NCT05388669 · 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
- All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
- Other-event reporting threshold
- 5%
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Arm A: Lazertinib With Amivantamab SC-CF | 59 / 206 | 201 / 206 | 43 / 206 |
| Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion | 64 / 210 | 207 / 210 | 61 / 210 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 210
- term
- Acute Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 210
- term
- Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 210
- term
- Cardiac Arrest
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 210
- term
- Ischaemic Cardiomyopathy
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 210
- term
- Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 210
- term
- Diplopia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 210
- term
- Abdominal Pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 210
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 210
- term
- Gastritis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 210
- term
- Haematemesis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 210
- term
- Ileus
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 210
- term
- Lower Gastrointestinal Haemorrhage
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 39
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 40
- num At Risk
- 210
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 210
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 210
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 210
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 33
- num At Risk
- 210
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 42
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 42
- num At Risk
- 210
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 39
- num At Risk
- 210
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 210
- term
- Gingival Bleeding
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 210
- term
- Haemorrhoids
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 60
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 52
- num At Risk
- 210
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 57
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 69
- num At Risk
- 210
- term
- Stomatitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 41
- num At Risk
- 210
- term
- Vomiting
Complete source fields
- description
- Safety analysis set included all randomized participants who received at least 1 dose of study drug.
- event Groups
- deaths Num Affected
- 43
- deaths Num At Risk
- 206
- description
- Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
- id
- EG000
- other Num Affected
- 201
- other Num At Risk
- 206
- serious Num Affected
- 59
- serious Num At Risk
- 206
- title
- Arm A: Lazertinib With Amivantamab SC-CF
- deaths Num Affected
- 61
- deaths Num At Risk
- 210
- description
- Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
- id
- EG001
- other Num Affected
- 207
- other Num At Risk
- 210
- serious Num Affected
- 64
- serious Num At Risk
- 210
- title
- Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
- frequency Threshold
- 5
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 39
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 40
- num At Risk
- 210
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 210
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 210
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 210
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 33
- num At Risk
- 210
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 42
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 42
- num At Risk
- 210
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 39
- num At Risk
- 210
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 210
- term
- Gingival Bleeding
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 210
- term
- Haemorrhoids
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 60
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 52
- num At Risk
- 210
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 57
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 69
- num At Risk
- 210
- term
- Stomatitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 41
- num At Risk
- 210
- term
- Vomiting
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 210
- term
- Acute Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 210
- term
- Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 210
- term
- Cardiac Arrest
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 210
- term
- Ischaemic Cardiomyopathy
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 210
- term
- Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 210
- term
- Diplopia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 210
- term
- Abdominal Pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 210
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 210
- term
- Gastritis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 210
- term
- Haematemesis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 210
- term
- Ileus
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 25.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 206
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 210
- term
- Lower Gastrointestinal Haemorrhage
- time Frame
- All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
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