Table 3.
Adverse events in MD (Part II) by system organ class
| CJM112 15 mg (n = 11) | CJM112 50 mg (n = 10) | CJM112 150 mg low (n = 10) | CJM112 150 mg high (n = 11) | CJM112 Total (n = 42) | Secukinumab 150 mg (n = 6) | Placebo (n = 6) | |
|---|---|---|---|---|---|---|---|
| Patients with AE | 5 (45.5) | 5 (50) | 4 (40) | 9 (81.8) | 23 (54.8) | 2 (33.3) | 5 (83.3) |
| System organ class (SOC) | |||||||
| Infections and infestations† | 0 | 1 (10) | 2 (20) | 6 (54.5) | 9 (21.4) | 1 (16.7) | 2 (33.3) |
| Skin and subcutaneous tissue disorders | 2 (18.2) | 1 (10) | 3 (30) | 1 (9.1) | 7 (16.7) | 0 | 1 (16.7) |
| Gastrointestinal disorders † , ‡ | 1 (9.1) | 2 (20) | 1 (10) | 1 (9.1) | 5 (11.9) | 1 (16.7) | 0 |
| Nervous system disorders | 2 (18.2) | 2 (20) | 1 (10) | 0 | 5 (11.9) | 0 | 1 (16.7) |
| Investigations | 0 | 2 (20) | 2 (20) | 0 | 4 (9.5) | 0 | 1 (16.7) |
| Musculoskeletal and connective tissue disorders | 1 (9.1) | 1 (10) | 1 (10) | 1 (9.1) | 4 (9.5) | 0 | 1 (16.7) |
| Injury, poisoning and procedural complications | 0 | 0 | 1 (10) | 3 (27.3) | 4 (9.5) | 0 | 0 |
| Respiratory, thoracic and mediastinal disorders | 0 | 0 | 1 (10) | 1 (9.1) | 2 (4.8) | 0 | 1 (16.7) |
| Cardiac disorders | 0 | 1 (10) | 0 | 1 (9.1) | 2 (4.8) | 0 | 0 |
| General disorders and administration site conditions | 1 (9.1) | 0 | 0 | 1 (9.1) | 2 (4.8) | 0 | 0 |
| Neoplasms benign, malignant and unspecified | 1 (9.1) | 0 | 1 (10) | 0 | 2 (4.8) | 0 | 0 |
| Psychiatric disorders | 0 | 1 (10) | 0 | 0 | 1 (2.4) | 0 | 1 (16.7) |
| Eye disorders | 1 (9.1) | 0 | 0 | 0 | 1 (2.4) | 0 | 0 |
| Immune system disorders | 0 | 1 (10) | 0 | 0 | 1 (2.4) | 0 | 0 |
| Metabolism and nutrition disorders | 0 | 0 | 1 (10) | 0 | 1 (2.4) | 0 | 0 |
| Renal and urinary disorders | 0 | 0 | 0 | 1 (9.1) | 1 (2.4) | 0 | 0 |
| Reproductive system and breast disorders | 1 (9.1) | 0 | 0 | 0 | 1 (2.4) | 0 | 0 |
†
Infections and infestations include adenovirus (n = 1), conjunctivitis (1), cystitis (1), ear infection (1), gastroenteritis (3), nasopharyngitis (n = 1), otitis externa (n = 1), tinea infection (n = 2), upper respiratory tract infection (n = 4).
‡
Gastrointestinal disorders include abdominal wall haematoma (n = 1), aphthous ulcer (n = 1), constipation (n = 1), diarrhoea (n = 2), dyspepsia (n = 1) and nausea (n = 1). Subjects with multiple adverse events within a body system are counted only once in the table above.