Table 7 The involved organs frequency of serious ADRs in two periods
Period 1 | Period 2 | ||
|---|---|---|---|
Involved systems and organs | No. | Involved systems and organs | No. |
Body as a whole-general disorders | 10 (47.6%) | Gastro-intestinal system disorders | 129 (45.0%) |
Liver and biliary system disorders | 6 (28.6%) | Liver and biliary system disorders | 81 (28.2%) |
Skin and appendages disorders | 2 (9.5%) | Body as a whole-general disorders | 25 (8.7%) |
Platelet, bleeding & clotting disorders | 2 (9.5%) | Metabolic and nutritional disorders | 12 (4.2%) |
Resistance mechanism disorders | 1 (4.8%) | Urinary system disorders | 9 (3.1%) |
Heart rate and rhythm disorders | 6 (2.1%) | ||
Central & peripheral nervous system disorders | 5 (1.7%) | ||
Others | 20 (7.0%) | ||