Table 4.
Summary of AEs: combined analysis of the Japanese population (treated set, combined studies)
| Olodaterol 5 μg, n (%) | Tiotropium 2.5 μg, n (%) | Tiotropium 5 μg, n (%) | Tiotropium + olodaterol 2.5/5 μg, n (%) | Tiotropium + olodaterol 5/5 μg, n (%) | Total, n (%) | |
|---|---|---|---|---|---|---|
| Patients | 108 (100.0) | 72 (100.0) | 76 (100.0) | 78 (100.0) | 79 (100.0) | 413 (100.0) |
| All AEs | 91 (84.3) | 55 (76.4) | 63 (82.9) | 66 (84.6) | 64 (81.0) | 339 (82.1) |
| Severe AEs | 8 (7.4) | 3 (4.2) | 4 (5.3) | 4 (5.1) | 11 (13.9) | 30 (7.3) |
| Treatment-related AEs | 10 (9.3) | 5 (6.9) | 4 (5.3) | 7 (9.0) | 9 (11.4) | 35 (8.5) |
| AEs leading to discontinuation | 9 (8.3) | 5 (6.9) | 6 (7.9) | 7 (9.0) | 10 (12.7) | 37 (9.0) |
| Serious AEs | 16 (14.8) | 7 (9.7) | 14 (18.4) | 18 (23.1) | 15 (19.0) | 70 (16.9) |
| Fatal | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (2.5) | 2 (0.5) |
| Life-threatening | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Disabling/incapacitating | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Requiring hospitalization | 16 (14.8) | 7 (9.7) | 13 (17.1) | 15 (19.2) | 11 (13.9) | 62 (15.0) |
| Prolonging hospitalization | 1 (0.9) | 1 (1.4) | 0 (0.0) | 1 (1.3) | 1 (1.3) | 4 (1.0) |
| Other | 0 (0.0) | 1 (1.4) | 1 (1.3) | 6 (7.7) | 1 (1.3) | 9 (2.2) |
| Specific AEs with an incidence of SOC | ||||||
| PT >3% in any one group (SOC/PT) | ||||||
| Respiratory, thoracic, and mediastinal disorders | 38 (35.2) | 24 (33.3) | 25 (32.9) | 22 (28.2) | 31 (39.2) | 140 (33.9) |
| COPD (including COPD exacerbation/worsening) | 21 (19.4) | 14 (19.4) | 13 (17.1) | 9 (11.5) | 19 (24.1) | 76 (18.4) |
| Upper respiratory tract inflammation | 7 (6.5) | 3 (4.2) | 1 (1.3) | 4 (5.1) | 3 (3.8) | 18 (4.4) |
| Cough | 3 (2.8) | 1 (1.4) | 0 (0.0) | 3 (3.8) | 1 (1.3) | 8 (1.9) |
| Oropharyngeal pain | 1 (0.9) | 2 (2.8) | 3 (3.9) | 2 (2.6) | 1 (1.3) | 9 (2.2) |
| Infections and infestations | 61 (56.5) | 38 (52.8) | 36 (47.4) | 33 (42.3) | 42 (53.2) | 210 (50.8) |
| Nasopharyngitis | 28 (25.9) | 23 (31.9) | 15 (19.7) | 20 (25.6) | 24 (30.4) | 110 (26.6) |
| Bronchitis | 9 (8.3) | 1 (1.4) | 9 (11.8) | 5 (6.4) | 12 (15.2) | 36 (8.7) |
| Pneumonia | 9 (8.3) | 2 (2.8) | 2 (2.6) | 4 (5.1) | 4 (5.1) | 21 (5.1) |
| Influenza | 3 (2.8) | 5 (6.9) | 3 (3.9) | 2 (2.6) | 1 (1.3) | 14 (3.4) |
| Upper respiratory tract infection | 6 (5.6) | 2 (2.8) | 3 (3.9) | 0 (0.0) | 3 (3.8) | 14 (3.4) |
| Pharyngitis | 1 (0.9) | 1 (1.4) | 4 (5.3) | 1 (1.3) | 2 (2.5) | 9 (2.2) |
| Gastroenteritis | 2 (1.9) | 3 (4.2) | 2 (2.6) | 3 (3.8) | 1 (1.3) | 11 (2.7) |
| Herpes zoster | 1 (0.9) | 1 (1.4) | 0 (0.0) | 0 (0.0) | 3 (3.8) | 5 (1.2) |
| Gastrointestinal disorders | 23 (21.3) | 14 (19.4) | 20 (26.3) | 20 (25.6) | 13 (16.5) | 90 (21.8) |
| Constipation | 7 (6.5) | 2 (2.8) | 4 (5.3) | 7 (9.0) | 1 (1.3) | 21 (5.1) |
| Diarrhea | 6 (5.6) | 2 (2.8) | 3 (3.9) | 1 (1.3) | 3 (3.8) | 15 (3.6) |
| Gastro-esophageal reflux | 1 (0.9) | 3 (4.2) | 3 (3.9) | 1 (1.3) | 1 (1.3) | 9 (2.2) |
| Abdominal discomfort | 0 (0.0) | 0 (0.0) | 3 (3.9) | 1 (1.3) | 1 (1.3) | 5 (1.2) |
| Vomiting | 0 (0.0) | 0 (0.0) | 3 (3.9) | 1 (1.3) | 1 (1.3) | 5 (1.2) |
| Dry mouth | 1 (0.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (3.8) | 4 (1.0) |
| Musculoskeletal and connective tissue disorders | 15 (13.9) | 7 (9.7) | 8 (10.5) | 13 (16.7) | 8 (10.1) | 51 (12.3) |
| Back pain | 5 (4.6) | 1 (1.4) | 1 (1.3) | 3 (3.8) | 1 (1.3) | 11 (2.7) |
| Muscle spasms | 2 (1.9) | 0 (0.0) | 1 (1.3) | 3 (3.8) | 2 (2.5) | 8 (1.9) |
| Metabolism and nutrition disorders | 8 (7.4) | 8 (11.1) | 6 (7.9) | 4 (5.1) | 6 (7.6) | 32 (7.7) |
| Diabetes mellitus | 1 (0.9) | 3 (4.2) | 1 (1.3) | 2 (2.6) | 1 (1.3) | 8 (1.9) |
| Hyperuricemia | 2 (1.9) | 1 (1.4) | 1 (1.3) | 1 (1.3) | 3 (3.8) | 8 (1.9) |
| Vascular disorders | 7 (6.5) | 4 (5.6) | 3 (3.9) | 4 (5.1) | 5 (6.3) | 23 (5.6) |
| Hypertension | 7 (6.5) | 2 (2.8) | 3 (3.9) | 3 (3.8) | 1 (1.3) | 16 (3.9) |
| Skin and subcutaneous tissue disorders | 12 (11.1) | 8 (11.1) | 10 (13.2) | 12 (15.4) | 10 (12.7) | 52 (12.6) |
| Dermatitis (contact) | 2 (1.9) | 1 (1.4) | 4 (5.3) | 0 (0.0) | 1 (1.3) | 8 (1.9) |
| Eczema | 3 (2.8) | 1 (1.4) | 1 (1.3) | 4 (5.1) | 1 (1.3) | 10 (2.4) |
| Eczema (asteatotic) | 0 (0.0) | 1 (1.4) | 1 (1.3) | 0 (0.0) | 3 (3.8) | 5 (1.2) |
| Pruritus | 2 (1.9) | 0 (0.0) | 2 (2.6) | 3 (3.8) | 0 (0.0) | 7 (1.7) |
| Reproductive system and breast disorders | 4 (3.7) | 3 (4.2) | 1 (1.3) | 3 (3.8) | 3 (3.8) | 14 (3.4) |
| Benign prostatic hyperplasia | 1 (0.9) | 3 (4.2) | 1 (1.3) | 3 (3.8) | 2 (2.5) | 10 (2.4) |
| Psychiatric disorders | 7 (6.5) | 1 (1.4) | 4 (5.3) | 3 (3.8) | 3 (3.8) | 18 (4.4) |
| Insomnia | 6 (5.6) | 1 (1.4) | 3 (3.9) | 2 (2.6) | 3 (3.8) | 15 (3.6) |
| Investigations | 11 (10.2) | 6 (8.3) | 5 (6.6) | 9 (11.5) | 2 (2.5) | 33 (8.0) |
| Blood urine present | 2 (1.9) | 0 (0.0) | 3 (3.9) | 2 (2.6) | 0 (0.0) | 7 (1.7) |
| Injury, poisoning, and procedural complications | 10 (9.3) | 7 (9.7) | 8 (10.5) | 4 (5.1) | 7 (8.9) | 36 (8.7) |
| Ligament sprain | 0 (0.0) | 3 (4.2) | 2 (2.6) | 0 (0.0) | 0 (0.0) | 5 (1.2) |
Abbreviations: AE, adverse event; SOC, System Organ Class; PT, preferred term.