Table 3.
Incidence of most common treatment-emergent adverse events ≥3% in any treatment group and/or with statistically significant treatment difference, by preferred term.
| MedDRA preferred term | Double-blind treatment phase | P valuea | ||
|---|---|---|---|---|
| Pomaglumetad methionil N = 511 n (%) |
Aripiprazole N = 161 n (%) |
Total N = 672 n (%) |
||
| Nausea | 98 (19.2) | 18 (11.2) | 116 (17.3) | 0.023* |
| Insomnia | 50 (9.8) | 19 (11.8) | 69 (10.3) | 0.459 |
| Headache | 57 (11.2) | 10 (6.2) | 67 (10.0) | 0.071 |
| Vomiting | 41 (8.0) | 12 (7.5) | 53 (7.9) | >0.999 |
| Nasopharyngitis | 38 (7.4) | 8 (5.0) | 46 (6.8) | 0.371 |
| Blood creatine phosphokinase increased | 29 (5.7) | 4 (2.5) | 33 (4.9) | 0.141 |
| Anxiety | 22 (4.3) | 9 (5.6) | 31 (4.6) | 0.519 |
| Decreased appetite | 22 (4.3) | 6 (3.7) | 28 (4.2) | >0.999 |
| Diarrhea | 20 (3.9) | 8 (5.0) | 28 (4.2) | 0.651 |
| Schizophrenia | 24 (4.7) | 2 (1.2) | 26 (3.9) | 0.058 |
| Dizziness | 17 (3.3) | 8 (5.0) | 25 (3.7) | 0.343 |
| Akathisia | 13 (2.5) | 12 (7.5) | 25 (3.7) | 0.007* |
| Dry mouth | 15 (2.9) | 5 (3.1) | 20 (3.0) | >0.999 |
| Fatigue | 14 (2.7) | 6 (3.7) | 20 (3.0) | 0.594 |
| Back pain | 9 (1.8) | 5 (3.1) | 14 (2.1) | 0.341 |
| Dyspepsia | 5 (1.0) | 6 (3.7) | 11 (1.6) | 0.027* |
| Pyrexia | 2 (0.4) | 4 (2.5) | 6 (0.9) | 0.032* |
| Nasal congestion | 1 (0.2) | 3 (1.9) | 4 (0.6) | 0.045* |
*P < 0.05.
a P values are from Fisher's exact test.
N: total number of patients in each treatment group; MedDRA: Medical Dictionary for Regulatory Activities; TEAE: treatment-emergent adverse event.