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NCT02125461 · ADVERSE EVENTS

Adverse events

A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer · Source last updated 2023-10-10

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
Serious and Other (non-serious) treatment-emergent adverse event (TEAE) data collected during the 12-month treatment period. All-cause mortality (death due to any cause) collected for entire duration of the study. Assessed until 11 Jan 2021 DCO for completion of long-term survival; approximately 5 years from last patient enrolled.
Other-event reporting threshold
5%

TEAEs included events from first dose of study drug until the earlier of 90 days after last dose or date of first subsequent therapy. 473 and 236 patients in the durvalumab and placebo groups, respectively, received treatment but 2 patients randomized to placebo received 1 dose of durvalumab in error and are included in the durvalumab safety analysis set.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Durvalumab (MEDI4736)

Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.

138 / 475436 / 475262 / 475
Placebo

Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.

54 / 234212 / 234154 / 234

Group identifiers: EG000: Durvalumab (MEDI4736) · EG001: Placebo

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      475
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      475
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      475
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
      num Events
      1
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      475
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      475
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      475
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Arrhythmia supraventricular
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      475
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
      num Events
      1
    term
    Arteriospasm coronary
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      475
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      475
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
      num Events
      1
    term
    Atrioventricular block complete
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      475
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
      num Events
      1
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      475
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Cardiac disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      475
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Cardiac failure

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      475
      num Events
      39
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      234
      num Events
      32
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      475
      num Events
      39
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      234
      num Events
      4
    term
    Hyperthyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      475
      num Events
      62
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      234
      num Events
      4
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      475
      num Events
      59
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      234
      num Events
      27
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      475
      num Events
      136
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      234
      num Events
      56
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      475
      num Events
      45
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      234
      num Events
      25
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      475
      num Events
      69
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      234
      num Events
      30
    term
    Upper respiratory tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      475
      num Events
      88
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      234
      num Events
      43
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      475
      num Events
      73
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      234
      num Events
      50
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      475
      num Events
      130
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      234
      num Events
      52
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      475
      num Events
      42
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      234
      num Events
      13
    term
    Urinary tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      475
      num Events
      36
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      234
      num Events
      25
    term
    Dizziness
Complete source fields
description
TEAEs included events from first dose of study drug until the earlier of 90 days after last dose or date of first subsequent therapy. 473 and 236 patients in the durvalumab and placebo groups, respectively, received treatment but 2 patients randomized to placebo received 1 dose of durvalumab in error and are included in the durvalumab safety analysis set.
event Groups
  1. deaths Num Affected
    262
    deaths Num At Risk
    475
    description
    Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
    id
    EG000
    other Num Affected
    436
    other Num At Risk
    475
    serious Num Affected
    138
    serious Num At Risk
    475
    title
    Durvalumab (MEDI4736)
  2. deaths Num Affected
    154
    deaths Num At Risk
    234
    description
    Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
    id
    EG001
    other Num Affected
    212
    other Num At Risk
    234
    serious Num Affected
    54
    serious Num At Risk
    234
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      475
      num Events
      39
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      234
      num Events
      32
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      475
      num Events
      39
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      234
      num Events
      4
    term
    Hyperthyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      475
      num Events
      62
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      234
      num Events
      4
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      475
      num Events
      59
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      234
      num Events
      27
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      475
      num Events
      136
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      234
      num Events
      56
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      475
      num Events
      45
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      234
      num Events
      25
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      475
      num Events
      69
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      234
      num Events
      30
    term
    Upper respiratory tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      475
      num Events
      88
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      234
      num Events
      43
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      475
      num Events
      73
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      234
      num Events
      50
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      475
      num Events
      130
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      234
      num Events
      52
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      475
      num Events
      42
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      234
      num Events
      13
    term
    Urinary tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      475
      num Events
      36
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      234
      num Events
      25
    term
    Dizziness
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      475
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      475
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      475
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
      num Events
      1
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      475
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      475
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      475
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Arrhythmia supraventricular
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      475
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
      num Events
      1
    term
    Arteriospasm coronary
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      475
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      475
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
      num Events
      1
    term
    Atrioventricular block complete
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      475
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
      num Events
      1
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      475
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Cardiac disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      475
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
      num Events
      0
    term
    Cardiac failure
time Frame
Serious and Other (non-serious) treatment-emergent adverse event (TEAE) data collected during the 12-month treatment period. All-cause mortality (death due to any cause) collected for entire duration of the study. Assessed until 11 Jan 2021 DCO for completion of long-term survival; approximately 5 years from last patient enrolled.

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