Table 6.
Summary of AEs
| ANHELTO 1
|
ANHELTO 2
|
|||
|---|---|---|---|---|
| Tiotropium + placebo (n=565) | Olodaterol + tiotropium (n=567) | Tiotropium + placebo (n=569) | Olodaterol + tiotropium (n=566) | |
| Any AE | 242 (42.8) | 257 (45.3) | 246 (43.2) | 227 (40.1) |
| Serious AE | 26 (4.6) | 40 (7.1) | 27 (4.7) | 24 (4.2) |
| AE leading to death | ||||
| During treatment | 0 | 2 (0.4)a | 1 (0.2) | 1 (0.2) |
| During 21-day follow-up | 1 (0.2) | 5 (0.9)a,b | 1 (0.2) | 2 (0.4) |
| After 21-day follow-up | 1 (0.2) | 0 | 0 | 0 |
| AE preferred term occurring with an incidence of ≥1% in any group | ||||
| Upper respiratory tract infection | 10 (1.8) | 6 (1.1) | 13 (2.3) | 10 (1.8) |
| Bronchitis | 7 (1.2) | 11 (1.9) | 11 (1.9) | 4 (0.7) |
| Sinusitis | 7 (1.2) | 12 (2.1) | 9 (1.6) | 6 (1.1) |
| Nasopharyngitis | 14 (2.5) | 14 (2.5) | 8 (1.4) | 4 (0.7) |
| Influenza | 5 (0.9) | 7 (1.2) | 2 (0.4) | 3 (0.5) |
| Urinary tract infection | 7 (1.2) | 6 (1.1) | 8 (1.4) | 4 (0.7) |
| Candidiasis | 1 (0.2) | 3 (0.5) | 6 (1.1) | 4 (0.7) |
| Anemia | 2 (0.4) | 0 | 6 (1.1) | 1 (0.2) |
| Headache | 10 (1.8) | 8 (1.4) | 7 (1.2) | 6 (1.1) |
| Dizziness | 1 (0.2) | 7 (1.2) | 6 (1.1) | 3 (0.5) |
| Hypertension | 2 (0.4) | 5 (0.9) | 4 (0.7) | 6 (1.1) |
| COPD | 61 (10.8) | 74 (13.1) | 55 (9.7) | 52 (9.2) |
| Cough | 17 (3.0) | 9 (1.6) | 11 (1.9) | 8 (1.4) |
| Dysphonia | 5 (0.9) | 3 (0.5) | 7 (1.2) | 2 (0.4) |
| Dyspnea | 11 (1.9) | 6 (1.1) | 6 (1.1) | 4 (0.7) |
| Dry mouth | 15 (2.7) | 16 (2.8) | 14 (2.5) | 16 (2.8) |
| Diarrhea | 10 (1.8) | 7 (1.2) | 10 (1.8) | 4 (0.7) |
| Constipation | 6 (1.1) | 8 (1.4) | 7 (1.2) | 3 (0.5) |
| Vomiting | 3 (0.5) | 8 (1.4) | 5 (0.9) | 5 (0.9) |
| Nausea | 3 (0.5) | 5 (0.9) | 3 (0.5) | 6 (1.1) |
| Arthralgia | 2 (0.4) | 5 (0.9) | 7 (1.2) | 1 (0.2) |
| Back pain | 2 (0.4) | 6 (1.1) | 7 (1.2) | 6 (1.1) |
| Muscle spasms | 3 (0.5) | 5 (0.9) | 4 (0.7) | 6 (1.1) |
| Chest pain | 4 (0.7) | 4 (0.7) | 7 (1.2) | 4 (0.7) |
Notes:
a
One patient had two AEs identified as leading to death: COPD exacerbation was cited during treatment and acute respiratory failure during 21-day washout
b
one patient had two AES leading to death: myocardial infarction and arteriosclerosis.
Abbreviations: AE, adverse event; COPD, chronic obstructive pulmonary disease.