Table 3. Subjects Experiencing at Least One Unsolicited or Solicited Adverse Events (FAS, N = 632).

Subject based	Diagnosed AD (N = 350) n (%)	Healthy (N = 282) n (%)	P-value
At least one AE documented	331 (94.6)	268 (95.0)	0.858
SAE in active study period	1 (0.3)	2 (0.7)	0.589
AESI	58 (16.6)	38 (13.5)	0.316
AE leading to withdrawal from study	0 (0.0)	1 (0.4)	0.446
Causally related AE	236 (67.4)	168 (59.6)	0.046
Causally related AE graded ≥ 3	27 (7.7)	16 (5.7)	0.343

N = number of subjects in the specified group; n = number of subjects in the specified category (with at least one adverse event); % = percentages of n based on N; AD = atopic dermatitis; AE = adverse event; AESI = adverse event of special interest; SAE = serious adverse event; related AE = AE considered by the investigator to have a possible, probable, definite or missing relationship to study medication; Grade ≥ 3 = AE which prevented normal everyday activities or body temperature ≥ 39°C; FAS = full analysis set. P-value is Fisher’s exact test of the differences in proportions between groups.