Page 91 - Drug Class Review
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Drug Effectiveness Review Project
galantamine PRC placebo galantamine 70 72 79 3 7 6 5 14 17 7 7 5 2 9 7 3 5 6 6 4 8 4 7 10 6 6 8 5 4 5 8 7 7 6 6 6 Post randomization exclusions: NR Overall loss to follow-up: 197 (20%) Loss to follow-up differential high: No placebo galantamine galantamine PRC 17% (54) 23% (75) 21% (68) 5% (15) 7% (24) 9% (28) Page 76 of 205
Not reported ITT: Yes Yes Yes Yes Good
Final Report Update 1 Authors: Brodaty et al. Year: 2005 ADVERSE EVENTS: Overall adverse effects reported (%) Anorexia • Nausea • Diarrhea • Vomiting • Depression • Injury • Dizziness • Headache • Respiratory tract infection • Urinary tract infection • Fall • Significant differences in adverse events: ANALYSIS: ADEQUATE RANDOMIZATION: ADEQUATE ALLOCATION CONCEALMENT: BLINDING OF OUTCOME ASSESSORS: ATTRITION (overall): ATTRITION (treatment specific): Loss to follow-up: Withdrawals due to adverse events: QUALITY RATING: *prim
