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.