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NCT05460273 · ADVERSE EVENTS

Adverse events

A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02) · Source last updated 2026-08-31

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 had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dato-DXd_NSCLC

Final Analysis with DCO on 27Nov2024

12 / 4038 / 4027 / 40
Dato-DXd_TNBC

Final Analysis with DCO on 06May2024

13 / 7977 / 7943 / 79

Group identifiers: EG000: Dato-DXd_NSCLC · EG001: Dato-DXd_TNBC

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 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Stomatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Drug-induced liver injury
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Hyperbilirubinaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      79
      num Events
      2
    term
    Covid-19
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Gastrointestinal infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Periodontitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      79
      num Events
      6
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Pneumonia bacterial
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Alanine aminotransferase increased

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 26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
      num Events
      14
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      79
      num Events
      30
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      79
      num Events
      4
    term
    Dyspepsia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      3
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      79
      num Events
      9
    term
    Mouth ulceration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      40
      num Events
      93
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      79
      num Events
      92
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      40
      num Events
      43
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      79
      num Events
      60
    term
    Stomatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
      num Events
      37
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      79
      num Events
      51
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
      num Events
      11
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      79
      num Events
      16
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
      num Events
      18
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      79
      num Events
      11
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      79
      num Events
      4
    term
    Oedema peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      40
      num Events
      37
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      79
      num Events
      29
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      40
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      79
      num Events
      10
    term
    Covid-19
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Conjunctivitis
Complete source fields
event Groups
  1. deaths Num Affected
    27
    deaths Num At Risk
    40
    description
    Final Analysis with DCO on 27Nov2024
    id
    EG000
    other Num Affected
    38
    other Num At Risk
    40
    serious Num Affected
    12
    serious Num At Risk
    40
    title
    Dato-DXd_NSCLC
  2. deaths Num Affected
    43
    deaths Num At Risk
    79
    description
    Final Analysis with DCO on 06May2024
    id
    EG001
    other Num Affected
    77
    other Num At Risk
    79
    serious Num Affected
    13
    serious Num At Risk
    79
    title
    Dato-DXd_TNBC
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
      num Events
      14
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      79
      num Events
      30
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      79
      num Events
      4
    term
    Dyspepsia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      3
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      79
      num Events
      9
    term
    Mouth ulceration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      40
      num Events
      93
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      79
      num Events
      92
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      40
      num Events
      43
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      79
      num Events
      60
    term
    Stomatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
      num Events
      37
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      79
      num Events
      51
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
      num Events
      11
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      79
      num Events
      16
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
      num Events
      18
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      79
      num Events
      11
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      79
      num Events
      4
    term
    Oedema peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      40
      num Events
      37
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      79
      num Events
      29
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      40
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      79
      num Events
      10
    term
    Covid-19
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Conjunctivitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Stomatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Drug-induced liver injury
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Hyperbilirubinaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      79
      num Events
      2
    term
    Covid-19
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Gastrointestinal infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Periodontitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      79
      num Events
      6
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Pneumonia bacterial
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Alanine aminotransferase increased
time Frame
Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.

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