Table 3.

Incidence and exposure-adjusted incidence of treatment-emergent adverse events

	Number (%) of patients	Exposure-adjusted incidence per 100 PY from Day 1 to Week 60	Exposure-adjusted incidence per 100 PY from Day 1 to Week 252
Patients with ≥1 TEAE	228 (98.7)	187.7	174.6
Cardiac-related TEAEs
Hypertension	36 (15.6)	7.67	5.35
Atrial fibrillation	33 (14.3)	6.57	4.50
Dyspnoea	23 (10.0)	3.59	3.11
Palpitations	16 (6.9)	3.95	2.10
Cardiac failure	14 (6.1)	3.55	1.94
Ejection fraction decreased	13 (5.6)	2.12	1.51
Other TEAEs
COVID-19 infection	92 (39.8)	6.80	15.06
Dizziness	41 (17.7)	8.43	6.13
Nasopharyngitis	36 (15.6)	7.83	5.41
Fatigue	29 (12.6)	8.17	4.27
Back pain	24 (10.4)	5.03	3.46
Arthralgia	24 (10.4)	4.32	3.45
Headache	23 (10.0)	7.35	3.34

Table includes treatment-emergent adverse events of any grade reported in ≥10% of patients, except for cardiac failure, ejection fraction decreased, and palpitations, for which the proportions of patients were <10%. Treatment-emergent adverse events were recorded and defined based on the discretion of the principal investigator.

PY, patient-years; TEAE, treatment-emergent adverse event.