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NCT02008227 · ADVERSE EVENTS

Adverse events

A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy · Source last updated 2019-12-20

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 5.28 years.
Other-event reporting threshold
5%

Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.

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

Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.

180 / 578535 / 578Not reported / Not reported
Atezolizumab

Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.

200 / 609541 / 609Not reported / Not reported

Group identifiers: EG000: Docetaxel · EG001: Atezolizumab

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      609
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Acute myocardial infarction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Angina pectoris
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Arrhythmia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      609
    term
    Atrial fibrillation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Atrial flutter
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Cardiac arrest
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      609
    term
    Cardiac tamponade
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      609
    term
    Left ventricular dysfunction

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      609
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      609
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      609
    term
    Lacrimation increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      609
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      609
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      138
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      609
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      131
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      609
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      609
    term
    Stomatitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      609
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      117
      num At Risk
      609
    term
    Asthenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      609
    term
    Chest pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      206
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      165
      num At Risk
      609
    term
    Fatigue
Complete source fields
description
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
event Groups
  1. description
    Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
    id
    EG000
    other Num Affected
    535
    other Num At Risk
    578
    serious Num Affected
    180
    serious Num At Risk
    578
    title
    Docetaxel
  2. description
    Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
    id
    EG001
    other Num Affected
    541
    other Num At Risk
    609
    serious Num Affected
    200
    serious Num At Risk
    609
    title
    Atezolizumab
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      609
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      609
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      609
    term
    Lacrimation increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      609
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      609
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      138
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      609
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      131
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      609
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      609
    term
    Stomatitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      609
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      117
      num At Risk
      609
    term
    Asthenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      609
    term
    Chest pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      206
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      165
      num At Risk
      609
    term
    Fatigue
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      609
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Acute myocardial infarction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Angina pectoris
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Arrhythmia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      609
    term
    Atrial fibrillation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Atrial flutter
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      609
    term
    Cardiac arrest
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      609
    term
    Cardiac tamponade
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      578
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      609
    term
    Left ventricular dysfunction
time Frame
Baseline up to approximately 5.28 years.

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