of TEAEs were similar between tazarotene- and vehicle-treated males (19.0% vs 19.3%; Table 2). TEAE rates for tazarotene-treated females, however, were greater than vehicle-treated females (30.8% vs 19.0%). Tazarotene-treated females also had higher TEAE rates than males treated with tazarotene (19.0%) or vehicle (19.3%). The majority of TEAEs were of mild to moderate severity and generally deemed unrelated to treatment, except in tazarotene-treated females who had similar incidences of related and unrelated TEAEs (14.7% and 16.1%, respectively). The most common TEAEs (≥5% of females or males in any treatment group) were application site pain and application site dryness; these were reported by a greater percentage of tazarotenetreated females than males. Discontinuations due to AEs were <4% with either treatment in both females and males, although rates were higher in females (3.7% tazarotene and 0.8% vehicle) than males (1.1% and 0%) in both treatment arms. None of the reported serious AEs were considered by the investigator to be related to treatment.
