Serious and non-serious adverse events occurring during the study.
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SSG = sodium stibogluconate; PM = paromomycin sulphate; SSG & PM = combination treatment;AE, adverse event; SAE, serious adverse event; TEAE, treatment emergent adverse event;aThere were two consent withdrawals in the PM arm (after 4 and 6 days on treatment) and 1 withdrawal in the SSG & PM arm (after 6 days on treatment) - data were therefore collected only up to the day of withdrawal for these patients.bTreatment emergent adverse event is defined as onset being between day 1 of treatment and 30 days post end of treatment, inclusive.cNo patient experienced more than one SAE.dAdverse drug reaction is defined as any adverse event the investigator recorded as having a probable, possible or unlikely relationship to the study drug.eCause of deaths were as follows: SSG: unknown (1), Acute Renal Failure (2), cardiotoxicity (1); PM: VL; SSG & PM: Pericarditis tuberculosis (1), malaria (1).fPerson-days at risk is defined as the treatment period per study drug regimen plus an additional 30 days post end of treatment.
创建时间:
2015-12-02



