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NCT03529110 · ADVERSE EVENTS

Adverse events

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] · Source last updated 2025-10-21

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 33 months.
Other-event reporting threshold
5%

A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.

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

Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).

49 / 257256 / 25733 / 257
Ado-trastuzumab Emtansine (T-DM1)

Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.

47 / 261249 / 26153 / 261

Group identifiers: EG000: Trastuzumab Deruxtecan (T-DXd) · EG001: Ado-trastuzumab Emtansine (T-DM1)

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      261
    term
    Vomiting
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Interstitial lung disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      261
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      261
    term
    Disease progression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      261
    term
    Urinary tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      261
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Cellulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Hypokalaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Pregnancy, puerperium and perinatal conditions
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Seizure

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      195
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      261
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      126
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      261
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      261
    term
    Alopecia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      261
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      261
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      261
    term
    Decreased appetite
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      261
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      261
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      261
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      261
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      261
    term
    White blood cell count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      261
    term
    Alanine aminotransferase increased
Complete source fields
description
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
event Groups
  1. deaths Num Affected
    33
    deaths Num At Risk
    257
    description
    Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
    id
    EG000
    other Num Affected
    256
    other Num At Risk
    257
    serious Num Affected
    49
    serious Num At Risk
    257
    title
    Trastuzumab Deruxtecan (T-DXd)
  2. deaths Num Affected
    53
    deaths Num At Risk
    261
    description
    Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
    id
    EG001
    other Num Affected
    249
    other Num At Risk
    261
    serious Num Affected
    47
    serious Num At Risk
    261
    title
    Ado-trastuzumab Emtansine (T-DM1)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      195
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      261
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      126
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      261
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      261
    term
    Alopecia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      261
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      261
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      261
    term
    Decreased appetite
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      261
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      261
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      261
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      261
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      261
    term
    White blood cell count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      261
    term
    Alanine aminotransferase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      261
    term
    Vomiting
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Interstitial lung disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      261
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      261
    term
    Disease progression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      261
    term
    Urinary tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      261
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Cellulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Hypokalaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Pregnancy, puerperium and perinatal conditions
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      261
    term
    Seizure
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 33 months.

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