The most frequently reported nondental treatment-emergent adverse events in the 3 multicenter US trials were headache, infection, flu syndrome, and pain.
Table 5: Adverse Events (AEs) Reported in ≥ 3% of the Combined Clinical
SRP Alone N=250 |
SRP + Vehicle N=249 |
SRP + ARESTIN® N=423 |
|
Number (%) of Patients Treatment-emergent AEs |
62.4% | 71,9% | 68.1% |
Total Number of AEs | 543 | 589 | 987 |
Periodontitis | 25.6% | 28.1% | 16.3% |
Tooth Disorder | 12.0% | 13.7% | 12.3% |
Tooth Caries | 9.2% | 11.2% | 9.9% |
Dental Pain | 8.8% | 8.8% | 9.9% |
Gingivitis | 7.2% | 8.8% | 9.2% |
Headache | 7.2% | 11,6% | 9.0% |
Infection | 8.0% | 9.6% | 7.6% |
Stomatitis | 8.4% | 6.8% | 6.4% |
Mouth Ulceration | 1.6% | 3.2% | 5.0% |
Flu Syndrome | 3.2% | 6.4% | 5.0% |
Pharyngitis | 3.2% | 1.6% | 4.3% |
Pain | 4.0% | 1.2% | 4.3% |
Dyspepsia | 2.0% | 0 | 4.0% |
Infection Dental | 4.0% | 3.6% | 3.8% |
Mucous Membrane Disorder | 2.4% | 0.8% | 3.3% |
Trial Population of 3 Multicenter US Trials by Treatment Group
The change in clinical attachment levels was similar across all study arms, suggesting that neither the vehicle nor ARESTIN® compromise clinical attachment.