Table 4.

Treatment-emergent AEs

Parameter, n (%) preferred term	PBO N=16	DAZ 3000 mg×1 N=18	DAZ 1500 mg×2 N=17	DAZ 3000 mg×2 N=13	DAZ 1500 mg×4 N=14	DAZ total N=62
≥1 AE	10 (62.5)	10 (55.6)	14 (82.4)	11 (84.6)	11 (78.6)	46 (74.2)
≥1 AE related to study drug	4 (25.0)	3 (16.7)	4 (23.5)	2 (15.4)	2 (14.3)	11 (17.7)
≥1 AE leading to death	0	0	1 (5.9)	0	0	1 (1.6)
≥1 AE leading to discontinuation	0	1 (5.6)	0	0	0	1 (1.6)
≥1 SAE	0	1 (5.6)	1 (5.9)	0	1 (7.1)	3 (4.8)
≥1 SAE related to study drug	0	0	0	0	0	0
≥1 AESI	0	1 (5.6)	1 (5.9)	0	0	2 (3.2)
Most common AEs*
COVID-19	1 (6.3)	2 (11.1)	3 (17.6)	0	3 (21.4)	8 (12.9)
Rheumatoid arthritis	1 (6.3)	0	3 (17.6)	2 (15.4)	1 (7.1)	6 (9.7)
Alanine aminotransferase  increased	0	1 (5.6)	2 (11.8)	1 (7.7)	0	4 (6.5)
Spinal osteoarthritis	0	2 (11.1)	2 (11.8)	0	0	4 (6.5)
Upper respiratory tract  infection	1 (6.3)	1 (5.6)	0	3 (23.1)	0	4 (6.5)
Hypertension	0	1 (5.6)	0	1 (7.7)	1 (7.1)	3 (4.8)
Nasopharyngitis	0	0	1 (5.9)	1 (7.7)	1 (7.1)	3 (4.8)
Osteoarthritis	0	0	0	3 (23.1)	0	3 (4.8)
Pharyngitis	0	0	0	2 (15.4)	1 (7.1)	3 (4.8)
Anaemia	1 (6.3)	2 (11.1)	0	0	0	2 (3.2)
Arthralgia	0	0	1 (5.9)	0	1 (7.1)	2 (3.2)
Aspartate aminotransferase  increased	0	0	2 (11.8)	0	0	2 (3.2)
Back pain	0	1 (5.6)	1 (5.9)	0	0	2 (3.2)
Hypercholesterolaemia	0	1 (5.6)	0	1 (7.7)	0	2 (3.2)
Lymphopenia	0	0	2 (11.8)	0	0	2 (3.2)
Pyrexia	0	0	1 (5.9)	0	1 (7.1)	2 (3.2)
Cystitis	2 (12.5)	0	0	0	1 (7.1)	1 (1.6)
Urinary tract infection	2 (12.5)	0	1 (5.9)	0	0	1 (1.6)

*Reported in ≥2 participants in PBO group or ≥2 participants in combined DAZ groups.

AE, adverse event; AESI, adverse event of special interest; PBO, placebo; SAE, serious adverse event.