Characteristics of safety information obtained from postmarketing observational studies for re-examination in Japan

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Table 1 Characteristics of the products investigated (176 drug products for Fig. 1, 45 drug products for Fig. 2 and 162 drug products for Fig. 3)

	(A) 176 drug products	(B) 45 drug products	(C) 162 drug products
Therapeutic group
A—alimentary tract and metabolism	18	8	17
B—blood and blood-forming organs	9	3	8
C—cardiovascular system	20	3	20
D—dermatologicals	6	3	5
G—genitourinary system and sex hormones	13	1	13
H—systemic hormonal preparations, excluding sex hormones and insulins	7	1	6
J—anti-infectives for systemic use	25	5	23
L—anti-neoplastic and immunomodulating agents	10	3	10
M—musculoskeletal system	6	3	6
N—nervous system	24	8	23
P—anti-parasitic products, insecticides, and repellents	2	0	1
R—respiratory system	15	4	10
S—sensory organs	6	1	6
V—various	15	2	14
Re-examination dates
January 2009 to December 2009	45	6	42
January 2010 to December 2010	44	13	42
January 2011 to December 2011	30	9	27
January 2012 to December 2012	21	5	20
January 2013 to December 2013	19	8	16
January 2014 to December 2014	17	4	15

(A) Drug products for which both the adverse reaction rate in clinical studies for NDA and in postmarketing observational (PMO) studies were available (Fig. 1)
(B) Drug products for which both the adverse reaction rate in clinical studies for NDA and in postmarketing intervention (PMI) studies were available (Fig. 2)
(C) Drug products for which the incidence rate of the most common adverse reaction in clinical studies for NDA and in PMO studies for re-examination were available (Fig. 3)