Table 3.

Summary of adverse events during week 0–24 (early TEAEs)

Adverse event (Week 0–24)	HA N = 8		16 M N = 17		32 M N = 17		64 M N = 15		Total N = 57
[Event # (E)/Subject # (S) (%)]	E	S (%)	E	S (%)	E	S (%)	E	S (%)	E	S (%)
At least one below	11	4 (50.0%)	40	15 (88.2%)	41	14 (82.4%)	25	11 (73.3%)	117	44 (77.2%)
Cardiac disorders	1	1 (12.5%)	0	0 (0.0%)	1	1 (5.9%)	0	0 (0.0%)	2	2 (3.5%)
Eye disorders	1	1 (12.5%)	2	2 (11.8%)	0	0 (0.0%)	0	0 (0.0%)	3	3 (5.3%)
Gastrointestinal disorders	1	1 (12.5%)	3	2 (11.8%)	4	3 (17.6%)	1	1 (6.7%)	9	7 (12.3%)
General disorders and administration site conditions	1	1 (12.5%)	4	3 (17.6%)	7	7 (41.2%)	7	6 (40.0%)	19	17 (29.8%)
Hepatobiliary disorders	0	0 (0.0%)	0	0 (0.0%)	1	1 (5.9%)	0	0 (0.0%)	1	1 (1.8%)
Infections and infestations	1	1 (12.5%)	6	6 (35.3%)	3	2 (11.8%)	4	3 (20.0%)	14	12 (21.1%)
Injury, poisoning, and procedural complications	0	0 (0.0%)	2	1 (5.9%)	1	1 (5.9%)	0	0 (0.0%)	3	2 (3.5%)
Investigations	0	0 (0.0%)	0	0 (0.0%)	1	1 (5.9%)	0	0 (0.0%)	1	1 (1.8%)
Metabolism and nutrition disorders	0	0 (0.0%)	2	1 (5.9%)	0	0 (0.0%)	0	0 (0.0%)	2	1 (1.8%)
Musculoskeletal and connective tissue disorders	5	2 (25.0%)	15	6 (35.3%)	13	10 (58.8%)	11	5 (33.3%)	44	23 (40.4%)
Neoplasms benign, malignant, and unspecified (including cysts and polyps)	0	0 (0.0%)	2	2 (11.8%)	1	1 (5.9%)	0	0 (0.0%)	3	3 (5.3%)
Nervous system disorders	1	1 (12.5%)	1	1 (5.9%)	2	2 (11.8%)	1	1 (6.7%)	5	5 (8.8%)
Psychiatric disorders	0	0 (0.0%)	0	0 (0.0%)	1	1 (5.9%)	0	0 (0.0%)	1	1 (1.8%)
Renal and urinary disorders	0	0 (0.0%)	0	0 (0.0%)	1	1 (5.9%)	0	0 (0.0%)	1	1 (1.8%)
Respiratory, thoracic, and mediastinal disorders	0	0 (0.0%)	1	1 (5.9%)	2	2 (11.8%)	1	1 (6.7%)	4	4 (7.0%)
Skin and subcutaneous tissue disorders	0	0 (0.0%)	1	1 (5.9%)	1	1 (5.9%)	0	0 (0.0%)	2	2 (3.5%)
Surgical and medical procedures	0	0 (0.0%)	1	1 (5.9%)	2	1 (5.9%)	0	0 (0.0%)	3	2 (3.5%)

Dictionary: MedDRA version 19.0