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NCT01889186 · ADVERSE EVENTS

Adverse events

A Study of the Efficacy of ABT-199 in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia With the 17p Deletion · Source last updated 2021-12-16

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
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 80 months for the Main Cohort and up to 69 months for the Safety Expansion Cohort.
Other-event reporting threshold
5%

TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Main Cohort

Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.

78 / 107103 / 10762 / 107
Safety Expansion Cohort

Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.

34 / 5150 / 5119 / 51

Group identifiers: EG000: Main Cohort · EG001: Safety Expansion Cohort

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      107
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      107
      num Events
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    AUTOIMMUNE HAEMOLYTIC ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      107
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
      num Events
      2
    term
    FEBRILE NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    HAEMOLYSIS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    term
    HAEMORRHAGIC DIATHESIS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    term
    IMMUNE THROMBOCYTOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      107
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    LYMPHADENOPATHY
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
      num Events
      2
    term
    NEUTROPENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      107
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    THROMBOCYTOPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    ACUTE CORONARY SYNDROME
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    ACUTE MYOCARDIAL INFARCTION
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    ANGINA PECTORIS

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      107
      num Events
      55
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      51
      num Events
      16
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      51
      num Events
      4
    term
    AUTOIMMUNE HAEMOLYTIC ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      107
      num Events
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
      num Events
      2
    term
    LEUKOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      107
      num Events
      127
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      51
      num Events
      49
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      107
      num Events
      55
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      51
      num Events
      20
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      107
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
      num Events
      2
    term
    VERTIGO
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      107
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      51
      num Events
      9
    term
    ABDOMINAL PAIN
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      107
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      51
      num Events
      4
    term
    ABDOMINAL PAIN UPPER
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      107
      num Events
      15
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      51
      num Events
      10
    term
    CONSTIPATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      107
      num Events
      60
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      51
      num Events
      45
    term
    DIARRHOEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      107
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      51
      num Events
      3
    term
    DYSPEPSIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      107
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      51
      num Events
      4
    term
    FLATULENCE
Complete source fields
description
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
event Groups
  1. deaths Num Affected
    62
    deaths Num At Risk
    107
    description
    Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
    id
    EG000
    other Num Affected
    103
    other Num At Risk
    107
    serious Num Affected
    78
    serious Num At Risk
    107
    title
    Main Cohort
  2. deaths Num Affected
    19
    deaths Num At Risk
    51
    description
    Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
    id
    EG001
    other Num Affected
    50
    other Num At Risk
    51
    serious Num Affected
    34
    serious Num At Risk
    51
    title
    Safety Expansion Cohort
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      107
      num Events
      55
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      51
      num Events
      16
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      51
      num Events
      4
    term
    AUTOIMMUNE HAEMOLYTIC ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      107
      num Events
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
      num Events
      2
    term
    LEUKOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      107
      num Events
      127
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      51
      num Events
      49
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      107
      num Events
      55
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      51
      num Events
      20
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      107
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
      num Events
      2
    term
    VERTIGO
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      107
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      51
      num Events
      9
    term
    ABDOMINAL PAIN
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      107
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      51
      num Events
      4
    term
    ABDOMINAL PAIN UPPER
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      107
      num Events
      15
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      51
      num Events
      10
    term
    CONSTIPATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      107
      num Events
      60
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      51
      num Events
      45
    term
    DIARRHOEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      107
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      51
      num Events
      3
    term
    DYSPEPSIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      107
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      51
      num Events
      4
    term
    FLATULENCE
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      107
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      107
      num Events
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    AUTOIMMUNE HAEMOLYTIC ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      107
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
      num Events
      2
    term
    FEBRILE NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    HAEMOLYSIS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    term
    HAEMORRHAGIC DIATHESIS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    term
    IMMUNE THROMBOCYTOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      107
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    LYMPHADENOPATHY
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
      num Events
      2
    term
    NEUTROPENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      107
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    THROMBOCYTOPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    ACUTE CORONARY SYNDROME
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    ACUTE MYOCARDIAL INFARCTION
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    term
    ANGINA PECTORIS
time Frame
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 80 months for the Main Cohort and up to 69 months for the Safety Expansion Cohort.

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