Table 2.
Safety measure | Double-blind treatment phase | P valuea | ||
---|---|---|---|---|
Pomaglumetad methionil N = 511 |
Aripiprazole N = 161 |
Total N = 672 |
||
SAEs | 42 (8.2) | 5 (3.1) | 47 (7.0) | 0.032* |
Discontinuations due to AEs | 83 (16.2) | 14 (8.7) | 97 (14.4) | 0.020* |
TEAEs | 370 (72.4) | 109 (67.7) | 479 (71.3) | 0.272 |
*P < 0.05.
a P values are from Fisher's exact test.
AE: adverse event; N: total number of patients in each treatment group; SAE: serious adverse event; TEAE: treatment-emergent adverse event.