Table 5.

Number of patients with an adverse drug reaction in the observation period

Total population (n = 8237)	O20, A5 (patients, n)	O40, A5 (patients, n)	O40, A10 (patients, n)	Total (patients, n)
Patients without ADR	4141	2472	1400	8013
Patients with ADR	91	54	79	226*
Serious	5	4	3	13
Not serious	86	50	76	213
Change in dose*	O20, A5 (n, % of patients with ADRs)	O40, A5 (n, % of patients with ADRs)	O40, A10 (n, % of patients with ADRs)	Total (n, % of patients with ADRs)
Not changed	3 (1.33)	4 (1.78)	4 (1.78%)	11 (4.89%)
Drug withdrawn	86 (38.22)	49 (21.78)	68 (30.22%)	204 (90.67%)**
Dose reduced	1 (0.44)	1 (0.44)	6 (2.67%)	8 (3.56%)
Dose increased	1 (0.44)	0 (0)	0 (0%)	1 (0.44%)
Unknown	0 (0)	0 (0)	1 (0.44%)	1 (0.44%)

Notes:

^*Data from one patient not included;

^**One patient with unknown dose.

Abbreviation: ADRs, adverse drug reactions.