Table 5.

Adverse events among 3489 individuals who initiated pre-exposure prophylaxis

	Total (n=3489)
Any grade 3 or 4 adverse event	28 (0·8%)
Grade 3 creatinine elevation	1 (0·03%)
Grade 4 creatinine elevation	0
Grade 3 adverse event possibly related to the study drug	5 (0·1%)
Grade 4 adverse event possibly related to the study drug	0
Any serious adverse event	29 (0·8%)
Death	7 (0·2%)

Grade 3 or 4 adverse events, serious adverse events, and causes of death are listed in the appendix (p 7). Adverse events possibly related to the study drug were creatinine elevation (n=1), dizziness (n=2), fatigue (n=1), and headache (n=1). All other grade 3 or 4 adverse events were judged to be unlikely (n=2) or not related to the study drug. One serious adverse event was judged to be possibly related to the study drug: a 71-year-old man was treated in hospital for urinary retention and found to have bilateral hydronephrosis and grade 3 creatinine elevation. Creatinine returned to baseline following relief of urinary obstruction and cessation of the study drug.