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NCT03456076 · ADVERSE EVENTS

Adverse events

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer · Source last updated 2026-07-15

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
Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
Other-event reporting threshold
5%

All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.

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

Participants received 600 mg oral alectinib twice daily (BID) for 2 years

17 / 128124 / 1282 / 130
Platinum-Based Chemotherapy

Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).

10 / 120110 / 1205 / 127

Group identifiers: EG000: Alectinib · EG001: Platinum-Based Chemotherapy

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      128
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      120
      num Events
      0
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Epigastric discomfort
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      120
      num Events
      0
    term
    Gastritis erosive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      120
      num Events
      0
    term
    Ileus paralytic
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      120
      num Events
      2
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Pancreatitis acute
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Regurgitation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Fatigue

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      128
      num Events
      45
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      120
      num Events
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      120
      num Events
      14
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      128
      num Events
      2
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      120
      num Events
      34
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      128
      num Events
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      120
      num Events
      0
    term
    Bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      128
      num Events
      62
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      120
      num Events
      34
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      128
      num Events
      17
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      120
      num Events
      14
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      128
      num Events
      12
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      120
      num Events
      174
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      128
      num Events
      12
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      120
      num Events
      62
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      128
      num Events
      17
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      120
      num Events
      29
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      128
      num Events
      18
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      120
      num Events
      21
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      128
      num Events
      6
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      120
      num Events
      24
    term
    Malaise
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      128
      num Events
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Oedema peripheral
Complete source fields
description
All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    130
    description
    Participants received 600 mg oral alectinib twice daily (BID) for 2 years
    id
    EG000
    other Num Affected
    124
    other Num At Risk
    128
    serious Num Affected
    17
    serious Num At Risk
    128
    title
    Alectinib
  2. deaths Num Affected
    5
    deaths Num At Risk
    127
    description
    Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
    id
    EG001
    other Num Affected
    110
    other Num At Risk
    120
    serious Num Affected
    10
    serious Num At Risk
    120
    title
    Platinum-Based Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      128
      num Events
      45
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      120
      num Events
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      120
      num Events
      14
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      128
      num Events
      2
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      120
      num Events
      34
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      128
      num Events
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      120
      num Events
      0
    term
    Bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      128
      num Events
      62
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      120
      num Events
      34
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      128
      num Events
      17
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      120
      num Events
      14
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      128
      num Events
      12
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      120
      num Events
      174
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      128
      num Events
      12
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      120
      num Events
      62
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      128
      num Events
      17
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      120
      num Events
      29
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      128
      num Events
      18
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      120
      num Events
      21
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      128
      num Events
      6
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      120
      num Events
      24
    term
    Malaise
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      128
      num Events
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Oedema peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      128
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      120
      num Events
      0
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Epigastric discomfort
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      120
      num Events
      0
    term
    Gastritis erosive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      120
      num Events
      0
    term
    Ileus paralytic
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      120
      num Events
      2
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Pancreatitis acute
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Regurgitation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Fatigue
time Frame
Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)

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