Table 2.
Demographics and baseline disease characteristics of the study populations for patients treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria*
| Characteristic | Adults | Children | ||
|---|---|---|---|---|
| Efficacy mITT population (n = 599) | Safety population (n = 647) | Efficacy mITT population (n = 877) | Enrolled population (n = 1,333†) | |
| Male sex, no. (%) | 434 (72.5) | 472 (73.0) | 476 (54.3) | 711 (53.3%) |
| Age (years) | ||||
| Mean ± SD | 31.2 ± 11.5 | 31.0 ± 11.4 | 4.2 ± 4.1 | 4.1 ± 3.7 |
| Range | 17–71‡ | 17–71§ | 0–16 | 0–16 |
| > 0 to ≤ 2, no. (%) | – | – | 410 (46.8) | 587 (44.0) |
| > 2 to ≤ 12, no. (%) | – | – | 410 (46.8) | 680 (51.0) |
| > 12 to ≤ 16, no. (%) | – | – | 57 (6.5) | 66 (5.0) |
| Race, no. (%) | ||||
| Caucasian | 77 (12.9) | 80 (12.4) | 0 | 0 |
| Black | 40 (6.7) | 40 (6.2) | 762 (86.9) | 1,209 (90.7) |
| Asian | 0 | 44 (6.8) | 0 | 9 (0.7) |
| Other | 45 (7.5) | 45 (7.0) | 0 | 0 |
| Not collected | 437 (73.0) | 438 (67.7) | 115 (13.1) | 115 (8.6) |
| Body weight (kg) | ||||
| Mean ± SD | 57.4 ± 13.4¶ | 57.0 ± 13.2 | 15.6 ± 9.1 | 15.3 ± 8.4 |
| Range | 34–119¶ | 34–119# | 5.0–58.0 | 5.0–58.0 |
| 5–< 10, no. (%) | – | – | 238 (27.1) | 323 (24.2) |
| 10–< 15, no. (%) | – | – | 309 (35.2) | 498 (37.4) |
| 15–< 25, no. (%) | – | – | 217 (24.7) | 361 (27.1) |
| 25–< 35, no. (%) | – | – | 57 (6.5) | 87 (6.5) |
| ≥ 35, no. (%) | – | – | 56 (6.4) | 64 (4.8) |
| P. falciparum parasite count (asexual forms/μL) | ||||
| Median | 4,618 | 5,236 | 23,762 | 24,178 |
| Range | 13–464,880 | 0–464,880 | 188–628,571 | 0–628,571 |
| ≤ 100,000, no. (%) | 464 (77.5) | 505 (78.1) | 786 (89.6) | 1,183 (88.7) |
| <2,000, no. (%) | 163 (27.2) | 176 (27.2) | 44 (5.0) | 50 (3.8) |
| 2,000–< 5,000 | 90 (15.0) | 92 (14.2) | 112 (12.8) | 165 (12.4) |
| 5,000–< 15,000 | 66 (11.0) | 92 (14.2) | 194 (22.1) | 276 (20.7) |
| 15,000–< 50,000 | 98 (16.4) | 110 (17.0) | 262 (29.9) | 440 (33.0) |
| 50,000–< 100,000 | 47 (7.8) | 51 (7.9) | 174 (19.8) | 252 (18.9) |
| > 100,000, no. (%) | 34 (5.7) | 37 (5.7) | 91 (10.4) | 147 (11.0) |
| None, no. (%) | 0 | 4 (0.6) | 0 | 1 (0.1) |
| Missing/different unit, no. (%) | 101 (16.9) | 101 (15.6) | 0 | 2 (0.2) |
| Body temperature (°C) | ||||
| Mean ± SD | 37.9 ± 1.1 | 37.8 ± 1.1 | 38.2 ± 1.0 | 38.2 ± 1.1 |
| < 37.5, no. (%) | 235 (39.2) | 267 (41.3) | 164 (18.7) | 301 (22.6) |
| 37.5–< 39.0, no. (%) | 243 (40.6) | 255 (39.4) | 485 (55.3) | 709 (53.2) |
| ≥ 39.0, no. (%) | 121 (20.2) | 125 (19.3) | 227 (25.9) | 319 (23.9) |
| Missing, no. (%) | 0 | 0 | 1 (0.1) | 4 (0.3) |
| Renal function at baseline** | ||||
| Normal, no. (%) | 223 (37.2) | 225 (34.8) | 184 (21.5) | 326 (24.5)†† |
| Mild dysfunction, no. (%) | 143 (23.9) | 143 (22.1) | 321 (36.6) | 510 (38.3)†† |
| Moderate dysfunction, no. (%) | 9 (1.5) | 10 (1.5) | 191 (21.8) | 292 (21.9)†† |
| Severe dysfunction, no. (%) | 0 (0) | 0 (0) | 92 (10.5) | 102 (7.7)†† |
| Missing, no. (%) | 224 (37.4) | 269 (41.6) | 89 (10.1) | 102 (7.7)†† |
| Hepatic function at baseline‡‡ | ||||
| Normal, no. (%) | 164 (27.4) | 167 (25.8) | 144 (16.4) | 144 (10.8) |
| Mild dysfunction, no. (%) | 121 (20.2) | 121 (18.7) | 170 (19.4) | 170 (12.8) |
| Moderate dysfunction, no. (%) | 60 (10.0) | 60 (9.3) | 24 (2.7) | 24 (1.8) |
| Severe dysfunction, no. (%) | 17 (2.8) | 17 (2.6) | 2 (0.2) | 2 (0.2) |
| Missing, no. (%) | 237 (39.6) | 282 (43.6) | 537 (61.2) | 992 (74.5) |
mITT = modified intent-to-treat.
One patient in study B2412 did not receive artemether-lumefantrine and was excluded from the safety population.
Three patients were ≥ 65 years of age.
Two patients were ≥ 65 years of age.
Study A2401: mean ± SD = 72.9 ± 13.5 kg, range 47–119 kg (66 patients weighed > 70 kg and 5 patients weighed > 100 kg). # One patient weighed < 35 kg.
Defined by creatinine clearance (Cockcroft-Gault/Shull): normal > 80 mL/minute; mild dysfunction ≥ 50–≤ 80 mL/minute; moderate dysfunction ≥ 30–< 50 mL/minute; or severe dysfunction < 30 mL/minute.
Safety population (n = 1,332).
Defined as normal, either total bilirubin ≤ upper limit of normal [ULN], and aspartate aminotransferase [AST] ≤ ULN or total bilirubin ≤ ULN and AST value missing; mild dysfunction, either total bilirubin ≤ ULN and AST> ULN, or total bilirubin > ULN – 1.5 × ULN regardless of AST value; moderate dysfunction, total bilirubin > 1.5 – 3 × ULN regardless of AST value; severe dysfunction, total bilirubin > 3 × ULN regardless of AST value; missing, baseline for total bilirubin is missing regardless of whether AST value is missing. If baseline AST value was missing, baseline alanine aminotransferase value was used as per the criteria for AST.