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Table 12 Major complications related to study drugs

From: Low dose compared to variable dose Warfarin and to Fondaparinux as prophylaxis for thromboembolism after elective hip or knee replacement surgery; a randomized, prospective study

Relationship to study drug

n

Description

Study arm

Possibly related

1

Painless hematochezia following hard bowel movement (minor)

B

Probably related

1

Hematoma, operative leg, from post-op trauma (minor; delayed discharge)

B

1

Hematoma evaluated, no intervention required (minor; delayed discharge)

B

Related

1

Hemorrhage with ischemic colitis. INR prolonged on 1 mg warfarin

C

  

per day due to VKORC-1 genome disorder. (major; readmitted to hospital)

Â