NCT03258554 · 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
- Weekly during RT, RT end, from end of RT: months 1, (Cetuximab: 2, 3,) 4, 8, 12, 18, 24, 30, 36, then annually. Additionally, prior to each adjuvant durvalumab cycle. Maximum follow-up at time of analysis= 4.2 yr.
- Other-event reporting threshold
- 0%
All-cause mortality was assessed in all enrolled participants. Adverse events were assessed in enrolled participants who started study treatment. CTCAE 4.0 was used in the lead-in component and CTCAE 5.0 was used in the phase II component.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| (Lead-in) RT + Durvalumab | 4 / 10 | 10 / 10 | 3 / 10 |
| RT + Cetuximab | 51 / 61 | 61 / 61 | 17 / 63 |
| RT + Durvalumab | 84 / 119 | 118 / 119 | 41 / 123 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 119
- term
- Anemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Febrile neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Leukocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Atrial fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 119
- term
- Atrial flutter
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 119
- term
- Cardiac disorders - Other
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Chest pain - cardiac
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 119
- term
- Heart failure
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 119
- term
- Myocardial infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 119
- term
- Pericardial effusion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 119
- term
- Sinus bradycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Sinus tachycardia
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 119
- term
- Anemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 43
- num At Risk
- 119
- term
- Anemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 119
- term
- Lymph node pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Atrial fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Cardiac disorders - Other
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 119
- term
- Chest pain - cardiac
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 119
- term
- Conduction disorder
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 119
- term
- Heart failure
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Myocardial infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 119
- term
- Palpitations
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 119
- term
- Sinus bradycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 119
- term
- Sinus bradycardia
Complete source fields
- description
- All-cause mortality was assessed in all enrolled participants. Adverse events were assessed in enrolled participants who started study treatment. CTCAE 4.0 was used in the lead-in component and CTCAE 5.0 was used in the phase II component.
- event Groups
- deaths Num Affected
- 3
- deaths Num At Risk
- 10
- description
- IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
- id
- EG000
- other Num Affected
- 10
- other Num At Risk
- 10
- serious Num Affected
- 4
- serious Num At Risk
- 10
- title
- (Lead-in) RT + Durvalumab
- deaths Num Affected
- 17
- deaths Num At Risk
- 63
- description
- IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
- id
- EG001
- other Num Affected
- 61
- other Num At Risk
- 61
- serious Num Affected
- 51
- serious Num At Risk
- 61
- title
- RT + Cetuximab
- deaths Num Affected
- 41
- deaths Num At Risk
- 123
- description
- IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
- id
- EG002
- other Num Affected
- 118
- other Num At Risk
- 119
- serious Num Affected
- 84
- serious Num At Risk
- 119
- title
- RT + Durvalumab
- frequency Threshold
- 0
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 119
- term
- Anemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 43
- num At Risk
- 119
- term
- Anemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 119
- term
- Lymph node pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Atrial fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Cardiac disorders - Other
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 119
- term
- Chest pain - cardiac
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 119
- term
- Conduction disorder
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 119
- term
- Heart failure
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Myocardial infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 119
- term
- Palpitations
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 119
- term
- Sinus bradycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 119
- term
- Sinus bradycardia
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 119
- term
- Anemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Febrile neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Leukocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Atrial fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 119
- term
- Atrial flutter
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 119
- term
- Cardiac disorders - Other
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Chest pain - cardiac
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 119
- term
- Heart failure
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 119
- term
- Myocardial infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 119
- term
- Pericardial effusion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 119
- term
- Sinus bradycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 10
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 61
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 119
- term
- Sinus tachycardia
- time Frame
- Weekly during RT, RT end, from end of RT: months 1, (Cetuximab: 2, 3,) 4, 8, 12, 18, 24, 30, 36, then annually. Additionally, prior to each adjuvant durvalumab cycle. Maximum follow-up at time of analysis= 4.2 yr.
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Preserved source evidence · Not medical advice
Triangle