Table 4.
Subpopulation analysis of 28-day PCR-corrected parasitologic cure rate (evaluable population) for patients treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria *
| Characteristic | Adults (all patients), no./total (%) | Adults (Study A2401), no./total (%) | Children, no./total (%) |
|---|---|---|---|
| Age | |||
| > 1 month–≤ 2 years | – | – | 366/377 (97.1) |
| 2 years–≤ 12 years | – | – | 374/384 (97.4) |
| 12–≤ 16 years | – | – | 52/53 (98.1) |
| Body weight (kg) | |||
| 5–< 10 | – | – | 210/217 (96.8) |
| 10–< 15 | – | – | 283/290 (97.6) |
| 15–< 25 | – | – | 198/204 (97.1) |
| 25–< 35 | – | – | 50/51 (98.0) |
| ≥ 35 | – | – | 50/51 (98.0) |
| Body weight (kg) | |||
| < 70 | – | 52/52 (100.0) | – |
| ≥ 70 | – | 66/71 (93.0) | – |
| Baseline parasite density, no. (%)† | |||
| ≤ 100,000/μL | 399/408 (97.8) | 50/50 (100.0) | 718/737 (97.4) |
| > 100,000/μL | 27/28 (96.4) | 0/0 | 74/77 (96.1) |
| Renal function,‡ no. (%) | |||
| Normal | 182/188 (96.8) | 87/91 (95.6) | 169/173 (97.7) |
| Mild dysfunction | 118/126 (93.7) | 27/28 (96.4) | 289/302 (95.7) |
| Moderate dysfunction | 9/9 (100.0) | 0/0 | 174/176 (98.9) |
| Severe dysfunction | 0/0 | 0/0 | 85/86 (98.8) |
| Missing | 186/187 (99.5) | 5/5 (100.0) | 75/77 (97.4) |
| Hepatic function,§ no. (%) | |||
| Normal | 146/147 (99.3) | 57/58 (98.3) | 137/141 (97.2) |
| Mild dysfunction | 101/106 (95.3) | 33/35 (94.3) | 159/164 (97.0) |
| Moderate dysfunction | 45/48 (93.8) | 16/17 (94.1) | 21/22 (95.5) |
| Severe dysfunction | 9/13 (69.2) | 0/0 | 1/2 (50.0) |
| Missing¶ | 194/196 (99.0) | 13/14 (92.9) | 474/485 (97.7) |
PCR = polymerase chain reaction. PCR analysis was not performed in study A2401.
Data on baseline parasite count not available in parasites/microliter for all patients.
According to creatinine clearance (Cockcroft-Gault/Shull): normal, > 80 mL/minute; mild dysfunction, ≥ 50–≤ 80 mL/minute; moderate dysfunction, ≥ 30–< 50 mL/minute; severe dysfunction, < 30 mL/minute.
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.
Total bilirubin value was missing.