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NCT02048813 · ADVERSE EVENTS

Adverse events

Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma · Source last updated 2026-08-28

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
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Other-event reporting threshold
5%

Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Ibrutinib, Rituximab)

Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.

270 / 352348 / 3524 / 354
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)

Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.

132 / 158154 / 15810 / 175

Group identifiers: EG000: Arm A (Ibrutinib, Rituximab) · EG001: Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)

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
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Ear pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      158
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      158
    term
    Febrile neutropenia
  4. assessment Type
    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
      352
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      158
    term
    Hemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    term
    Leukocytosis
  6. assessment Type
    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
      352
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    term
    Blood and lymphatic system disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Asystole
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Atrial flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Atrioventricular block complete
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Chest pain - cardiac

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
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      183
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      99
      num At Risk
      158
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    term
    Palpitations
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      158
    term
    Chills
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      158
    term
    Edema limbs
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      235
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      158
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      158
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      158
    term
    Infusion related reaction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      158
    term
    Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    term
    General disorders and administration site conditions - Other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      158
    term
    Dry skin
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      158
    term
    Pruritus
Complete source fields
description
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    354
    description
    Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
    id
    EG000
    other Num Affected
    348
    other Num At Risk
    352
    serious Num Affected
    270
    serious Num At Risk
    352
    title
    Arm A (Ibrutinib, Rituximab)
  2. deaths Num Affected
    10
    deaths Num At Risk
    175
    description
    Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
    id
    EG001
    other Num Affected
    154
    other Num At Risk
    158
    serious Num Affected
    132
    serious Num At Risk
    158
    title
    Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      183
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      99
      num At Risk
      158
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    term
    Palpitations
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      158
    term
    Chills
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      158
    term
    Edema limbs
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      235
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      158
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      158
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      158
    term
    Infusion related reaction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      158
    term
    Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    term
    General disorders and administration site conditions - Other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      158
    term
    Dry skin
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      158
    term
    Pruritus
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Ear pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      158
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      158
    term
    Febrile neutropenia
  4. assessment Type
    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
      352
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      158
    term
    Hemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    term
    Leukocytosis
  6. assessment Type
    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
      352
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    term
    Blood and lymphatic system disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Asystole
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Atrial flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Atrioventricular block complete
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      352
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    term
    Chest pain - cardiac
time Frame
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years

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