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Table 3 Adverse events reported by interventional investigators

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 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%)

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