Table 1. Baseline data on patient demographics, clinical characteristics and laboratory values.
| Multiple dose 21 mg/kg N = 63 | Single dose 7.5 mg/kg N = 21 | Single dose 10 mg/kg N = 40 | ||
| Age in years | Mean (SD) | 16 (9.0) | 21 (9.2) | 14 (7.4) |
| Children (4–17 y), n (%) | 37 (59) | 4 (19) | 25 (63) | |
| Adults (≥18 y), n (%) | 26 (41) | 17 (81) | 15 (37) | |
| Sex | Female, n (%) | 10 (16) | 2 (11) | 10 (25) |
| Male, n (%) | 53 (84) | 19 (91) | 30 (75) | |
| Spleen size in cm | Mean (SD) | 9.5 (5.3) | 12.0 (6.0) | 9.1 (5.3) |
| Nutritional status† | Weight [kg], mean (SD) | 36 (14.5) | 44 (12.2) | 33 (14.4) |
| Severe underweight, n (%) | 18 (29) | 9 (43) | 11 (28) | |
| Underweight, n (%) | 22 (35) | 7 (33) | 17 (43) | |
| Normal weight, n (%) | 22 (35) | 5 (24) | 12 (30) | |
| Hemoglobin (g/dl) | Mean (SD) | 7.9 (1.7) | 7.7 (1.6) | 7.7 (1.4) |
| AST | Mean (SD) | 52 (27.1) | 48 (28.5) | 54 (29.0) |
| ALT | Mean (SD) | 32 (20.7) | 35 (21.3) | 33 (20.0) |
| Parasite Count (log scale) | 6+, n (%) | 2 (3) | 2 (10) | 0 |
| 5+, n (%) | 7 (11) | 5 (23) | 7 (18) | |
| 4+, n (%) | 14 (22) | 6 (29) | 4 (10) | |
| 3+, n (%) | 15 (23) | 4 (19) | 9 (22) | |
| 2+, n (%) | 11 (17) | 4 (19) | 9 (22) | |
| 1+, n (%) | 12 (20) | 0 | 10 (25) | |
| 0 or missing, n (%) | 2* (3) | 0 | 1** (3) |
Data are n (%) or means (SD). AST aspartate aminotransferase, ALT alanine aminotransferase.
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.
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.
no parasite count recorded on a log scale in which VL was confirmed by lymph node aspirate.