Table 2.

Effect of lansoprazole on each component of the primary and secondary endpoints

	Lansoprazolea (n = 183)	Gefarnateb (n = 181)	Hazard ratio (95% CI)	P valuec
Number at risk at baselined	168	162
Primary endpoint
Gastric or duodenal ulcer	15	46	0.2510 (0.1400–0.4499)	<0.0001
Secondary endpoints
Gastric/duodenal ulcer and/or hemorrhagic lesion	15	52	0.2196 (0.1235–0.3904)	<0.0001
Gastric/duodenal ulcer, hemorrhagic lesion and/or treatment discontinuation due to lack of efficacy	18	65	0.2158 (0.1279–0.3640)	<0.0001
Componente
Gastric or duodenal ulcer	13	42
Hemorrhagic lesion	0	4
Treatment discontinuation due to lack of efficacy	3	13
Gastric or duodenal ulcer and hemorrhagic lesion	2	4
Hemorrhagic lesion and treatment discontinuation due to lack of efficacy	0	2

^aPatients received lansoprazole 15 mg daily

^bPatients received gefarnate 50 mg twice daily

^cLog-rank test

^dThe number of patients at risk included all full analysis set patients who received at least one endoscopy assessment post-randomization, and had no acute-stage or healing-stage gastric or duodenal ulcer as confirmed by the Independent Adjudication Committee

^eThe ‘component’ section is intended to indicate the components of the endpoints given above and not the endpoints themselves. Hence, the hazard ratios and P values have not been calculated