Table 3.
Incidence of adverse events by region
| 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