TABLE 4.
Frequency of TEAEs by system organ class and preferred terma
| System organ class/preferred term | Data by renal function |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mild impairment (n = 8) |
Moderate impairment (n = 8) |
Severe impairment (n = 8) |
Normal (n = 8) |
Total (n = 32) |
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| F | No. of subjects with AEs | % subjects with AEs | F | No. of subjects with AEs | % subjects with AEs | F | No. of subjects with AEs | % subjects with AEs | F | No. of subjects with AEs | % subjects with AEs | F | No. of subjects with AEs | % subjects with AEs | |
| Total TEAEs | 2 | 2 | 25.0 | 0 | 0 | 0 | 9 | 4 | 50 | 2 | 1 | 12.5 | 14 | 8 | 25.0 |
| Gastrointestinal disorders | 3 | 2 | 25 | 3 | 2 | 6.3 | |||||||||
| Erosive gastritis | 1 | 1 | 12.5 | 1 | 1 | 3.1 | |||||||||
| Melena | 1 | 1 | 12.5 | 1 | 1 | 3.1 | |||||||||
| Oral paresthesia | 1 | 1 | 12.5 | 1 | 1 | 3.1 | |||||||||
| General disorders and administration site conditions | 2 | 2 | 25.0 | 1 | 1 | 12.5 | 1 | 1 | 12.5 | 4 | 4 | 12.5 | |||
| Infusion site erythema | 1 | 1 | 12.5 | 1 | 1 | 12.5 | 1 | 1 | 12.5 | 3 | 3 | 9.4 | |||
| Fatigue | 1 | 1 | 12.5 | 1 | 1 | 3.1 | |||||||||
| Investigations | 6 | 3 | 37.5 | 6 | 3 | 9.4 | |||||||||
| Blood potassium decreased | 1 | 1 | 12.5 | 1 | 1 | 3.1 | |||||||||
| Hematocrit decreased | 1 | 1 | 12.5 | 1 | 1 | 3.1 | |||||||||
| Hemoglobin decreased | 1 | 1 | 12.5 | 1 | 1 | 3.1 | |||||||||
| Neutrophil count increased | 1 | 1 | 12.5 | 1 | 1 | 3.1 | |||||||||
| Red blood cell count decreased | 1 | 1 | 12.5 | 1 | 1 | 3.1 | |||||||||
| White blood cell count increased | 1 | 1 | 12.5 | 1 | 1 | 3.1 | |||||||||
| Nervous system disorders | 1 | 1 | 12.5 | 1 | 1 | 3.1 | |||||||||
| Headache | 1 | 1 | 12.5 | 1 | 1 | 3.1 | |||||||||
a
Adverse events were coded using MedDRA version 14.0. F, number of AEs.