Table 5 Summary of the 139 reported adverse events occurring in the 24 UC-MSC- and 21 placebo-treated patients
| Â | UC-MSC | Placebo | Total | p value |
|---|---|---|---|---|
Adverse events D0–D14 |  |  |  |  |
 Subjects with AEs | 18/21 (85.7%) | 18/24 (75%) | 36/45 (80%) | 0.47 |
 AEs reported | 49/97 (50.5%) | 48/97 (49.5%) | 97 (100%) | 0.29 |
 Subjects with SAEs | 6/21 (28.6%) | 6/24 (25%) | 12/45 (26.7%) | 0.79 |
 SAEs reported | 10/49 (20.4%) | 6/48 (12.5%) | 16/97 (16.5%) | 0.29 |
 AEs by severity |  |  |  | 0.99 |
  Mild | 16/49 (32.7%) | 15/48 (31.3%) | 31/97 (32%) |  |
  Moderate | 24/49 (49%) | 24/48 (50%) | 48/97 (49.5) |  |
  Severe | 9/49 (18.4%) | 9/48 (18.7%) | 18/97 (18.6) |  |
 AE gradea |  |  |  | 0.14 |
  Grade 1 | 19/47(40.4%) | 10/48 (20.8%) | 29/95 (30.5%) |  |
  Grade 2 | 15/47 (31.9%) | 19/48 (39.6%) | 34/95 (35.8%) |  |
  Grade 3 | 9/47 (19.1%) | 16/48 (33.3%) | 25/95 (26.3%) |  |
  Grade 4 | 4/47 (12.5%) | 3/48 (6.3%) | 7/95 (7.4%) |  |
 AEs by treatment relatedness |  |  |  | 0.41 |
  Possible | 1/48 (2.1%)b | 0 (0%) | 1/95 (1.1%) |  |
  Other treatment | 4/48 (8.3%) | 2/47 (4.3%) | 6/95 (6.3%) |  |
  Other disease | 1/48 (2.1%) | 1/47 (2.1%) | 2/95 (2.1%) |  |
  COVID-19 progression | 28/48 (58.3%) | 37/47 (78.7%) | 65/95 (68.4%) |  |
  Other causes | 3/48 (6.3%) | 2/47 (4.3%) | 5/95 (5.3%) |  |
  Undetermined | 11/48 (22.9%) | 5/47 (10.6%) | 16/95 (16.8%) |  |
Adverse events after D14 | Â | Â | Â | Â |
 Subjects with AEs | 9/21 (38.1%) | 9/24 (37.5%) | 18/45 (40%) | 0.71 |
 AEs reported | 19/42 (45.2%) | 23/42 (54.8%) | 42 (100%) | 1.00 |
 Subjects with SAEs | 4/21 (19%) | 4/24 (16.7%) | 8/45 (17.8%) | 1.00 |
 SAEs reported | 4/19 (21.1%) | 4/23 (17.4%) | 8/42 (19%) | 1.00 |
 AEs by severity |  |  |  | 0.19 |
  Mild | 7/19 (36.8%) | 3/23 (13%) | 10/42 (23.8%) |  |
  Moderate | 7/19 (36.8%) | 12/23 (52.2%) | 19/42 (45.2%) |  |
  Severe | 5/19 (26.3%) | 8/23 (34.8%) | 13/42 (31%) |  |
 AE gradea |  |  |  | 0.18 |
  Grade 1 | 7/18 (38.9%) | 3/23 (13%) | 10/41 (24.4%) |  |
  Grade 2 | 7/18 (38.9%) | 15/23 (65.2%) | 22/41 (53.7%) |  |
  Grade 3 | 1/18 (5.6%) | 3/23 (1%) | 4/41 (9.8%) |  |
  Grade 4 | 3/18 (16.7%) | 2/23 (8.7%) | 5/41 (12.2%) |  |
 AEs by treatment relatedness |  |  |  | 0.54 |
  Possible | 0 (0%) | 0 (0%) | 0 (0.0%) |  |
  Other treatment | 3/14 (21.4%) | 4/20 (20%) | 7/34 (20.6%) |  |
  Other disease | 1/14 (7.1%) | 0 (0%) | 1/34 (2.9%) |  |
  COVID-19 progression | 8/14 (57.1%) | 11/20 (55%) | 19/34 (55.9%) |  |
  Other causes | 2/14 (14.3%) | 2/20 (10%) | 4/34 (11.8%) |  |
  Undetermined | 0 (0%) | 3/20 (15%) | 3/34 (8.8%) |  |