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Participant characteristics Intervention details Outcome assessment Allocated: a, 58, b 53, c 60 Completed: a 46, b 25, c 45 Drop-out: a 12, b 28, c 15 Assessed for GI symptoms: a 58, b 53, c 60 Outcomes reported: GI symptoms, endoscopic ulcers, anaemia, GI drop-outs How were adverse events assessed: participants asked if there had been any problems since last visit How was compliance assessed: tablet count Risk factors: history of ulcers (1 year or more ago) a 10, b 14, c 14; all participants aged 60 years or more CVD a 0, b 0 FUNDING Funded by: SmithKline Beecham Pharmaceuticals Affiliation of contact author: Arthritis Center, Phoenix, AZ, USA Affiliation of statistician: unclear Affiliation of trial administrator: unclear No.
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Participant characteristics Intervention details Outcome assessment Allocated: a 134, b 134, c 136, d 133 Completed: a 111, b 111, c 122, d 114 Drop-out: a 23, b 23, c 14 d 19 Assessed: a 133, b 134, c 136, d 132 Outcomes reported: mortality, serious GI complications, serious cardiovascular or renal illness (extra data) endoscopic ulcers, total drop-outs How were adverse events assessed: participants kept diary of daily symptoms and asked direct questions at each visit How was compliance assessed: tablet count, 90% in groups a, c and d were compliant compared with 73% in group b (misoprostol) Risk factors: history of ulcers: all participants FUNDING Funded by: TAP Pharmaceutical Products Affiliation of contact author: Veterans Affairs Medical Center, Houston, TX, USA Affiliation of statistician: Abbott Laboratories Affiliation of study administrator: TAP Pharmaceutical Products No.
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Director of Medical Affairs for Searle India Other: unclear how many participants in each group had aspirin Risk factors, funding, other notes Baseline GI status: normal endoscopy Type and duration of arthritis (years): OA: a 15, b 15; RA: a 15, b 15; seronegative spondarthropathy: a 15, b 15 (no other details) Age: a 38.
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Traducerea acestei pagini Between January 2004 and October 2012, 2 individuals taking ACLASTA reported ALPHA 1 GLOBULIN INCREASED to the FDA.
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Traducerea acestei pagini Analysis of PAIN as a potential adverse side effect of ACLASTA.
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Traducerea acestei pagini Analysis of THROMBOCYTOPENIA as a potential adverse side effect of ACLASTA.
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