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NCT00949650 · ADVERSE EVENTS

Adverse events

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation · Source last updated 2018-04-06

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
First administration of trial medication until 28 days after last administration of trial medication.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Afatinib 40 mg

Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.

72 / 229229 / 229Not reported / Not reported
Pemetrexed/Cisplatin Chemotherapy

Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.

25 / 111108 / 111Not reported / Not reported

Group identifiers: EG000: Afatinib 40 mg · EG001: Pemetrexed/Cisplatin 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 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      111
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Mitral valve incompetence
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    term
    Myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Cataract
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Abdominal discomfort
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Gastritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Gastrooesophageal reflux disease

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 19.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      111
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      111
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      111
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      111
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      111
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      111
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      111
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Cheilitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      111
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      216
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      111
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      111
    term
    Dyspepsia
Complete source fields
event Groups
  1. description
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    id
    EG000
    other Num Affected
    229
    other Num At Risk
    229
    serious Num Affected
    72
    serious Num At Risk
    229
    title
    Afatinib 40 mg
  2. description
    Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
    id
    EG001
    other Num Affected
    108
    other Num At Risk
    111
    serious Num Affected
    25
    serious Num At Risk
    111
    title
    Pemetrexed/Cisplatin Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      111
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      111
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      111
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      111
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      111
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      111
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      111
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Cheilitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      111
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      216
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      111
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      111
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      111
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Mitral valve incompetence
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    term
    Myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Cataract
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Abdominal discomfort
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Gastritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Gastrooesophageal reflux disease
time Frame
First administration of trial medication until 28 days after last administration of trial medication.

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