TABLE 4.
Treatment‐emergent adverse events
| Preferred term | Renal impairment category a , b | AE severity |
|---|---|---|
| Upper respiratory tract infection | Mild (n = 1); severe (n = 1) | Moderate |
| Vertigo | Mild (n = 1) | Moderate |
| Hypertension | Moderate (n = 1) | Moderate |
| Vessel puncture site hemorrhage | Mild (n = 3); severe (n = 1) | Mild |
| Headache | Mild (n = 1); moderate (n = 1) | Mild |
| Vessel puncture site hematoma | Mild (n = 2) | Mild |
| Leukocytosis | Normal (n = 1) | Mild |
| Constipation | Normal (n = 1) | Mild |
| Administration site extravasation | Normal (n = 1) | Mild |
| Oropharyngeal pain | Mild (n = 1) | Mild |
| Vessel puncture site erythema | Mild (n = 1) | Mild |
| Vessel puncture site paresthesia | Mild (n = 1) | Mild |
| Diarrhea | Moderate (n = 1) | Mild |
| Dizziness | Moderate (n = 1) | Mild |
| Confusional state | Moderate (n = 1) | Mild |
| Skin abrasion | Severe (n = 1) | Mild |
Abbreviations: AE, adverse event; eGFR, estimated glomerular filtration rate.
a
Normal renal function = eGFR ≥ 90 ml/min, mild renal impairment = eGFR 60–<90 ml/min, moderate renal impairment = eGFR 30–<60 ml/min, and severe renal impairment = eGFR <30 ml/min.
b
n refers to the number of events; some subjects reported multiple events.