TABLE 1.
Baseline characteristics of the intention-to-treat study population according to treatment arm, either sequential or concomitant chloroquine plus primaquine
| Variable | Value for treatment regimen group |
|
|---|---|---|
| Sequential CQ-PQ (arm 1) (n = 96) |
Concomitant CQ-PQ (arm 2) (n = 92) |
|
| Mean age (yr) (range) | 27.8 (5–63) | 25.7 (7–60) |
| No. of male subjects/no. of female subjects | 55/41 | 62/32 |
| Mean wt (kg) (range) | 58.8 (20.3–101.0) | 57.8 (20.0–94.0) |
| No. (%) of individuals with temp > 37.5°C | 40 (42.1) | 42 (46.7) |
| No. (%) of subjects with reported sign or symptom in the past 48 h | ||
| Fever | 91 (94.8) | 87 (94.6) |
| Headache | 87 (90.6) | 84 (91.3) |
| Chills | 64 (66.7) | 54 (58.7) |
| Dizziness | 58 (60.4) | 56 (60.9) |
| Malaise | 72 (75.0) | 67 (72.8) |
| Arthralgia | 69 (71.9) | 51 (55.4) |
| Myalgia | 65 (67.7) | 51 (55.4) |
| Low back pain | 60 (62.5) | 41 (44.6) |
| Abdominal pain | 18 (18.8) | 11 (12.0) |
| Appetite loss | 55 (57.3) | 57 (62.0) |
| Vomiting | 30 (31.3) | 22 (23.4) |
| Diarrhea | 3 (3.1) | 5 (5.4) |
| Tinnitus | 6 (6.3) | 6 (6.5) |
| Blurred vision | 8 (8.3) | 6 (6.5) |
| Dark urine | 13 (13.5) | 9 (9.6) |
| Mean no. of days ill prior to enrollment (range) | 2.7 (1–7) | 2.7 (1–8) |
| Mean hemoglobin level (g/100 ml) (range) | 12.5 (7.1–16.3) | 12.7 (8.8–17.2) |
| Mean no. (%) of subjects with anemia | 31 (32.3) | 34 (37.0) |
| Mean platelet count (109/liter) (range) (n = 160) | 155.8 (35.0–367.0) (n = 88) | 152.9 (39.0–319.0) (n = 72) |
| No. (%) of subjects with thrombocytopenia | 45 (51.1) (n = 88) | 33 (45.8) (n = 72) |
| No. (%) of subjects with predicted CYP2D6 activity phenotype (n = 175) | 88 | 87 |
| Poor metabolizer | 5 (5.7) | 4 (4.6) |
| Intermediate metabolizer | 4 (4.5) | 4 (4.6) |
| Normal-slow metabolizer | 18 (20.5) | 27 (31.0) |
| Normal-fast metabolizer | 56 (63.6) | 50 (57.5) |
| Ultrarapid metabolizer | 5 (5.7) | 2 (2.3) |
| Parasitemia (no. of asexual forms/μl) | ||
| Mean (range) | 3,160.1 (87–25,000) | 3,332.8 (60–24,383) |
| Median | 2,228 | 2,761 |
| No. (%) of subjects with gametocyte carriage detected by PCR (n = 187) | 72 (75.1) (n = 96) | 59 (64.8) (n = 91) |