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NCT02122172 · ADVERSE EVENTS

Adverse events

Afatinib in Advanced Refractory Urothelial Cancer · Source last updated 2025-04-25

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 the initiation of treatment to 28 days after the last administration of trial drugs, up to 1 year
Other-event reporting threshold
5%

For the Other Adverse Events, the number of participants reported for each adverse event is an upper bound estimate.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Afatinib) - Phase II Study

Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. afatinib dimaleate: Given PO Enrolled as part of the main Phase II study

11 / 2323 / 2321 / 23
Treatment (Afatinib) - Molecularly Selected Cohort

Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. afatinib dimaleate: Given PO Enrolled as part of the molecularly selected cohort

3 / 99 / 99 / 9

Group identifiers: EG000: Treatment (Afatinib) - Phase II Study · EG001: Treatment (Afatinib) - Molecularly Selected Cohort

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Small bowel obstruction
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Vomiting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Leukocytosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Edema limbs
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Fever
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Urinary tract infection
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Dyspnea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Pain in extremity
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    intracranial hemorrhage due to fall
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Skull fracture due to fall
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Altered mental status

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
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Depression
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Hypotension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Chronic kidney disease
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Proteinuria
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Rash acneiform
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Dysgeusia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Weight loss
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Lymphocyte count decreased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Lipase increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    INR increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Hyperkalemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      9
    term
    Anemia
Complete source fields
description
For the Other Adverse Events, the number of participants reported for each adverse event is an upper bound estimate.
event Groups
  1. deaths Num Affected
    21
    deaths Num At Risk
    23
    description
    Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. afatinib dimaleate: Given PO Enrolled as part of the main Phase II study
    id
    EG000
    other Num Affected
    23
    other Num At Risk
    23
    serious Num Affected
    11
    serious Num At Risk
    23
    title
    Treatment (Afatinib) - Phase II Study
  2. deaths Num Affected
    9
    deaths Num At Risk
    9
    description
    Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. afatinib dimaleate: Given PO Enrolled as part of the molecularly selected cohort
    id
    EG001
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    3
    serious Num At Risk
    9
    title
    Treatment (Afatinib) - Molecularly Selected Cohort
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Depression
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Hypotension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Chronic kidney disease
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Proteinuria
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Rash acneiform
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Dysgeusia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Weight loss
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Lymphocyte count decreased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Lipase increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    INR increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    term
    Hyperkalemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      9
    term
    Anemia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Small bowel obstruction
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Vomiting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Leukocytosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Edema limbs
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Fever
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Urinary tract infection
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Dyspnea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Pain in extremity
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    intracranial hemorrhage due to fall
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Skull fracture due to fall
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    term
    Altered mental status
time Frame
From the initiation of treatment to 28 days after the last administration of trial drugs, up to 1 year

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