A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Sumycin Side Effects, and Drug Interactions - Tetracycline (periodontal)
Sumycin Side Effects, and Drug Interactions - Tetracycline (periodontal)
SIDE EFFECTS
Actisite® fiber has
been studied in 1437 patients distributed as follows over pivotal,
controlled, and open-label studies.
| Study Type |
| Demographics |
Pivotal |
Controlled |
Uncontrolled |
TOTAL |
|
Gender:
|
| Male |
113 |
70 |
455 |
638 |
| Female |
113 |
55 |
631 |
799 |
|
Age Range
|
25-88 |
25-73 |
13-87 |
13-88 |
|
Race:
|
| Black |
13 |
12 |
41 |
66 |
| Asian |
4 |
1 |
10 |
15 |
| Hispanic |
3 |
3 |
11 |
17 |
| Caucasian |
206 |
105 |
964 |
1275 |
| Native American |
0 |
2 |
56 |
58 |
| Other |
0 |
2 |
5 |
7 |
Demographics Pivotal Controlled Uncontrolled TOTAL Gender: Male
113 70 455 638 Female 113 55 631 799 Age Range 25-88 25-73 13-87
13-88 Race: Black 13 12 41 66 Asian 4 1 10 15 Hispanic 3 3 11 17
Caucasian 206 105
964 1275 Native American 0 2 56 58 Other 0 2 5 7
The most frequently reported adverse reactions in the 226 patients
in the pivotal clinical
trials were discomfort on fiber
placement (10%) and local erythema
following removal (11%).
In controlled and open-label trials patients, the following adverse
reactions have been reported in less than 1% of patients: oral
candidiasis, glossitis, possible allergic
response, staining
of the tongue, severe gingival inflammation, throbbing
pain, pain
following placement in an abscessed area, and minor
throat irritation.
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