NCT02574455 · ADVERSE EVENTS
Adverse events
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.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Sacituzumab Govitecan | 69 / 258 | 256 / 258 | 201 / 267 |
| Treatment of Physician's Choice (TPC) | 64 / 224 | 213 / 224 | 222 / 262 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 224
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 224
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 224
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 224
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 224
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 224
- term
- Mitral valve incompetence
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 224
- term
- Pericardial effusion
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 224
- term
- Sinus tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 224
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 224
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 224
- term
- Colitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 224
- term
- Constipation
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 102
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 61
- num At Risk
- 224
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 108
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 56
- num At Risk
- 224
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 14
- num At Risk
- 224
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 54
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 224
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 23
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 224
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 96
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 52
- num At Risk
- 224
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 168
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 38
- num At Risk
- 224
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 224
- term
- Gastrooesophageal reflux disease
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 160
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 68
- num At Risk
- 224
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 27
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 14
- num At Risk
- 224
- term
- Stomatitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 85
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 36
- num At Risk
- 224
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 39
- num At Risk
- 258
- 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
- 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
- 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
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 102
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 61
- num At Risk
- 224
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 108
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 56
- num At Risk
- 224
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 14
- num At Risk
- 224
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 54
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 224
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 23
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 224
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 96
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 52
- num At Risk
- 224
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 168
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 38
- num At Risk
- 224
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 224
- term
- Gastrooesophageal reflux disease
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 160
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 68
- num At Risk
- 224
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 27
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 14
- num At Risk
- 224
- term
- Stomatitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 85
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 36
- num At Risk
- 224
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 39
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 224
- term
- Asthenia
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 224
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 224
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 224
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 224
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 224
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 224
- term
- Mitral valve incompetence
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 224
- term
- Pericardial effusion
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 224
- term
- Sinus tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 224
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 224
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 224
- term
- Colitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- 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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