Table 2.
Safety assessment
| TEAEs | All patients (N = 294) | |
|---|---|---|
| nE | nE/100PY | |
| Total number of TEAEs | 1131 | 370.2 |
| Total number of serious TEAEs | 5 | 1.6 |
| Total number of severe TEAEs | 12 | 3.9 |
| Total number of TEAEs related to treatment | 120 | 39.3 |
| Total number of TEAEs related to permanent treatment discontinuation | 2 | 0.7 |
| n (%) | nP/100PY | |
|---|---|---|
| Patients with any TEAE | 217 (73.8) | 194.6 |
| Patients with any serious TEAE | 5 (1.7) | 1.7 |
| Patients with any severe TEAE | 11 (3.7) | 3.8 |
| Patients with any TEAEs related to treatment | 53 (18.0) | 20.2 |
| Patients with any TEAEs leading to permanent discontinuation | 2 (0.7) | 0.7 |
| Conjunctivitis clustera | 26 (8.8) | 9.2 |
| Injection-site reactions (HLT) | 19 (6.5) | 6.6 |
| Skin infections and infestations (SOC)b | 37 (12.6) | 13.9 |
| Most common TEAEs reported in ≥3% of patients (PT) | ||
| Nasopharyngitis | 60 (20.4) | 23.6 |
| Dermatitis atopic | 56 (19.0) | 21.3 |
| Upper respiratory tract infection | 35 (11.9) | 12.5 |
| Headache | 26 (8.8) | 9.3 |
| Oropharyngeal pain | 16 (5.4) | 5.6 |
| Vomiting | 13 (4.4) | 4.5 |
| Influenza | 13 (4.4) | 4.4 |
| Oral herpes | 12 (4.1) | 4.2 |
| Conjunctivitis | 12 (4.1) | 4.1 |
| Pyrexia | 12 (4.1) | 4.1 |
| Acne | 11 (3.7) | 3.8 |
| Conjunctivitis allergic | 11 (3.7) | 3.7 |
| Diarrhea | 10 (3.4) | 3.5 |
| Abdominal pain upper | 10 (3.4) | 3.4 |
| Cough | 9 (3.1) | 3.1 |
| Sinusitis | 9 (3.1) | 3.0 |
| Viral upper respiratory tract infection | 9 (3.1) | 3.0 |
ESM electronic supplementary material, HLT MedDRA high-level term, MedDRA Medical Dictionary for Regulatory Activities, nE number of events, nP number of patients, PT MedDRA preferred term; 100PY 100 patient-years, SOC system organ class, TEAE treatment-emergent adverse event
aConjunctivitis cluster includes conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, allergic conjunctivitis, and atopic keratoconjunctivitis; further details of conjunctivitis are presented in Table S4 in the ESM
bFurther details of skin infections are presented in Table S5 in the ESM