Table 2.
Summary of treatment-emergent adverse events in the safety set from 6 months after treatment.α
| ADMSC (n = 11) |
|
|---|---|
| Patient summary | |
| Patients with TEAEs | 11 (100) |
| Treatment-related TEAEs | 0 (0) |
| Patients with SAE | 1 (9.1) |
| Treatment-related SAE | 0 (0) |
| Most common TEAEs† | |
| Back pain | 4 (36.4) |
| Hypertension | 3 (27.3) |
| Arthralgia | 2 (18.2) |
| Hyperlipidemia | 2 (18.2) |
| Benign prostatic hyperplasia | 2 (18.2) |
| Event summary | |
| Total number of TEAEs | 47 (100) |
| SAE | 1 (2.1) |
| Severity by NCI-CTCAE scale | |
| Grade 1 | 24 (51.1) |
| Grade 2 | 20 (42.6) |
| Grade 3 | 3 (6.3) |
| Grade 4 | 0 (0) |
| Grade 5 | 0 (0) |
| Relationship to treatment | |
| Certain | 0 (0) |
| Probable/likely | 0 (0) |
| Possible | 0 (0) |
| Unlikely | 47 (100) |
| Conditional/unclassified | 0 (0) |
| Unassessable/unclassifiable | 0 (0) |
| Result of TEAEs | |
| Recovered/resolved | 27 (57.5) |
| Recovering/resolving | 16 (34.0) |
| Not recovered/not resolved | 4 (8.5) |
| Recovered or resolved with sequelae | 0 (0) |
| Death | 0 (0) |
| Unknown | 0 (0) |
Values are presented as numbers (%).
TEAEs occurred in more than 2 patients during the study period.
Abbreviations: ADMSC, adipose-derived mesenchymal stem cells; NCI-CTCAE, National Cancer Institute-Common Terminology Criteria for Adverse Events; TEAE, treatment-emergent adverse events; SAE, serious adverse event.