Table 3.
Treatment-emergent adverse events following three weekly subcutaneous doses of RPC4046 in patients with asthma
| MedDRA SOC preferred term, n (%) | Part 3: patients with asthma | |||
|---|---|---|---|---|
| Placebo (n = 4) | RPC4046 3 weekly SC doses | |||
| 0.3 mg/kg (n = 4) | 3 mg/kg (n = 4) | Total (N = 8) | ||
| Any AE | 3 (75.0) | 4 (100) | 2 (50.0) | 6 (75.0) |
| URTI | 1 (25.0) | 3 (75.0) | 0 | 3 (37.5) |
| Viral URTI | 0 | 1 (25.0) | 0 | 1 (12.5) |
| Infusion site pain | 0 | 0 | 0 | 0 |
| Any AE at least possibly drug related | 1 (25.0) | 0 | 0 | 0 |
| Any severe AE | 0 | 0 | 0 | 0 |
| Any SAE | 0 | 0 | 0 | 0 |
| Any AE leading to study drug discontinuation | 0 | 0 | 0 | 0 |
| Any fatal AE | 0 | 0 | 0 | 0 |
AE adverse event, MedDRA Medical Dictionary for Regulatory Activities, SAE serious AE, SC subcutaneous, SOC system organ class, URTI upper respiratory tract infection