Table 2.
Summary of treatment-emergent adverse events and serious treatment-emergent adverse events up to the 31 August 2023 data cut-off
| Number (%) of patients | Number of events | |
|---|---|---|
| Any TEAE | 228 (98.7) | 1870 |
| Severity | ||
| Mild | 66 (28.6) | 1283 |
| Moderate | 119 (51.5) | 506 |
| Severe | 39 (16.9) | 77 |
| Fatal | 4 (1.7) | 4 |
| Drug-related TEAE | 54 (23.4) | 128 |
| Cardiovascular drug–related TEAE of clinical interest | 28 (12.1) | 40 |
| Serious TEAE | 63 (27.3) | 117 |
| Cardiovascular serious TEAE of clinical interesta | 28 (12.1) | 40 |
| Drug-related serious TEAE | 10 (4.3) | 10b |
| LVEF < 50% | 20 (8.7) | 22c |
| LVEF < 40% | 6 (2.6) | 6c |
| Death | 5 (2.2) | 5d,e |
Treatment-emergent adverse events were recorded and defined based on the discretion of the principal investigator.
LVEF, left ventricular ejection fraction; QTcF, QT interval corrected using Fridericia’s formula; TEAE, treatment-emergent adverse event.
aDefined as serious TEAEs related to major adverse cardiovascular events, atrial fibrillation, ventricular arrhythmias, syncope/pre-syncope, cardiac failure, hypotension, and QTcF prolongation.
bIncludes cardiac failure (n = 3), ejection fraction decreased (n = 5), atrial fibrillation (n = 1), and atrial flutter (n = 1).
cNumber of events that occurred while patients were receiving treatment at the time of the event.
dOwing to bacterial endocarditis (n = 1), cardiac arrest (n = 1), acute myocardial infarction (n = 1; sudden death without an autopsy performed), intracerebral haemorrhage due to arteriovenous malformation (n = 1), and progression of liver metastases with cholangitis and new onset biliary dilatation (n = 1); all unrelated to treatment.
eOf the five patients who died, one did not experience an individual TEAE considered to be of fatal severity.