Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer’s disease clinical program

Cummings, Jeffrey L.; Atri, Alireza; Ballard, Clive; Boneva, Neli; Frölich, Lutz; Molinuevo, José Luis; Raket, Lars Lau; Tariot, Pierre N.

doi:10.1186/s13195-018-0443-2

Alzheimer's Research & Therapy

Table 3 Incidence of adverse events by region

From: Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer’s disease clinical program

	Eastern Europe/Turkey (n = 759)	Western Europe/Israel (n = 709)	USA/Canada (n = 444)	South America/Mexico (n = 361)	Asia (n = 134)	Australia/South Africa (n = 99)
AEs per patient, mean (SD)
Placebo	1.01 (1.46) (n = 290)	1.64 (1.64) (n = 273)	1.63 (2.21) (n = 163)	1.24 (1.44) (n = 136)	1.48 (1.72) (n = 56)	1.76 (2.11) (n = 37)
Idalopirdine 10 mg/day	0.83 (1.45) (n = 82)	1.89 (1.68) (n = 76)	1.69 (2.09) (n = 67)	1.05 (1.59) (n = 39)	1.24 (1.61) (n = 21)	– (n = 0)
Idalopirdine 30 mg/day	0.98 (1.35) (n = 191)	1.97 (2.06) (n = 153)	2.14 (2.44) (n = 119)	1.58 (2.06) (n = 90)	1.36 (1.97) (n = 22)	2.68 (2.00) (n = 19)
Idalopirdine 60 mg/day	1.24 (1.82) (n = 196)	1.98 (2.11) (n = 207)	2.60 (3.01) (n = 95)	1.67 (2.21) (n = 96)	2.29 (1.98) (n = 35)	2.40 (2.21) (n = 43)
SAEs per patient, mean (SD)
Placebo	0.08 (0.35) (n = 290)	0.05 (0.25) (n = 273)	0.10 (0.67) (n = 163)	0.02 (0.19) (n = 136)	0.16 (0.85) (n = 56)	0.16 (0.50) (n = 37)
Idalopirdine 10 mg/day	0.05 (0.22) (n = 82)	0.04 (0.26) (n = 76)	0.09 (0.34) (n = 67)	0.03 (0.16) (n = 39)	0.00 (0.00) (n = 21)	– (n = 0)
Idalopirdine 30 mg/day	0.06 (0.26) (n = 191)	0.05 (0.21) (n = 153)	0.08 (0.33) (n = 119)	0.07 (0.25) (n = 90)	0.00 (0.00) (n = 22)	0.05 (0.23) (n = 19)
Idalopirdine 60 mg/day	0.11 (0.39) (n = 196)	0.08 (0.35) (n = 207)	0.12 (0.35) (n = 95)	0.07 (0.33) (n = 96)	0.06 (0.34) (n = 35)	0.02 (0.15) (n = 43)
Deaths per patient, mean (SD)
Placebo	0.01 (0.10) (n = 290)	0.00 (0.00) (n = 273)	0.00 (0.00) (n = 163)	0.00 (0.00) (n = 136)	0.00 (0.00) (n = 56)	0.00 (0.00) (n = 37)
Idalopirdine 10 mg/day	0.00 (0.00) (n = 82)	0.00 (0.00) (n = 76)	0.00 (0.00) (n = 67)	0.00 (0.00) (n = 39)	0.00 (0.00) (n = 21)	– (n = 0)
Idalopirdine 30 mg/day	0.01 (0.07) (n = 191)	0.01 (0.08) (n = 153)	0.00 (0.00) (n = 119)	0.00 (0.00) (n = 90)	0.00 (0.00) (n = 22)	0.00 (0.00) (n = 19)
Idalopirdine 60 mg/day	0.01 (0.10) (n = 196)	0.00 (0.00) (n = 207)	0.00 (0.00) (n = 95)	0.01 (0.10) (n = 96)	0.00 (0.00) (n = 35)	0.00 (0.00) (n = 43)

AE adverse event, SAE serious adverse event, SD standard deviation

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