Sign Out
Most common TEAEs (i.e., TEAEs reported in at least 1% of subjects in any treatment group were reported by 206 (16.9%) subjects in the Aklief cream group (total of 297 TEAEs) and in 116 (9.7%) subjects in the Vehicle Cream group (total of 140 TEAEs), as shown in the Table 4 as follows. (See Table 4.)
Click on icon to see table/diagram/imageLocal cutaneous reactions such as erythema, scaling, dryness, and stinging/burning were collected separately from other adverse events as a measure of local tolerance. These cutaneous reactions are very common and of mild, moderate and severe intensity for up to 39%, 29.7% and 6.2% of patients, respectively on the face. On the trunk, up to 32.9%, 18.9%, 5.2% of patients had mild, moderate and severe reactions respectively. The maximum severity typically occurred at Week 1 for the face, and at Week 2 to 4 for the trunk, and decreased with continued use of the medication (see Precautions).
The most "commonly" reported adverse reactions as described as follows in Table 5 are application site irritation, application site pruritus and sunburn, occurring in 1.2% to 6.5% of patients treated with Aklief cream in clinical studies.
Tabulated summary of adverse reactions: Adverse reactions reported in the 12-week vehicle-controlled Phase 3 studies in 1220 patients treated with Aklief cream (and for which the rate for Aklief cream exceeds the rate for vehicle cream) are presented in Table 5.
The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to 1 <100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). (See Table 5.)
Click on icon to see table/diagram/image
View ADR Reporting Link
Continue with Google