Table 2 Characteristics of the most common adverse reaction in clinical studies for NDA (162 drug products, 192 sets for Fig. 3)
System organ class | Serious adverse reaction 20 sets | Non-serious adverse reaction 172 sets |
|---|---|---|
Blood and lymphatic system disorders | 1 | 1 |
Cardiac disorders | 3 | 0 |
Eye disorders | 0 | 8 |
Gastrointestinal disorders | 0 | 42 |
General disorders and administration site conditions | 1 | 26 |
Hepatobiliary disorders | 2 | 1 |
Immune system disorders | 1 | 0 |
Investigations | 0 | 24 |
Metabolism and nutrition disorders | 6 | 3 |
Musculoskeletal and connective tissue disorders | 0 | 2 |
Nervous system disorders | 1 | 30 |
Psychiatric disorders | 0 | 1 |
Renal and urinary disorders | 0 | 1 |
Reproductive system and breast disorders | 0 | 5 |
Respiratory, thoracic and mediastinal disorders | 0 | 2 |
Skin and subcutaneous tissue disorders | 0 | 17 |
Vascular disorders | 5 | 9 |