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NCT01523587 · ADVERSE EVENTS

Adverse events

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy · Source last updated 2019-02-15

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
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
Other-event reporting threshold
5%

All adverse events (AEs) reported for this trial are on treatment AEs.

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

Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.

174 / 392383 / 39277 / 392
Erlotinib

Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.

175 / 395371 / 39571 / 395

Group identifiers: EG000: Afatinib · EG001: Erlotinib

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 20.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      395
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      395
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      395
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      395
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      395
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      395
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      395
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      395
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      395
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      395
    term
    Cardiac tamponade
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      395
    term
    Cardio-respiratory arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      395
    term
    Cardiopulmonary 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 20.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      395
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      395
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      284
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      158
      num At Risk
      395
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      395
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      395
    term
    Stomatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      395
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      395
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      395
    term
    Chest pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      395
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      395
    term
    Mucosal inflammation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      395
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      395
    term
    Paronychia
Complete source fields
description
All adverse events (AEs) reported for this trial are on treatment AEs.
event Groups
  1. deaths Num Affected
    77
    deaths Num At Risk
    392
    description
    Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
    id
    EG000
    other Num Affected
    383
    other Num At Risk
    392
    serious Num Affected
    174
    serious Num At Risk
    392
    title
    Afatinib
  2. deaths Num Affected
    71
    deaths Num At Risk
    395
    description
    Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
    id
    EG001
    other Num Affected
    371
    other Num At Risk
    395
    serious Num Affected
    175
    serious Num At Risk
    395
    title
    Erlotinib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      395
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      395
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      284
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      158
      num At Risk
      395
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      395
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      395
    term
    Stomatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      395
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      395
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      395
    term
    Chest pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      395
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      395
    term
    Mucosal inflammation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      395
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      395
    term
    Paronychia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      395
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      395
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      395
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      395
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      395
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      395
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      395
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      395
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      395
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      395
    term
    Cardiac tamponade
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      395
    term
    Cardio-respiratory arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      392
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      395
    term
    Cardiopulmonary failure
time Frame
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

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