Table 3.
Adverse events of patients with moderate-to-severe atopic dermatitis (safety set).
| Items |
CM310 high-dose
(n = 40) |
CM310 low-dose
(n = 40) |
Placebo
(n = 40) |
|---|---|---|---|
| No. of TEAEs | 64 | 79 | 83 |
| Any TEAE | 30 (75) | 32 (80) | 30 (75) |
| Grade 3 | 0 | 1 (2) | 1 (2) |
| Grade 4/5 | 0 | 0 | 0 |
| No. of study drug-related TEAEs | 10 | 5 | 13 |
| Any study drug-related TEAE | 8 (20) | 5 (12) | 5 (12) |
| Grade 3 | 0 | 0 | 0 |
| Any SAE | 0 | 1 (2) | 2 (5) |
| TEAE leading to treatment discontinuation | 0 | 1 (2) | 1 (2) |
| TEAE leading to study discontinuation | 0 | 1 (2) | 0 |
| Death | 0 | 0 | 0 |
| TEAEs occurring in ≥5% of patients in any treatment group (MedDRA SOC or PT) | |||
| Investigations | 13 (32) | 14 (35) | 15 (38) |
| Blood bilirubin increased | 3 (8) | 2 (5) | 1 (2) |
| White blood cells urine positive | 3 (8) | 2 (5) | 0 |
| Blood uric acid increased | 2 (5) | 2 (5) | 1 (2) |
| Alanine aminotransferase increased | 1 (2) | 2 (5) | 2 (5) |
| Blood creatine phosphokinase increased | 2 (5) | 1 (2) | 2 (5) |
| Urinary occult blood positive | 0 | 2 (5) | 2 (5) |
| Blood triglycerides increased | 1 (2) | 1 (2) | 2 (5) |
| Blood lactate dehydrogenase increased | 1 (2) | 2 (5) | 1 (2) |
| Red blood cells urine positive | 0 | 0 | 3 (8) |
| Aspartate aminotransferase increased | 2 (5) | 0 | 1 (2) |
| White blood cell count increased | 0 | 0 | 2 (5) |
| Blood glucose increased | 0 | 2 (5) | 0 |
| Infections and infestations | 14 (35) | 9 (22) | 13 (32) |
| Upper respiratory tract infection | 8 (20) | 2 (5) | 4 (10) |
| Urinary tract infection | 2 (5) | 0 | 2 (5) |
| Skin infection | 0 | 3 (8) | 0 |
| Nasopharyngitis | 0 | 2 (5) | 1 (2) |
| Folliculitis | 1 (2) | 0 | 2 (5) |
| Skin and subcutaneous tissue disorders | 5 (12) | 6 (15) | 10 (25) |
| Dermatitis atopic | 0 | 3 (8) | 4 (10) |
| Urticaria | 3 (8) | 0 | 0 |
| Erythema | 0 | 0 | 2 (5) |
| Skin erosion | 0 | 0 | 2 (5) |
| Metabolism and nutrition disorders | 5 (12) | 6 (15) | 6 (15) |
| Hyperlipidemia | 4 (10) | 2 (5) | 1 (2) |
| Hyperuricemia | 0 | 5 (12) | 1 (2) |
| Gastrointestinal disorders | 1 (2) | 4 (10) | 3 (8) |
| Dental caries | 0 | 2 (5) | 0 |
| Hepatobiliary disorders | 1 (2) | 0 | 2 (5) |
| Hepatic function abnormal | 0 | 0 | 2 (5) |
| General disorders and administration site conditions | 1 (2) | 2 (5) | 0 |
| Injection site reaction | 0 | 2 (5) | 0 |
Data are presented as n (%), unless otherwise indicated. MedDRA: Medical Discovery for Regulatory Activities; PT: Preferred term; SAE: Serious adverse event; SOC: System organ class; TEAE: Treatment-emergent adverse event. Unless otherwise stated, data are presented as the number and percentage of patients. TEAEs were encoded by MedDRA v24.1.