Table 4. Adverse events.

	Short cycle therapy		Continuous therapy		Total		P-Value*
Young people randomised and included, N	99		100		199
Number of events [Number of YP]
Grade 3 and 4 AEs	27	[18]	21	[16]	48	[34]	0.71
ART related AEs	13	[10]	17	[12]	30	[22]	0.82
Treatment modifying AEs	7	[6]	8	[8]	15	[14]	0.78
Serious AEs	20	[16‡]	8	[4]	29	[20]	0.005
New CDC stage B events	3	[3]	1	[1]	4	[4]	0.37
New CDC stage C events	0	[0]	0	[0]	0	[0]	1.00
Event Rate per 100 PYs					Rate ratio† (95% CI)
Grade 3 and 4 AEs	7.44		5.85		1.28 (0.62, 2.65)		0.50
ART related AEs	3.58		4.73		0.76 (0.32, 1.80)		0.53
Treatment modifying AEs	1.93		2.23		0.87 (0.31, 2.44)		0.79
Serious AEs	5.79		2.23		2.49 (0.71, 8.66)		0.15

YP = young people, PYs = person-years, AEs = adverse events.

*P-values in top half of table compare number of young people experiencing an event between arms;

†Adjusted for stratification factors; incidence rate ratio from Poisson regression model, with CT as the reference category. Fixed-effects model with standard error adjusted for clustering within participant

‡One young person in the short cycle therapy arm died of bacterial sepsis.