Table 2

Expected numbers of cases (patients with ≥1 events) over 1 year for every 10 000 patients (men, age <65 years) treated with and without roflumilast

Type of outcome	Patients’ projected 1-year risk of having ≥1 moderate or severe COPD exacerbations
	30%			60%			90%
	Roflumilast	Placebo	Number of cases (patients with ≥1 event) prevented or caused*	Roflumilast	Placebo	Number of cases (patients with ≥1 event) prevented or caused*	Roflumilast	Placebo	Number of cases (patients with ≥1 event) prevented or caused*
Moderate or severe exacerbation	2299	2487	188	4055	4338	284	5397	5718	321
Acute pancreatitis	4	1	−3	4	1	−3	4	1	−3
Insomnia	509	170	−339	509	170	−339	509	170	−339
Anxiety	237	123	−115	237	123	−115	237	123	−115
Depression	260	154	−106	260	154	−106	260	154	−106
Suicide (completed)	7	1	−6	7	1	−6	7	1	−6
Diarrhoea	1574	394	−1180	1574	394	−1180	1574	394	−1180
Nausea	834	220	−615	834	220	−615	834	220	−615
Weight loss	508	127	−381	508	127	−381	508	127	−381
Headache	751	304	−446	751	304	−446	751	304	−446
Dizziness	399	181	−218	399	181	−218	399	181	−218

*Positive number indicates cases prevented and negative number indicates cases caused by roflumilast.