TABLE 2.
Results of the analysis of the primary outcome in the observational study compared with the ROCKET AF trial
| Arms | Observational study | ROCKET AF trial | ||||
|---|---|---|---|---|---|---|
| ITT | PP | As‐treated | ITT | PP | As‐treated | |
| Rivaroxaban | ||||||
| Number of events | 92 | 40 | 72 | 269 | 188 | 189 |
| Event rate: number/100 person‐years | 0.90 | 1.01 | 1.19 | 2.10 | 1.70 | 1.70 |
| Warfarin | ||||||
| Number of events | 987 | 254 | 462 | 306 | 241 | 243 |
| Event rate: number/100 person‐years | 0.81 | 0.98 | 1.01 | 2.40 | 2.20 | 1.01 |
| Hazard ratio (95% CI) Original analysis | 1.04 (0.84‐1.30) | 0.98 (0.70‐1.38) | 1.11 (0.86‐1.42) | 0.88 (0.75‐1.03) | 0.79 (0.66‐0.96) | 0.79 (0.65‐0.95) |