Table 6. Univariate and multivariate risk factors for PCR confirmed recrudescent failures at day 42.
| Variable | Total n [n]a | Univariable Analysis | Multivariable Analysisb | PARc | |||
| Crude HR [95% CI] | p-Value | Adjusted HR [95% CI] | p-Value | Freq. | PAR | ||
| Age (y) | 7,070 [127] | 0.97 [0.94–1] | 0.037 | — | — | — | — |
| Body weight (kg) | 7,070 [127] | 0.97 [0.95–0.99] | 0.010 | — | — | — | — |
| PIP dose (mg/kg) (every 5 unit increase) | 7,070 [127] | 0.86 [0.78–0.94] | 0.001 | 0.87 [0.79–0.95] | 0.002 | 20.3%d | 7.7% |
| Enrolment clinical variables | |||||||
| Parasitemia (log-scale) | 7,070 [127] | 1.26 [1.10–1.44] | 0.001 | 1.23 [1.08–1.41] | 0.003 | 9.3% | 6.5% |
| Baseline fever (>37.5°C) | 6,625 [124] | 1.08 [0.75–1.56] | 0.670 | — | — | — | — |
| Baseline haemoglobin (g/dl) | 6,670 [122] | 0.92 [0.83–1.01] | 0.080 | — | — | — | — |
| Baseline anaemia (hb <10 g/dl) | 6,670 [122] | 1.22 [0.81–1.84] | 0.350 | — | — | — | — |
| Baseline gametocyte carriage | 5,494 [111] | 1.79 [1.05–3.04] | 0.032 | — | — | — | — |
| Gender | |||||||
| Female (reference) | 2,935 [49] | 1 | — | — | — | — | — |
| Male | 4,019 [78] | 1.35 [0.94–1.94] | 0.100 | — | — | — | — |
| Age category | |||||||
| ≥12 y (reference) | 2,259 [15] | 1 | — | — | — | — | — |
| <1 y | 439 [7] | 2.36 [0.79–7.06] | 0.200 | 2.39 [0.79–7.25] | 0.120 | 6.2% | 7.8% |
| 1 to <5 y | 3,429 [9] | 3.71 [1.66–8.26] | 0.002 | 3.22 [1.42–7.33] | 0.005 | 48.5% | 53.5% |
| 5 to <12 y | 943 [7] | 1.48 [0.56–3.91] | 0.610 | 1.56 [0.59–4.13] | 0.370 | 13.3% | 5.7% |
| Region | |||||||
| Asia (reference) | 2,805 [28] | 1 | — | — | — | — | — |
| Africa | 4,009 [97] | 1.74 [0.67–4.51] | 0.260 | — | — | — | — |
| S. America | 256 [2] | 0.45 [0.02–8.61] | 0.600 | — | — | — | — |
| Treatment supervision | |||||||
| Full (reference) | 6,472 [124] | 1 | — | — | — | — | — |
| Partial | 474 [2] | 0.26 [0.04–1.73] | 0.170 | — | — | — | — |
| Co-administration with fat | |||||||
| With fat meal (reference) | 960 [16] | 1 | — | — | — | — | — |
| Without fat meal | 2,448 [77] | 2.92 [0.73–11.55] | 0.130 | — | — | — | — |
| Unknown | 3,662 [34] | 0.95 [0.25–3.55] | 0.940 | — | — | — | — |
| Drug Formulation | |||||||
| Duo-Cotecxin (reference) | 1,467 [18] | 1 | — | — | — | — | — |
| Artekin | 54 [3] | 2.92 [0.14–58.56] | 0.480 | — | — | — | — |
| Artecan | 2,168 [22] | 0.96 [0.27–3.46] | 0.960 | — | — | — | — |
| Eurartesim | 3,381 [84] | 1.47 [0.48–4.50] | 0.500 | — | — | — | — |
n) for each variable/levels of factor with number of recrudescence [n] by day 42.a Number of patients (
p = 0.32 for global test for proportional hazards assumption. Variance of random effect = 1.17. Non-significant likelihood ratio test for weight (p = 0.27) and hemoglobin (p = 0.26) and thus dropped from the multivariable analysis. Baseline gametocytemia (p = 0.02) improved the model but 22.3% (1,576/7,070) of patient had missing observation for this variable and hence not kept for multivariable analysis. Inclusion (or exclusion) of gametocytemia didn't alter the significance of the other variable and its effect on model coefficient for age and dose was small.b
Overall PAR for model: 65.1%.
HR (95% CI) = 1.48 [0.99–2.19] p = 0.054 and AHR (95% CI) = 1.39 [0.94–2.06], p = 0.10 for mg/kg PIP dose <48 mg/kg in univariable and multivariable analysis, respectively.