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Table 4 Serious adverse effects

From: Mesenchymal stromal cells plus basiliximab, calcineurin inhibitor as treatment of steroid-resistant acute graft-versus-host disease: a multicenter, randomized, phase 3, open-label trial

Event

MSC group (N = 99)

Control group (N = 99)

Any adverse event

41 (41.4%)

44 (44.4%)

Hematologica

9 (9.1%)

13 (13.1%)

 Platelets decreased

6 (6.1%)

8 (8.1%)

 Platelet and neutrophil both decreased

3 (3.0%)

5 (5.1%)

Skinb

0 (0%)

1 (1.0%)

Gastrointestinalb

4 (4.0%)

5 (5.1%)

Hepatobilinary or pancreaticb

2 (2.0%)

2 (2.0%)

Cardiac (heart failure)

4 (4.0%)

6 (6.1%)

Renal or genitourinary (cystitis non-infective)

4 (4.0%)

5 (5.1%)

Vascular (thrombotic microangiopathy)

0 (0%)

1 (1.0%)

Infections

12 (12.1%)

16 (16.2%)

Secondary malignant disease

0 (0%)

0 (0%)

  1. aIncluded patients with decreases in platelet counts and neutrophil counts
  2. bExcluded patients with aGVHD