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NCT02574455 · ADVERSE EVENTS

Adverse events

Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) · Source last updated 2022-06-15

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: First dose date up to last follow-up (maximum up to 30.8 months); All-Cause Mortality: From randomization up to 30.8 months
Other-event reporting threshold
5%

Serious Adverse Events and Other Adverse Events: Safety Population included all participants who received at least one dose of sacituzumab govitecan or TPC. All-Cause Mortality: The ITT Population included all randomized participants.

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 either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.

69 / 258256 / 258201 / 267
Treatment of Physician's Choice (TPC)

Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m\^2 at North American sites and 1.23 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\^2 and 0.67 mg/m\^2 for North American and European sites, respectively). 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 for up to 10.6 months. Gemcitabine 800 to 1200 mg/m\^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.

64 / 224213 / 224222 / 262

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 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      224
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      224
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      224
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      224
    term
    Mitral valve incompetence
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      224
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      224
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      224
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      224
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Constipation

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 22.1
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      224
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      224
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      224
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      224
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      224
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      224
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      168
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      224
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      224
    term
    Gastrooesophageal reflux disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      160
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      224
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      224
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      224
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      224
    term
    Asthenia
Complete source fields
description
Serious Adverse Events and Other Adverse Events: Safety Population included all participants who received at least one dose of sacituzumab govitecan or TPC. All-Cause Mortality: The ITT Population included all randomized participants.
event Groups
  1. deaths Num Affected
    201
    deaths Num At Risk
    267
    description
    Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
    id
    EG000
    other Num Affected
    256
    other Num At Risk
    258
    serious Num Affected
    69
    serious Num At Risk
    258
    title
    Sacituzumab Govitecan
  2. deaths Num Affected
    222
    deaths Num At Risk
    262
    description
    Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m\^2 at North American sites and 1.23 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\^2 and 0.67 mg/m\^2 for North American and European sites, respectively). 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 for up to 10.6 months. Gemcitabine 800 to 1200 mg/m\^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
    id
    EG001
    other Num Affected
    213
    other Num At Risk
    224
    serious Num Affected
    64
    serious Num At Risk
    224
    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 22.1
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      224
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      224
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      224
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      224
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      224
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      224
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      168
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      224
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      224
    term
    Gastrooesophageal reflux disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      160
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      224
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      224
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      224
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      224
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      224
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      224
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      224
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      224
    term
    Mitral valve incompetence
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      224
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      224
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      224
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      224
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      258
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Constipation
time Frame
Adverse Events: First dose date up to last follow-up (maximum up to 30.8 months); All-Cause Mortality: From randomization up to 30.8 months

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