Table 5.
Patients with liver and biliary system adverse events over 6 years of lanthanum carbonate treatment: no event was considered likely to be related to lanthanum carbonate treatment
| Number of patients (%) at beginning of year | Year 1 |
Year 2 |
Year 3 |
Year 4 |
Year 5 |
Year 6 |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| US (n = 52) | EU (n = 41) | US (n = 51) | EU (n = 41) | US (n = 46) | EU (n = 40) | US (n = 17) | EU (n = 39) | US (n = 1) | EU (n = 35) | US (n = 0) | EU (n = 22) | |
| Cholelithiasis | 1 (1.9) | 1 (2.6) | 2 (5.7) | |||||||||
| Hepatic enzymes increased | 1 (2.4) | 1 (2.9) | ||||||||||
| Hepatitis cholestatic | 1 (2.4) | |||||||||||
| Hepatomegaly | 1 (1.9) | 1 (2.0) | ||||||||||
| GGT increased | 1 (2.0) | 2 (4.3) | ||||||||||
GGT = Gamma-glutamyltranspeptidase. Treatment exposure years were defined as: year 1 = >0 to <1 year of treatment; year 2 = 1 to <2 years; year 3 = 2 to <3 years; year 4 = 3 to <4 years; year 5 = 4 to <5 years; year 6 = ≥5 years. Empty cells indicate no events observed.