Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01808573 · ADVERSE EVENTS

Adverse events

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting · Source last updated 2021-06-11

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
From time of first dose, through 28 days after last dose, assessed up to 41 months.
Other-event reporting threshold
5%

Safety population: Participants receiving at least 1 dose of investigational product. All-Cause Mortality was monitored/assessed for all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the safety population For All-Cause Mortality and Serious/Other Adverse Events, the result is based on final data cut.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Neratinib Plus Capecitabine

neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.

103 / 303301 / 303219 / 307
Lapatinib Plus Capecitabine

lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.

93 / 311309 / 311243 / 314

Group identifiers: EG000: Neratinib Plus Capecitabine · EG001: Lapatinib Plus 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 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      311
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      311
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      311
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      311
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      311
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      311
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      311
    term
    Cardiac tamponade
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      311
    term
    Cardiomyopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      311
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      311
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      311
    term
    Tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      311
    term
    Vertigo

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 20.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      311
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      311
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      311
    term
    Abdominal distension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      311
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      311
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      311
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      248
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      205
      num At Risk
      311
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      311
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      311
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      161
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      130
      num At Risk
      311
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      311
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      138
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      311
    term
    Vomiting
Complete source fields
description
Safety population: Participants receiving at least 1 dose of investigational product. All-Cause Mortality was monitored/assessed for all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the safety population For All-Cause Mortality and Serious/Other Adverse Events, the result is based on final data cut.
event Groups
  1. deaths Num Affected
    219
    deaths Num At Risk
    307
    description
    neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
    id
    EG000
    other Num Affected
    301
    other Num At Risk
    303
    serious Num Affected
    103
    serious Num At Risk
    303
    title
    Neratinib Plus Capecitabine
  2. deaths Num Affected
    243
    deaths Num At Risk
    314
    description
    lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
    id
    EG001
    other Num Affected
    309
    other Num At Risk
    311
    serious Num Affected
    93
    serious Num At Risk
    311
    title
    Lapatinib Plus Capecitabine
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      311
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      311
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      311
    term
    Abdominal distension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      311
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      311
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      311
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      248
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      205
      num At Risk
      311
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      311
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      311
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      161
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      130
      num At Risk
      311
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      311
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      138
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      311
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      311
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      311
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      311
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      311
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      311
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      311
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      311
    term
    Cardiac tamponade
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      311
    term
    Cardiomyopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      311
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      311
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      311
    term
    Tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      303
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      311
    term
    Vertigo
time Frame
From time of first dose, through 28 days after last dose, assessed up to 41 months.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice