Table 14Summary of Harms — ANCHOR Study

Category, n (%)

Icosapent ethyl

N = 233

Placebo

N = 233

Patients with at least 1 TEAE106 (45.5)112 (48.1)
Patients with SAEs7 (3.0)5 (2.1)
Deaths0 (0.0)1 (0.4)
Patients with an adverse event leading to discontinuation from the study5 (2.1)7 (3.0)
Patients with an SAE leading to discontinuation1 (0.4)2 (0.9)
Most common AEs with > 3% prevalence, n (%)
Diarrheaa8 (3.4)10 (4.3)
Nausea5 (2.1)7 (3.0)
Nasopharyngitis1 (0.4)7 (3.0)
Arthralgia4 (1.7)1 (0.4)
GI bleedinga1 (0.4)1 (0.4)
CNS bleedinga1 (0.4)0 (0)
Atrial fibrillationa0 (0)1 (0.4)
Peripheral edemaa3 (1.3)1 (0.4)
Musculoskeletal paina3 (1.3)2 (0.9)
Constipationa2 (0.9)4 (1.7)
Gouta0 (0)2 (0.9)

AE = adverse event; CNS = central nervous system; GI = gastrointestinal; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

Note: A TEAE was defined as an adverse event that started after the first dose of double-blind study drug or occurred before the first dose and worsened in severity during the double-blind treatment period. % = n/N, where n is the number of patients with at least 1 TEAE for the specified category and N is the number of patients for the treatment group. For maximum severity summary, only the worst severity for each patient was used. Each patient was counted only once.

a

Notable harm as stated in this review protocol (Table 4).

Source: Clinical Study Report for the ANCHOR2 study.

From: Clinical Evidence

Cover of Clinical Review Report: Icosapent Ethyl (Vascepa)
Clinical Review Report: Icosapent Ethyl (Vascepa): (HLS Therapeutics Inc.): Indication: Prevention of cardiovascular events in statin-treated patients [Internet].
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