Table 6. Subjects Experiencing at Least One Unsolicited Adverse Events (Occurring in ≥ 2% of Subjects in any Study Group, FAS, N = 632).
| System organ class Preferred term (MedDRA 9.0) | Diagnosed AD (N = 350) n (%) | Healthy (N = 282) n (%) | p-Value |
|---|---|---|---|
| At least one unsolicited AE | 240 (68.6) | 182 (64.5) | 0.3083 |
| Unsolicited AE Grade 1 | 298 (68.5) | 432 (80.1) | 0.1108 |
| Unsolicited AE Grade 3 | 29 (6.7) | 21 (3.9) | 0.7627 |
| Systemic disorders and administration site conditions | 119 (34.0) | 65 (23.0) | 0.0027 |
| Injection site pruritus | 100 (28.6) | 48 (17.0) | 0.0007 |
| Injection site bruising | 7 (2.0) | 2 (0.7) | 0.3114 |
| Injection site induration | 3 (0.9) | 6 (2.1) | 0.1977 |
| Investigations | 63 (18.0) | 46 (16.3) | 0.5979 |
| Troponin I increased | 54 (15.4) | 37 (13.1) | 0.4273 |
| Infections and infestations | 56 (16.0) | 55 (19.5) | 0.2930 |
| Nasopharyngitis | 23 (6.6) | 11 (3.9) | 0.1582 |
| Influenza | 11 (3.1) | 8 (2.8) | 1.0000 |
| Upper respiratory tract infection | 6 (1.7) | 9 (3.2) | 0.2946 |
| Pharyngitis | 4 (1.1) | 9 (3.2) | 0.0916 |
| Pharyngotonsillitis | 3 (0.9) | 7 (2.5) | 0.1196 |
| Gastrointestinal disorders | 30 (8.6) | 29 (10.3) | 0.4933 |
| Diarrhoea | 9 (2.6) | 7 (2.5) | 1.0000 |
| Nervous system disorders | 29 (8.3) | 27 (9.6) | 0.5766 |
| Headache | 16 (4.6) | 19 (6.7) | 0.2940 |
| Dizziness | 11 (3.1) | 7 (2.5) | 0.8107 |
| Skin and subcutaneous tissue disorders | 35 (10.0) | 10 (3.5) | 0.0017 |
| Dermatitis atopica | 15 (4.3) | 0 (0.0) | 0.0002 |
| Respiratory, thoracic and mediastinal disorders | 16 (4.6) | 25 (8.9) | 0.0345 |
| Cough | 3 (0.9) | 8 (2.8) | 0.0705 |
| Pharyngolaryngeal pain | 2 (0.6) | 8 (2.8) | 0.0275 |
| Rhinorrhoea | 3 (0.9) | 6 (2.1) | 0.1977 |
| Musculoskeletal and connective tissue disorders | 13 (3.7) | 19 (6.7) | 0.1008 |
| Injury, poisoning and procedural procedures | 9 (2.6) | 15 (5.3) | 0.0932 |
| Reproductive system and breast disorders | 9 (2.6) | 11 (3.9) | 0.3683 |
| Dysmenorrhoea | 8 (2.3) | 7 (2.5) | 1.0000 |
| Psychiatric disorders | 7 (2.0) | 9 (3.2) | 0.4464 |
| Eye disorders | 7 (2.0) | 3 (1.1) | 0.5243 |
N = number of subjects in the specified group; n = number of subjects in the specified category (with at least one report of a unsolicited AE); % = percentages of n based on N; AD = atopic dermatitis; AE = adverse event; MedDRA = Medical Dictionary for Regulatory Activities; FAS = full analysis set.