Outcomes/Endpoints
ICH, Seriousness
ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT
Microfilarial density thresholds, below which onwards transmission by the Chrysops vector cannot be sustained, are currently unknown but may depend on several factors including the life span of the insect vector [Secondary efficacy outcomes were the proportion of individuals in each treatment group being amicrofilaraemic at the last observation on day 168; the median reduction of Principal safety outcomes were defined as the occurrence of any related or unrelated grade 3 adverse event or serious adverse event (SAE) and occurrence of all adverse events at least possibly related to study medication assessed after the initiation of study treatment. Adverse event type, severity, seriousness and relationship to study drugs were assessed by the investigator. Seriousness was determined based on the serious adverse event definition in the ICH guidelines.