Page 245 - Drug Class Review
P. 245
Drug Effectiveness Review Project
55.7%; 58.9%; 70.4% placebo galantamine 18; 24; 36 mg/d 43.7% 4.6% 17%; 7.1%; 16.7% 3.4% 17%; 17.9%; 37% 4.6% 5.7%; 10.7%; 14.8% Post randomization exclusions: Yes Overall loss to follow-up: 27.7% Loss to follow-up differential high: Yes; highest between high dose GAL and placebo placebo galantamine 18; 24; 36 mg/d 16% 28%; 25%; 48% 9.2% 21.6%; 17.9%; 44.4% Page 153 of 205
NR ITT: Yes Yes Yes Yes Fair
Final Report Update 1 Authors: Wilkinson et al. Year:2001 ADVERSE EVENTS: Overall adverse effects reported: Vomiting • Nausea • Headache • 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: *primary outcome measures Alzheimer's Drugs
