Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison
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
valuea
Pomaglumetad methionil
(%)
Aripiprazole
(%)
Total
(%)
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*
. values are from Fisher’s exact test. : total number of patients in each treatment group; MedDRA: Medical Dictionary for Regulatory Activities; TEAE: treatment-emergent adverse event.
