Table 2.

Unplanned visits and adverse events occurring from enrolment through week 28 (n=397)

		Overall (n=397)	United States (n=129)	Brazil (n=131)	Thailand (n=110)	Uganda (n=15)	South Africa (n=12)
Unplanned visits*
Participants reporting at least one unplanned visits*		15 (4%)	3 (2%)	3 (2%)	4 (4%)	3 (20%)	2 (17%)
Total number of unplanned visits		21	3	5	4	3	6
Reason for unplanned visits
	Lab evaluations	8	1	0	3	0	4
	Adverse event	3	1	1	0	0	1
	Clinical event (non-AE)	6	0	3	0	3	0
	Other†	4	1	1	1	0	1
Serious adverse events (primary safety outcome)
Total number of participants reporting at least one SAE		14 (4%)	7 (5%)	0	5 (5%)	0	2 (17%)
Toxicity grade
	Grade 3	12	7	0	4	0	1
	Grade 4	2	0	0	1	0	1
SAE occurring while on study medication		5	1	0	3	0	1
SAE leading to discontinuation of study drug		0	0	0	0	0	0
SAE related to study medication		0	0	0	0	0	0
Death		0	0	0	0	0	0
Adverse events (excluding serious adverse events) (secondary safety outcome)
Participants reporting at least one AE (excluding SAEs)		23 (6%)	7 (5%)	8 (6%)	7 (6%)	0	1 (8%)
Total number of adverse events		28	12	8	7	0	1
AE occurred while on study medication		8	7	1	0	0	0
AE related to study medication		5	4	1	0	0	0
AE leading to discontinuation of study drug‡		1	1	0	0	0	0

Data are n or n (%). AE=adverse event. SAE=serious adverse event.

^*All participants who initiated treatment were included in the denominator for unplanned visits (n=399).

^†Other included unscheduled study visit outside of window (n=1), visited site to clarify query on study treatment (n=1), visited site for counseling and collect vitamin B12 for management of pernicious anaemia (n=1), participant newly diagnosed with HIV and wanted to initiate antiretroviral therapy (n=1).

^‡One case of abdominal distension attributed to study product resulted in discontinuation.