Table 4.
Summary of adverse events by MedDRA system organ class and preferred safety population
| Overall (N = 92) | |
|---|---|
| Patients with at [east one AE, n (%)1 | 16 (17) |
| Patients reporting one AE | 4 (25) |
| Patients reporting more than one AE | 12 (75) |
| AEs by severity, n (%)2 | |
| Mild | 42 (98) |
| Moderate | 1 (2) |
| Severe | 0 (0) |
| Type of AE | Overall | aCT1 + SOC | SOC | P-Value | |
|---|---|---|---|---|---|
| n (%) | n | n | n | ||
| Incision site infection | 2 (2) | 2 | 1 | 1 | 1.00 |
| Incision site pain | 8 (9) | 14 | 8 | 6 | 0.79 |
| Incision site edema | 6 (7) | 11 | 6 | 5 | 0.76 |
| Incision site complication3 | 5 (5) | 10 | 5 | 5 | 1.00 |
| Incision site erythema | 1 (1) | 2 | 1 | 1 | 1.00 |
| Incision site hematoma | 1 (1) | 1 | 1 | 0 | — |
| Wound secretion | 1 (1) | 1 | 1 | 0 | — |
| Cough | 1 (1) | 1 | — | — | — |
| Dyspnea | 1 (1) | 1 | — | — | — |
| Total AEs in 16 patients | 43 | ||||
Abbreviations: AE, adverse event; SOC, standard of care.
1
Percentages were calculated by taking respective column header group count as denominator.
2
Percentages were calculated by taking count of total AEs in 16 patients in corresponding treatment group as denominator.
3
Incision site complication included reports of a combination of inflammatory symptoms (e.g., inflammation, redness) categorized as incision site complication per investigator discretion.