Overview of assessment of treatment effects.
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D: Day, M: Month. X indicates examination at each time point indicated in the top row, numbers indicate the day or alternative days for performing the examination.
1PE: Physical examination including neurological examination and subcutaneous nodule palpation.
2VS: Vital signs including temperature, respiratory rate, pulse rate (PR) and blood pressure (BP) after at least 5 minutes supine.
PR and BP were repeated after 2 minutes standing following ≥5 minutes supine.
Day 1: once before and 3 times after drug administration PR and BP after ≥5 minutes supine and subsequent 2 minutes standing still, Days 2–8: 5 times, PR and BP after ≥5 minutes supine and subsequent 2 minutes standing still, Days 9–17: twice, supine only, M1–M18: once, supine only.
312 lead ECG on day 1 approximately 4 hours after drug administration.
4OE: Ocular Examination included visual acuity, visual fields (calibrated Goldman perimeter), colour vision, intraocular pressure, examination of the fundus, slit lamp examination of anterior segment, counting of microfilariae in anterior chamber, living and dead microfilariae in cornea and punctate opacities.
Colour fundus photography and fluorescein angiography to month 3, thereafter as per protocol only in participants with lesions or visual defects on OE (which was not applicable).
5LE: Laboratory evaluations included: serum biochemistry (Na+, K+, Cl−, bicarbonate, glucose, total protein, albumin, urea, creatinine, alkaline phosphatase, lactic dehydrogenase, total bilirubin, gamma-glutamyl transpeptidase, aspartate aminotransferase, and alanine aminotransferase), hematology (prothrombin time, a complete blood cell count, hematocrit, hemoglobin, 5-part differential white blood cell count, platelet count), dipstick semiquantitative urinalysis microscopic urine evaluation, urine and blood microfilariae quantitation after nucleopore membrane filtration and Giemsa staining.
6Minimum of 1 mg from each iliac crest and calf with a 2 mm corneoscleral punch.
7Aseptical excision of all palpable nodules under 2% xylocaine anaesthesia.
8Blood sampling time points for pharmacokinetics (PK) on day 1–4: within 2 hours of drug administration, 1, 2, 4, 8, 24, and 72 hours after treatment.
创建时间:
2014-06-26



