Comparing recruitment, retention, and safety reporting among geographic regions in multinational Alzheimer’s disease clinical trials

Table 3 Treatment-emergent adverse event rates per participant per month for combined trial arms among regions ^a

Study program	Treatment group	North America	Western Europe	Australia/South Africa	Japan	Asia	Eastern Europe/Russia	South America/Mexico
IDENTITY	Placebo	0.52 ± 1.31^SA,EE,JP	0.37 ± 0.78^EE,JP	0.34 ± 0.48	0.14 ± 0.17 ^WE,NA	0.31 ± 0.63	0.31 ± 0.84^WE,NA	0.25 ± 0.56^NA
IDENTITY	Semagacestat 140 mg PO	1.10 ± 1.59^EE,JP	0.76 ± 1.02^EE	0.87 ± 0.85^EE	0.57 ± 0.86^NA	0.69 ± 0.89	0.62 ± 1.28^AU,WE,NA	0.88 ± 1.36
EXPEDITION	Placebo	0.40 ± 0.57^SA,EE,JP,WE	0.24 ± 0.27^SA,EE,NA	0.42 ± 0.31^{SA,EE, JP,WE}	0.16 ± 0.13^AU,NA	0.31 ± 0.42^EE	0.19 ± 0.40^AS,AU,WE,NA	0.22 ± 0.28^AU,NA
EXPEDITION	Solanezumab 400 mg IV	0.41 ± 0.68^SA,EE,JP,WE	0.24 ± 0.63^NA	0.51 ± 1.04^SA,EE	0.21 ± 0.22^NA	0.29 ± 0.68^EE	0.11 ± 0.13^AS,AU,NA	0.19 ± 0.29^AU,NA

^aData are presented as mean ± standard deviation. SA = P < 0.01 vs South America/Mexico; EE = P < 0.01 vs Eastern Europe/Russia; AS = P < 0.01 vs Asia; JP = P < 0.01 vs Japan; AU = P < 0.01 vs Australia/South Africa; WE = P < 0.01 vs Western Europe; NA = P < 0.01 vs North America; IV = Intravenously; PO = By mouth.

ISSN: 1758-9193