Table 2.

Summary of treatment-emergent adverse events during the open-label treatment period

n (%) of patients	Evinacumab-naïve (n = 46)	Evinacumab-continue (n = 70)	Total (n = 116)
Any TEAE	33 (71.7)	60 (85.7)	93 (80.2)
Treatment-emergent SAEs	5 (10.9)	22 (31.4)	27 (23.3)
TEAEs leading to treatment discontinuation	0	3 (4.3)a	3 (2.6)
TEAEs leading to death	1 (2.2)	1 (1.4)	2 (1.7)
TEAEs occurring in ≥5% of patients by preferred term
Nasopharyngitis	11 (23.9)	12 (17.1)	23 (19.8)
Coronavirus disease 2019	5 (10.9)	14 (20.0)	19 (16.4)
Headache	7 (15.2)	12 (17.1)	19 (16.4)
Influenza-like illness	4 (8.7)	12 (17.1)	16 (13.8)
Arthralgia	6 (13.0)	9 (12.9)	15 (12.9)
Back pain	4 (8.7)	10 (14.3)	14 (12.1)
Nausea	4 (8.7)	10 (14.3)	14 (12.1)
Cough	6 (13.0)	6 (8.6)	12 (10.3)
Diarrhoea	3 (6.5)	7 (10.0)	10 (8.6)
Gastroenteritis	7 (15.2)	3 (4.3)	10 (8.6)
Pyrexia	3 (6.5)	7 (10.0)	10 (8.6)
Urinary tract infection	3 (6.5)	7 (10.0)	10 (8.6)
Pain in extremity	3 (6.5)	5 (7.1)	8 (6.9)
Upper respiratory tract infection	3 (6.5)	5 (7.1)	8 (6.9)
Abdominal pain	4 (8.7)	3 (4.3)	7 (6.0)
Dizziness	0	7 (10.0)	7 (6.0)
Myalgia	2 (4.3)	5 (7.1)	7 (6.0)
Toothache	2 (4.3)	5 (7.1)	7 (6.0)
Vomiting	3 (6.5)	4 (5.7)	7 (6.0)
Contusion	2 (4.3)	4 (5.7)	6 (5.2)
Gastro-oesophageal reflux disease	1 (2.2)	5 (7.1)	6 (5.2)
Oropharyngeal pain	5 (10.9)	1 (1.4)	6 (5.2)
Immunization reaction	1 (2.2)	4 (5.7)	5 (4.3)
Alanine aminotransferase increased	3 (6.5)	1 (1.4)	4 (3.4)
Aspartate aminotransferase increased	3 (6.5)	1 (1.4)	4 (3.4)
Angina pectoris	0	4 (5.7)	4 (3.4)
Blood creatine phosphokinase increased	3 (6.5)	1 (1.4)	4 (3.4)
Chest pain	0	4 (5.7)	4 (3.4)
Acne	3 (6.5)	0	3 (2.6)
Paraesthesia	3 (6.5)	0	3 (2.6)

SAE, serious adverse event; TEAE, treatment-emergent adverse event.

^aTEAEs leading to treatment discontinuation were due to pregnancy in two patients and headache in one patient.