TABLE 8.
Number and percentage of ADRs related to system organ class by patents.
| System organ class | Branded drugs N = 495 (%) | Biosimilars N = 80 (%) | p value a |
|---|---|---|---|
| General disorders and administration site conditions | 122 (24.65) | 20 (25) | 0.95 |
| Skin and subcutaneous tissue disorders | 75 (15.15) | 12 (15) | 0.97 |
| Gastrointestinal disorders | 74 (14.95) | 7 (8.75) | 0.14 |
| Blood and lymphatic system disorders | 41 (8.28) | 9 (11.25) | 0.38 |
| Respiratory, thoracic, and mediastinal disorders | 38 (7.68) | 12 (15) | 0.03 |
| Cardiac disorders | 23 (4.65) | 5 (6.25) | 0.35 b |
| Vascular disorders | 19 (3.84) | 3 (3.75) | 0.63 b |
| Investigations | 17 (3.43) | 3 (3.75) | 0.54 b |
| Endocrine disorders | 18 (3.64) | 1 (1.25) | 0.23 b |
| Nervous system disorders | 15 (3.03) | 3 (3.75) | 0.47 b |
| Immune system disorders | 12 (2.42) | 2 (2.5) | 0.60 b |
| Hepatobiliary disorders | 11 (2.22) | 1 (1.25) | 0.49 b |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 11 (2.22) | 0 (0) | NE |
| Renal and urinary disorders | 6 (1.21) | 2 (2.5) | 0.31 b |
| Metabolism and nutrition disorders | 5 (1.01) | 0 (0) | NE |
| Musculoskeletal and connective tissue disorders | 5 (1.01) | 0 (0) | NE |
| Injury, poisoning, and procedural complications | 3 (0.61) | 0 (0) | NE |
a
Chi-squared test.
b
Fisher exact test.
NE, not evaluated.