Table 6.
The incidence of adverse events per treatment group*
| Treatment groups | Placebo | SFPP
|
||
|---|---|---|---|---|
| 10 mg | 20 mg | 40 mg | ||
| Safety population, n | 127 | 121 | 127 | 134 |
| Completed, n (%) | 124 (97.6) | 120 (99.2) | 125 (98.4) | 129 (96.3) |
|
| ||||
| Study discontinuations, n (%) | ||||
| Caused by AEs | 2 (1.6) | 1 (0.8) | 1 (0.8) | 1 (0.7) |
| Caused by Drug-related AEs | 1 (0.8) | 1 (0.8) | 1 (0.8) | 1 (0.7) |
|
| ||||
| AEs, n (%) | ||||
| All-cause | 18 (14.2) | 19 (15.7) | 18 (14.2) | 23 (17.2) |
| Drug-related | 10 (7.9) | 16 (13.2) | 10 (7.9) | 19 (14.2) |
| AEs of application site conditions, n (%) | ||||
| All-cause | 7 (5.5) | 12 (9.9) | 5 (3.9) | 14 (10.4) |
| Drug-related | 7 (5.5) | 12 (9.9) | 5 (3.9) | 14 (10.4) |
| Most common drug-related AEs† | ||||
| Application site dermatitis | 7 (5.5) | 8 (6.6) | 3 (2.4) | 10 (7.5) |
| Systemic AEs, n (%) | ||||
| All-cause | 12 (9.4) | 10 (8.3) | 13 (10.2) | 11‡ (8.2) |
| Drug-related | 3 (2.4) | 5 (4.1) | 5 (3.9) | 5 (3.7) |
| Most common drug-related AEs† | ||||
| Blood urea increased | 1 (0.8) | 2 (1.7) | 2 (1.6) | 3 (2.2) |
| Drug-related AEs of gastrointestinal disorders | ||||
| Gastric ulcer | 0 (0.0) | 0 (0.0) | 1 (0.8) | 0 (0.0) |
| Epigastric discomfort | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.7) |
Notes:
*
The same patient may be listed under different adverse events.
†
More than 2% in any of the groups
‡
An AE that led to hospitalization (vertigo) was observed in one subject. The investigator ruled out the causal relationship to the study treatment.
Abbreviations: SFPP, S-flurbiprofen plaster; AEs, adverse events.