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NCT05104866 · ADVERSE EVENTS

Adverse events

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) · Source last updated 2026-08-24

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 Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.
Other-event reporting threshold
5%

All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)

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

Arm 1: Dato-DXd

62 / 360348 / 360223 / 365
Investigator's Choice of Chemotherapy (ICC)

Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)

67 / 351329 / 351213 / 367

Group identifiers: EG000: Dato-DXd · EG001: Investigator's Choice of Chemotherapy (ICC)

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
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      360
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      351
      num Events
      2
    term
    Cardiac failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      360
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Dizziness postural
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      360
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
      num Events
      1
    term
    Epilepsy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      360
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Hemiparesis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      360
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Seizure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      360
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Syncope
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      360
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Suicidal ideation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      360
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
      num Events
      1
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      360
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Acute kidney injury
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      360
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
      num Events
      1
    term
    Chronic kidney disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      360
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
      num Events
      1
    term
    Renal impairment
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      360
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Asthma

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
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      360
      num Events
      21
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      351
      num Events
      14
    term
    Dysgeusia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      360
      num Events
      35
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      351
      num Events
      46
    term
    Headache
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      360
      num Events
      6
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      351
      num Events
      28
    term
    Neuropathy peripheral
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      360
      num Events
      10
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      351
      num Events
      26
    term
    Paraesthesia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      360
      num Events
      58
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      351
      num Events
      36
    term
    Cough
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      360
      num Events
      16
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      351
      num Events
      23
    term
    Dyspnoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      360
      num Events
      36
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      351
      num Events
      6
    term
    Oropharyngeal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      136
      num At Risk
      360
      num Events
      139
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      351
      num Events
      80
    term
    Alopecia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      360
      num Events
      23
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      351
      num Events
      6
    term
    Dry skin
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      360
      num Events
      9
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      351
      num Events
      52
    term
    Palmar-plantar erythrodysaesthesia syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      360
      num Events
      37
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      351
      num Events
      8
    term
    Pruritus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      360
      num Events
      35
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      351
      num Events
      11
    term
    Rash
Complete source fields
description
All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
event Groups
  1. deaths Num Affected
    223
    deaths Num At Risk
    365
    description
    Arm 1: Dato-DXd
    id
    EG000
    other Num Affected
    348
    other Num At Risk
    360
    serious Num Affected
    62
    serious Num At Risk
    360
    title
    Dato-DXd
  2. deaths Num Affected
    213
    deaths Num At Risk
    367
    description
    Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
    id
    EG001
    other Num Affected
    329
    other Num At Risk
    351
    serious Num Affected
    67
    serious Num At Risk
    351
    title
    Investigator's Choice of Chemotherapy (ICC)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      360
      num Events
      21
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      351
      num Events
      14
    term
    Dysgeusia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      360
      num Events
      35
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      351
      num Events
      46
    term
    Headache
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      360
      num Events
      6
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      351
      num Events
      28
    term
    Neuropathy peripheral
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      360
      num Events
      10
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      351
      num Events
      26
    term
    Paraesthesia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      360
      num Events
      58
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      351
      num Events
      36
    term
    Cough
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      360
      num Events
      16
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      351
      num Events
      23
    term
    Dyspnoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      360
      num Events
      36
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      351
      num Events
      6
    term
    Oropharyngeal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      136
      num At Risk
      360
      num Events
      139
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      351
      num Events
      80
    term
    Alopecia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      360
      num Events
      23
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      351
      num Events
      6
    term
    Dry skin
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      360
      num Events
      9
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      351
      num Events
      52
    term
    Palmar-plantar erythrodysaesthesia syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      360
      num Events
      37
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      351
      num Events
      8
    term
    Pruritus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      360
      num Events
      35
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      351
      num Events
      11
    term
    Rash
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      360
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      351
      num Events
      2
    term
    Cardiac failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      360
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Dizziness postural
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      360
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
      num Events
      1
    term
    Epilepsy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      360
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Hemiparesis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      360
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Seizure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      360
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Syncope
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      360
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Suicidal ideation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      360
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
      num Events
      1
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      360
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Acute kidney injury
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      360
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
      num Events
      1
    term
    Chronic kidney disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      360
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
      num Events
      1
    term
    Renal impairment
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      360
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
      num Events
      0
    term
    Asthma
time Frame
Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.

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