Sensitivity, specificity, negative and positive predictive values of the DiaMed IT-LEISH and the Signal KA for VL diagnosis in Kacheliba and Kimalel, Rift Valley province, Kenya.

<p>Abbreviations: PPV = positive predictive value, NPV = negative predictive value, CI = Confidence Interval.</p

Comparison of demographic and laboratory characteristics between VL and non-VL patients in Kacheliba and Kimalel, Rift Valley province, Kenya.

<p>IQR = inter-quartile range.</p>*<p>p-value from t-test or Kruskal-Wallis test for continuous variables and Chi-square or Fisher Exact test for categorical variables.</p>**<p>measured between tip of spleen and left costal margin (at anterior axillary line level).</p

Baseline biological markers.

<p>Baseline biological markers.</p

Incidence of adverse drug reactions.^*

<p>Incidence of adverse drug reactions.^{<a href="http://www.plosntds.org/article/info:doi/10.1371/journal.pntd.0004880#t008fn001" target="_blank">*</a>}</p

Parasite clearance from the blood in the first week of treatment.

<p>All parasite blood loads are relative to the individual parasite load at baseline. The full lines indicate the mean and the error bars its 95% confidence interval, stratified per treatment arm.</p

Baseline parasite count.

<p>Baseline parasite count.</p

Sequential stopping for the three arms.

<p>The horizontal axis (<i>V</i>) is proportional to sample size. The vertical axis (<i>Z</i>) is the observed minus expected number of cures, so higher values are more favourable. Each arm is shown by a line with three points representing, from left to right, the first interim analysis (decision: continue for all arms), the second interim analysis (decision: continue for all arms) and the final analysis. The final analysis (shown here) includes patients whose follow-up was still in progress at the time of the third interim analysis, and confirmed the ‘stop’ decisions. Having all stopped at the same analysis, the point estimates of proportion cured are the same for all arms (85%), as are the 95% confidence intervals (77–97%). Based on the probability tree method, the point estimate at day 210 for AmBisome + SSG is 87% (95% CI 77–97%); for AmBisome + Miltefosine it is 77% (64–90%) and for Miltefosine 72% (60–85%).</p

Stratified D210 efficacy.

<p>Stratified D210 efficacy.</p

Baseline demographic characteristics.

<p>Baseline demographic characteristics.</p

Safety summary.

<p>Safety summary.</p