Table 4.

Summary of safety results

		Placebo (n=214)	Brensocatib 25 mg (n=192)	Odds ratio (95% CI)	p value
Any TEAE		99 (46%)	86 (45%)	0·94 (0·64–1·39)	0·77
TEAE maximum severity
	Mild	44 (21%)	36 (19%)	..	..
	Moderate	24 (11%)	12 (6%)	..	..
	Severe	31 (15%)	38 (20%)	1·01 (0·70– 1·47)	0·94
TEAEs in ≥5% of patients in any group*
	Gastrointestinal disorders	30 (14%)	18 (9%)	0·63 (0·34–1·18)	0·15
	Infections and infestations	31 (15%)	31 (16%)	1·14 (0·66–1·95)	0·64
	Respiratory, thoracic, and mediastinal disorders	12 (6%)	15 (8%)	1·43 (0·65–3·13)	0·38
	Nervous system disorders	11 (5%)	11 (6%)	1·12 (0·47–2·65)	0·79
	Skin and subcutaneous tissue disorders	14 (7%)	12 (6%)	0·95 (0·43–2·11)	0·91
	TEAE resulting in treatment discontinuation	7 (3%)	9 (5%)	1·45 (0·53–3·98)	0·47
Adverse events of special interest
	Hyperkeratosis	0	0	..	..
	Dental complications	1 (0%)	0	..	1·00
	Secondary infections	7 (3%)	6 (3%)	0·95 (0·31–2·89)	0·93
Serious TEAE
	Infections and infestations	23 (11%)	26 (14%)	1·30 (0·72–2·37)	0·39
	Respiratory, thoracic, and mediastinal disorders	5 (2%)	6 (3%)	..	0·76
	Gastrointestinal disorders	2 (1%)	1 (1%)	..	1·00
Relation to drug treatment†
	Adverse event related to study drug	37 (17%)	39 (20%)	1·22 (0·74–2·01)	0·44
	Deaths related to study drug	1 (0%)	0	..	1·00

Data are n (%), unless otherwise specified. Safety analyses were based on the safety population, which included all patients who received at least one dose of brensocatib or placebo. p values are brensocatib group vs placebo logistic regression, except TEAE maximum severity, which was analysed using ordinal regression. If odds ratios were not provided then p values were determined using Fisher's exact test. TEAE=treatment-emergent adverse event.

^*Adverse events are reported and classified based on Medical Dictionary for Regulatory Activities terminology.

^†Judged as possible or probable by the site principal investigator.