TABLE 3.
Signal detection of four anti-CGRP mAbs at the SOC level.
| Erenumab | Galcanezumab | Fremanezumab | Eptinezumab | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SOC | PT | n | % | SOC | PT | n | % | SOC | PT | n | % | SOC | PT | n | % |
| General disorders and administration site conditions | 30 | 6,918 | 42.97 | General disorders and administration site conditions | 35 | 10,539 | 62.97 | General disorders and administration site conditions | 35 | 3,465 | 58.87 | Respiratory, thoracic and mediastinal disorders | 11 | 323 | 29.74 |
| Gastrointestinal disorders | 17 | 3,434 | 21.33 | Skin and subcutaneous tissue disorders | 6 | 1,701 | 10.16 | Skin and subcutaneous tissue disorders | 12 | 885 | 15.04 | General disorders and administration site conditions | 11 | 305 | 28.08 |
| Skin and subcutaneous tissue disorders | 5 | 1,459 | 9.06 | Psychiatric disorders | 13 | 1,160 | 6.93 | Psychiatric disorders | 11 | 336 | 5.71 | Infections and infestations | 2 | 92 | 8.47 |
| Psychiatric disorders | 8 | 1,444 | 8.97 | Gastrointestinal disorders | 6 | 683 | 4.08 | Gastrointestinal disorders | 6 | 247 | 4.20 | Skin and subcutaneous tissue disorders | 1 | 89 | 8.20 |
| Musculoskeletal and connective tissue disorders | 7 | 1,091 | 6.78 | Nervous system disorders | 10 | 597 | 3.57 | Musculoskeletal and connective tissue disorders | 3 | 223 | 3.79 | Immune system disorders | 3 | 82 | 7.55 |
| Nervous system disorders | 10 | 616 | 3.83 | Musculoskeletal and connective tissue disorders | 6 | 567 | 3.39 | Nervous system disorders | 8 | 203 | 3.45 | Gastrointestinal disorders | 4 | 59 | 5.43 |
| Investigations | 3 | 425 | 2.64 | Investigations | 3 | 547 | 3.27 | Investigations | 2 | 144 | 2.45 | Vascular disorders | 2 | 34 | 3.13 |
| Cardiac disorders | 3 | 267 | 1.66 | Immune system disorders | 3 | 329 | 1.97 | Immune system disorders | 1 | 112 | 1.90 | Nervous system disorders | 2 | 29 | 2.67 |
| Reproductive system and breast disorders | 8 | 182 | 1.13 | Eye disorders | 1 | 194 | 1.16 | Cardiac disorders | 1 | 85 | 1.44 | Injury, poisoning and procedural complications | 3 | 29 | 2.67 |
| Injury, poisoning and procedural complications | 6 | 91 | 0.57 | Reproductive system and breast disorders | 8 | 131 | 0.78 | Injury, poisoning and procedural complications | 5 | 63 | 1.07 | Investigations | 1 | 17 | 1.57 |
| Vascular disorders | 2 | 54 | 0.34 | Cardiac disorders | 2 | 124 | 0.74 | Respiratory, thoracic and mediastinal disorders | 4 | 53 | 0.90 | Eye disorders | 2 | 12 | 1.10 |
| Respiratory, thoracic and mediastinal disorders | 1 | 46 | 0.29 | Respiratory, thoracic and mediastinal disorders | 2 | 54 | 0.32 | Reproductive system and breast disorders | 4 | 32 | 0.54 | Musculoskeletal and connective tissue disorders | 1 | 9 | 0.83 |
| Eye disorders | 2 | 34 | 0.21 | Injury, poisoning and procedural complications | 3 | 42 | 0.25 | Vascular disorders | 1 | 14 | 0.24 | Metabolism and nutrition disorders | 1 | 6 | 0.55 |
| Immune system disorders | 1 | 21 | 0.13 | Vascular disorders | 1 | 35 | 0.21 | Infections and infestations | 2 | 12 | 0.20 | ||||
| Endocrine disorders | 1 | 11 | 0.07 | Infections and infestations | 3 | 19 | 0.11 | Eye disorders | 2 | 12 | 0.20 | ||||
| Renal and urinary disorders | 1 | 6 | 0.04 | Ear and labyrinth disorders | 1 | 14 | 0.08 | ||||||||
| Total | 105 | 16,099 | 100.00 | 103 | 16,736 | 100.00 | 97 | 5,886 | 100.00 | 44 | 1,086 | 100.00 | |||
Notes:SOC: system organ class; PT: preferred term.