Demographic and hematological profile of patients undergoing rK39 RDT testing for visceral leishmaniasis, Gondar, Ethiopia, 2012–2013.

<p>IQR: interquartile range; RDT: rapid diagnostic test; WBC: white blood cells</p><p>Demographic and hematological profile of patients undergoing rK39 RDT testing for visceral leishmaniasis, Gondar, Ethiopia, 2012–2013.</p

Use of Hormonal Contraceptives by Participant Characteristics^*

*<p>Response variable coded as: 0 = Did not use hormonal contraceptives, 1 = Used hormonal contraceptives.</p>**<p>Significant observation.</p

Duration of Contraceptive use prior to Screening, Contraceptive Methods Used at enrollment and Pregnancies Reported

<p>Duration of Contraceptive use prior to Screening, Contraceptive Methods Used at enrollment and Pregnancies Reported</p

Demographic Characteristics of Female Study Participants by Site

<p>Demographic Characteristics of Female Study Participants by Site</p

Pattern of Contraceptive Use at Enrolment by Selected Demographic Factors (All Sites)

<p>Pattern of Contraceptive Use at Enrolment by Selected Demographic Factors (All Sites)</p

Previous Condom Use as Contraception by Participant Characteristics^*

*<p>Response variable coded as: 0 = Did not use condom for contraception, 1 = Used condoms as contraception.</p>**<p>Significant observation.</p

Trials differ in Europe and Africa.

<p>Classification of a random sample of 100 trials for each of five countries in Europe (France, Germany, Italy, Spain, and the United Kingdom) and Sub-Saharan Africa (Kenya, Mali, Tanzania, Uganda, and Zambia). Trials in Africa focus predominantly on paediatric populations (A) and infectious disease (B) and are non-industry sponsored (C). Data were abstracted from the ClinicalTrials.gov website in August 2009.</p

Infusion-related and drug-related treatment emergent AEs.

<p>TEADR = treatment emergent adverse drug reaction; treatment emergent = onset between day 1 and day 60 inclusive; adverse drug reaction if investigator judged relationship to treatment as “probable”, “possible” or “unlikely”.</p><p>This includes patients with infusion related reactions.</p><p>Renal impairment: 3 mild cases and 1 moderate as graded by investigator, all resolved during study period.</p

Patient flow chart.

<p>Consort Patient flow chart: AmBisome® multi dose vs. single dose, ITT Intention to treat, PP per protocol, LTFU Lost to Follow-up.</p

Baseline data on patient demographics, clinical characteristics and laboratory values.

<p>Data are n (%) or means (SD). AST aspartate aminotransferase, ALT alanine aminotransferase.</p><p>classified using weight for height and BMI for age in those aged ≤19 years and BMI in those aged >19: normal if −2SD≤ weight for height or BMI for age <+1SD or 18.5≤BMI<25.0; underweight if −3SD≤ weight for height or BMI for age <−2SD or 16.0≤BMI<18.5; severely underweight if weight for height or BMI for age <−3SD or BMI<16.0.</p><p>1 case of unconfirmed VL with no parasites detected (major protocol deviation, excluded from analysis) and one case of no parasite count recorded on a log scale in which VL was confirmed by lymph node aspirate.</p><p>no parasite count recorded on a log scale in which VL was confirmed by lymph node aspirate.</p