Table 5

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 ADRs94 (2.3)19674.7880 (2.5)15325.2260 (2.8)10735.59140 (2.6)26055.37
Any bleeding ADR27 (0.7)NENE30 (0.9)NENE39 (1.8)NENE69 (1.3)NENE
Serious ADRs26 (0.6)19811.3125 (0.8)15411.6215 (0.7)10841.3840 (0.7)26251.52
Serious bleeding ADR8 (0.2)NENE4 (0.1)NENE3 (0.1)NENE7 (0.1)NENE
ADRs leading to discontinuation43 (1.1)19812.1732 (1.0)15442.074 (0.2)10860.3736 (0.7)26301.37
Bleeding ADRs leading to discontinuation13 (0.3)NENE16 (0.5)NENE2 (0.1)NENE18 (0.3)NENE
Fatal ADRs5 (0.1)19840.252 (0.1)15450.134 (0.2)10860.376 (0.1)26310.23
Fatal bleeding ADR0NENE0NENE0NENE0NENE
  • ADR, adverse drug reaction; NE, not evaluated; pt-yrs, patient-years; VKA, vitamin K antagonist.