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. Author manuscript; available in PMC: 2012 Jan 17.
Published in final edited form as: JAMA. 2010 Nov 3;304(17):1903–1911. doi: 10.1001/jama.2010.1510

Table 2.

Adverse Events in Docosahexaenoic Acid (DHA) and Placebo Groupsa

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
a

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.

b

Unable to calculate because of zero value.

c

Defined as events that result in death, hospitalization, prolongation of hospitalization, or are life threatening (based on the judgment of the study physician).