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NCT03901339 · ADVERSE EVENTS

Adverse events

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer · Source last updated 2024-10-21

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 and All-Cause Mortality: Up to 43.4 months
Other-event reporting threshold
5%

Adverse Events: The Safety Population included all participants who received at least 1 dose of study drug; All-Cause Mortality: The ITT Population included all participants who were randomized, regardless of whether they received study treatment or not.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Sacituzumab Govitecan

Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).

74 / 268264 / 268234 / 272
Treatment of Physician's Choice (TPC)

Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.

48 / 249234 / 249238 / 271

Group identifiers: EG000: Sacituzumab Govitecan · EG001: Treatment of Physician's Choice (TPC)

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 Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      249
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      249
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      249
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      249
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      249
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      249
    term
    Thrombocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      249
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      249
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      249
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      249
    term
    Myocardial ischaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      249
    term
    Secondary adrenocortical insufficiency
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      249
    term
    Blepharospasm

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 Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      249
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      249
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      249
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      184
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      134
      num At Risk
      249
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      249
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      249
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      249
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      249
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      249
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      163
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      249
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      249
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      249
    term
    Dyspepsia
Complete source fields
description
Adverse Events: The Safety Population included all participants who received at least 1 dose of study drug; All-Cause Mortality: The ITT Population included all participants who were randomized, regardless of whether they received study treatment or not.
event Groups
  1. deaths Num Affected
    234
    deaths Num At Risk
    272
    description
    Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).
    id
    EG000
    other Num Affected
    264
    other Num At Risk
    268
    serious Num Affected
    74
    serious Num At Risk
    268
    title
    Sacituzumab Govitecan
  2. deaths Num Affected
    238
    deaths Num At Risk
    271
    description
    Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
    id
    EG001
    other Num Affected
    234
    other Num At Risk
    249
    serious Num Affected
    48
    serious Num At Risk
    249
    title
    Treatment of Physician's Choice (TPC)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      249
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      249
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      249
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      184
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      134
      num At Risk
      249
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      249
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      249
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      249
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      249
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      249
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      163
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      249
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      249
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      249
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      249
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      249
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      249
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      249
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      249
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      249
    term
    Thrombocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      249
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      249
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      249
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      249
    term
    Myocardial ischaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      249
    term
    Secondary adrenocortical insufficiency
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      249
    term
    Blepharospasm
time Frame
Adverse Events and All-Cause Mortality: Up to 43.4 months

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