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NCT02614794 · ADVERSE EVENTS

Adverse events

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer · Source last updated 2023-08-14

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
Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 60.1 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Tuc+Cap+Tra

Tucatinib in combination with capecitabine \& trastuzumab

124 / 404399 / 404262 / 410
Pbo+Cap+Tra

Placebo in combination with capecitabine \& trastuzumab

62 / 197188 / 197152 / 202

Group identifiers: EG000: Tuc+Cap+Tra · EG001: Pbo+Cap+Tra

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 v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      404
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      404
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      197
      num Events
      1
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      197
      num Events
      1
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      404
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      197
      num Events
      1
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Cardiac failure acute
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Cardiovascular disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      404
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      197
      num Events
      1
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      404
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      197
      num Events
      2
    term
    Pericardial effusion

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 v24.1
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      404
      num Events
      146
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      197
      num Events
      32
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      404
      num Events
      87
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      197
      num Events
      40
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      404
      num Events
      41
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      197
      num Events
      15
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      404
      num Events
      25
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      197
      num Events
      10
    term
    Dry eye
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      404
      num Events
      30
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      197
      num Events
      13
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      404
      num Events
      98
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      197
      num Events
      40
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      404
      num Events
      43
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      197
      num Events
      20
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      404
      num Events
      90
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      197
      num Events
      46
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      330
      num At Risk
      404
      num Events
      812
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      197
      num Events
      181
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      404
      num Events
      22
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      197
      num Events
      5
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      404
      num Events
      53
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      197
      num Events
      22
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      404
      num Events
      27
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      197
      num Events
      7
    term
    Gastrooesophageal reflux disease
Complete source fields
event Groups
  1. deaths Num Affected
    262
    deaths Num At Risk
    410
    description
    Tucatinib in combination with capecitabine \& trastuzumab
    id
    EG000
    other Num Affected
    399
    other Num At Risk
    404
    serious Num Affected
    124
    serious Num At Risk
    404
    title
    Tuc+Cap+Tra
  2. deaths Num Affected
    152
    deaths Num At Risk
    202
    description
    Placebo in combination with capecitabine \& trastuzumab
    id
    EG001
    other Num Affected
    188
    other Num At Risk
    197
    serious Num Affected
    62
    serious Num At Risk
    197
    title
    Pbo+Cap+Tra
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      404
      num Events
      146
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      197
      num Events
      32
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      404
      num Events
      87
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      197
      num Events
      40
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      404
      num Events
      41
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      197
      num Events
      15
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      404
      num Events
      25
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      197
      num Events
      10
    term
    Dry eye
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      404
      num Events
      30
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      197
      num Events
      13
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      404
      num Events
      98
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      197
      num Events
      40
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      404
      num Events
      43
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      197
      num Events
      20
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      404
      num Events
      90
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      197
      num Events
      46
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      330
      num At Risk
      404
      num Events
      812
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      197
      num Events
      181
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      404
      num Events
      22
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      197
      num Events
      5
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      404
      num Events
      53
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      197
      num Events
      22
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      404
      num Events
      27
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      197
      num Events
      7
    term
    Gastrooesophageal reflux disease
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      404
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      404
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      197
      num Events
      1
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      197
      num Events
      1
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      404
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      197
      num Events
      1
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Cardiac failure acute
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      404
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      197
      num Events
      0
    term
    Cardiovascular disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      404
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      197
      num Events
      1
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      404
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      197
      num Events
      2
    term
    Pericardial effusion
time Frame
Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 60.1 months

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