NCT03915951 · 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
- From the time the participant provided informed consent, through and including a minimum of 30 calendar days, after the last administration of the study intervention, and the safety follow-up visit (30 days [±7 days] after the EOT visit) (up to 36 months)
- Other-event reporting threshold
- 5%
Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who received at least 1 dose of study intervention.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Treatment-Naive | 25 / 59 | 59 / 59 | 5 / 59 |
| Previously Treated | 17 / 39 | 38 / 39 | 7 / 39 |
| Total | 42 / 98 | 97 / 98 | 12 / 98 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 98
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Disseminated intravascular coagulation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 98
- term
- Myocardial infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Atrial fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Pericardial effusion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Supraventricular tachyarrhythmia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Tachycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Retinal detachment
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 98
- term
- Colitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Duodenal ulcer
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 20
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 30
- num At Risk
- 98
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 20
- num At Risk
- 98
- term
- Vision blurred
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 37
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 56
- num At Risk
- 98
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 20
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 49
- num At Risk
- 98
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 23
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 36
- num At Risk
- 98
- term
- Vomiting
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 26
- num At Risk
- 98
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 20
- num At Risk
- 98
- term
- Abdominal pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 8
- num At Risk
- 98
- term
- Abdominal pain upper
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 45
- num At Risk
- 98
- term
- Fatigue
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 22
- num At Risk
- 98
- term
- Pyrexia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 20
- num At Risk
- 98
- term
- Oedema peripheral
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 16
- num At Risk
- 98
- term
- Asthenia
Complete source fields
- description
- Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who received at least 1 dose of study intervention.
- event Groups
- deaths Num Affected
- 5
- deaths Num At Risk
- 59
- description
- Treatment-naïve participants with BRAF V600E-mutant metastatic NSCLC were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
- id
- EG000
- other Num Affected
- 59
- other Num At Risk
- 59
- serious Num Affected
- 25
- serious Num At Risk
- 59
- title
- Treatment-Naive
- deaths Num Affected
- 7
- deaths Num At Risk
- 39
- description
- Patients who had received 1) first-line treatment with standard platinum-based chemotherapy, or 2) first-line treatment with an anti-PD-1/PD-L1 inhibitor given alone, or in combination with platinum-based chemotherapy, or in combination with immunotherapy (eg, ipilimumab) with or without platinum-based chemotherapy were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID was to be administered in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
- id
- EG001
- other Num Affected
- 38
- other Num At Risk
- 39
- serious Num Affected
- 17
- serious Num At Risk
- 39
- title
- Previously Treated
- deaths Num Affected
- 12
- deaths Num At Risk
- 98
- description
- Sum of all participants in the Study C4221008 (ARRAY-818-202)
- id
- EG002
- other Num Affected
- 97
- other Num At Risk
- 98
- serious Num Affected
- 42
- serious Num At Risk
- 98
- title
- Total
- frequency Threshold
- 5
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 20
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 30
- num At Risk
- 98
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 20
- num At Risk
- 98
- term
- Vision blurred
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 37
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 56
- num At Risk
- 98
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 20
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 49
- num At Risk
- 98
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 23
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 36
- num At Risk
- 98
- term
- Vomiting
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 26
- num At Risk
- 98
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 20
- num At Risk
- 98
- term
- Abdominal pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 8
- num At Risk
- 98
- term
- Abdominal pain upper
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 45
- num At Risk
- 98
- term
- Fatigue
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 22
- num At Risk
- 98
- term
- Pyrexia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 20
- num At Risk
- 98
- term
- Oedema peripheral
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 16
- num At Risk
- 98
- term
- Asthenia
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 98
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Disseminated intravascular coagulation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 98
- term
- Myocardial infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Atrial fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Pericardial effusion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Supraventricular tachyarrhythmia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Tachycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Retinal detachment
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 98
- term
- Colitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA version 25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 59
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 39
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 98
- term
- Duodenal ulcer
- time Frame
- From the time the participant provided informed consent, through and including a minimum of 30 calendar days, after the last administration of the study intervention, and the safety follow-up visit (30 days [±7 days] after the EOT visit) (up to 36 months)
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Preserved source evidence · Not medical advice
Triangle