Table 3. Primary safety endpoint events^* serious adverse events (SAEs), deaths and suspected bacterial infections requiring hospitalisation.

Timing	Randomised	16 weeks (N=602)	24 weeks (N=602)	Total (N=1204)
Overall	DAIDS grade 3, 4 or 5 adverse events	49	66	115
	Participants with at least one DAIDS grade 3, 4 or 5 adverse event ¤	47 (8)	48 (8)	95 (8)
Before week 16	Grade 3, 4 or 5 adverse events	35	52	87
	Participants with at least one grade 3, 4 or 5 adverse event	33 (5)	40 (7)	73 (6)
After week 16	Grade 3, 4 or 5 adverse events	14	14	28
	Participants with at least one grade 3, 4 or 5 adverse event	14 (2)	12 (2)	26 (2)
Overall	SAEs	88	104	192
	Participants with at least one SAE ¤	75 (12)	75 (12)	150 (12)
Before week 16	SAEs	35	50	85
	Participants with at least one SAE	33	40	73
After week 16	SAEs	53	54	107
	Participants with at least one SAE	47	44	91
Total	No. of Deaths	12	19	31
Before week 16	Deaths	5	6	11
	Deaths considered related to TB	3	2	5
After week 16	Deaths	7	13	20
	Deaths considered related to TB	2	6	8
Overall	No. of adverse drug reactions ¥ on treatment and within 30 days of completing treatment	6 (1)	11 (2)	17 (1)
Overall	Events described as bacterial infection requiring hospitalisation	40	40	80
	Participants with at least one episode of bacterial infection requiring hospitalisation*	36 (6)	30 (5)	66 (5)

Data presented as number of events or number of participants with at least one event (%) as indicated. DAIDS = Division of AIDS table for grading the severity of adult and paediatric adverse events; SAE=serious adverse event, defined using International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) definitions as adverse event resulting in death, is life-threatening, requires hospitalisation or prolongs existing hospitalisation, results in persistent or significant disability or incapacity, consists of a congenital anomaly or birth defect, or considered to be another important medical condition.

^*Primary safety endpoint events include on-treatment grade 3 or higher adverse events up to 30 days after the last dose of study drugs.

^¤Participants can appear in both before and after 16 week breakdown.

^¥Adverse drug reactions were defined as being possibly, probably or definitely related to the trial drugs as assessed by the site investigator. Further information on these can be found in the listing in the supplementary material and include event type and information on treatment discontinuation.