Summary of rates of adverse events across all treatment groups. Rates are calculated as number of events/patient-years × 100 = events per 100 patient-years.
| Adverse Event | RADIUS 1, All Patients, n = 4968 | RADIUS 2, All Patients, n = 5103 | ||
|---|---|---|---|---|
| Patient-yrs = 16,167 | Patient-yrs = 17,040 | |||
| No. Events | Exposure-adjusted Event Rate, % (95% CI) | No. Events | Exposure-adjusted Event Rate, % (95% CI) | |
| SAE | 2378 | 14.7 (14.1, 15.3) | 2096 | 12.3 (11.8, 12.8) |
| SIE | 512 | 3.2 (2.9, 3.5) | 485 | 2.9 (2.6, 3.1) |
| Malignancy | 172 | 1.1 (0.9, 1.2) | 180 | 1.1 (0.9, 1.2) |
| Cardiovascular event | 232 | 1.4 (1.3, 1.6) | 184 | 1.1 (0.9, 1.3) |
| Death | 202 | 1.3 (1.1, 1.4) | 142 | 0.8 (0.7, 1.0) |
SAE: serious adverse event; SIE: serious infectious event.