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Table 5 Summary of the 139 reported adverse events occurring in the 24 UC-MSC- and 21 placebo-treated patients

From: Treatment of COVID-19-associated ARDS with mesenchymal stromal cells: a multicenter randomized double-blind trial

  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     
 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%)  
  1. Values are expressed as number (%). AEs adverse events. SAEs severe adverse events. UC-MSC umbilical cord-derived mesenchymal stromal cells
  2. aGrade from the Common Terminology Criteria for Adverse Events classification
  3. bPossible non-serious treatment-related AE: diarrhoea