Blood collection and assessment of adverse events
TEAE, Subjective TEAEs, TEAEs, Cancer
ADVERSE EVENT, EVENT, CANCER
For part I, groups of 10 same sex participants were brought to the research center the night prior to treatment for screening, which included baseline laboratory tests, physical exams and scrotal ultrasound examinations for men. The following morning, starting at 7 a.m., and within about 30 minutes after breakfast, participants were treated with a single co-administered dose of the study medications according to the randomization scheme. All study medications were administered as directly observed therapy and participants were observed for 30 minutes after administration. Biochemistry and urine tests were repeated at 24 and 48 hours and 7 days post-treatment. There was 100% compliance with all blood draws for the pharmacokinetic samples as well as biochemistry laboratory assessments. TEAE is defined as an undesirable event that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. After treatment, participants were monitored for TEAEs every 6 hours for the first 48 hours, then every 12 hours until 72 hours, and again at day 7 post-treatment. Upon returning to their home village after the first 72 hours, passive surveillance for potential TEAEs was conducted by trained community health workers in the participants’ home villages on days 4–6 with active follow up on day 7 by study personnel. New or worsening symptoms, changes in vital signs, or new abnormal findings on laboratory tests or physical examination were considered to be TEAEs and were scored using a modified version of the National Cancer Institute Common Terminology Criteria for Adverse Events, v4.0. We evaluated both objective and subjective TEAEs. Subjective TEAEs were symptoms felt and reported by the participants, while objective TEAEs were measured laboratory values, vital signs or physical exam findings.After a pre-specified review of safety data from Part I (inpatient monitoring), the DSMB recommended continuation to part II (outpatient treatment and monitoring). Participants in part II were enrolled and treated in their village of residence, applying the same screening and eligibility criteria as part I. Active follow up of all participants was performed in their village at 24 and 48 hours after treatment. Biochemistry and urine tests were repeated at 48 hours after treatment. Passive surveillance was performed by trained village health workers through day 7. Any grade 2 (moderate) or higher TEAE was followed until resolution or stabilization.