Table 3.
Adverse events by group.
| Characteristic | HB-adMSCs 100MM, N = 33 | Placebo, N = 15 | Overall, N = 48 | |||
|---|---|---|---|---|---|---|
| N (%) | Events | N (%) | Events | N (%) | Events | |
| Adverse events | 33 | 80 | 15 | 39 | 48 | 119 |
| Adverse event, n (%) | ||||||
| Body Aches | 7 (21.2%) | 9 | 4 (26.7%) | 5 | 11 (22.9%) | 14 |
| Dyspnea | 7 (21.2%) | 7 | 2 (13.3%) | 2 | 9 (18.8%) | 9 |
| Cardiopulmonary failure | 6 (18.2%) | 6 | 2 (13.3%) | 2 | 8 (16.7%) | 8 |
| Cough | 5 (15.2%) | 5 | 3 (20.0%) | 3 | 8 (16.7%) | 8 |
| Headache | 2 (6.1%) | 4 | 3 (20.0%) | 4 | 5 (10.4%) | 4 |
| Hyperthermia | 4 (12.1%) | 6 | 2 (13.3%) | 2 | 6 (12.5%) | 8 |
| Fatigue | 2 (6.1%) | 2 | 4 (26.7%) | 4 | 6 (12.5%) | 6 |
| (For complete list, see Supplementary material) | ||||||
| Adverse event severity, n (%) | ||||||
| Mild | 25 (75.8%) | 68 | 12 (80.0%) | 37 | 37 (77.1%) | 105 |
| Moderate | 2 (6.1%) | 2 | 0 (0.0%) | 2 (4.2%) | 2 | |
| Severe | 1 (3.0%) | 1 | 0 (0.0%) | 1 (2.1%) | 1 | |
| Life-threatening | 1 (3.0%) | 1 | 0 (0.0%) | 1 (2.1%) | 1 | |
| Fatal | 8 (24.2%) | 8 | 2 (13.3%) | 2 | 10 (20.8%) | 10 |
| Attribution to study drug, n (%) | ||||||
| Definite | ||||||
| Probable | ||||||
| Possible | ||||||
| Unlikely | 8 (24.2%) | 18 | 8 (53.3%) | 15 | 16 (33.3%) | 33 |
| Unrelated | 24 (72.7%) | 62 | 11 (73.3%) | 24 | 35 (72.9%) | 86 |
| Serious, n (%) | 9 (26.5%) | 10 | 2 (14.3%) | 2 | 11 (22.9%) | 12 |
HB-adMSCs 100MM, allogeneic Hope Biosciences adipose-derived MSCs 1×108 cells. Adverse event types with 5 or more occurrences are listed in the table. For full list of adverse events and serious adverse events, see Supplementary Table S2.