Table 2.
No. (%) | |||
---|---|---|---|
Adverse Event | DHA Group (n = 238) | Placebo Group (n = 164) | P Value |
Any adverse event | 214 (89.9) | 144 (87.8) | .52 |
Diarrhea | 18 (7.6) | 10 (6.1) | .69 |
Urinary tract infection | 23 (9.7) | 12 (7.3) | .47 |
Fall | 42 (17.6) | 33 (20.1) | .60 |
Dizziness | 12 (5.0) | 9 (5.5) | .82 |
Agitation | 24 (10.1) | 12 (7.3) | .38 |
International normalized ratio | |||
Decreased | 3 (1.3) | 0 | NAb |
Increased | 0 | 1 (0.6) | NAb |
Serious adverse eventsc | |||
Any | 76 (31.9) | 50 (30.5) | .83 |
Hospitalization | 67 (28.2) | 43 (26.2) | .73 |
Death | 11 (4.6) | 4 (2.4) | .29 |
Deep venous thrombosis or pulmonary embolus | 8 (3.4) | 2 (1.2) | .32 |
Includes adverse events occurring in at least 5% of participants, warfarin-associated adverse events of interest, all serious adverse events, and thrombosis-associated adverse events of interest.
Unable to calculate because of zero value.
Defined as events that result in death, hospitalization, prolongation of hospitalization, or are life threatening (based on the judgment of the study physician).