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NCT02677324 · ADVERSE EVENTS

Adverse events

Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia · Source last updated 2022-05-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
ABT199

ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist

13 / 3333 / 330 / 33

Group identifiers: EG000: ABT199

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
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Upper Respiratory Infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Sepsis due to Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Soft tissue infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Hip fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Hyperuricemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Laboratory tumor lysis syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Syncope
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Renal calculi
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Pulmonary edema

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
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      33
      num Events
      23
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      33
      num Events
      8
    term
    Fever
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
      num Events
      6
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
      num Events
      5
    term
    Edema limbs
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      33
      num Events
      9
    term
    Myalgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
      num Events
      4
    term
    Non-cardiac chest pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
      num Events
      3
    term
    Chills
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
      num Events
      2
    term
    Dizziness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      33
      num Events
      11
    term
    Hyperhidrosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      33
      num Events
      15
    term
    Upper respiratory infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
      num Events
      6
    term
    Sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
      num Events
      4
    term
    Urinary tract infection
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    33
    description
    ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
    id
    EG000
    other Num Affected
    33
    other Num At Risk
    33
    serious Num Affected
    13
    serious Num At Risk
    33
    title
    ABT199
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      33
      num Events
      23
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      33
      num Events
      8
    term
    Fever
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
      num Events
      6
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
      num Events
      5
    term
    Edema limbs
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      33
      num Events
      9
    term
    Myalgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
      num Events
      4
    term
    Non-cardiac chest pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
      num Events
      3
    term
    Chills
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
      num Events
      2
    term
    Dizziness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      33
      num Events
      11
    term
    Hyperhidrosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      33
      num Events
      15
    term
    Upper respiratory infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
      num Events
      6
    term
    Sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
      num Events
      4
    term
    Urinary tract infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Upper Respiratory Infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Sepsis due to Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Soft tissue infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Hip fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Hyperuricemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Laboratory tumor lysis syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Syncope
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Renal calculi
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Pulmonary edema
time Frame
Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.

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