MedDRA-coded drug-related side effects
| Drug-related side effect (MedDRA SOC & LLT) | Total number (n) | mAb (n) | Placebo (n) |
|---|---|---|---|
| Gastrointestinal disorders | 6 | ||
| Diarrhea | 1 | 2 | |
| Nausea | 2 | 1 | |
| General disorders and administration site conditions | 3 | ||
| Ankle edema | 1 | ||
| Erythema | 1 | ||
| Limb edema | 1 | ||
| Infections and infestations | 3 | ||
| Herpes simplex infection | 1 | 1 | |
| Shingles | 1 | ||
| Musculoskeletal and connective tissue disorders | 2 | ||
| Arthralgia | 1 | 1 | |
| Nervous system disorders | 12 | ||
| Lethargy | 8 | 4 | |
| Psychiatric disorders | 2 | ||
| Insomnia | 1 | 1 | |
| Total number of drug-related side effects | 18 | 10 | |
| Total number of patients with drug-related side effects (%) | 12/19 (63.16) | 8/12 (66.67) | |
| Total number of patients with serious drug-related side effects (%) | 0/19 (0.00) | 0/12 (0.00) | |
n: number of patients/events. LLT: lower limit term; mAb: monoclonal antibody; MedDRA: Medical Dictionary for Regulatory Activities; SOC: system organ class