Table 2.
Treatment‐emergent adverse events (TEAEs) (MedRA v16.0) of interest related to the CV system, serious CV‐related TEAEs and frequency of adjudicated CV‐related TEAEs (SAF)
| TEAEs of interest SOC and PT | Patients, n (%) [95% CI] | ||
|---|---|---|---|
| Combination (n=725) | Solifenacin 5 mg (n=728) | Solifenacin 10 mg (n=719) | |
| Increased blood pressure | |||
| Overall | 12 (1.7) [0.7 to 2.6] | 6 (0.8) [0.2 to 1.5] | 13 (1.8) [0.8 to 2.8] |
| Vascular disorders | 8 (1.1) [0.3 to 1.9] | 5 (0.7) [0.1 to 1.3] | 7 (1.0) [0.3 to 1.7] |
| Hypertension | 8 (1.1) [0.3 to 1.9] | 5 (0.7) [0.1 to 1.3] | 6 (0.8) [0.2 to 1.5] |
| Hypertensive crisis | 0 | 0 | 1 (0.1) [0.0 to 0.4] |
| Investigations | 4 (0.6) [0.0 to 1.1] | 1 (0.1) [0.0 to 0.4] | 6 (0.8) [0.2 to 1.5] |
| Blood pressure increased | 4 (0.6) [0.0 to 1.1] | 1 (0.1) [0.0 to 0.4] | 6 (0.8) [0.2 to 1.5] |
| QT prolongation | |||
| Overall | 1 (0.1) [0.0 to 0.4] | 1 (0.1) [0.0 to 0.4] | 2 (0.3) [0.0 to 0.7] |
| Investigations | 1 (0.1) [0.0 to 0.4] | 1 (0.1) [0.0 to 0.4] | 1 (0.1) [0.0 to 0.4] |
| ECG QT prolonged | 1 (0.1) [0.0 to 0.4] | 1 (0.1) [0.0 to 0.4] | 1 (0.1) [0.0 to 0.4] |
| Nervous system disorders | 0 | 0 | 1 (0.1) [0.0 to 0.4] |
| Syncope | 0 | 0 | 1 (0.1) [0.0 to 0.4] |
| Increased heart rate, tachycardia, atrial fibrillation and palpitations | |||
| Overall | 7 (1.0) [0.3 to 1.7] | 5 (0.7) [0.1 to 1.3] | 4 (0.6) [0.0 to 1.1] |
| Cardiac disorders | 7a (1.0) [0.3 to 1.7] | 5 (0.7) [0.1 to 1.3] | 3 (0.4) [0.0 to 0.9] |
| Palpitations | 6 (0.8) [0.2 to 1.5] | 2 (0.3) [0.0 to 0.7] | 2 (0.3) [0.0 to 0.7] |
| Tachycardia | 2 (0.3) [0.0 to 0.7] | 1 (0.1) [0.0 to 0.4] | 0 |
| Atrial fibrillation | 0 | 1 (0.1) [0.0 to 0.4] | 0 |
| Supraventricular extrasystoles | 0 | 0 | 1 (0.1) [0.0 to 0.4] |
| Ventricular extrasystoles | 0 | 1 (0.1) [0.0 to 0.4] | 0 |
| Nervous system disorders | 0 | 0 | 1 (0.1) [0.0 to 0.4] |
| Syncope | 0 | 0 | 1 (0.1) [0.0 to 0.4] |
| Serious CV‐related TEAEs (PT only) | |||
| Arteriogram coronary normal | 1 (0.1) | 0 | 0 |
| Acute myocardial infarction | 0 | 0 | 1 (0.1) |
| Atrial fibrillation | 0 | 1 (0.1) | 0 |
| Atrioventricular block complete | 1 (0.1) | 0 | 0 |
| Transient ischaemic attack | 0 | 0 | 1 (0.1) |
| Hypertensive crisis | 0 | 0 | 1 (0.1) |
| Thrombosis | 0 | 1 (0.1) | 0 |
| Adjudicated serious CV‐related TEAEs | |||
| Overall | 4 (0.6) | 2 (0.3) | 4 (0.6) |
| APTC/MACE CV events | 0 | 0 | 1 (0.1) |
| Non‐fatal myocardial infarction | 0 | 0 | 1 (0.1) |
| Non‐fatal stroke | 0 | 0 | 0 |
| CV death | 0 | 0 | 0 |
| Non‐APTC/MACE CV events | 1 (0.1) | 2 (0.3) | 2 (0.3) |
| Unstable angina | 0 | 0 | 0 |
| Coronary revascularization | 0 | 0 | 0 |
| Transient ischaemic attack | 0 | 0 | 1 (0.1) |
| Venous and peripheral arterial vascular thrombotic event | 0 | 1 (0.1) | 0 |
| Congestive heart failure | 0 | 0 | 0 |
| Arrhythmia, no evidence of ischaemia | 1 (0.1) | 1 (0.1) | 0 |
| Other serious non‐MACE CV event | 0 | 0 | 1 (0.1) |
| Other | 3 (0.4) | 0 | 1 (0.1) |
| Insufficient data | 0 | 0 | 1 (0.1) |
| Non‐CV event | 3 (0.4) | 0 | 0 |
APTC, antiplatelet trialists collaboration; CV, cardiovascular; ECG, electrocardiogram; MACE, major adverse cardiovascular event; PT, preferred term; SOC, system organ class; TEAEs, treatment‐emergent adverse events.
TEAE refers to an AE which started or worsened in the period from first double‐blind medication intake until 30 days after the last double‐blind medication intake.
a
One patient experienced both tachycardia and palpitations; the patient is counted once under each of palpitations and tachycardia, but only once under the SOC cardiac disorders.