Table 3.
Summary of procedure related AEs by study arm
| MedDRA system organ class (preferred term) | Arm 1 (BMAC bone marrow harvest) (N = 139) | Arm 2 (SVF fat harvest) (N = 145) | Arm 3 (UCT CSI no harvest) (N = 156) | |||
|---|---|---|---|---|---|---|
| n (%) | 95% CI | n (%) | 95% CI | n (%) | 95% CI | |
| Injury, poisoning and procedural complications | ||||||
| Post-procedural contusion | 17 (12.2) | 7.3, 18.9 | 56 (38.6) | 30.7, 47.1 | 0 | 0.0, 2.3 |
| Post-procedural hematoma | 4 (2.9) | 0.8, 7.2 | 18 (12.4) | 7.5, 18.9 | 0 | 0.0, 2.3 |
| Procedural pain | 41 (29.5) | 22.1, 37.8 | 49 (33.8) | 26.2, 42.1 | 1 (0.6) | 0.0, 3.5 |
The safety population is defined as the 440 subjects who received study treatment. The AEs are those with an incidence of at least 5%. MedDRA denotes Medical Dictionary for Regulatory Activities, version 21.1.
95% CIs that do not overlap are statistically significant.