NCT03762018 · 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 were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months.
- Other-event reporting threshold
- 5%
Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Atezolizumab Plus Bevacizumab Plus Chemotherapy | 92 / 199 | 197 / 199 | 145 / 200 |
| Bevacizumab Plus Chemotherapy | 67 / 199 | 197 / 199 | 150 / 200 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 199
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 199
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Immune thrombo-cytopenic purpura
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Asystole
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 199
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 199
- term
- Chest pain - cardiac
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Heart failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Myocarditis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Supraventricular tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Ventricular arrhythmia
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 113
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 110
- num At Risk
- 199
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 84
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 93
- num At Risk
- 199
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 83
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 81
- num At Risk
- 199
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 73
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 71
- num At Risk
- 199
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 73
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 62
- num At Risk
- 199
- term
- Hypertension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 65
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 57
- num At Risk
- 199
- term
- Neutrophil count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 59
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 54
- num At Risk
- 199
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 56
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 56
- num At Risk
- 199
- term
- Epistaxis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 65
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 47
- num At Risk
- 199
- term
- Mucositis oral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 57
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 40
- num At Risk
- 199
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 44
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 51
- num At Risk
- 199
- term
- Dyspnea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 31
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 36
- num At Risk
- 199
- term
- Non-cardiac chest pain
Complete source fields
- description
- Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
- event Groups
- deaths Num Affected
- 145
- deaths Num At Risk
- 200
- description
- Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
- id
- EG000
- other Num Affected
- 197
- other Num At Risk
- 199
- serious Num Affected
- 92
- serious Num At Risk
- 199
- title
- Atezolizumab Plus Bevacizumab Plus Chemotherapy
- deaths Num Affected
- 150
- deaths Num At Risk
- 200
- description
- Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
- id
- EG001
- other Num Affected
- 197
- other Num At Risk
- 199
- serious Num Affected
- 67
- serious Num At Risk
- 199
- title
- Bevacizumab Plus Chemotherapy
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 113
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 110
- num At Risk
- 199
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 84
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 93
- num At Risk
- 199
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 83
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 81
- num At Risk
- 199
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 73
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 71
- num At Risk
- 199
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 73
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 62
- num At Risk
- 199
- term
- Hypertension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 65
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 57
- num At Risk
- 199
- term
- Neutrophil count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 59
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 54
- num At Risk
- 199
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 56
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 56
- num At Risk
- 199
- term
- Epistaxis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 65
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 47
- num At Risk
- 199
- term
- Mucositis oral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 57
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 40
- num At Risk
- 199
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 44
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 51
- num At Risk
- 199
- term
- Dyspnea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 31
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 36
- num At Risk
- 199
- term
- Non-cardiac chest pain
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 199
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 199
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Immune thrombo-cytopenic purpura
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Asystole
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 199
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 199
- term
- Chest pain - cardiac
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Heart failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Myocarditis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Supraventricular tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (v5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 199
- term
- Ventricular arrhythmia
- time Frame
- Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months.
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