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NCT02094573 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Efficacy of Brigatinib (AP26113) in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib · Source last updated 2021-03-15

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: From first dose of study drug up to end of the study (approximately up to 69 months); Serious and Other Adverse Events: From first dose of study drug up to 30 days following the last dose of study drug (approximately up to 69 months)
Other-event reporting threshold
5%

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Brigatinib 90 mg

Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).

58 / 109108 / 10964 / 109
Brigatinib 90 mg - 180 mg

Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).

69 / 110105 / 11054 / 110

Group identifiers: EG000: Brigatinib 90 mg · EG001: Brigatinib 90 mg - 180 mg

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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      110
    term
    Neoplasm progression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      110
    term
    Malignant pleural effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      110
    term
    Metastases to central nervous system
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      110
    term
    Metastases to meninges
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      110
    term
    Pneumonitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      110
    term
    Dyspnoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      110
    term
    Pulmonary embolism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      110
    term
    Dyspnoea exertional
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      110
    term
    Haemoptysis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      110
    term
    Respiratory failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      110
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      110
    term
    Appendicitis

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      110
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      110
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      110
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      110
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      110
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      110
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      110
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      110
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      110
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      110
    term
    Dizziness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      110
    term
    Paraesthesia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      110
    term
    Peripheral sensory neuropathy
Complete source fields
description
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
event Groups
  1. deaths Num Affected
    64
    deaths Num At Risk
    109
    description
    Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).
    id
    EG000
    other Num Affected
    108
    other Num At Risk
    109
    serious Num Affected
    58
    serious Num At Risk
    109
    title
    Brigatinib 90 mg
  2. deaths Num Affected
    54
    deaths Num At Risk
    110
    description
    Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).
    id
    EG001
    other Num Affected
    105
    other Num At Risk
    110
    serious Num Affected
    69
    serious Num At Risk
    110
    title
    Brigatinib 90 mg - 180 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      110
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      110
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      110
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      110
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      110
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      110
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      110
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      110
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      110
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      110
    term
    Dizziness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      110
    term
    Paraesthesia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      110
    term
    Peripheral sensory neuropathy
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      110
    term
    Neoplasm progression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      110
    term
    Malignant pleural effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      110
    term
    Metastases to central nervous system
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      110
    term
    Metastases to meninges
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      110
    term
    Pneumonitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      110
    term
    Dyspnoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      110
    term
    Pulmonary embolism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      110
    term
    Dyspnoea exertional
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      110
    term
    Haemoptysis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      110
    term
    Respiratory failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      110
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      110
    term
    Appendicitis
time Frame
All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 69 months); Serious and Other Adverse Events: From first dose of study drug up to 30 days following the last dose of study drug (approximately up to 69 months)

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