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NCT01243944 · ADVERSE EVENTS

Adverse events

Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial) · Source last updated 2019-03-06

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
The initial data reported was for the study up to Week 32. This time frame defines the comparative phase of the study where the majority of participants remained on their original randomized assignment and exposure between ruxolitinib and best available therapy was similar. Data inclusive of end of study was reported up to week 256 for Ruxolitinib group. Long term Follow Up for BAT was not reported as all patients have completed the study or crossed over to Ruxolitinib group by week 80.
Other-event reporting threshold
5%

Safety population: All participants who were enrolled and took at least 1 dose of study medication. The initial data reported at Week 32 was based on MedDRA 15.1; the remaining data reported for end of study was based on MedDRA 20.1.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ruxolitinib - Through Week 32

Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy

15 / 110105 / 110Not reported / Not reported
Best Available Therapy - Through Week 32

Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.

10 / 111104 / 111Not reported / Not reported
Ruxolitinib - Week 256 Close Out

Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy

44 / 110107 / 110Not reported / Not reported

Group identifiers: EG000: Ruxolitinib - Through Week 32 · EG001: Best Available Therapy - Through Week 32 · EG002: Ruxolitinib - Week 256 Close Out

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 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Leukocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      110
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Cardiac failure congestive
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Cataract
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Glaucoma
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Retinal detachment
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Dental necrosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      110
    term
    Chest pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Bronchitis viral

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 20.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      110
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      110
    term
    Headache
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      110
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      110
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      110
    term
    Pruritus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      110
    term
    Dizziness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      110
    term
    Dyspnoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      110
    term
    Muscle spasms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      110
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      110
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      110
    term
    Nasopharyngitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      110
    term
    Thrombocytopenia
Complete source fields
description
Safety population: All participants who were enrolled and took at least 1 dose of study medication. The initial data reported at Week 32 was based on MedDRA 15.1; the remaining data reported for end of study was based on MedDRA 20.1.
event Groups
  1. description
    Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
    id
    EG000
    other Num Affected
    105
    other Num At Risk
    110
    serious Num Affected
    15
    serious Num At Risk
    110
    title
    Ruxolitinib - Through Week 32
  2. description
    Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
    id
    EG001
    other Num Affected
    104
    other Num At Risk
    111
    serious Num Affected
    10
    serious Num At Risk
    111
    title
    Best Available Therapy - Through Week 32
  3. description
    Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
    id
    EG002
    other Num Affected
    107
    other Num At Risk
    110
    serious Num Affected
    44
    serious Num At Risk
    110
    title
    Ruxolitinib - Week 256 Close Out
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      110
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      110
    term
    Headache
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      110
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      110
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      110
    term
    Pruritus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      110
    term
    Dizziness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      110
    term
    Dyspnoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      110
    term
    Muscle spasms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      110
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      110
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      110
    term
    Nasopharyngitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      110
    term
    Thrombocytopenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Leukocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      110
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Cardiac failure congestive
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Cataract
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Glaucoma
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Retinal detachment
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Dental necrosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      110
    term
    Chest pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
    term
    Bronchitis viral
time Frame
The initial data reported was for the study up to Week 32. This time frame defines the comparative phase of the study where the majority of participants remained on their original randomized assignment and exposure between ruxolitinib and best available therapy was similar. Data inclusive of end of study was reported up to week 256 for Ruxolitinib group. Long term Follow Up for BAT was not reported as all patients have completed the study or crossed over to Ruxolitinib group by week 80.

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Preserved source evidence · Not medical advice