Table 5.
TEAEs of special interest.
| n (%) | Total (N = 163) |
|---|---|
| Cardiac TEAEs | |
| Any TEAE | 24 (14.7) |
| Cardiac disorders | 23 (14.1) |
| Cardiac failure | 6 (3.7) |
| Atrial fibrillation | 5 (3.1) |
| Tachycardia | 3 (1.8) |
| Arrhythmia | 2 (1.2) |
| Bradycardia | 2 (1.2) |
| Cardiac failure congestive | 2 (1.2) |
| Atrial flutter | 1 (0.6) |
| Atrioventricular block complete | 1 (0.6) |
| Bundle branch block right | 1 (0.6) |
| Cardiac failure acute | 1 (0.6) |
| Cardiac flutter | 1 (0.6) |
| Cardiogenic shock | 1 (0.6) |
| Extrasystoles | 1 (0.6) |
| Sinus bradycardia | 1 (0.6) |
| Investigations | 1 (0.6) |
| Electrocardiogram QT interval prolonged | 1 (0.6) |
| Vascular TEAEs | |
| Any TEAE | 19 (11.7) |
| Cardiovascular | 5 (3.1) |
| Angina pectoris | 2 (1.2) |
| Angina unstable | 1 (0.6) |
| Coronary artery occlusion | 1 (0.6) |
| Myocardial ischemia | 1 (0.6) |
| Cerebrovascular | 5 (3.1) |
| Cerebrovascular accident | 2 (1.2) |
| Transient ischemic attack | 2 (1.2) |
| Carotid artery stenosis | 1 (0.6) |
| Peripheral vascular | 10 (6.1) |
| Peripheral arterial occlusive disease | 3 (1.8) |
| Peripheral ischemia | 2 (1.2) |
| Aortic stenosis | 1 (0.6) |
| Arterial rupture | 1 (0.6) |
| Intermittent claudication | 1 (0.6) |
| Peripheral coldness | 1 (0.6) |
| Vascular pain | 1 (0.6) |
| Effusion TEAEs | |
| Any TEAE | 30 (18.4) |
| Pleural effusion | 27 (16.6) |
| Pericardial effusion | 8 (4.9) |
| Metabolic TEAEs | |
| Any TEAE | 13 (8.0) |
| Hyperglycemia | 5 (3.1) |
| Diabetes mellitus | 4 (2.5) |
| Hypercholesterolemia | 3 (1.8) |
| Hypertriglyceridemia | 3 (1.8) |
| Hyperlipidemia | 1 (0.6) |
| Gastrointestinal TEAEs | |
| Any TEAE | 149 (91.4) |
| Diarrhea | 143 (87.7) |
| Abdominal pain | 67 (41.1) |
| Nausea | 65 (39.9) |
| Vomiting | 53 (32.5) |
| Constipation | 28 (17.2) |
Full analysis set. Classification of adverse events is based on the Medical Dictionary for Regulatory Activities (v21.1). See Supp. Methods for adverse events of special interest cluster definitions.
Totals for the number of patients at a higher level are not necessarily the sum of those at the lower levels since a patient may report two or more different TEAEs within the higher level category.
TEAE treatment-emergent adverse events.