Table 2.
Haematological safety outcomes in patients with glucose-6-phosphate dehydrogenase activity of 30% or higher
| No primaquine | Low daily dose primaquine (<0·375 mg/kg per day) | Intermediate daily dose primaquine (≥0·375 mg/kg per day to <0·75 mg/kg per day) | High daily dose primaquine (≥0·75 mg/kg per day) | |
|---|---|---|---|---|
| >25% reduction in haemoglobin concentration to <7 g/dL | ||||
| Percentage (95% CI) | 0·1% (0·0 to 0·5) | 0·0% (0·0 to 0·4) | 0·3% (0·1 to 0·8) | 0·5% (0·2 to 1·0) |
| n/N | 1/1208 | 0/893 | 5/1464 | 6/1269 |
| Absolute change in haemoglobin concentration between day 0 and days 2–3 (g/dL), unadjusted* | ||||
| Mean (SD) | −0·5 (1·0) | −0·5 (0·9) | −0·7 (1·1) | −0·7 (1·1) |
| Range | −6·0 to 4·0 | −4·6 to 6·0 | −5·5 to 7·5 | −5·7 to 4·3 |
| N | 1146 | 831 | 1392 | 1209 |
| Absolute change in haemoglobin concentration between day 0 and days 5–7 (g/dL), unadjusted* | ||||
| Mean (SD) | −0·2 (1·0) | −0·2 (0·9) | −0·4 (1·2) | −0·5 (1·4) |
| Range | −4·9 to 5·2 | −3·5 to 6·0 | −6·1 to 8·2 | −6·2 to 3·5 |
| N | 1130 | 833 | 1348 | 1179 |
| Composite measure of haemoglobin change† | ||||
| Percentage (95% CI) | 0·1% (0·0 to 0·5) | 0·0% (0·0 to 0·4) | 0·5% (0·2 to 1·1) | 0·6% (0·3 to 1·2) |
| n/N | 1/1208 | 0/893 | 8/1464 | 8/1269 |
*
Negative values for absolute change indicate a decrease compared with baseline, whereas positive values indicate an increase.
†
Composite measure of haemoglobin change is a composite indicator of a post-treatment reduction in haemoglobin concentration to less than 5 g/dL or an absolute decrease in haemoglobin concentration of more than 5 g/dL from day 0 to days 1–14, renal failure needing dialysis, blood transfusion, or death between day 1 and day 28. The 95% CIs are binomial exact confidence intervals.