Table 9 |
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Common* adverse events by exposure group |
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MedDRA Primary System Organ Class: MedDRA Preferred Term |
Artemether-lumefantrine N = 495 n (%) |
Sulphadoxine-pyrimethamine N = 506 n (%) |
|
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Total number of patients with any adverse events |
171 (34.5) |
186 (36.8) |
|
|
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Blood and lymphatic system disorders: |
7 (1.4) |
16 (3.4) |
|
|
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|
Anaemia |
7 (1.4) |
15 (3.2) |
|
|
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Infections and infestations: |
61 (12.3) |
66 (13.0) |
|
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|
Malaria |
17 (3.4) |
34 (6.7) |
|
Syphilis |
24 (4.8) |
20 (4.0) |
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Respiratory tract infection |
9 (1.8) |
5 (1.0) |
|
Urinary tract infection |
5 (1.0) |
5 (1.0) |
|
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Nervous system disorders: |
1 (0.2) |
8 (1.6) |
|
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Headache |
1 (0.2) |
6 (1.2) |
|
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Pregnancy, puerperium, and perinatal conditions: |
108 (21.8) |
120 (23.7) |
|
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Premature baby |
69 (13.9) |
87 (17.2) |
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Stillbirth |
9 (1.8) |
13 (2.6) |
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Cephalo-pelvic disproportion |
11 (2.2) |
6 (1.2) |
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Abortion spontaneous |
6 (1.2) |
5 (1.0) |
|
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Enrolled population: pregnant women who gave informed consent. MedDRA = medical dictionary for regulatory activities A pregnant woman with multiple occurrences of an adverse event is counted only once in the corresponding adverse event category. *Preferred terms occurring in at least 1% of women in either exposure group are presented along with the corresponding primary system organ class. |
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Manyando et al. Malaria Journal 2010 9:249 doi:10.1186/1475-2875-9-249 |
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