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NCT02151981 · ADVERSE EVENTS

Adverse events

AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer · Source last updated 2025-01-07

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
AEs from start of study drug until 28 days post treatment discontinuation up to 4 years and 7 months (at the time of analysis)
Other-event reporting threshold
5%

Systematic assessment due to regular investigator assessment at study visits.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Osimertinib 80 mg

Daily single dose of Osimertinib 80mg

84 / 279275 / 279188 / 279
Chemotherapy

Platinum-based doublet chemotherapy

36 / 136134 / 13693 / 136

Group identifiers: EG000: Osimertinib 80 mg · EG001: 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 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      136
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      136
      num Events
      1
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      136
      num Events
      1
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      136
      num Events
      0
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      136
      num Events
      1
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      136
      num Events
      1
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      136
      num Events
      1
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      279
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      136
      num Events
      1
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      136
      num Events
      0
    term
    Intestinal ischaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      279
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      136
      num Events
      0
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      136
      num Events
      0
    term
    Electrocardiogram QT prolonged
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      279
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      136
      num Events
      0
    term
    Back pain

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 21.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      279
      num Events
      38
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      136
      num Events
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      279
      num Events
      33
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      136
      num Events
      12
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      279
      num Events
      24
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      136
      num Events
      26
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      279
      num Events
      30
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      136
      num Events
      15
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      279
      num Events
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      136
      num Events
      7
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      136
      num Events
      10
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      279
      num Events
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      136
      num Events
      11
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      279
      num Events
      56
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      136
      num Events
      94
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      279
      num Events
      226
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      136
      num Events
      21
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      279
      num Events
      75
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      136
      num Events
      144
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      279
      num Events
      70
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      136
      num Events
      26
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      279
      num Events
      53
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      136
      num Events
      49
    term
    Vomiting
Complete source fields
description
Systematic assessment due to regular investigator assessment at study visits.
event Groups
  1. deaths Num Affected
    188
    deaths Num At Risk
    279
    description
    Daily single dose of Osimertinib 80mg
    id
    EG000
    other Num Affected
    275
    other Num At Risk
    279
    serious Num Affected
    84
    serious Num At Risk
    279
    title
    Osimertinib 80 mg
  2. deaths Num Affected
    93
    deaths Num At Risk
    136
    description
    Platinum-based doublet chemotherapy
    id
    EG001
    other Num Affected
    134
    other Num At Risk
    136
    serious Num Affected
    36
    serious Num At Risk
    136
    title
    Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      279
      num Events
      38
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      136
      num Events
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      279
      num Events
      33
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      136
      num Events
      12
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      279
      num Events
      24
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      136
      num Events
      26
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      279
      num Events
      30
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      136
      num Events
      15
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      279
      num Events
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      136
      num Events
      7
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      136
      num Events
      10
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      279
      num Events
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      136
      num Events
      11
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      279
      num Events
      56
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      136
      num Events
      94
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      279
      num Events
      226
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      136
      num Events
      21
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      279
      num Events
      75
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      136
      num Events
      144
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      279
      num Events
      70
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      136
      num Events
      26
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      279
      num Events
      53
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      136
      num Events
      49
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      136
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      136
      num Events
      1
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      136
      num Events
      1
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      136
      num Events
      0
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      136
      num Events
      1
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      136
      num Events
      1
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      136
      num Events
      1
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      279
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      136
      num Events
      1
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      136
      num Events
      0
    term
    Intestinal ischaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      279
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      136
      num Events
      0
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      136
      num Events
      0
    term
    Electrocardiogram QT prolonged
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      279
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      136
      num Events
      0
    term
    Back pain
time Frame
AEs from start of study drug until 28 days post treatment discontinuation up to 4 years and 7 months (at the time of analysis)

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