Table 3 Laboratory adverse effects: possibly, probably or definitely drug related
 | 8-week period (%) | 12-week period (%) |
---|---|---|
Patients with one or more AEs | 18/420 (4.3) | 30/420 (7.1) |
Hematological test | ||
 Hematocrit decreased | 1/417 (0.2) | 1/417 (0.2) |
 Hemoglobin decreased | 2/418 (0.5) | 3/420 (0.7) |
Blood chemistry test | ||
 Alanine aminotransferase increased | 2/420 (0.5) | 2/420 (0.5) |
 Aspartate aminotransferase increased | 2/420 (0.5) | 2/420 (0.5) |
 Blood creatinine increased | — | 1/420 (0.2) |
 Blood glucose increased | 2/418 (0.5) | 3/418(0.7) |
 Blood potassium decreased | 2/420(0.5) | 3/420 (0.7) |
 Blood urea nitrogen increased | 4/292(1.4) | 7/292 (2.4) |
 Blood uric acid increased | 11/416(2.6) | 18/416 (4.3) |
 Creatine phosphokinase increased | — | 1/420 (0.2) |
 Hemoglobin A1C increased | — | 1/417 (0.2) |
Urinalysis test | ||
 Albumin urine present | 1/310 (0.3) | 1/310 (0.3) |