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NCT03523585 · ADVERSE EVENTS

Adverse events

DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] · Source last updated 2026-02-27

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 46 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. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.

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 standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).

103 / 404398 / 404143 / 406
Trastuzumab+Capecitabine

Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine.

19 / 8779 / 8740 / 91
Lapatinib+Capecitabine

Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Lapatinib/Capecitabine.

27 / 108102 / 10846 / 111

Group identifiers: EG000: Trastuzumab Deruxtecan (T-DXd) · EG001: Trastuzumab+Capecitabine · EG002: Lapatinib+Capecitabine

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
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Haemolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Stress Cardiomyopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Autoimmune Thyroiditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Autoimmune Thyroiditis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Scleritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Abdominal Pain

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
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      108
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      108
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      108
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      108
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      108
    term
    Dry Eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      292
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      108
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      108
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      108
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      109
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      69
      num At Risk
      108
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      108
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      108
    term
    Abdominal Pain
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. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
event Groups
  1. deaths Num Affected
    143
    deaths Num At Risk
    406
    description
    Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), 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
    398
    other Num At Risk
    404
    serious Num Affected
    103
    serious Num At Risk
    404
    title
    Trastuzumab Deruxtecan (T-DXd)
  2. deaths Num Affected
    40
    deaths Num At Risk
    91
    description
    Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine.
    id
    EG001
    other Num Affected
    79
    other Num At Risk
    87
    serious Num Affected
    19
    serious Num At Risk
    87
    title
    Trastuzumab+Capecitabine
  3. deaths Num Affected
    46
    deaths Num At Risk
    111
    description
    Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Lapatinib/Capecitabine.
    id
    EG002
    other Num Affected
    102
    other Num At Risk
    108
    serious Num Affected
    27
    serious Num At Risk
    108
    title
    Lapatinib+Capecitabine
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      108
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      108
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      108
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      108
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      108
    term
    Dry Eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      292
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      108
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      108
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      108
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      109
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      69
      num At Risk
      108
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      108
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      108
    term
    Abdominal Pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Haemolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Stress Cardiomyopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Autoimmune Thyroiditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Autoimmune Thyroiditis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Scleritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      404
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      87
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    term
    Abdominal Pain
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 46 months.

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Preserved source evidence · Not medical advice