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NCT02492711 · ADVERSE EVENTS

Adverse events

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer · Source last updated 2025-03-17

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
AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years.
Other-event reporting threshold
5%

AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Margetuximab Plus Chemotherapy

Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.

47 / 264213 / 264194 / 266
Trastuzumab Plus Chemotherapy

Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.

51 / 266210 / 266191 / 270
Margetuximab Infusion Substudy

Margetuximab with or without chemotherapy

17 / 8868 / 8856 / 88

Group identifiers: EG000: Margetuximab Plus Chemotherapy · EG001: Trastuzumab Plus Chemotherapy · EG002: Margetuximab Infusion Substudy

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 21.10
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Cardiac failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Ventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      88
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Colitis

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 21.10
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      88
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      88
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      88
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      88
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      88
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      88
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      88
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      88
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      88
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      88
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      88
    term
    Fatigue
Complete source fields
description
AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
event Groups
  1. deaths Num Affected
    194
    deaths Num At Risk
    266
    description
    Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
    id
    EG000
    other Num Affected
    213
    other Num At Risk
    264
    serious Num Affected
    47
    serious Num At Risk
    264
    title
    Margetuximab Plus Chemotherapy
  2. deaths Num Affected
    191
    deaths Num At Risk
    270
    description
    Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
    id
    EG001
    other Num Affected
    210
    other Num At Risk
    266
    serious Num Affected
    51
    serious Num At Risk
    266
    title
    Trastuzumab Plus Chemotherapy
  3. deaths Num Affected
    56
    deaths Num At Risk
    88
    description
    Margetuximab with or without chemotherapy
    id
    EG002
    other Num Affected
    68
    other Num At Risk
    88
    serious Num Affected
    17
    serious Num At Risk
    88
    title
    Margetuximab Infusion Substudy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      88
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      88
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      88
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      88
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      88
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      88
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      88
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      88
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      88
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      88
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      88
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Cardiac failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Ventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      88
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      264
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Colitis
time Frame
AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years.

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Preserved source evidence · Not medical advice