Clinical Study
Phase 4 Pharmacovigilance Trial of Paromomycin Injection for the Treatment of Visceral Leishmaniasis in India
Table 5
Mean change from baseline to study day 8, study day 15, and EOT/ET for tests of liver and renal function.
| | Indice | Mean (SD) Visit Value | Mean (SD) Change from Baseline |
| | AST (U/L) | | | | Baseline () | 52.89 (27.16) | | | Day 8 () | 73.54 (72.01) | 20.47 (67.13) | | Day 15 () | 64.36 (48.60) | 11.26 (49.75) | | EOT/ETa () | 58.37 (26.21) | 5.28 (32.65) | | ALT (U/L) | | | | Baseline () | 39.62 (27.25) | | | Day 8 () | 58.22 (70.62) | 18.50 (62.96) | | Day 15 () | 58.17 (54.35) | 18.39 (52.00) | | EOT/ETa () | 51.83 (30.18) | 12.05 (32.64) | | Alkaline phosphatase (U/L) | | | | Baseline () | 229.00 (127.84) | | | Day 8 () | 261.70 (168.80) | 31.92 (129.97) | | Day 15 () | 261.60 (137.59) | 32.12 (114.93) | | EOT/ETa () | 254.23 (119.51) | 24.75 (116.80) | | Bilirubin total (mg/dL) | | | | Baseline () | 0.60 (0.26) | | | Day 8 () | 0.57 (0.37) | −0.03 (0.38) | | Day 15 () | 0.56 (0.23) | −0.03 (0.29) | | EOT/ETa () | 0.57 (0.22) | −0.03 (0.29) | | BUN (mg/dL) | | | | Baseline () | 12.58 (4.15) | | | Day 8 () | 10.20 (3.32) | −2.33 (4.55) | | Day 15 () | 11.07 (3.64) | −1.46 (4.66) | | EOT/ETa () | 11.54 (4.39) | −0.99 (5.35) | | Serum creatinine (mg/dL) | | | | Baseline () | 0.83 (0.26) | | | Day 8 () | 0.75 (0.25) | −0.08 (0.20) | | Day 15 () | 0.75 (0.26) | −0.09 (0.23) | | EOT/ETa () | 0.75 (0.30) | −0.09 (0.28) |
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ALT, alanine aminotransferase; AST, aspartate aminotransferase.
aEnd of treatment or early termination.
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