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.