Advertisement
Table 2 Summary of AEs and SAEs in the RAPID 2 RCT and OLE (safety population, n = 612)
| Patients, number (%) | Total number of events | Event rate per 100 PYsa | Incidence rate per 100 PYs | |
|---|---|---|---|---|
| Total AEs | 546 (89.2) | 3789 | 163.0 | 87.4 |
| Infections and infestationsb | 420 (68.6) | 1257 | 54.1 | 36.4 |
| Tuberculosisc | 6 (1.0) | 6 | 0.26 | 0.26 |
| Herpes zosterc | 10 (1.6) | 11 | 0.47 | 0.43 |
| Neoplasms (benign, malignant and unspecified)b | 19 (3.1) | 20 | 0.9 | 0.8 |
| Most frequent AEs by preferred term (ER >4.0 per 100 PYs) | ||||
| Upper respiratory tract infections | 93 (15.2) | 154 | 6.6 | 4.4 |
| Nasopharyngitis | 67 (10.9) | 101 | 4.3 | 3.1 |
| Urinary tract infections | 65 (10.6) | 94 | 4.0 | 3.0 |
| AEs leading to withdrawal | 119 (19.4) | 157 | N/A | 5.2 |
| AEs leading to death by system organ class | 19 (3.1) | 25 | N/A | 0.8 |
| Neoplasms (benign, malignant and unspecified) | 5 (0.8) | 5 | N/A | 0.2 |
| Cardiac disorders | 4 (0.7) | 6 | N/A | 0.2 |
| Nervous system disorders | 4 (0.7) | 4 | N/A | 0.2 |
| Injury, poisoning and procedural complications | 4 (0.7) | 4 | N/A | 0.2 |
| Infections and infestations | 2 (0.3) | 2 | N/A | 0.03 |
| Hepatobiliary disorders | 1 (0.2) | 1 | N/A | 0.04 |
| Musculoskeletal and connective tissue disorders | 1 (0.2) | 1 | N/A | 0.04 |
| Total SAEs by system organ class | 219 (35.8) | 364 | 15.7 | 11.2 |
| Infections/infestations | 90 (14.7) | 105 | 4.5 | 4.1 |
| Musculoskeletal and connective tissue disorders | 47 (7.7) | 65 | 2.8 | 2.1 |
| Neoplasms (benign, malignant and unspecified) | 27 (4.4) | 29 | 1.3 | 1.2 |
| Injury, poisoning and procedural complications | 23 (3.8) | 25 | 1.1 | 1.0 |
