Preferred term |
New/ Fasted
(n= 30) |
New/ Semi-fed
(n= 30) |
Current/ Fasted
(n= 30) |
Current/ Semi-fed
(n= 30) |
Overall
(n= 30) |
n (%)[1] |
nAE[2] |
n (%)[1] |
nAE[2] |
n (%)[1] |
nAE[2] |
n (%)[1] |
nAE[2] |
n (%)[1] |
nAE[2] |
Abdominal Pain |
1 (3.3) |
2 |
1 (3.3) |
1 |
2 (6.7) |
2 |
2 (6.7) |
2 |
2 (6.7) |
7 |
Abdominal Pain Upper |
0 |
0 |
1 (3.3) |
1 |
1 (3.3) |
1 |
0 |
0 |
2 (6.7) |
2 |
Nausea |
0 |
0 |
1 (3.3) |
1 |
1 (3.3) |
1 |
0 |
0 |
2 (6.7) |
2 |
Headache |
1 (3.3) |
1 |
1 (3.3) |
1 |
2 (6.7) |
2 |
2 (6.7) |
2 |
6 (20.0) |
6 |
Dizziness |
0 |
0 |
1 (3.3) |
1 |
1 (3.3) |
1 |
2 (6.7) |
3 |
3 (10.0) |
5 |
Burning Sensation |
1 (3.3) |
1 |
0 |
0 |
0 |
0 |
1 (3.3) |
1 |
2 (6.7) |
2 |
Oropharyngeal pain |
1 (3.3) |
1 |
0 |
0 |
0 |
0 |
2 (6.7) |
2 |
3 (10.0) |
3 |
|
[1] n(%)= Number (percent of subjects)
[2] nAE= Number of adverse events |
Table 4: Most frequently occurring AEs in the study (overall incidence of occurrence ≥5%) listed. |