Table 3.
Adverse events reported by interventional investigators
| Event | MSC group (N = 99) | Control group (N = 99) | ||
|---|---|---|---|---|
| Any grade | Grade ≧ 3 | Any grade | Grade ≧ 3 | |
| Any adverse event | 92 (92.9) | 83 (83.8%) | 95 (96.0%) | 85 (85.9%) |
| Hematologica | – | 37 (37.4%) | – | 53 (53.5%) |
| Platelets decreased | – | 21 (21.2%) | – | 30 (30.3%) |
| Neutrophils decreased | – | 16 (16.2%) | – | 23 (23.2%) |
| Skinb | 27 (27.3%) | 8 (8.1%) | 32 (32.3%) | 12 (12.1%) |
| Gastrointestinalb | 30 (30.3%) | 5 (5.1%) | 37 (37.4%) | 8 (8.1%) |
| Hepatobilinary or pancreaticb | 16 (16.2%) | 5 (5.1%) | 18 (18.2%) | 4 (4.0%) |
| Cardiac | 39 (39.4%) | 13 (13.1%) | 41 (41.4%) | 16 (16.2%) |
| Renal or genitourinary | 27 (27.3%) | 10 (10.1%) | 28 (28.3%) | 11 (11.1%) |
| Vascular | 18 (18.2%) | 7 (7.1%) | 19 (19.2%) | 10 (10.1%) |
| Infections | 75 (75.8%) | 65 (65.7%) | 81 (81.8%) | 78 (78.8%) |
| Secondary malignant disease | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Table shows the adverse events that have an incidence of at least 10% in either group. The safety population included all patients who received at least one dose of trial therapy
aIncluded patients with decreases in platelet counts and neutrophil counts
bExcluded patients with aGVHD