Examples of ethnicity and geography issues in global clinical trials ...

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Geographic Regions CV Death, MI, Stroke Geographic region Total patients KM at month 12 Tic Clop HR (95% CI) Interaction p-values Asia / Australia 1714 11.4 14.8 0.80 (0.61, 1.04) Central America / South America Europe / Middle East / Africa 1237 13859 15.2 8.8 17.9 11.0 0.86 (0.65, 1.13) 0.80 (0.72, 0.90) 0.045 0.01 North America 1814 11.9 9.6 1.25 (0.93, 1.67) 0.5 1.0 2.0 Ticagrelor better Clopidogrel better
No Systematic Errors • US and ROW exhibited similar data quality based on query rates • Pharmacokinetic substudy samples of US ticagrelor patients had ticagrelor in their plasma • US patients had lower study drug compliance (62% vs. 85%) and higher study drug discontinuation (31% vs. 22%) but similar by treatment group • No bias observed in event reporting
Page 1 and 2: Examples of ethnicity and geography
Page 3 and 4: Trial Design Placebo NSTE Acute Cor
Page 5 and 6: Subgroups GUSTO Moderate/Severe Pri
Page 7 and 8: PLATO study design NSTE-ACS (modera
Page 9 and 10: Cumulative incidence (%) PLATO: pri
Page 11 and 12: Primary endpoint in predefined subg
Page 13: Primary endpoint in predefined subg
Page 17 and 18: High-dose Aspirin Use: Landmark Tim
Page 19 and 20: Primary Efficacy Outcome US and Non
Page 21 and 22: Summary • In PLATO, ticagrelor re
Page 23 and 24: RE-LY ® - participating countries
Page 25 and 26: Primary Outcome Sub-groups (3) Dabi
Page 27 and 28: % per year Stroke / SSE According t
Page 30 and 31: Ethnicity and geography issues in g

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