Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01578707 · ADVERSE EVENTS

Adverse events

A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia · Source last updated 2019-12-18

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
From first dose of study drug to within 30 days of last dose.
Other-event reporting threshold
5%

196 subjects were randomized to the Ofa arm with 191 received drug thus 5 patients were not included in the number of participants at risk.

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

An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)

59 / 191185 / 19116 / 191
Ibrutinib (Arm B)

A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity

141 / 195194 / 19524 / 195

Group identifiers: EG000: Ofatumumab (Arm A) · EG001: Ibrutinib (Arm B)

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
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      195
    term
    Febrile Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      195
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      195
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      195
    term
    Spontaneous Haematoma
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      195
    term
    Lymphadenopathy
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      195
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      195
    term
    Autoimmune Haemolytic Anaemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      195
    term
    Haemolytic Anaemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      195
    term
    Methaemoglobinaemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      195
    term
    Atrial Fibrillation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      195
    term
    Cardiac Failure Congestive
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      195
    term
    Atrioventricular Block

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
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      195
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      195
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      195
    term
    Increased Tendency to Bruise
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      195
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      195
    term
    Lymphocytosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      195
    term
    Atrial Fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      195
    term
    Dry Eye
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      195
    term
    Vision Blurred
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      195
    term
    Lacrimation Increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      195
    term
    Cataract
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      195
    term
    Visual Acuity Reduced
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      195
    term
    Eye Irritation
Complete source fields
description
196 subjects were randomized to the Ofa arm with 191 received drug thus 5 patients were not included in the number of participants at risk.
event Groups
  1. deaths Num Affected
    16
    deaths Num At Risk
    191
    description
    An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
    id
    EG000
    other Num Affected
    185
    other Num At Risk
    191
    serious Num Affected
    59
    serious Num At Risk
    191
    title
    Ofatumumab (Arm A)
  2. deaths Num Affected
    24
    deaths Num At Risk
    195
    description
    A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity
    id
    EG001
    other Num Affected
    194
    other Num At Risk
    195
    serious Num Affected
    141
    serious Num At Risk
    195
    title
    Ibrutinib (Arm B)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      195
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      195
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      195
    term
    Increased Tendency to Bruise
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      195
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      195
    term
    Lymphocytosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      195
    term
    Atrial Fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      195
    term
    Dry Eye
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      195
    term
    Vision Blurred
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      195
    term
    Lacrimation Increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      195
    term
    Cataract
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      195
    term
    Visual Acuity Reduced
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      195
    term
    Eye Irritation
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      195
    term
    Febrile Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      195
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      195
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      195
    term
    Spontaneous Haematoma
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      195
    term
    Lymphadenopathy
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      195
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      195
    term
    Autoimmune Haemolytic Anaemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      195
    term
    Haemolytic Anaemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      195
    term
    Methaemoglobinaemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      195
    term
    Atrial Fibrillation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      195
    term
    Cardiac Failure Congestive
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MeDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      191
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      195
    term
    Atrioventricular Block
time Frame
From first dose of study drug to within 30 days of last dose.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice