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NCT00934544 · ADVERSE EVENTS

Adverse events

Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial · Source last updated 2019-08-19

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ruxolitinib Randomized

Ruxolitinib Randomized

51 / 146145 / 146Not reported / Not reported
Ruxolitinib Randomized + Extension Phase

Ruxolitinib Randomized + Extension Phase

85 / 146145 / 146Not reported / Not reported
BAT Randomized

BAT Randomized

22 / 7364 / 73Not reported / Not reported
Ruxolitinib Cross-over

Ruxolitinib cross-over

20 / 4542 / 45Not reported / Not reported

Group identifiers: EG000: Ruxolitinib Randomized · EG001: Ruxolitinib Randomized + Extension Phase · EG002: BAT Randomized · EG003: Ruxolitinib Cross-over

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 17.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Anaemia of chronic disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Coagulopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Lymphadenopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Paratracheal lymphadenopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Splenic infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Splenomegaly
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      45
    term
    Thrombocytopenia

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 17.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      45
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Vertigo
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      45
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    term
    Ascites
Complete source fields
event Groups
  1. description
    Ruxolitinib Randomized
    id
    EG000
    other Num Affected
    145
    other Num At Risk
    146
    serious Num Affected
    51
    serious Num At Risk
    146
    title
    Ruxolitinib Randomized
  2. description
    Ruxolitinib Randomized + Extension Phase
    id
    EG001
    other Num Affected
    145
    other Num At Risk
    146
    serious Num Affected
    85
    serious Num At Risk
    146
    title
    Ruxolitinib Randomized + Extension Phase
  3. description
    BAT Randomized
    id
    EG002
    other Num Affected
    64
    other Num At Risk
    73
    serious Num Affected
    22
    serious Num At Risk
    73
    title
    BAT Randomized
  4. description
    Ruxolitinib cross-over
    id
    EG003
    other Num Affected
    42
    other Num At Risk
    45
    serious Num Affected
    20
    serious Num At Risk
    45
    title
    Ruxolitinib Cross-over
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      45
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Vertigo
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      45
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    term
    Ascites
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Anaemia of chronic disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Coagulopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Lymphadenopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Paratracheal lymphadenopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Splenic infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Splenomegaly
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      146
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      146
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      45
    term
    Thrombocytopenia

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Preserved source evidence · Not medical advice