Table 4.
Details of adverse events.
| ADMSC (n = 13) |
Control (n = 13) |
|
|---|---|---|
| Patients with AEs, n (%)a | 9 (69.2) | 9 (69.2) |
| Treatment-related | 0 | 0 |
| Donor-site complication | 0 | - |
| Patients with SAEs, n (%)b | 0 | 0 |
| Treatment-related | 0 | 0 |
| AEs by NCI-CTCAE scale, n | 13 | 21 |
| Grade 1 | 8 | 6 |
| Grade 2 | 5 | 15 |
| Grade 3 | 0 | 0 |
| Grade 4 | 0 | 0 |
| Grade 5 | 0 | 0 |
An AE is defined as any undesired medical incident that does not necessarily have a cause-and-effect relationship with the treatment.
An SAE is defined as any undesired medical incident that causes death, life-threatening, hospitalization, disability, congenital abnormality, or birth-death.
Abbreviations: AE, adverse events; ADMSC, adipose-derived mesenchymal stem cell; CTCAE, National Cancer Institute-Common Terminology Criteria for Adverse Events; SAE, severe adverse events.