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NCT02141282 · ADVERSE EVENTS

Adverse events

A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy · Source last updated 2022-12-19

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
All-cause mortality reported from enrollment to 30 d after last dose of study drug; median time on follow up was up to 1694 d for those with ibrutinib-resistant or refractory CLL and up to 1942 d for those with idelalisib-resistant or refractory CLL. TEAEs and SAEs collected from first dose of study drug until 30 d after last dose of study drug; mean duration on study drug was 819.8 d (ibrutinib-resistant or refractory CLL cohorts) and 1151.5 d (idelalisib-resistant or refractory CLL cohorts).
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
ABT-199 After Ibrutinib Therapy: Main Cohort

Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main Cohort

35 / 4343 / 4325 / 43
ABT-199 After Idelalisib Therapy: Main Cohort

Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main Cohort

14 / 2121 / 219 / 21
ABT-199 After Ibrutinib or Idelalisib Therapy: Main Cohort

Participants with ibrutinib-resistant/refractory or idelalisib-resistant/refractory chronic lymphocytic leukemia (CLL) in the Main Cohort

49 / 6464 / 6434 / 64
ABT-199 After Ibrutinib Therapy: Expansion Cohort

Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Expansion Cohort

26 / 4848 / 4817 / 48
ABT-199 After Idelalisib Therapy: Expansion Cohort

Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Expansion Cohort

9 / 1515 / 154 / 15
ABT-199 After Ibrutinib or Idelalisib Therapy: Expansion Cohort

Participants with ibrutinib-resistant/refractory or idelalisib-resistant/refractory chronic lymphocytic leukemia (CLL) in the Expansion Cohort

35 / 6363 / 6321 / 63
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts

Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts

61 / 9191 / 9142 / 91
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts

Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts

23 / 3636 / 3613 / 36
All Participants

All participants in the Main and Expansion Cohorts

84 / 127127 / 12755 / 127

Group identifiers: EG000: ABT-199 After Ibrutinib Therapy: Main Cohort · EG001: ABT-199 After Idelalisib Therapy: Main Cohort · EG002: ABT-199 After Ibrutinib or Idelalisib Therapy: Main Cohort · EG003: ABT-199 After Ibrutinib Therapy: Expansion Cohort · EG004: ABT-199 After Idelalisib Therapy: Expansion Cohort · EG005: ABT-199 After Ibrutinib or Idelalisib Therapy: Expansion Cohort · EG006: ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts · EG007: ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts · EG008: All Participants

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 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      48
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      63
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      91
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      1
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      127
      num Events
      2
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      48
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      91
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      127
      num Events
      3
    term
    AUTOIMMUNE HAEMOLYTIC ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      43
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      64
      num Events
      14
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      48
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      63
      num Events
      4
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      91
      num Events
      17
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      1
    9. group Id
      EG008
      num Affected
      14
      num At Risk
      127
      num Events
      18
    term
    FEBRILE NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      91
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    HAEMOLYTIC ANAEMIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      91
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    LYMPHOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      91
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    NEUTROPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      91
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    THROMBOCYTOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      91
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    ANGINA UNSTABLE
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      91
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      2
    term
    ATRIAL FIBRILLATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      91
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    ATRIAL FLUTTER
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      91
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    CARDIAC FAILURE CONGESTIVE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      48
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      91
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      127
      num Events
      2
    term
    MYOCARDIAL INFARCTION

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 24.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      43
      num Events
      44
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      21
      num Events
      25
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      64
      num Events
      69
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      48
      num Events
      51
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      15
      num Events
      3
    6. group Id
      EG005
      num Affected
      24
      num At Risk
      63
      num Events
      54
    7. group Id
      EG006
      num Affected
      45
      num At Risk
      91
      num Events
      95
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      36
      num Events
      28
    9. group Id
      EG008
      num Affected
      52
      num At Risk
      127
      num Events
      123
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      64
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      91
      num Events
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      1
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      127
      num Events
      4
    term
    LYMPH NODE PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      43
      num Events
      32
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      21
      num Events
      27
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      64
      num Events
      59
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      48
      num Events
      44
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      15
      num Events
      15
    6. group Id
      EG005
      num Affected
      29
      num At Risk
      63
      num Events
      59
    7. group Id
      EG006
      num Affected
      36
      num At Risk
      91
      num Events
      76
    8. group Id
      EG007
      num Affected
      19
      num At Risk
      36
      num Events
      42
    9. group Id
      EG008
      num Affected
      55
      num At Risk
      127
      num Events
      118
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      43
      num Events
      14
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      21
      num Events
      24
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      64
      num Events
      38
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      48
      num Events
      25
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      15
      num Events
      7
    6. group Id
      EG005
      num Affected
      18
      num At Risk
      63
      num Events
      32
    7. group Id
      EG006
      num Affected
      25
      num At Risk
      91
      num Events
      39
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      36
      num Events
      31
    9. group Id
      EG008
      num Affected
      35
      num At Risk
      127
      num Events
      70
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      64
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      48
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      63
      num Events
      2
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      91
      num Events
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      36
      num Events
      2
    9. group Id
      EG008
      num Affected
      6
      num At Risk
      127
      num Events
      6
    term
    ABDOMINAL DISCOMFORT
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      64
      num Events
      3
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      48
      num Events
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      15
      num Events
      2
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      63
      num Events
      7
    7. group Id
      EG006
      num Affected
      8
      num At Risk
      91
      num Events
      8
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      36
      num Events
      2
    9. group Id
      EG008
      num Affected
      10
      num At Risk
      127
      num Events
      10
    term
    ABDOMINAL DISTENSION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      43
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      64
      num Events
      10
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      48
      num Events
      16
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      15
      num Events
      5
    6. group Id
      EG005
      num Affected
      16
      num At Risk
      63
      num Events
      21
    7. group Id
      EG006
      num Affected
      20
      num At Risk
      91
      num Events
      26
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      36
      num Events
      5
    9. group Id
      EG008
      num Affected
      23
      num At Risk
      127
      num Events
      31
    term
    ABDOMINAL PAIN
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      64
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      48
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      15
      num Events
      4
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      63
      num Events
      7
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      91
      num Events
      5
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      36
      num Events
      5
    9. group Id
      EG008
      num Affected
      8
      num At Risk
      127
      num Events
      10
    term
    ABDOMINAL PAIN UPPER
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      43
      num Events
      12
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      21
      num Events
      7
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      64
      num Events
      19
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      48
      num Events
      18
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      15
      num Events
      4
    6. group Id
      EG005
      num Affected
      20
      num At Risk
      63
      num Events
      22
    7. group Id
      EG006
      num Affected
      24
      num At Risk
      91
      num Events
      30
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      36
      num Events
      11
    9. group Id
      EG008
      num Affected
      34
      num At Risk
      127
      num Events
      41
    term
    CONSTIPATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      43
      num Events
      38
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      21
      num Events
      18
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      64
      num Events
      56
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      48
      num Events
      56
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      15
      num Events
      15
    6. group Id
      EG005
      num Affected
      34
      num At Risk
      63
      num Events
      71
    7. group Id
      EG006
      num Affected
      48
      num At Risk
      91
      num Events
      94
    8. group Id
      EG007
      num Affected
      17
      num At Risk
      36
      num Events
      33
    9. group Id
      EG008
      num Affected
      65
      num At Risk
      127
      num Events
      127
    term
    DIARRHOEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      21
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      64
      num Events
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      48
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      63
      num Events
      5
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      91
      num Events
      7
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      36
      num Events
      3
    9. group Id
      EG008
      num Affected
      10
      num At Risk
      127
      num Events
      10
    term
    DRY MOUTH
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      64
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      48
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      91
      num Events
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      2
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      127
      num Events
      6
    term
    DYSPEPSIA
Complete source fields
event Groups
  1. deaths Num Affected
    25
    deaths Num At Risk
    43
    description
    Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main Cohort
    id
    EG000
    other Num Affected
    43
    other Num At Risk
    43
    serious Num Affected
    35
    serious Num At Risk
    43
    title
    ABT-199 After Ibrutinib Therapy: Main Cohort
  2. deaths Num Affected
    9
    deaths Num At Risk
    21
    description
    Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main Cohort
    id
    EG001
    other Num Affected
    21
    other Num At Risk
    21
    serious Num Affected
    14
    serious Num At Risk
    21
    title
    ABT-199 After Idelalisib Therapy: Main Cohort
  3. deaths Num Affected
    34
    deaths Num At Risk
    64
    description
    Participants with ibrutinib-resistant/refractory or idelalisib-resistant/refractory chronic lymphocytic leukemia (CLL) in the Main Cohort
    id
    EG002
    other Num Affected
    64
    other Num At Risk
    64
    serious Num Affected
    49
    serious Num At Risk
    64
    title
    ABT-199 After Ibrutinib or Idelalisib Therapy: Main Cohort
  4. deaths Num Affected
    17
    deaths Num At Risk
    48
    description
    Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Expansion Cohort
    id
    EG003
    other Num Affected
    48
    other Num At Risk
    48
    serious Num Affected
    26
    serious Num At Risk
    48
    title
    ABT-199 After Ibrutinib Therapy: Expansion Cohort
  5. deaths Num Affected
    4
    deaths Num At Risk
    15
    description
    Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Expansion Cohort
    id
    EG004
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    9
    serious Num At Risk
    15
    title
    ABT-199 After Idelalisib Therapy: Expansion Cohort
  6. deaths Num Affected
    21
    deaths Num At Risk
    63
    description
    Participants with ibrutinib-resistant/refractory or idelalisib-resistant/refractory chronic lymphocytic leukemia (CLL) in the Expansion Cohort
    id
    EG005
    other Num Affected
    63
    other Num At Risk
    63
    serious Num Affected
    35
    serious Num At Risk
    63
    title
    ABT-199 After Ibrutinib or Idelalisib Therapy: Expansion Cohort
  7. deaths Num Affected
    42
    deaths Num At Risk
    91
    description
    Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
    id
    EG006
    other Num Affected
    91
    other Num At Risk
    91
    serious Num Affected
    61
    serious Num At Risk
    91
    title
    ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts
  8. deaths Num Affected
    13
    deaths Num At Risk
    36
    description
    Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
    id
    EG007
    other Num Affected
    36
    other Num At Risk
    36
    serious Num Affected
    23
    serious Num At Risk
    36
    title
    ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
  9. deaths Num Affected
    55
    deaths Num At Risk
    127
    description
    All participants in the Main and Expansion Cohorts
    id
    EG008
    other Num Affected
    127
    other Num At Risk
    127
    serious Num Affected
    84
    serious Num At Risk
    127
    title
    All Participants
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      43
      num Events
      44
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      21
      num Events
      25
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      64
      num Events
      69
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      48
      num Events
      51
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      15
      num Events
      3
    6. group Id
      EG005
      num Affected
      24
      num At Risk
      63
      num Events
      54
    7. group Id
      EG006
      num Affected
      45
      num At Risk
      91
      num Events
      95
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      36
      num Events
      28
    9. group Id
      EG008
      num Affected
      52
      num At Risk
      127
      num Events
      123
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      64
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      91
      num Events
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      1
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      127
      num Events
      4
    term
    LYMPH NODE PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      43
      num Events
      32
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      21
      num Events
      27
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      64
      num Events
      59
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      48
      num Events
      44
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      15
      num Events
      15
    6. group Id
      EG005
      num Affected
      29
      num At Risk
      63
      num Events
      59
    7. group Id
      EG006
      num Affected
      36
      num At Risk
      91
      num Events
      76
    8. group Id
      EG007
      num Affected
      19
      num At Risk
      36
      num Events
      42
    9. group Id
      EG008
      num Affected
      55
      num At Risk
      127
      num Events
      118
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      43
      num Events
      14
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      21
      num Events
      24
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      64
      num Events
      38
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      48
      num Events
      25
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      15
      num Events
      7
    6. group Id
      EG005
      num Affected
      18
      num At Risk
      63
      num Events
      32
    7. group Id
      EG006
      num Affected
      25
      num At Risk
      91
      num Events
      39
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      36
      num Events
      31
    9. group Id
      EG008
      num Affected
      35
      num At Risk
      127
      num Events
      70
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      64
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      48
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      63
      num Events
      2
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      91
      num Events
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      36
      num Events
      2
    9. group Id
      EG008
      num Affected
      6
      num At Risk
      127
      num Events
      6
    term
    ABDOMINAL DISCOMFORT
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      64
      num Events
      3
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      48
      num Events
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      15
      num Events
      2
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      63
      num Events
      7
    7. group Id
      EG006
      num Affected
      8
      num At Risk
      91
      num Events
      8
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      36
      num Events
      2
    9. group Id
      EG008
      num Affected
      10
      num At Risk
      127
      num Events
      10
    term
    ABDOMINAL DISTENSION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      43
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      64
      num Events
      10
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      48
      num Events
      16
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      15
      num Events
      5
    6. group Id
      EG005
      num Affected
      16
      num At Risk
      63
      num Events
      21
    7. group Id
      EG006
      num Affected
      20
      num At Risk
      91
      num Events
      26
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      36
      num Events
      5
    9. group Id
      EG008
      num Affected
      23
      num At Risk
      127
      num Events
      31
    term
    ABDOMINAL PAIN
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      64
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      48
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      15
      num Events
      4
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      63
      num Events
      7
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      91
      num Events
      5
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      36
      num Events
      5
    9. group Id
      EG008
      num Affected
      8
      num At Risk
      127
      num Events
      10
    term
    ABDOMINAL PAIN UPPER
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      43
      num Events
      12
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      21
      num Events
      7
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      64
      num Events
      19
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      48
      num Events
      18
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      15
      num Events
      4
    6. group Id
      EG005
      num Affected
      20
      num At Risk
      63
      num Events
      22
    7. group Id
      EG006
      num Affected
      24
      num At Risk
      91
      num Events
      30
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      36
      num Events
      11
    9. group Id
      EG008
      num Affected
      34
      num At Risk
      127
      num Events
      41
    term
    CONSTIPATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      43
      num Events
      38
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      21
      num Events
      18
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      64
      num Events
      56
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      48
      num Events
      56
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      15
      num Events
      15
    6. group Id
      EG005
      num Affected
      34
      num At Risk
      63
      num Events
      71
    7. group Id
      EG006
      num Affected
      48
      num At Risk
      91
      num Events
      94
    8. group Id
      EG007
      num Affected
      17
      num At Risk
      36
      num Events
      33
    9. group Id
      EG008
      num Affected
      65
      num At Risk
      127
      num Events
      127
    term
    DIARRHOEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      21
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      64
      num Events
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      48
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      63
      num Events
      5
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      91
      num Events
      7
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      36
      num Events
      3
    9. group Id
      EG008
      num Affected
      10
      num At Risk
      127
      num Events
      10
    term
    DRY MOUTH
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      64
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      48
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      91
      num Events
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      2
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      127
      num Events
      6
    term
    DYSPEPSIA
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      48
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      63
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      91
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      1
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      127
      num Events
      2
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      48
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      91
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      127
      num Events
      3
    term
    AUTOIMMUNE HAEMOLYTIC ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      43
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      64
      num Events
      14
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      48
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      63
      num Events
      4
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      91
      num Events
      17
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      1
    9. group Id
      EG008
      num Affected
      14
      num At Risk
      127
      num Events
      18
    term
    FEBRILE NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      91
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    HAEMOLYTIC ANAEMIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      91
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    LYMPHOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      91
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    NEUTROPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      91
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    THROMBOCYTOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      91
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    ANGINA UNSTABLE
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      91
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      2
    term
    ATRIAL FIBRILLATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      91
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    ATRIAL FLUTTER
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      48
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      91
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      36
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    CARDIAC FAILURE CONGESTIVE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      48
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      91
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      36
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      127
      num Events
      2
    term
    MYOCARDIAL INFARCTION
time Frame
All-cause mortality reported from enrollment to 30 d after last dose of study drug; median time on follow up was up to 1694 d for those with ibrutinib-resistant or refractory CLL and up to 1942 d for those with idelalisib-resistant or refractory CLL. TEAEs and SAEs collected from first dose of study drug until 30 d after last dose of study drug; mean duration on study drug was 819.8 d (ibrutinib-resistant or refractory CLL cohorts) and 1151.5 d (idelalisib-resistant or refractory CLL cohorts).

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