Phase 4 Pharmacovigilance Trial of Paromomycin Injection for the Treatment of Visceral Leishmaniasis in India

Table 3

Summary of treatment-emergent adverse events.

Type of adverse event	Intent-to-treat population (𝑁=494)
Treatment-emergent adverse events, 𝑛 (%)
Any adverse event	379 (77%)
Treatment related	320 (65%)
Severe or life threatening^a	35 (7%)
Led to premature discontinuation of study drug	5 (1%)
Serious, excluding death	13 (3%)^b
Death, 𝑛 (%)	2 (<1%)^c

^aGrade 3 or 4 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) definition.
^bTwo events (injection site reaction and renal failure acute) were considered to be related to study drug.
^cBoth deaths were considered not related to study drug.