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NCT02075840 · ADVERSE EVENTS

Adverse events

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants · Source last updated 2026-05-29

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
Baseline up to approximately 10 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Alectinib

Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

70 / 152138 / 15276 / 152
Crizotinib

Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

48 / 151143 / 15173 / 151

Group identifiers: EG000: Alectinib · EG001: Crizotinib

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      151
      num Events
      4
    term
    Pneumonitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    term
    Pneumothorax
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      152
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      1
    term
    Dyspnoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      1
    term
    Haemoptysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      152
      num Events
      11
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      151
      num Events
      4
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    term
    Bronchitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    term
    Bacteraemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      2
    term
    Cellulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    term
    Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    term
    Influenza
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      1
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      1
    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 Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      152
      num Events
      81
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      151
      num Events
      57
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      152
      num Events
      31
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      151
      num Events
      91
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      152
      num Events
      24
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      151
      num Events
      83
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      152
      num Events
      6
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      151
      num Events
      15
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      151
      num Events
      12
    term
    Dysphagia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      152
      num Events
      4
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      151
      num Events
      26
    term
    Dysgeusia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      152
      num Events
      26
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      151
      num Events
      23
    term
    Dizziness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      152
      num Events
      22
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      151
      num Events
      19
    term
    Headache
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      152
      num Events
      4
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      151
      num Events
      9
    term
    Paraesthesia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      152
      num Events
      47
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      151
      num Events
      14
    term
    Arthralgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      152
      num Events
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      151
      num Events
      5
    term
    Myalgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      152
      num Events
      55
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      151
      num Events
      15
    term
    Anaemia
Complete source fields
event Groups
  1. deaths Num Affected
    76
    deaths Num At Risk
    152
    description
    Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG000
    other Num Affected
    138
    other Num At Risk
    152
    serious Num Affected
    70
    serious Num At Risk
    152
    title
    Alectinib
  2. deaths Num Affected
    73
    deaths Num At Risk
    151
    description
    Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    EG001
    other Num Affected
    143
    other Num At Risk
    151
    serious Num Affected
    48
    serious Num At Risk
    151
    title
    Crizotinib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      152
      num Events
      81
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      151
      num Events
      57
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      152
      num Events
      31
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      151
      num Events
      91
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      152
      num Events
      24
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      151
      num Events
      83
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      152
      num Events
      6
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      151
      num Events
      15
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      151
      num Events
      12
    term
    Dysphagia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      152
      num Events
      4
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      151
      num Events
      26
    term
    Dysgeusia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      152
      num Events
      26
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      151
      num Events
      23
    term
    Dizziness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      152
      num Events
      22
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      151
      num Events
      19
    term
    Headache
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      152
      num Events
      4
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      151
      num Events
      9
    term
    Paraesthesia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      152
      num Events
      47
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      151
      num Events
      14
    term
    Arthralgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      152
      num Events
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      151
      num Events
      5
    term
    Myalgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      152
      num Events
      55
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      151
      num Events
      15
    term
    Anaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      151
      num Events
      4
    term
    Pneumonitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    term
    Pneumothorax
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      152
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      1
    term
    Dyspnoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      1
    term
    Haemoptysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      152
      num Events
      11
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      151
      num Events
      4
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    term
    Bronchitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    term
    Bacteraemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      2
    term
    Cellulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    term
    Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
      num Events
      0
    term
    Influenza
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      1
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
      num Events
      1
    term
    Appendicitis
time Frame
Baseline up to approximately 10 years

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