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. 2016 Jul 6;95(1):83–87. doi: 10.4269/ajtmh.15-0816

Table 3.

Details on MAEs in children aged 12–24 months participating in an anthelminthic trial in Peru (2011–2013)

No. Intervention group MAE Study visit before MAE Days between intervention and MAE Intervention received before MAE
1 MEB/MEB* Acute urticaria Baseline 0.13 Mebendazole
2 PBO/MEB Emetic syndrome Baseline 0.13 Placebo
3 PBO/PBO Acute pharyngitis, urticaria Baseline 0.25 Placebo
4 PBO/PBO ADD Baseline 0.25 Placebo
5 PBO/PBO ADD with dehydration Baseline 0.33 Placebo
6 PBO/MEB ADD Baseline 0.42 Placebo
7 PBO/PBO Allergic reaction 18-month 0.42 Placebo
8 MEB/PBO§ ADD, urinary tract infection 18-month 0.46 Placebo
9 MEB/PBO ADD Baseline 0.5 Mebendazole
10 MEB/MEB ADD without dehydration Baseline 0.67 Mebendazole
11 PBO/MEB Acute pharyngitis Baseline 1 Placebo
12 PBO/MEB ADD with dehydration Baseline 1 Placebo
13 PBO/PBO Suspected dysentery Baseline 1 Placebo
14 MEB/PBO ADD without dehydration Baseline 1 Mebendazole
15 PBO/MEB ADD with dehydration Baseline 1 Placebo
16 MEB/MEB ADD without dehydration Baseline 1 Mebendazole
17 PBO/PBO ADD with dehydration Baseline 1 Placebo
18 MEB/MEB ADD, bronchial hyperactivity Baseline 1 Mebendazole
19 PBO/PBO ADD Baseline 2 Placebo
20 MEB/PBO ADD Baseline 2 Mebendazole
21 MEB/PBO Allergic reaction Baseline 2 Mebendazole
22 MEB/MEB ADD without dehydration Baseline 2 Mebendazole
23 MEB/MEB ADD without dehydration Baseline 2 Mebendazole
24 MEB/MEB ADD without dehydration Baseline 2 Mebendazole
25 MEB/MEB ADD without dehydration 18-month 3 Mebendazole
26 MEB/MEB Conjunctivitis 18-month 3 Mebendazole
27 PBO/MEB Febrile syndrome 18-month 3 Mebendazole
28 PBO/MEB Acute rhinopharyngitis Baseline 3 Placebo
29 PBO/MEB ADD with dehydration Baseline 4 Placebo
30 PBO/MEB Common cold, ADD without dehydration Baseline 5 Placebo
31 PBO/PBO ADD with dehydration, febrile syndrome Baseline 6 Placebo

ADD = Acute diarrheal disease; MAE = minor adverse events.

*

Group 3 (MEB/MEB): mebendazole at the 12- and 18-month visits.

Group 2 (PBO/MEB): placebo at the 12-month visit and mebendazole at the 18-month visit.

Group 4 (PBO/PBO): placebo at the 12- and 18-month visits.

§

Group 1 (MEB/PBO): mebendazole at the 12-month visit and placebo at the 18-month visit.