Table 5.
ARs occurring in ≥ 3 subjects (N = 25).
| Preferred term | Subjects (N = 25) n (%) | Infusions (n = 368) n (%) |
|---|---|---|
| Headache | 11 (44·0) | 21 (5·7) |
| Sinusitis | 6 (24·0) | 8 (2·2) |
| Hypotension | 4 (16·0) | 10 (2·7) |
| Tachycardia | 3 (12·0) | 5 (1·4) |
| Pyrexia | 3 (12·0) | 4 (1·1) |
| Hypertension | 3 (12·0) | 4 (1·1) |
| Fatigue | 3 (12·0) | 4 (1·1) |
| Infusion‐site reaction | 3 (12·0) | 4 (1·1) |
| Dry skin | 3 (12·0) | 3 (0·8) |
| Nasal congestion | 3 (12·0) | 3 (0·8) |
| Upper respiratory tract infection | 3 (12·0) | 3 (0·8) |
| Abdominal pain | 3 (12·0) | 2 (0·5) |
An adverse reaction (AR) was defined as a treatment‐emergent adverse event that began during an infusion or within 72 h after completion of an infusion, that was considered by investigators to be possibly, probably or definitely related to study drug, or for which the investigator's causality assessment was either missing or indeterminate.