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NCT00525148 · ADVERSE EVENTS

Adverse events

LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations · Source last updated 2016-09-16

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, up to 93 months.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
BIBW 40mg

Subjects receiving starting doses 40 mg of Afatinib daily.

9 / 3030 / 30Not reported / Not reported
BIBW 50mg

Subjects receiving starting doses 50 mg of Afatinib daily.

44 / 9998 / 99Not reported / Not reported

Group identifiers: EG000: BIBW 40mg · EG001: BIBW 50mg

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Cardiac failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Cardiac failure congestive
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Cardiac tamponade
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    term
    Duodenal ulcer
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
    term
    Gastric ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Gastric ulcer haemorrhage

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      99
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    term
    Blepharitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
    term
    Dry eye
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Eye pruritus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      99
    term
    Vision blurred
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      99
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      99
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      99
    term
    Cheilitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      99
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      99
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      99
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    term
    Dyspepsia
Complete source fields
event Groups
  1. description
    Subjects receiving starting doses 40 mg of Afatinib daily.
    id
    EG000
    other Num Affected
    30
    other Num At Risk
    30
    serious Num Affected
    9
    serious Num At Risk
    30
    title
    BIBW 40mg
  2. description
    Subjects receiving starting doses 50 mg of Afatinib daily.
    id
    EG001
    other Num Affected
    98
    other Num At Risk
    99
    serious Num Affected
    44
    serious Num At Risk
    99
    title
    BIBW 50mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      99
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    term
    Blepharitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
    term
    Dry eye
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Eye pruritus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      99
    term
    Vision blurred
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      99
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      99
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      99
    term
    Cheilitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      99
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      99
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      99
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Cardiac failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Cardiac failure congestive
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Cardiac tamponade
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    term
    Duodenal ulcer
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
    term
    Gastric ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    term
    Gastric ulcer haemorrhage
time Frame
First administration of trial medication until 28 days after last administration of trial medication, up to 93 months.

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