NCT03901339 · 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 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.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Sacituzumab Govitecan | 74 / 268 | 264 / 268 | 234 / 272 |
| Treatment of Physician's Choice (TPC) | 48 / 249 | 234 / 249 | 238 / 271 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 249
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 249
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 249
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 249
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 249
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 249
- term
- Thrombocytosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 249
- term
- Arrhythmia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 249
- term
- Cardiac failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 249
- term
- Myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 249
- term
- Myocardial ischaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 249
- term
- Secondary adrenocortical insufficiency
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 249
- term
- Blepharospasm
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 97
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 68
- num At Risk
- 249
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 37
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 25
- num At Risk
- 249
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 32
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 29
- num At Risk
- 249
- term
- Lymphopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 184
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 134
- num At Risk
- 249
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 41
- num At Risk
- 249
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 249
- term
- Abdominal distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 51
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 34
- num At Risk
- 249
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 249
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 93
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 61
- num At Risk
- 249
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 163
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 57
- num At Risk
- 249
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 249
- term
- Dry mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 19
- num At Risk
- 268
- 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
- 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
- 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
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 97
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 68
- num At Risk
- 249
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 37
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 25
- num At Risk
- 249
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 32
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 29
- num At Risk
- 249
- term
- Lymphopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 184
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 134
- num At Risk
- 249
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 41
- num At Risk
- 249
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 249
- term
- Abdominal distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 51
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 34
- num At Risk
- 249
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 249
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 93
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 61
- num At Risk
- 249
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 163
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 57
- num At Risk
- 249
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 249
- term
- Dry mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 19
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 249
- term
- Dyspepsia
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 249
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 249
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 249
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 249
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 249
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 249
- term
- Thrombocytosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 249
- term
- Arrhythmia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 249
- term
- Cardiac failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 249
- term
- Myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 249
- term
- Myocardial ischaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 268
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 249
- term
- Secondary adrenocortical insufficiency
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 268
- 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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