Table 5.

Number of subjects with suspected cases of ADRs and number of suspected cases by SOC and PT (beginning of event between first and last intake of investigational product).

	Treatment
	WS® 5570 3 × 300 mg/d		Paroxetine 20 mg/d
System organ class and preferred term	n (%)	Total ADR	n (%)	Total ADR
All
Total patients with suspected cases of ADRs	6 (19.35)	15	20 (60.61)	61
Total patients	31 (100)		33 (100)
Gastrointestinal disorders
Total	2 (6.45)	3	16 (48.48)	22
Abdominal pain	2 (6.45)	2	1 (3.03)	1
Constipation	1 (3.23)	1	1 (3.03)	1
Diarrhoea NOS			4 (12.12)	5
Dry mouth			4 (12.12)	4
Nausea			11 (33.33)	11
General disorders and administration site conditions
Total	3 (9.68)	3	6 (18.18)	7
Fatigue	2 (6.45)	2	4 (12.12)	4
Weakness	1 (3.23)	1	3 (9.09)	3
Immune system disorders
Total	1 (3.23)	1
Hypersensitivity NOS	1 (3.23)	1
Nervous system disorders
Total	3 (9.68)	3	11 (33.33)	16
Depressed level of consciousness	1 (3.23)	1	1 (3.03)	1
Dizziness (Exc. Vertigo)	2 (6.45)	2	6 (18.18)	6
Headache NOS			4 (12.12)	4
Insomnia NEC			1 (3.03)	1
Somnolence			2 (6.06)	2
Tremor NEC			2 (6.06)	2
Psychiatric disorders
Total	2 (6.45)	3	5 (15.15)	8
Agitation	1 (3.23)	1	1 (3.03)	1
Flat affect	1 (3.23)	2	1 (3.03)	1
Loss of libido			1 (3.03)	1
Restlessness			1 (3.03)	1
Sleep disorder NOS			4 (12.12)	4
Reproductive system and breast disorders
Total		1	1 (3.03)	1
Ejaculation disorder NOS		1	1(3.03)	1
Skin and subcutaneous tissue disorders
Total	2 (6.45)	2	6 (18.18)	7
Photosensitivity reaction	1 (3.23)	1	6 (18.18)	7
NOS	1 (3.23)	1
Sweating increased

ADRs: adverse drug reactions; SOC: system organ class; PT: preferred term; NOS: not otherwise specified; NEC: not elsewhere classified.