. Author manuscript; available in PMC: 2019 Sep 4.

Published in final edited form as: Lancet Infect Dis. 2019 Jul 25;19(9):973–987. doi: 10.1016/S1473-3099(19)30156-2

Table 2. Serious adverse events.

	IPT (n=681 women, n=524 infants)^*			IST (n=854 women, n=712 infants)^†			SST (n=744 women, n=634 infants)^‡
	Number of participants with event (%)	Total number of events	Incidence per 100 person-years (95% CI)	Number of participants with event (%)	Total number of events	Incidence per 100 person-years (95% CI)	Number of participants with event (%)	Total number of events	Incidence per 100 person-years (95% CI)
Mothers

Any serious adverse event	56 (8·2%)	85	54·2 (43·3–67·1)	77 (9·0%)	105	47·2 (38·6–57·2)	71 (9·5%)	113	60·4 (49·8–72·6)
Pregnancy, puerperium and perinatal conditions	47 (6·9%)	62	39·6 (30·3–50·7)	60 (7·0%)	71	31·9 (25–40·3)	51 (6·9%)	65	34·7 (26·8–44·3)
Infections and infestations	8 (1·2%)	8	5·1 (2·2–10·1)	9 (1·1%)	11	4·9 (2·5–8·9)	17 (2·3%)	26	13·9 (9·1–20·4)
Gastrointestinal disorders	2 (0·3%)	3	1·9 (0·4–5·6)	1 (0·1%)	2	0·9 (0·1–3·3)	2 (0·3%)	3	1·6 (0·3–4·7)
Surgical and medical procedures	0	0	0 (0–0)	1 (0·1%)	1	0·4 (0–2·5)	1 (0·1%)	1	0·5 (0–3)
Blood and lymphatic system disorders	7 (1·0%)	7	4·5 (1·8–9·2)	12 (1·4%)	14	6·3 (3·4–10·6)	15 (2·0%)	15	8 (4·5–13·2)
Nervous system disorders	0	0	0 (0–0)	0	0	0 (0–0)	1 (0·1%)	2	1·1 (0·1–3·9)
Reproductive system and breast disorders	1 (0·1%)	1	0·6 (0–3·6)	1 (0·1%)	1	0·4 (0–2·5)	0	0	0 (0–0)
Injury, poisoning and procedural complications	0	0	0 (0–0)	1 (0·1%)	1	0·4 (0–2·5)	0	0	0 (0–0)
Respiratory, thoracic and mediastinal disorders	1 (0·1%)	1	0·6 (0–3·6)	0	0	0 (0–0)	0	0	0 (0–0)
Vascular disorders	1 (0·1%)	1	0·6 (0–3·6)	0	0	0 (0–0)	0	0	0 (0–0)
Metabolism and nutrition disorders	1 (0·1%)	1	0·6 (0–3·6)	2 (0·2%)	2	0·9 (0·1–3·3)	0	0	0 (0–0)
Hepatobiliary disorders	0	0	0 (0–0)	1 (0·1%)	1	0·4 (0–2·5)	0	0	0 (0–0)
Cardiac disorders	0	0	0 (0–0)	1 (0·1%)	1	0·4 (0–2·5)	1 (0·1%)	1	0·5 (0–3)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)	1 (0·1%)	1	0·6 (0–3·6)	0	0	0 (0–0)	0	0	0 (0–0)

Infants

Any serious adverse event	40 (7·6%)	56	88 (66·5–114·3)	53 (7·4%)	75	89·5 (70·4–112·2)	51 (8·0%)	69	86·5 (67·3–109·5)
Congenital, familial and genetic disorders	11 (2·1%)	11	17·3 (8·6–30·9)	18 (2·5%)	19	22·7 (13·7–35·4)	19 (3·0%)	19	23·8 (14·3–37·2)
Pregnancy, puerperium and perinatal conditions	6 (1·1%)	6	9·4 (3·5–20·5)	14 (2·0%)	14	16·7 (9·1–28)	10 (1·6%)	12	15 (7·8–26·3)
Infections and infestations	18 (3·4%)	19	29·9 (18–46·6)	23 (3·2%)	23	27·5 (17·4–41·2)	24 (3·8%)	25	31·4 (20·3–46·3)
Gastrointestinal disorders	0	0	0 (0–0)	1 (0·1%)	1	1·2 (0–6·7)	2 (0·3%)	2	2·5 (0·3–9·1)
Surgical and medical procedures	0	0	0 (0–0)	1 (0·1%)	1	0 (0–0)	0	0	0 (0–0)
Blood and lymphatic system disorders	1 (0·2%)	1	1·6 (0–8·8)	2 (0·3%)	2	2·4 (0·3–8·6)	0	0	0 (0–0)
Nervous system disorders	1 (0·2%)	1	1·6 (0–8·8)	1 (0·1%)	1	1·2 (0–6·7)	0	0	0 (0–0)
Reproductive system and breast disorders	1 (0·2%)	1	1·6 (0–8·8)	0	0	0 (0–0)	0	0	0 (0–0)
Respiratory, thoracic, and mediastinal disorders	13 (2·5%)	13	20·4 (10·9–34·9)	9 (1·3%)	9	10·7 (4·9–20·4)	10 (1·6%)	10	12·5 (6–23·1)
Metabolism and nutrition disorders	0	0	0 (0–0)	3 (0·4%)	3	3·6 (0·7–10·5)	0	0	0 (0–0)
Hepatobiliary disorders	0	0	0 (0–0)	0	0	0 (0–0)	1 (0·2%)	1	1·3 (0–7)
General disorders and administration site conditions	2 (0·4%)	3	4·7 (1–13·8)	2 (0·3%)	2	2·4 (0·3–8·6)	0	0	0 (0–0)
Neoplasms benign, malignant, and unspecified (including cysts and polyps)	1 (0·2%)	1	1·6 (0–8·8)	0	0	0 (0–0)	0 (0·0%)	0	0 (0–0)

All SAEs were coded using the Medical Dictionary of Regulatory Affairs and are presented here according to their system organ class, the highest level in the dictionary. IPT=intermittent preventive treatment. IST=intermittent screening and treatment. SST=single screening and treatment.