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NCT04639219 · ADVERSE EVENTS

Adverse events

A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations · Source last updated 2026-03-23

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
Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 47 days following the date of last dose of study treatment or before the initiation of first subsequent anti-cancer therapy following discontinuation of study treatment (whichever occurred first), up to DCO date of 25 Jan 2023 (approximately 24 months)
Other-event reporting threshold
5%

The SAF consisted of all participants who received at least 1 dose of study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
T-DXd

Description (Arm-group)

36 / 10296 / 10258 / 102

Group identifiers: EG000: T-DXd

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
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Sepsis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Urosepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Ankle fracture
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Shock hypoglycaemic
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
      num Events
      2
    term
    Bone pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Pain in extremity
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Ulcerative keratitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
      num Events
      2
    term
    Acute kidney injury
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Renal failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Prostatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
      num Events
      2
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
      num Events
      2
    term
    Dyspnoea

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
    Investigations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      102
      num Events
      18
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      102
      num Events
      21
    term
    Aspartate aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      102
      num Events
      26
    term
    Neutrophil count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      102
      num Events
      18
    term
    Platelet count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      102
      num Events
      24
    term
    Decreased appetite
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      102
      num Events
      10
    term
    Hypokalaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      102
      num Events
      8
    term
    Arthralgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      102
      num Events
      8
    term
    Headache
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      102
      num Events
      41
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      102
      num Events
      13
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      102
      num Events
      11
    term
    Dyspnoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      102
      num Events
      13
    term
    Abdominal pain
Complete source fields
description
The SAF consisted of all participants who received at least 1 dose of study treatment.
event Groups
  1. deaths Num Affected
    58
    deaths Num At Risk
    102
    description
    Description (Arm-group)
    id
    EG000
    other Num Affected
    96
    other Num At Risk
    102
    serious Num Affected
    36
    serious Num At Risk
    102
    title
    T-DXd
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      102
      num Events
      18
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      102
      num Events
      21
    term
    Aspartate aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      102
      num Events
      26
    term
    Neutrophil count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      102
      num Events
      18
    term
    Platelet count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      102
      num Events
      24
    term
    Decreased appetite
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      102
      num Events
      10
    term
    Hypokalaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      102
      num Events
      8
    term
    Arthralgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      102
      num Events
      8
    term
    Headache
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      102
      num Events
      41
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      102
      num Events
      13
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      102
      num Events
      11
    term
    Dyspnoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      102
      num Events
      13
    term
    Abdominal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Sepsis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Urosepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Ankle fracture
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Shock hypoglycaemic
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
      num Events
      2
    term
    Bone pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Pain in extremity
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Ulcerative keratitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
      num Events
      2
    term
    Acute kidney injury
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Renal failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Prostatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
      num Events
      2
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
      num Events
      2
    term
    Dyspnoea
time Frame
Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 47 days following the date of last dose of study treatment or before the initiation of first subsequent anti-cancer therapy following discontinuation of study treatment (whichever occurred first), up to DCO date of 25 Jan 2023 (approximately 24 months)

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Preserved source evidence · Not medical advice