Table 4.

Serious Adverse Events

Adverse Event	Iron	Control
Adult SAE	(n = 978)	(n = 976)
Accidental deatha	0	1
Obstetric death	2	1
Other obstetric SAEb	12	7
Severe malaria	27	20
Other deathc	1	1
Otherd	12	22
Total SAE	54	52
Infant SAE	(n = 231)	(n = 206)
Miscarriage	16	11
Stillbirth	13	17
Perinatal death*	6	0
Neonatal death	4	3
Infant death	1	1
Death from congenital abnormalitye	0	1
Other congenital abnormalitiesf, **	0	5
Other obstetric SAEb	2	0
Other deathg	1	0
Total SAE	43	38

Abbreviation: SAE, serious adverse event.

^aOne death from drowning.

^bSystems Order Classification = Pregnancy, puerperium and perinatal conditions, excluding deaths.

^cNeoplasms: benign, malignant, and unspecified (liposarcoma and thoracic pain).

^dSee Supplementary Data for summary of adverse events.

^eSpina bifida.

^fClub foot; congenital anomaly; polydactyly (all classified as unlikely or definitely not treatment related). Excludes abnormalities associated with stillbirth/miscarriage (one microcephaly).

^gParalytic ileus.

*P = .021 (Fisher exact test).

**P = .011 for all abnormalities.