Table 5.
Univariate analysis-presence of gametocytes after enrolment up to day 14
|
% (N) with gametocytes OR [95%] P-value |
||||
|
All (N = 6793) |
Thailand (N = 5069) |
The Gambia (N = 1110) |
Tanzania (N = 614) |
|
| Total1 | 15 (998) | 7 (342) | 36 (400) | 42 (256) |
| < 0.0012 | ||||
| Age (years)3 | ||||
| 0–5 | 28 (530) | 13 (118) | 40 (249) | 41(163) |
| 5–15 | 16 (432) | 10 (202) | 33 (159) | 56 (62) |
| > 15 | 13 (293) | 12 (251) | 75 (3) | 40 (39) |
| 0.985 [0.979–0.992] | 0.987 [0.979–0.995] | 0.963 [0.918–1.011] | 0.978 [0.963–0.993] | |
| < 0.001 | 0.001 | 0.131 | 0.005 | |
| Symptoms | ||||
| Yes | 14 (546) | 10 (364) | No Data | 51 (182) |
| No | 25 (42) | 9 (10) | 57 (32) | |
| 0.936 [0.586–1.486] | 1.147 [0.580–2.268] | 0.0.784 [0.444–1.387] | ||
| 0.784 | 0.694 | 0.403 | ||
| History of illness | ||||
| > = 3 days | 30 (193) | 25 (129) | No Data | 48 (64) |
| < 3 days | 12 (408) | 8 (234) | 57 (174) | |
| 2.030 [1.658–2.484]5 | 3.400 [2.640–4.380] | 0.683 [0.453–1.029] | ||
| < 0.001 | < 0.001 | 0.067 | ||
| Sex | ||||
| Male | 18 (446) | 10 (203) | 39 (136) | 57 (107) |
| Female | 19 (421) | 10 (172) | 37 (117) | 52 (132) |
| 1.071 [0.910–1.261] | 1.041 [0.836–1.295] | 1.052 [0.766–1.445] | 1.201 [0.821–1.758] | |
| 0.406 | 0.722 | 0.754 | 0.345 | |
| Severe Anaemia | ||||
| Yes | 33 (18) | 29 (7) | 37 (11) | No Data |
| No | 17 (636) | 10 (287) | 34 (341) | |
| 1.536 [0.858–2.747]5 | 2.433 [0.989–5.986]5 | 1.302 [0.586–2.893] | ||
| 0.145 | 0.045 | 0.515 | ||
| Anaemia | ||||
| Yes | 32 (294) | 26 (136) | 38 (157) | No Data |
| No | 12 (360) | 7 (158) | 32 (195) | |
| 2.308 [1.920–2.775]5 | 4.135 [3.156–5.418] | 1.402 [1.069–1.840] | ||
| < 0.001 | < 0.001 | 0.014 | ||
| Haematocrit3 | 0.917 [0.903–0.932]5 | 0.872 [0.853–0.891] | 0.974 [0.950–0.998] | No Data |
| < 0.001 | < 0.001 | 0.037 | ||
| Palpable liver | ||||
| Yes | 21 (156) | 17 (100) | 40 (56) | No Data |
| No | 13 (449) | 9 (256) | 37 (193) | |
| 1.725 [1.378–2.162] | 1.965 [1.513–2.551] | 1.216 [0.772–1.918] | ||
| < 0.001 | < 0.001 | 0.398 | ||
| Palpable spleen | ||||
| Yes | 22 (253) | 17 (143) | 40 (110) | No Data |
| No | 11 (355) | 8 (212) | 36 (143) | |
| 1.708 [1.412–2.065]5 | 2.227 [1.756–2.826]5 | 1.067 [0.768–1.483] | ||
| < 0.001 | < 0.001 | 0.698 | ||
| Temperature | ||||
| > = 37 C | 14 (385) | 9 (213) | 40 (172) | No Data |
| < 37.5 C | 15 (242) | 11 (161) | 33 (81) | |
| 0.947 [0.785–1.141] | 0.831 [0.664–1.040] | 1.273 [0.904–1.794] | ||
| 0.564 | 0.106 | 0.165 | ||
| Parasitaemia3,4(/μL) | ||||
| ≤ 1,600 | 13 (187) | 9(110) | 25 (16) | 46 (61) |
| 1,600–4,000 | 20 (205) | 10(76) | 30 (28) | 57 (101) |
| 4,000 – 20,000 | 18 (355) | 12(185) | 34 (100) | 55 (70) |
| > 20,000 | 21 (502) | 13 (200) | 41 (267) | 20 (35) |
| 1.120 [1.013–1.238] | 1.053 [0.936–1.184] | 1.335 [1.907–1.625] | 1.182 [0.960–1.458] | |
| 0.027 | 0.394 | 0.004 | 0.115 | |
| Mixed infection | ||||
| Yes | 4 (22) | |||
| No | No Data | 12 (549) | No Data | No Data |
| 0.366 [0.236–0.567]5 | ||||
| < 0.001 | ||||
| Treatment6 | ||||
| A | 10 (413) | 8 (287) | 16 (106) | 10 (11) |
| C-F | 26 (516) | 18 (276) | 27 (13) | 49 (227) |
| 3.073 [2.384–3.962] | 3.063 [2.330–4.026] | 3.259 [1.028–10.387] | 4.751 [1.530–14.754] | |
| < 0.001 | < 0.001 | 0.033 | 0.003 | |
| G-H | 70 (301) | No Data | 71 (283) | 62 (18)7 |
| 11.744 [8.019–17.199] | 11.936 [8.136–17.510] | |||
| < 0.001 | < 0.001 | |||
1 Percentages are calculated from patients with both non-missing counts on day 7 and day 14 (out of 4840, 1099 and 603 patients, respectively)
2 p-value from chi-square test
3 OR and test for the continuous representation
4 The Gambia, Thailand: OR calculated for log10 parasitaemia; Tanzania, All : OR for ordered categories, p-value is for test for trend.
5 p-value for homogeneity < 0.05
6 treatments groups are defined as: A: artemisisnin combination alone or with other treatments; C-F: other monotherapies (see Table 1); G-H: SP alone or SP with chloroquine. OR are calculated with reference to group A.
7 G-H/A at separate sites