Table 5.

Pregnancy safety assessment during exposure with 3HP or 9H treatment

	3HP Reported Pregnancy (n = 31)*	9H Reported Pregnancy (n = 56)*
Duration of study drug exposure, d	718	2,297
Median (IQR)	20 (1–80)	32.5 (1–242)
Study drug doses received, median (range)	8 (4–12)	160 (76–241)
Completed study treatment, n (%)	9 (29)	14 (25)
Pregnancy outcome after last study dose	8†	7‡
Participants who reported an adverse event, n (%)	0 (0)	7 (12.5)
Discontinued due to an adverse event, n (%)	0 (0)	1 (1.8)
Toxicity grade, n (%)§
Grade 1 or 2	0 (0)	6 (10.7)
Grade 3 or 4	0 (0)	1 (1.8)
Grade 5 (death)	0 (0)	0 (0)
Adverse event classification, n (%)ǁ
Drug-related adverse event
Hepatotoxicity only	0 (0)	1 (1.8)
Systemic drug reaction	0 (0)	0 (0)
Rash only	0 (0)	0 (0)
Other drug-related adverse event	0 (0)	3 (5.4)
Non–drug-related adverse event	0 (0)	3 (5.4)

Definition of abbreviations: 3HP = 12-dose once-weekly regimen of isoniazid (900 mg) plus rifapentine (900 mg); 9H = 9-month daily isoniazid (300 mg); IQR = interquartile range.

Adverse event other than pregnancy;

^*Women were considered exposed to the study drug(s) during pregnancy if they took at least one study dose and if the estimated date of conception was on or before the last study dose date.

^†Live birth (6), elective abortion (2).

^‡Live birth (6), fetal loss (1).

^§For participants reporting multiple adverse events with same toxicity, the earliest adverse event is reported.

^ǁParticipants with multiple adverse events can be present in more than one grade of toxicities and in more than one adverse event classification.