MedDRA-coded adverse events
| Adverse event (MedDRA SOC & LLT) | Total number (n) | mAb (n) | Placebo (n) |
|---|---|---|---|
| Cardiac disorders | 1 | ||
| Palpitations | 1 | ||
| Ear and labyrinth disorders | 1 | ||
| Ear noises | 1 | ||
| Eye disorders | 3 | ||
| Deterioration of visual acuity | 2 | ||
| Optic neuropathy# | 1 | ||
| Gastrointestinal disorders | 7 | ||
| Aphthae | 1 | ||
| Diarrhea | 1 | 2 | |
| Nausea | 2 | 1 | |
| General disorders and administration site conditions | 4 | ||
| Ankle edema | 2 | ||
| Erythema | 1 | ||
| Limb edema | 1 | ||
| Infections and infestations | 7 | ||
| Herpes simplex infection | 1 | 1 | |
| Hordeolum | 1 | ||
| Inguinal abscess | 1 | ||
| SARS-CoV-2 infection | 1 | ||
| Shingles | 1 | ||
| Vaginal mycosis | 1 | ||
| Injury, poisoning, and procedural complications | 1 | ||
| Sprain | 1 | ||
| Investigations | 2 | ||
| Increased intraocular pressure | 1 | 1 | |
| Musculoskeletal and connective tissue disorders | 5 | ||
| Arthralgia | 1 | 2 | |
| Groin pain | 1 | ||
| Myalgia | 1 | ||
| Nervous system disorders | 22 | ||
| Autoimmune encephalomyelitis# | 1 | ||
| Dizziness | 1 | ||
| Headache | 6 | ||
| Lethargy | 8 | 4 | |
| Paresis | 1 | ||
| Paresthesia | 1 | ||
| Psychiatric disorders | 2 | ||
| Insomnia | 1 | 1 | |
| Reproductive system and breast disorders | 3 | ||
| Irregular menstruation | 3 | ||
| Skin and subcutaneous tissue disorders | 1 | ||
| Neurodermatitis | 1 | ||
| Vascular disorders | 2 | ||
| Hypertension | 1 | 1 | |
| Total number of adverse events | 38 | 23 | |
| Total number of patients with adverse events (%) | 15/19 (78.95) | 11/12 (91.67) | |
| Total number of patients with serious adverse events (%) | 2/19 (10.52) | 0/12 (0.00) | |
# Adverse event classified as serious adverse event. n: number of patients/events. LLT: lower limit term; mAb: monoclonal antibody; MedDRA: Medical Dictionary for Regulatory Activities; SOC: system organ class