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NCT02038036 · ADVERSE EVENTS

Adverse events

Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy. · Source last updated 2021-07-20

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
Adverse events were collected from the day of first dose of study medication to the End of study (End of Treatment +30 days) visit which was Week 260 or prior (+30 days for Rux + crossover) and Week 80 or prior (+30 days for BAT only).
Other-event reporting threshold
5%

Any signs or symptoms that occured from the day of first dose of study medication to the End of study (End of Treatment +30 days) visit which was Week 260 or prior (+30 days for Rux + crossover) and Week 80 or prior (+30 days for BAT only).

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

Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid

34 / 7473 / 741 / 74
Best Available Therapy

Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib

9 / 7556 / 751 / 75
All Crossover Patients

Participants randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib

23 / 5856 / 583 / 58

Group identifiers: EG000: Ruxolitinib · EG001: Best Available Therapy · EG002: All Crossover Patients

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 (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Hyperleukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Thrombocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Aortic valve incompetence
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Cardiac disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Coronary artery disease

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 (22.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      58
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      58
    term
    Thrombocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      58
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      58
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
    term
    Diarrhoea
Complete source fields
description
Any signs or symptoms that occured from the day of first dose of study medication to the End of study (End of Treatment +30 days) visit which was Week 260 or prior (+30 days for Rux + crossover) and Week 80 or prior (+30 days for BAT only).
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    74
    description
    Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid
    id
    EG000
    other Num Affected
    73
    other Num At Risk
    74
    serious Num Affected
    34
    serious Num At Risk
    74
    title
    Ruxolitinib
  2. deaths Num Affected
    1
    deaths Num At Risk
    75
    description
    Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib
    id
    EG001
    other Num Affected
    56
    other Num At Risk
    75
    serious Num Affected
    9
    serious Num At Risk
    75
    title
    Best Available Therapy
  3. deaths Num Affected
    3
    deaths Num At Risk
    58
    description
    Participants randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib
    id
    EG002
    other Num Affected
    56
    other Num At Risk
    58
    serious Num Affected
    23
    serious Num At Risk
    58
    title
    All Crossover Patients
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      58
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      58
    term
    Thrombocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      58
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      58
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Hyperleukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Thrombocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Aortic valve incompetence
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
    term
    Cardiac disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
    term
    Coronary artery disease
time Frame
Adverse events were collected from the day of first dose of study medication to the End of study (End of Treatment +30 days) visit which was Week 260 or prior (+30 days for Rux + crossover) and Week 80 or prior (+30 days for BAT only).

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Preserved source evidence · Not medical advice