Table 2.
Most frequent treatment-emergent AEs by dose at time of AE onset in safety population
|
AE |
Sodium oxybate dose at event onset
a
|
||||
|---|---|---|---|---|---|
| 4.5 g (n = 545) | 6 g (n = 432) | 7.5 g (n = 239) | 9 g (n = 112) | Total (N = 560) b | |
| Any AE, number (%)c |
295 (54.1) |
265 (61.3) |
163 (68.2) |
88 (78.6) |
498 (88.9) |
| Nausea |
44 (8.1) |
44 (10.2) |
23 (9.6) |
10 (8.9) |
112 (20.0) |
| Headache |
42 (7.7) |
43 (10.0) |
21 (8.8) |
7 (6.3) |
106 (18.9) |
| Dizziness |
29 (5.3) |
28 (6.5) |
13 (5.4) |
6 (5.4) |
72 (12.9) |
| Nasopharyngitis |
25 (4.6) |
21 (4.9) |
7 (2.9) |
6 (5.4) |
57 (10.2) |
| Vomiting |
21 (3.9) |
16 (3.7) |
9 (3.8) |
7 (6.3) |
52 (9.3) |
| Sinusitis |
14 (2.6) |
21 (4.9) |
13 (5.4) |
4 (3.6) |
50 (8.9) |
| Diarrhea |
16 (2.9) |
24 (5.6) |
7 (2.9) |
4 (3.6) |
49 (8.8) |
| Anxiety |
18 (3.3) |
18 (4.2) |
11 (4.6) |
3 (2.7) |
44 (7.9) |
| Insomnia |
12 (2.2) |
14 (3.2) |
10 (4.2) |
3 (2.7) |
38 (6.8) |
| Influenza |
12 (2.2) |
14 (3.2) |
9 (3.8) |
3 (2.7) |
37 (6.6) |
| Somnolence |
10 (1.8) |
15 (3.5) |
4 (1.7) |
7 (6.3) |
34 (6.1) |
| Upper respiratory tract infection |
2 (0.4) |
18 (4.2) |
11 (4.6) |
4 (3.6) |
34 (6.1) |
| Muscle spasms |
7 (1.3) |
8 (1.9) |
10 (4.2) |
4 (3.6) |
29 (5.2) |
| Urinary tract infection |
5 (0.9) |
8 (1.9) |
5 (2.1) |
6 (5.4) |
22 (3.9) |
| Gastroenteritis viral | 1 (0.2) | 4 (0.9) | 5 (2.1) | 6 (5.4) | 16 (2.9) |
‘Most frequent’ is defined as ≥5% in any dose group or overall. aAll patients began treatment in the long-term extension study with SXB 4.5 g/night and remained at that dose level for at least one week, with subsequent dose adjustments to address the level of response as well as safety and tolerability as stated in ‘Methods;’ bif the dose at AE onset was not among the indicated doses, the patient was summarized in the ‘Total’ group only; cvalues of Any AE, (number and percent) may not match the sum of the listed individual events since uncommon events are not included. AE, adverse event.