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NCT01431209 · ADVERSE EVENTS

Adverse events

Ruxolitinib Phosphate to Treat Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin Lymphoma After Stem Cell Transplant · Source last updated 2023-10-05

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 Event monitoring should be continued for at least 30 days following the last dose of study treatment. Since this treatment trial was for relapsed or refractory disease in subjects, subjects were allowed to continue study treatment as long as they received benefit and met not reason for study discontinuation. The last subject remained on treatment for 7 1/2 years.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Diffuse Large B-cell Lymphoma (DLBCL)

Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Ruxolitinib Phosphate: Given PO

22 / 4743 / 4731 / 47
Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)

Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Ruxolitinib Phosphate: Given PO

7 / 1312 / 1311 / 13

Group identifiers: EG000: Diffuse Large B-cell Lymphoma (DLBCL) · EG001: Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
    term
    Fever
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Thrush
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Infections and infestiations - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    pneumonia
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Respiratory disorder- other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    Anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    cough
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Fall
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    febrile neutropenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hypernatremia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hyponatremia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hypophosphatemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hypotension

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    actelectasis
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Respiratory, thoracic and mediastinal disorder - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    fatigue
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    hyponatremia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    apnea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Fall
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    febrile neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    fever
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hypercalcemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hypophosphatemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hypotension
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    lung infection
Complete source fields
event Groups
  1. deaths Num Affected
    31
    deaths Num At Risk
    47
    description
    Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Ruxolitinib Phosphate: Given PO
    id
    EG000
    other Num Affected
    43
    other Num At Risk
    47
    serious Num Affected
    22
    serious Num At Risk
    47
    title
    Diffuse Large B-cell Lymphoma (DLBCL)
  2. deaths Num Affected
    11
    deaths Num At Risk
    13
    description
    Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Ruxolitinib Phosphate: Given PO
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    13
    serious Num Affected
    7
    serious Num At Risk
    13
    title
    Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    actelectasis
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Respiratory, thoracic and mediastinal disorder - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    fatigue
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    hyponatremia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    apnea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Fall
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    febrile neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    fever
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hypercalcemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hypophosphatemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hypotension
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    lung infection
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
    term
    Fever
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Thrush
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Infections and infestiations - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    pneumonia
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Respiratory disorder- other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    Anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    cough
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Fall
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    febrile neutropenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hypernatremia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hyponatremia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hypophosphatemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    hypotension
time Frame
Adverse Event monitoring should be continued for at least 30 days following the last dose of study treatment. Since this treatment trial was for relapsed or refractory disease in subjects, subjects were allowed to continue study treatment as long as they received benefit and met not reason for study discontinuation. The last subject remained on treatment for 7 1/2 years.

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