TABLE 3.
Adverse event incidence in subpopulations compared to the total long-term safety population*
| SUBPOPULATION (n) | TOTAL AE FOLD CHANGE† | INCREASED INDIVIDUAL AE INCIDENCE (>1.5-FOLD) | DECREASED INDIVIDUAL AE INCIDENCE (>0.5-FOLD) | |
|---|---|---|---|---|
| Subject disposition | ||||
| Gender | Male (113) Female (336) |
0.69 1.11 |
↓ Flushing | |
| Age (years) | ≤39 (82) 40-59 (255) ≤60 (112) |
1.18 1.00 0.89 |
↑ Flushing, erythema, skin discomfort | ↓ Irritation |
| Fitzpatrick skin type | I/II (213) III/IV (229) |
1.07 0.96 |
↑ Skin discomfort | ↓ Skin discomfort |
| Blood pressure (mmHg; mean systolic/diastolic) | <95 (138) 95-105 (194) >105 (117) |
0.95 0.97 1.10 |
||
| Rosacea variables | ||||
| Disease duration (years) | 0-5 (138) 6-15 (177) >15 (134) |
0.90 1.12 0.96 |
||
| Erythema severity | Moderate (394) Severe (55) |
1.02 0.83 |
↓ Skin discomfort, rosacea | |
| Inflammatory lesions | None (186) 1-5 (131) >5 (132) |
1.02 1.08 0.89 |
↑ Skin discomfort | |
*
The total subject population includes the subpopulation to which it is being compared
†
Bold font designates total AE incidence at least ±0.25-fold-different from the total subject population
AE=adverse event