Table 2 Treatment-emergent adverse events in the open-label extension period (safety analysis set)
No. (%) | ||||
|---|---|---|---|---|
Epti 100 mg / Epti 100 mg (n = 288) | Epti 300 mg / Epti 300 mg (n = 284) | Placebo / Epti 100 mg (n = 145) | Placebo / Epti 300 mg (n = 148) | |
Any TEAE | 159 (55.2) | 148 (52.1) | 72 (49.7) | 81 (54.7) |
Any SAE | 9 (3.1) | 9 (3.2) | 2 (1.4) | 7 (4.7) |
TEAE leading to withdrawal | 3 (1.0) | 6 (2.1) | 0 | 3 (2.0) |
TEAE leading to infusion interruption/termination | 1 (0.3) | 1 (0.4) | 0 | 0 |
Death | 0 | 0 | 0 | 0 |
TEAEs in ≥ 1.5% of patients | ||||
COVID-19 | 63 (21.9) | 63 (22.2) | 25 (17.2) | 31 (20.9) |
Nasopharyngitis | 19 (6.6) | 27 (9.5) | 7 (4.8) | 13 (8.8) |
Upper respiratory tract infection | 13 (4.5) | 8 (2.8) | 4 (2.8) | 6 (4.1) |
Arthralgia | 6 (2.1) | 6 (2.1) | 1 (0.7) | 2 (1.4) |
Pruritus | 2 (0.7) | 6 (2.1) | 1 (0.7) | 0 |
Dyspepsia | 1 (0.3) | 5 (1.8) | 0 | 1 (0.7) |
Gastroenteritis | 3 (1.0) | 5 (1.8) | 1 (0.7) | 1 (0.7) |
Post-vaccination syndrome | 0 | 5 (1.8) | 0 | 1 (0.7) |
Sinusitis | 4 (1.4) | 5 (1.8) | 2 (1.4) | 2 (1.4) |
Urinary tract infection | 3 (1.0) | 5 (1.8) | 3 (2.1) | 4 (2.7) |
Pharyngitis | 3 (1.0) | 4 (1.4) | 0 | 3 (2.0) |
Upper abdominal pain | 4 (1.4) | 3 (1.1) | 1 (0.7) | 3 (2.0) |
Bronchitis | 4 (1.4) | 3 (1.1) | 1 (0.7) | 3 (2.0) |
Cystitis | 1 (0.3) | 3 (1.1) | 0 | 5 (3.4) |
Migraine | 7 (2.4) | 3 (1.1) | 0 | 1 (0.7) |
Nausea | 2 (0.7) | 3 (1.1) | 1 (0.7) | 5 (3.4) |
Back pain | 8 (2.8) | 2 (0.7) | 1 (0.7) | 2 (1.4) |
Fatigue | 5 (1.7) | 2 (0.7) | 0 | 1 (0.7) |
Hypertension | 3 (1.0) | 2 (0.7) | 3 (2.1) | 0 |
Menopause | 1 (0.3) | 0 | 1 (0.7) | 3 (2.0) |