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Digestive: Anorexia, cholelithiasis, colitis, duodenal ulcer, duodenitis, esophageal haemorrhage, esophagitis, increased GGT, gastritis, gastroenteritis, gum haemorrhage, hematemesis, melena, peptic ulcer, periodontal abscess, rectal haemorrhage, stomach ulcer, tongue edema. Endocrine: Text Continues Below
Diabetes mellitus. Hemic and Lymphatic: Anemia, ecchymosis, iron deficiency anemia, polycythemia, purpura. Metabolic and Nutritional: Increased creatinine, gout, hyperlipemia, hyperuricemia. Musculoskeletal: Arthralgia, bone pain, bursitis. Nervous: Anxiety, insomnia, neuralgia. Respiratory: Asthma, epistaxis, hemoptysis, pneumonia, sinusitis.
Skin and Appendages:Dry skin, furunculosis, skin hypertrophy, urticaria. Special Senses: Amblyopia, blindness, conjunctivitis, diplopia, ear pain, eye haemorrhage, retinal haemorrhage, tinnitus. Urogenital: Albuminuria, cystitis, urinary frequency, vaginal haemorrhage, vaginitis.
Most Commonly Reported AEs (Incidence =2%) in Patients on PLETAL (PLT) 50 mg b.i.d. or 100 mg b.i.d. and Occurring at a Rate in the 100 mg b.i.d.
Group Higher Than in Patients on Placebo
Adverse Events (AEs) PTL 50 mg b.i.d. PTL 100 mg b.i.d. Placebo by Body System (N=303) (N=998) (N=973)
% % %
(N=303) (N=998) (N=973)
BODY AS A WHOLE
Abdominal pain 4 5 3
Back pain 6 7 6
Headache 27 34 14
Infection 14 10 8 CARDIOVASCULAR
Palpitation 5 10 1
Tachycardia 4 4 1 DIGESTIVE
Abnormal stools 12 15 4
Diarrhea 12 19 7
Dyspepsia 6 6 4
Flatulence 2 3 2
Nausea 6 7 6 Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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