Table 1.
Tolerability and effectiveness of different treatment regimens in 504 malaria-patients in Europe
|
Total |
AQ + PG* |
MQ* |
AR + LU* |
QUI* |
AR + MQ* |
QUI + CL* |
QUI + TC* |
QUI + AQPG* |
Other* |
Overall test p-Value |
|
|---|---|---|---|---|---|---|---|---|---|---|---|
| N = 504 | N = 253 | N = 97 | N = 39 | N = 33 | N = 20 | N = 20 | N = 16 | N = 15 | N = 11 | ||
|
Treatment change, N (%) |
|
|
|
|
|
|
|
|
|
|
0.0053a |
| · no change |
451 (89.5) |
223 (88.1) |
92 (94.9) |
37 (94.9) |
25 (75.8) |
19 (95.0) |
17 (85.0) |
13 (81.3) |
15 (100.0) |
10 (90.9) |
|
| · due to progress of severity§ |
2 (0.4) |
2 (0.8) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
|
| · due to AE other than vomiting |
10 (2.0) |
2 (0.8) |
0 (0.0) |
1 (2.6) |
5 (15.2) |
1 (5.0) |
1 (5.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
|
| · due to vomiting |
30 (6.0) |
22 (8.7) |
5 (5.2) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
3 (18.8) |
0 (0.0) |
0 (0.0) |
|
| · due to other reasons |
11 (2.2) |
4 (1.6) |
0 (0.0) |
1 (2.6) |
3 (9.1) |
0 (0.0) |
2 (10.0) |
0 (0.0) |
0 (0.0) |
1 (9.1) |
|
|
Pts. with any AE$, N (%) |
82 (16.3) |
34 (13.4) |
22 (22.7) |
1 (2.6) |
12 (36.4) |
2 (10.0) |
7 (35.0) |
2 (12.5) |
2 (13.3) |
0 (0.0) |
0.0009 a |
|
Parasite clearance time |
72 |
72 |
54 |
72 |
48 |
36 |
48 |
48 |
72 |
48 |
<0.0001b |
|
Hour median (min-max) |
(0-168) |
(0-168) |
(2-168) |
(24-168) |
(24-96) |
(12-96) |
(24-96) |
(24-108) |
(24-168) |
(0-96) |
|
|
Fever clearance time, |
48 |
48 |
24 |
48 |
24 |
16 |
48 |
72 |
48 |
36 |
<0.0001b |
|
Hour median (min-max) |
(0-192) |
(0-192) |
(0-168) |
(0-72) |
(0-144) |
(0-80) |
(24-96) |
(24-96) |
(0-168) |
(4-60) |
|
|
Duration of hospitalization# |
4 |
4 |
4 |
4 |
6 |
3.5 |
5 |
5 |
3.5 |
4 |
0.0002 b |
|
Day median (min-max) |
(1-18) |
(2-15) |
(1-18) |
(2-7) |
(1-13) |
(1-18) |
(3-7) |
(3-8) |
(3-7) |
(1-7) |
|
|
Cure rate at day 28& |
372/376 |
191/194 |
73/73 |
97.0 |
25/25 |
9/9 |
11/11 |
10/10 |
13/13 |
8/8 |
0.7371a |
| N cured/N followed-up (%) | (98.9) | (98.5) | (100.0) | (33) | (100.0) | (100.0) | (100.0) | (100.0) | (100.0) | (100.0) |
a : Monte Carlo estimate for the exact chi-square test (1000000 samples); b : Kruskal-Wallis Test.
Figures in bold italics indicate Bonferroni-Holm adjusted p-values <0.05 in against all other comparison.
* : see additional file 1.
§ : according to the WHO 2000 severity criterion.
$ : includes possible, mild adverse events.
# : N = 401 (95 non hospitalized patients and 8 with missing data).
& : complete case analysis (128 patients lost to follow-up not included in cure rate calculation; numbers of patients with follow-up data are given in the denominators of the cure rate).