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NCT04439136 · ADVERSE EVENTS

Adverse events

Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B) · Source last updated 2026-09-08

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
Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
Other-event reporting threshold
5%

All patients enrolled were included in the all-cause mortality analysis. Thirty-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Afatinib Dimaleate)

Patients receive afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO

18 / 3731 / 3737 / 40

Group identifiers: EG000: Treatment (Afatinib Dimaleate)

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
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Rash maculo-papular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Anal hemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      37
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Mucositis oral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Alkaline phosphatase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Neutrophil count decreased

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
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      37
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Chills
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      37
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Fever
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Dry skin
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Palmar-plantar erythrodysesthesia syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
    term
    Pruritus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      37
    term
    Rash acneiform
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      37
    term
    Rash maculo-papular
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Skin and subcutaneous tissue disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      37
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      37
    term
    Diarrhea
Complete source fields
description
All patients enrolled were included in the all-cause mortality analysis. Thirty-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
event Groups
  1. deaths Num Affected
    37
    deaths Num At Risk
    40
    description
    Patients receive afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO
    id
    EG000
    other Num Affected
    31
    other Num At Risk
    37
    serious Num Affected
    18
    serious Num At Risk
    37
    title
    Treatment (Afatinib Dimaleate)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      37
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Chills
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      37
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Fever
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Dry skin
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Palmar-plantar erythrodysesthesia syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
    term
    Pruritus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      37
    term
    Rash acneiform
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      37
    term
    Rash maculo-papular
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Skin and subcutaneous tissue disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      37
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      37
    term
    Diarrhea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Rash maculo-papular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Anal hemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      37
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Mucositis oral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Alkaline phosphatase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Neutrophil count decreased
time Frame
Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.

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