Percentage of Participants With Auditory Abnormalities at Day 7 Assessed by Auditory Brainstem Response (ABR) Wave III Latency Changes on Day 7(a Type of Hearing Test) 7 days [clinicaltrials_resource:e7b9424ae7b0d9cfa0f085ed428c630f]
To demonstrate the safety of artemether-lumefantrine after 3 days of treatment in patients with acute, uncomplicated falciparum malaria by testing the null hypothesis that the rate of auditory abnormalities is ≥ 15% in the population treated with artemether-lumefantrine as assessed by ABR at Day 7 following initiation of treatment compared with their baseline values. An "auditory nerve abnormality" is here defined as a greater than 0.30 ms change in Wave III latency from baseline to Day 7. Exact Pearson-Clopper two-sided 95% confidence limits were constructed for all three treatment groups.
clinicaltrials_vocabulary:primary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:primary-outcome]
Percentage of Participants With Auditory Abnormalities at Day 7 Assessed by Auditory Brainstem Response (ABR) Wave III Latency Changes on Day 7(a Type of Hearing Test) 7 days [clinicaltrials_resource:e7b9424ae7b0d9cfa0f085ed428c630f]
To demonstrate the safety of artemether-lumefantrine after 3 days of treatment in patients with acute, uncomplicated falciparum malaria by testing the null hypothesis that the rate of auditory abnormalities is ≥ 15% in the population treated with artemether-lumefantrine as assessed by ABR at Day 7 following initiation of treatment compared with their baseline values. An "auditory nerve abnormality" is here defined as a greater than 0.30 ms change in Wave III latency from baseline to Day 7. Exact Pearson-Clopper two-sided 95% confidence limits were constructed for all three treatment groups.
Bio2RDF identifier
e7b9424ae7b0d9cfa0f085ed428c630f
Bio2RDF namespace
clinicaltrials_resource
Bio2RDF uri
http://bio2rdf.org/clinicaltrials_resource:e7b9424ae7b0d9cfa0f085ed428c630f
measure [clinicaltrials_vocabulary:measure]
Percentage of Participants Wit ...... Day 7(a Type of Hearing Test)
time frame [clinicaltrials_vocabulary:time-frame]
description
To demonstrate the safety of a ...... or all three treatment groups.
identifier
clinicaltrials_resource:e7b9424ae7b0d9cfa0f085ed428c630f
title
Percentage of Participants Wit ...... a Type of Hearing Test) 7 days
@en
type
label
Percentage of Participants Wit ...... 9424ae7b0d9cfa0f085ed428c630f]
@en