Table 4.
Overall treatment-emergent adverse events (TEAEs), most common TEAEs (≥5% of patients in any treatment group) and TEAEs of special interest in the safety analysis set
| TEAE | Number of patients (%)b | p valuec | |
|---|---|---|---|
| Mirabegron (n = 319) | Tolterodine ER (n = 325) | ||
| Any TEAE | 150 (47.0) | 168 (51.7) | – |
| Drug-related TEAE | 89 (27.9) | 111 (34.2) | – |
| Deaths | 0 | 0 | – |
| Serious TEAE | 3 (0.9) | 8 (2.5) | – |
| Drug-related serious adverse eventa | 2 (0.6) | 0 | – |
| TEAEs leading to permanent discontinuation of study drug | 15 (4.7) | 20 (6.2) | – |
| Drug-related TEAEs leading to permanent discontinuation of study druga | 12 (3.8) | 12 (3.7) | – |
| Serious TEAEs leading to permanent discontinuation of study drug | 0 | 5 (1.5) | – |
| Drug-related serious TEAEs leading to permanent discontinuation of study druga | 0 | 0 | – |
| Most Common TEAEs (by Preferred Term) | |||
| Dry mouth | 29 (9.1) | 53 (16.3) | – |
| Constipation | 18 (5.6) | 20 (6.2) | – |
| Headache | 18 (5.6) | 19 (5.8) | – |
| TEAEs of special Interest (by System Organ Class and Preferred Term) | |||
| Common anticholinergic TEAEs | 65 (20.4) | 89 (27.4) | 0.042 |
| Gastrointestinal disorders | 47 (14.7) | 73 (22.5) | 0.015 |
| Dry mouth | 29 (9.1) | 53 (16.3) | – |
| Constipation | 18 (5.6) | 20 (6.2) | – |
| Nausea | 6 (1.9) | 8 (2.5) | – |
| Nervous system disorders | 20 (6.3) | 29 (8.9) | 0.235 |
| Headache | 18 (5.6) | 19 (5.8) | – |
| Somnolence | 4 (1.3) | 10 (3.1) | – |
| Eye disorders | 12 (3.8) | 11 (3.4) | 0.835 |
| Vision blurred | 12 (3.8) | 11 (3.4) | – |
| Respiratory, thoracic and mediastinal disorders | 2 (0.6) | 0 | 0.245 |
| Dry throat | 2 (0.6) | 0 | – |
| Cardiovascular TEAEs | 3 (0.9) | 5 (1.5) | 0.725 |
| Cardiac disorders | 3 (0.9) | 5 (1.5) | 0.725 |
| Atrial fibrillation | 2 (0.6) | 1 (0.3) | – |
| Tachycardia | 1 (0.3) | 2 (0.6) | – |
| Palpitations | 0 | 2 (0.6) | – |
| Vascular disorders | 11 (3.4) | 9 (2.8) | 0.656 |
| Hypertension | 11 (3.4) | 9 (2.8) | – |
| Urinary retention TEAEs | 1 (0.3) | 1 (0.3) | 1.000 |
| Renal and urinary disorders | 1 (0.3) | 1 (0.3) | 1.000 |
| Urinary retention | 1 (0.3) | 1 (0.3) | 1.000 |
| Urinary tract infections | 12 (3.8) | 17 (5.2) | – |
| Hypersensitivity | 2 (0.6) | 5 (1.5) | – |
| Glaucoma | 0 | 0 | – |
The data are presented as number (%) of patients
aPossible or probable drug-related event, as assessed by the investigator, or records where relationship was missing
bIf a patient reported a TEAE for the same treatment in two different periods (sequences MM/TT), then that patient was counted once
c p values were calculated for the common anticholinergic side effects, cardiovascular events and urinary retention events, and were based on Fisher’s exact test