Summary of ADRs and observed person-years (ie, time at risk) (safety analysis set)
| Cohort A (switched from VKA to dabigatran) | Cohort B (newly initiated on dabigatran or a VKA) | |||||||||||
| Total (n=4066) | Dabigatran (n=3164) | VKA (n=2181) | Total (n=5345) | |||||||||
| n (%) | Time at risk, pt-yrs | Rate/ 100 pt-yrs | n (%) | Time at risk, pt-yrs | Rate/ 100 pt-yrs | n (%) | Time at risk, pt-yrs | Rate/ 100 pt-yrs | n (%) | Time at risk, pt-yrs | Rate/ 100 pt-yrs | |
| Any ADRs | 94 (2.3) | 1967 | 4.78 | 80 (2.5) | 1532 | 5.22 | 60 (2.8) | 1073 | 5.59 | 140 (2.6) | 2605 | 5.37 |
| Any bleeding ADR | 27 (0.7) | NE | NE | 30 (0.9) | NE | NE | 39 (1.8) | NE | NE | 69 (1.3) | NE | NE |
| Serious ADRs | 26 (0.6) | 1981 | 1.31 | 25 (0.8) | 1541 | 1.62 | 15 (0.7) | 1084 | 1.38 | 40 (0.7) | 2625 | 1.52 |
| Serious bleeding ADR | 8 (0.2) | NE | NE | 4 (0.1) | NE | NE | 3 (0.1) | NE | NE | 7 (0.1) | NE | NE |
| ADRs leading to discontinuation | 43 (1.1) | 1981 | 2.17 | 32 (1.0) | 1544 | 2.07 | 4 (0.2) | 1086 | 0.37 | 36 (0.7) | 2630 | 1.37 |
| Bleeding ADRs leading to discontinuation | 13 (0.3) | NE | NE | 16 (0.5) | NE | NE | 2 (0.1) | NE | NE | 18 (0.3) | NE | NE |
| Fatal ADRs | 5 (0.1) | 1984 | 0.25 | 2 (0.1) | 1545 | 0.13 | 4 (0.2) | 1086 | 0.37 | 6 (0.1) | 2631 | 0.23 |
| Fatal bleeding ADR | 0 | NE | NE | 0 | NE | NE | 0 | NE | NE | 0 | NE | NE |
ADR, adverse drug reaction; NE, not evaluated; pt-yrs, patient-years; VKA, vitamin K antagonist.