TABLE 3.
Number and percentage of ADRs related to system organ damage.
| System organ class | mAbs N = 575 (%) | Non-mAb N = 15,335 (%) | p value a |
|---|---|---|---|
| Gastrointestinal disorders | 81 (14.09) | 5,762 (37.57) | <0.001 |
| Blood and lymphatic system disorders | 50 (8.70) | 3,559 (23.21) | <0.001 |
| Skin and subcutaneous tissue disorders | 87 (15.13) | 1,263 (8.24) | <0.001 |
| Investigations | 20 (3.48) | 1,158 (7.55) | <0.001 |
| General disorders and administration site conditions | 142 (24.70) | 833 (5.43) | <0.001 |
| Nervous system disorders | 18 (3.13) | 616 (4.02) | 0.286 |
| Respiratory, thoracic, and mediastinal disorders | 50 (8.70) | 578 (3.77) | <0.001 |
| Vascular disorders | 22 (3.83) | 264 (1.72) | <0.001 |
| Musculoskeletal and connective tissue disorders | 5 (0.87) | 276 (1.80) | 0.096 b |
| Cardiac disorders | 28 (4.87) | 249 (1.62) | <0.001 |
| Hepatobiliary disorders | 12 (2.09) | 251 (1.64) | 0.406 |
| Metabolism and nutrition disorders | 5 (0.87) | 204 (1.33) | 0.341 b |
| Immune system disorders | 14 (2.43) | 166 (1.08) | 0.003 |
| Renal and urinary disorders | 8 (1.39) | 72 (0.47) | 0.002 |
| Endocrine disorders | 19 (3.30) | 17 (0.11) | <0.001 |
| Psychiatric disorders | 0 (0) | 20 (0.13) | NE |
| Eye disorders | 0 (0) | 16 (0.10) | NE |
| Injury, poisoning, and procedural complications | 3 (0.52) | 10 (0.07) | 0.010 b |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 11 (1.91) | 1 (0.01) | <0.001 b |
| Ear and labyrinth disorders | 0 (0) | 10 (0.07) | NE |
| Infections and infestations | 0 (0) | 6 (0.04) | NE |
| Reproductive system and breast disorders | 0 (0) | 4 (0.03) | NE |
a
Chi-squared test.
b
Fisher exact test.
NE, not evaluated.