Table 2.

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

No.	Intervention group	SAE	Diagnosis	Study visit before SAE	Days between intervention and SAE	Intervention received before SAE
1	MEB/PBO	Hospitalization	Acute bronchial obstruction, ADD	Baseline	6	Mebendazole
2	MEB/PBO*	Death	Acute dehydration	Baseline	19	Mebendazole
3	MEB/MEB†	Hospitalization	Thrombocytopenia	Baseline	23	Mebendazole
4	MEB/PBO	Death	Respiratory insufficiency	Baseline	26	Mebendazole
5	MEB/MEB	Death	Multi-organ dysfunction	18-month	55	Mebendazole
6	MEB/PBO	Death	Hypovolemic shock	Baseline	86	Mebendazole
7	PBO/PBO	Death	Pneumonia	Baseline	92	Placebo
8	MEB/PBO	Death	Pneumonia	18-month	98	Placebo
9	MEB/PBO	Hospitalization	Cervical neuropathy	18-month	106	Placebo
10	PBO/PBO‡	Death	Multisystem failure	Baseline	137	Placebo
11	MEB/PBO	Death	Respiratory distress	Baseline	163	Mebendazole
12	MEB/MEB	Hospitalization	Convulsions	Baseline	169	Mebendazole
13	PBO/PBO	Hospitalization	Dysentery, amebiasis, giardiasis	18-month	172	Placebo
14	PBO/MEB§	Death	Pyelonephritis	Baseline	177	Placebo
15	PBO/PBO	Hospitalization	Pneumonia	Baseline	183	Placebo
16	MEB/MEB	Death	Information unavailable	Baseline	187	Mebendazole
17	PBO/PBO	Hospitalization	Dengue, malaria, leptospirosis	18-month	193	Placebo
18	MEB/MEB	Death	Probable dehydration from CDD	Baseline	227	Mebendazole

ADD = acute diarrheal disease; CDD = chronic diarrheal disease; SAE = serious adverse events.

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

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

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

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