| Adverse events | With LABA# | Without LABA# | ||
| Roflumilast¶ | Placebo | Roflumilast | Placebo | |
| Total n | 753 | 789 | 794 | 756 |
| COPD | 101 (13.4) | 130 (16.5) | 56 (7.1) | 74 (9.8) |
| Weight decrease | 77 (10.2) | 24 (3.0) | 80 (10.1) | 20 (2.6) |
| Diarrhoea | 58 (7.7) | 20 (2.5) | 72 (9.1) | 29 (3.8) |
| Nasopharyngitis | 42 (5.6) | 48 (6.1) | 50 (6.3) | 49 (6.5) |
| Bronchitis | 28 (3.7) | 38 (4.8) | 28 (3.5) | 26 (3.4) |
| Pneumonia | 28 (3.7) | 20 (2.5) | 14 (1.8) | 11 (1.5) |
| Back pain | 25 (3.3) | 20 (2.5) | 25 (3.1) | 15 (2.0) |
| Nausea | 24 (3.2) | 11 (1.4) | 38 (4.8) | 19 (2.5) |
| Headache | 22 (2.9) | 15 (1.9) | 29 (3.7) | 10 (1.3) |
| Hypertension | 21 (2.8) | 22 (2.8) | 17 (2.1) | 26 (3.4) |
| Insomnia | 16 (2.1) | 7 (0.9) | 21 (2.6) | 13 (1.7) |
| URTI | 14 (1.9) | 22 (2.8) | 35 (4.4) | 37 (4.9) |
| Dizziness | 10 (1.3) | 7 (0.9) | 20 (2.5) | 9 (1.2) |
| Influenza | 9 (1.2) | 11 (1.4) | 30 (3.8) | 27 (3.6) |
| Urinary tract infection | 9 (1.2) | 6 (0.8) | 21 (2.6) | 6 (0.8) |
| γ-glutamyltransferase increased | 1 (0.1) | 11 (1.4) | 10 (1.3) | 19 (2.5) |
Data are presented as n (%), unless otherwise stated. Adverse events were reported independently of the investigator causality assessments. Patients might have had more than one adverse event. COPD: chronic obstructive pulmonary disease; URTI: upper respiratory tract infection. #: post hoc analyses; ¶: incidence of adverse events in the roflumilast with LABA group, in descending order.