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. 2016 Jan 11;39:335–345. doi: 10.1007/s40264-015-0387-4

Table 6.

Top 10 SOCs in RoW reports vs. African reports

SOC RoW (%)a Africa (%)b
General disorders and administration site conditions 3,574,082 (30.49) 21,631 (20.91)
Skin and subcutaneous tissue disorders 2,295,539 (19.58) 32,225 (31.14)
Nervous system disorders 2,242,378 (19.13) 18,094 (17.48)
Gastrointestinal disorders 2,093,534 (17.86) 16,662 (16.10)
Investigations 1,080,507 (9.22) 5245 (5.07)
Respiratory, thoracic and mediastinal disorders 1,046,599 (8.93) 5912 (5.71)
Psychiatric disorders 1,042,390 (8.89) 4890 (4.72)
Injury, poisoning and procedural complications 946,308 (8.07) 3008 (2.91)
Musculoskeletal and connective tissue disorders 905,026 (7.72) 4512 (4.36)
Infections and infestations 846,842 (7.22) 3912 (3.78)

SOC system organ class, RoW rest of the world, ICSRs individual case safety reports

aPercentage of all RoW ICSRs (n = 11,721,305) in VigiBase®

bPercentage of all African ICSRs (n = 103,499) in VigiBase® (excluding Swaziland, n = 27)