Table 2.

Outcomes by study group^*

	BCG group	Placebo group	Risk ratio (95% CI)	p value
Primary outcome
QFT conversion (positivity threshold ≥0·35 IU/mL)	34/996 (3·4%)	32/989 (3·2%)	1·09 (0·67–1·77)	0·791
Secondary outcome
Sustained conversion (positivity threshold ≥0·35 IU/mL)	15/996 (1·5%)	19/989 (1·9%)	0·80 (0·41–1·57)	0·510
Exploratory outcomes
QFT conversion (positivity threshold ≥0·70 IU/mL)	15/996 (1·5%)	13/989 (1·3%)	1·15 (0·55–2·45)	0·713
QFT conversion (positivity threshold ≥2·00 IU/mL)	6/996 (0·6%)	5/989 (0·5%)	1·18 (0·36–3·85)	0·788
QFT conversion (positivity threshold ≥4·00 IU/mL)	2/996 (0·2%)	3/989 (0·3%)	0·64 (0·11–3·84)	0·633
QFT conversion (baseline QFT <0·20 IU/mL and positivity threshold ≥0·35 IU/mL)	22/957 (2·3%)	23/950 (2·4%)	0·96 (0·53–1·74)	0·903

Data are n/N (%), unless otherwise specified. QFT=QuantiFERON-TB Gold.

^*All analyses were done in the intention-to-treat population.