Clinical Study
Phase 4 Pharmacovigilance Trial of Paromomycin Injection for the Treatment of Visceral Leishmaniasis in India
Table 4
Treatment-related and treatment-emergent adverse events in ≥1% of patients.
| | System organ class | CTCAE gradea | | Total | | Preferred term | Grade 1 | Grade 2 | Grade 3 | Grade 4 | | () |
| | Any adverse event, (%) | 182 (37%) | 116 (23%) | 21 (4%) | 1 (<1%) | | 320 (65%) | | Investigations, (%) | | | | | | | | Alanine aminotransferase increased | 158 (32%) | 49 (10%) | 7 (1%) | 0 (0%) | | 214 (43%) | | Aspartate aminotransferase increased | 92 (19%) | 75 (15%) | 17 (3%) | 1 (<1%) | | 185 (37%) | | Blood alkaline phosphatase increased | 48 (10%) | 11 (2%) | 0 (0%) | 0 (0%) | | 59 (12%) | | Blood creatinine increased | 26 (5%) | 5 (1%) | 1 (<1%) | 0 (0%) | | 32 (6%) | | Blood bilirubin increased | 20 (4%) | 0 (0%) | 1 (<1%) | 0 (0%) | | 21 (4%) | | General disorders and administration site conditions, (%) | | | | | | | | Injection site pain | 18 (4%) | 31 (6%) | 1 (<1%) | 0 (0%) | | 50 (10%) |
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aNational Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) definition.
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