Table 2.

Adverse events recorded from the beginning of the 1-year ITT-PMS trial to the end of the 2-year extension trial for all participants

All events
Any event
Events—no. (no. per participant)	107 (4.7)
Patients with event—no. (%)	22 (96)
Severe adverse events
Events—no. (no. per participant)	2 (0.09)
Patients with event—no. (%)	2 (9)
Bacterial meningitis—no. (%)	2 (9)
Death—no. (%)	0 (0)
Discontinuation because of adverse event—no. (%)	2 (9)
Moderate adverse events
Events—no. (no. per participant)	23 (1.0)
Patients with event—no. (%)	15 (65)
Vertigo, Upper respiratory infection, Urinary tract infection, Depression, Fall, Basalioma, Bladder stone, Deep venous thrombosis, Diabetes Mellitus type 2, Gastroenteritis, Vomiting
Mild adverse events
Events—no. (no. per participant)	82 (3.6)
Patients with event—no. (%)	21 (91)
Vertigo, Urinary tract infection, Paraesthesia, Diplopia, Upper respiratory infection, Rash, Headache, Nausea, Eczema, Fall, Fatigue, Fever, Fungal infection, Vomiting, Dry eye, Gastroenteritis, Hypertension, Labial herpes, Myalgia, Obstipation, Tremor
Frequency of adverse events
Vertigo—no. (%)	23 (52)
Urinary tract infection—no. (%)	19 (43)
Upper respiratory infection—no. (%)	10 (26)
Paraesthesia—no. (%)	8 (13)
Nervous system disorders—Other, diplopia—no. (%)	6 (9)
Fall—no. (%)	4 (13)
Rash—no. (%)	4 (4)
Headache—no. (%)	3 (13)
Nausea—no. (%)	3 (9)
Vomiting—no. (%)	3 (13)
Depression—no. (%)	2 (4)
Eczema—no. (%)	2 (9)
Fatigue—no. (%)	2 (9)
Fever—no. (%)	2 (9)
Fungal infection—no. (%)	2 (4)
Gastroenteritis—no. (%)	2 (9)
Bacterial meningitis—no. (%)	2 (9)
Basalioma—no. (%)	1 (4)
Bladder stone—no. (%)	1 (4)
Deep venous thrombosis—no. (%)	1 (4)
Diabetes Mellitus type 2—no. (%)	1 (4)
Dry eye—no. (%)	1 (4)
Hypertension—no. (%)	1 (4)
Labial herpes—no. (%)	1 (4)
Myalgia—no. (%)	1 (4)
Obstipation—no. (%)	1 (4)
Tremor—no. (%)	1 (4)