QD

Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

75 / 165160 / 165Not reported / Not reported
140mg QD

Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.

78 / 163155 / 163Not reported / Not reported
50mg BID

Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.

89 / 167160 / 167Not reported / Not reported
70mg BID

Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.

92 / 167165 / 167Not reported / Not reported

Group identifiers: EG000: 100mg QD · EG001: 140mg QD · EG002: 50mg BID · EG003: 70mg BID

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
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      167
    term
    Abdominal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Acute respiratory distress syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Allergy to arthropod sting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Arrhythmia supraventricular
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      167
    term
    Blood creatinine increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Cardiac valve disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Cognitive disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Completed suicide
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Enteritis infectious
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      167
    term
    Extremity necrosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      167
    term
    Gastrointestinal haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      167
    term
    Gastrointestinal necrosis

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
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      167
    term
    Acne
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      167
    term
    Hypertension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      167
    term
    Pain in extremity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      167
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      51
      num At Risk
      167
    term
    Pleural effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      167
    term
    Back pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      54
      num At Risk
      167
    term
    Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      167
    term
    Erythema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      56
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      49
      num At Risk
      167
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      167
    term
    Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      167
    term
    Nasopharyngitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      167
    term
    Oral herpes
Complete source fields
event Groups
  1. description
    Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
    id
    EG000
    other Num Affected
    160
    other Num At Risk
    165
    serious Num Affected
    75
    serious Num At Risk
    165
    title
    100mg QD
  2. description
    Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
    id
    EG001
    other Num Affected
    155
    other Num At Risk
    163
    serious Num Affected
    78
    serious Num At Risk
    163
    title
    140mg QD
  3. description
    Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
    id
    EG002
    other Num Affected
    160
    other Num At Risk
    167
    serious Num Affected
    89
    serious Num At Risk
    167
    title
    50mg BID
  4. description
    Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
    id
    EG003
    other Num Affected
    165
    other Num At Risk
    167
    serious Num Affected
    92
    serious Num At Risk
    167
    title
    70mg BID
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      167
    term
    Acne
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      167
    term
    Hypertension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      167
    term
    Pain in extremity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      167
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      51
      num At Risk
      167
    term
    Pleural effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      167
    term
    Back pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      54
      num At Risk
      167
    term
    Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      167
    term
    Erythema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      56
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      49
      num At Risk
      167
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      167
    term
    Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      167
    term
    Nasopharyngitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      167
    term
    Oral herpes
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      167
    term
    Abdominal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Acute respiratory distress syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Allergy to arthropod sting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Arrhythmia supraventricular
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      167
    term
    Blood creatinine increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Cardiac valve disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Cognitive disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Completed suicide
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      167
    term
    Enteritis infectious
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      167
    term
    Extremity necrosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      167
    term
    Gastrointestinal haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      167
    term
    Gastrointestinal necrosis
time Frame
Baseline to 30 days post last dose, up to 7 years (study closure July 2014)

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Preserved source evidence · Not medical advice