|
Adverse Event (AE)
|
Study Visits
|
|---|
|
4-week
|
8-week
|
12-week
|
24-week
|
|---|
|
no. pts reporting AEs/total no. pts (%)
|
no. pts reporting AEs/total no. pts (%)
|
no. pts reporting AEs/total no. pts (%)
|
no. pts reporting AEs/total no. pts (%)
|
|---|
|
Throat/mouth irritation*
|
16/45 (35.6%)
|
9/43 (20.9%)
|
7/41 (17.1%)
|
4/38 (10.5%)
|
|
Dry throat/mouth
|
13/45 (28.9%)
|
10/43 (23.3%)
|
9/41 (22.0%)
|
7/38 (18.4%)
|
|
Headache
|
12/45 (26.7%)
|
9/43 (20.9%)
|
8/41 (19.5%)
|
8/38 (21.1%)
|
|
Dry cough
|
10/45 (22.2%)
|
7/43 (16.3%)
|
5/41 (12.2%)
|
2/38 (5.3%)
|
|
Dizziness§
|
7/45 (15.6%)
|
7/43 (16.3%)
|
5/41 (12.2%)
|
3/38 (7.9%)
|
|
Nausea
|
6/45 (13.3%)
|
5/43 (11.6%)
|
5/41 (12.2%)
|
5/38 (13.2%)
|
|
Sore throat
|
4/45 (8.9%)
|
3/43 (7.0%)
|
1/41 (2.4%)
|
1/38 (2.6%)
|
|
Palpitations
|
3/45 (6.7%)
|
3/43 (7.0%)
|
0/41 (0%)
|
0/38 (0%)
|
|
Choking sensation
|
2/45 (4.4%)
|
1/43 (2.3%)
|
0/41 (0%)
|
0/38 (0%)
|
- *Throat and mouth irritation were described either as tickling, itching, or burning sensation.
-
§Dizziness, was also used to mean vertigo and light-headedness.
