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.