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Table 4 Most frequent adverse events up to week 4 (safety population)*

From: Mesenchymal stromal cells plus basiliximab improve the response of steroid-refractory acute graft-versus-host disease as a second-line therapy: a multicentre, randomized, controlled trial

AEs

MSC group (n = 62)

Control group (n = 65)

P

Any AE

51 (82.3%)

50 (76.9%)

0.456

CMV infection

51 (82.3%)

50 (76.9%)

0.456

CMV disease

6 (9.7%)

6 (9.2%)

0.931

EBV infection

2 (3.2%)

9 (13.8%)

0.033

EBV disease

1 (1.6%)

5 (7.7%)

0.102

HHV-6 infection

5 (8.1%)

4 (6.2%)

0.675

Platelets decreaseda

6 (9.7%)

5 (7.7%)

0.691

Neutropeniaa

7 (11.3%)

11 (16.9%)

0.363

Anaemiaa

5 (8.1%)

2 (3.1%)

0.218

Sepsis

4 (6.5%)

2 (3.1%)

0.370

Bacterial pneumonia

1 (1.6%)

4 (6.2%)

0.188

Fungal infection

1 (1.6%)

1 (1.5%)

0.973

Abdominal or intestinal infection

4 (6.5%)

9 (13.8%)

0.169

Acute kidney injury

4 (6.5%)

4 (6.2%)

0.945

  1. Abbreviations: AEs adverse events, CMV cytomegalovirus, EBV Epstein–Barr virus, HHV-6 human herpesvirus-6
  2. *The safety population included all patients who received at least one dose of MSCs
  3. aThe new onset hematocytopenia after enrollment