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NCT04644237 · ADVERSE EVENTS

Adverse events

Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) · Source last updated 2025-11-21

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
Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
Other-event reporting threshold
5%

A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Trastuzumab Deruxtecan 5.4 mg/kg

Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).

42 / 101101 / 10152 / 102
Trastuzumab Deruxtecan 6.4 mg/kg

Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).

26 / 5050 / 5024 / 50

Group identifiers: EG000: Trastuzumab Deruxtecan 5.4 mg/kg · EG001: Trastuzumab Deruxtecan 6.4 mg/kg

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
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      101
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      50
      num Events
      2
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Myocarditis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Optic nerve disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      2
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Duodenal ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Ileus

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
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      101
      num Events
      113
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      50
      num Events
      81
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      101
      num Events
      35
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      50
      num Events
      29
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      101
      num Events
      166
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      50
      num Events
      85
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      101
      num Events
      56
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      50
      num Events
      26
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      101
      num Events
      63
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      50
      num Events
      38
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      101
      num Events
      42
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      50
      num Events
      32
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      101
      num Events
      22
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      50
      num Events
      12
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      101
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      101
      num Events
      10
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      50
      num Events
      9
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      101
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
      num Events
      3
    term
    Gastrooesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      101
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
      num Events
      3
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      101
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
      num Events
      3
    term
    Odynophagia
Complete source fields
description
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
event Groups
  1. deaths Num Affected
    52
    deaths Num At Risk
    102
    description
    Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    id
    EG000
    other Num Affected
    101
    other Num At Risk
    101
    serious Num Affected
    42
    serious Num At Risk
    101
    title
    Trastuzumab Deruxtecan 5.4 mg/kg
  2. deaths Num Affected
    24
    deaths Num At Risk
    50
    description
    Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    id
    EG001
    other Num Affected
    50
    other Num At Risk
    50
    serious Num Affected
    26
    serious Num At Risk
    50
    title
    Trastuzumab Deruxtecan 6.4 mg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      101
      num Events
      113
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      50
      num Events
      81
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      101
      num Events
      35
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      50
      num Events
      29
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      101
      num Events
      166
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      50
      num Events
      85
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      101
      num Events
      56
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      50
      num Events
      26
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      101
      num Events
      63
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      50
      num Events
      38
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      101
      num Events
      42
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      50
      num Events
      32
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      101
      num Events
      22
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      50
      num Events
      12
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      101
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      101
      num Events
      10
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      50
      num Events
      9
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      101
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
      num Events
      3
    term
    Gastrooesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      101
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
      num Events
      3
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      101
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
      num Events
      3
    term
    Odynophagia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      101
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      50
      num Events
      2
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Myocarditis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Optic nerve disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      2
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Duodenal ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Ileus
time Frame
Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months

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