Table 4.

Rates of clinical serious adverse events by group and study period

	Group						Study period					Total
	Maternal antiretroviral		Infant antiretroviral		No antiretroviral		0–28 weeks		29–48 weeks
	Number	Rate per 100 person-weeks	Number	Rate per 100 person-weeks	Number	Rate per 100 person-weeks	Number	Rate per 100 person-weeks	Number	Rate per 100 person-weeks	p value	Number	Rate per 100 person-weeks
Maternal
Pneumonia	6	0·019	4	0·012	6	0·026	13	0·023	3	0·010	0·1540	16	0·018
Serious febrile illness	16	0·051	16	0·049	7	0·030	15	0·027	24	0·077	0·0008	39	0·045
Tuberculosis	4	0·013	4	0·012	4	0·017	8	0·014	4	0·013	0·8562	12	0·014
Diarrhoea	4	0·013	2	0·006	2	0·009	4	0·007	4	0·013	0·4037	8	0·009
Hepatitis, clinical	2	0·006	0	0	0	0	2	0·004	0	0	0·2905	2	0·002
Rash	1	0·003	0	0	1	0·004	2	0·004	0	0	0·2905	2	0·002
Malaria	4	0·013	4	0·012	1	0·004	6	0·011	3	0·010	0·8753	9	0·010
Meningitis	2	0·006	0	0	0	0	0	0	2	0·006	0·0585	2	0·002
Nevirapine hypersensitivity*	6	0·019	0	0	0	0	6	0·011	0	0	0·0671	6	0·007
Vomiting	2	0·006	0	0	0	0	2	0·004	0	0	0·2905	2	0·002
Pelvic inflammatory disease	0	0	2	0·006	1	0·004	2	0·004	1	0·003	0·9278	3	0·003
Syphilis	1	0·003	0	0	0	0	1	0·002	0	0	0·4548	1	0·001
Death†	1	0·003	2	0·006	6	0·026	2	0·004	7	0·022	0·0087	9	0·010
Infant
Serious febrile illness	78	0·246	78	0·236	46	0·193	160	0·281	42	0·133	<0·0001	202	0·228
Pneumonia‡	56	0·176	54	0·163	60	0·252	104	0·183	66	0·209	0·4008	170	0·192
Diarrhoea	39	0·123	32	0·097	33	0·139	27	0·047	77	0·244	<0·0001	104	0·118
Malaria	23	0·072	43	0·130	22	0·093	32	0·056	56	0·177	<0·0001	88	0·099
Meningitis	10	0·031	12	0·036	8	0·034	24	0·042	6	0·019	0·0721	30	0·034
Nevirapine hypersensitivity§	1	0·003	16	0·048	0	0	17	0·030	0	0	0·0021	17	0·019
Growth faltering	17	0·054	26	0·079	13	0·055	8	0·014	48	0·152	<0·0001	56	0·063
Rash	2	0·006	3	0·009	1	0·004	6	0·011	0	0	0·0678	6	0·007
Vomiting	2	0·006	4	0·012	2	0·008	3	0·005	5	0·016	0·1142	8	0·009
Tuberculosis	2	0·006	1	0·003	3	0·013	1	0·002	5	0·016	0·0150	6	0·007
Death	23	0·072	24	0·073	28	0·118	37	0·065	38	0·120	0·0070	75	0·085

Only p values less than 0·05 are specified.

^*Maternal antiretroviral vs no antiretroviral p value is 0·0337.

^†Maternal antiretroviral vs no antiretroviral p value is 0·0221.

^‡Infant antiretroviral vs no antiretroviral p value is 0·0195.

^§Infant nevirapine antiretroviral vs no antiretroviral p value is 0·0007.