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Table 2 List of observed adverse events. Observed adverse events were not serious, and the required medical considerations were applied in case they needed

From: Mesenchymal stem cell transplantation in newly diagnosed type-1 diabetes patients: a phase I/II randomized placebo-controlled clinical trial

No

MedDRA code

CTCAE term

Observed grade

Placebo (n = 10)

MSC (n = 11)

N

Patient ID/time

N

Patient ID/time

Investigations

       

1

10001551

Alanine aminotransferase (ALT) increased

1

1

P-11/M6

  

2

10001675

Alkaline phosphatase (ALP) increased

1

4

P-3/M6

P-8/M6, 12

P-9/M12

5

P-2/M6, 9, 12

P-6/M6

P-10/M6

3

10003481

Aspartate aminotransferase (AST) increased

1

2

P-9/M12

P-11/M6

  

4

10025258

Lymphocyte count increased

2

  

1

P-2/M12

5

10047900

Weight loss

1

1

P-18/M6

  

General disorders and administration site conditions

       

6

10016558

Fever

1

1

P-18/M1

  

7

10022095

Injection site reaction

1

1

P-3/M1

1

P-6/W1

   

2

1

P-5/M1

1

P-6/M1

8

10033371

Pain (epigastric region)

1

1

P-12/M3

1

P-13/M2

Metabolism and nutrition disorders

       

9

10020587

Hypercalcemia

1

1

P-7/M12

  

10

10020647

Hyperkalemia

4

  

1

P-4/M12

11

10020907

Hyperuricemia

1

1

P-18/M12

  

12

10020949

Hypocalcemia

2

1

P-12/M12

  

14

10021018

Hypokalemia

1

1

P-14/M6

  

15

10021038

Hyponatremia

1

2

P-3/M12

P-9/M12

  

Skin and subcutaneous tissue disorder

       

16

10046735

Urticaria

3

  

1

P-1/First Injection

Endocrine

       

17

10021114

Hypothyroidism

1

1

P-8/M9

  

Neurology

       

18

10037175

Psychiatric disorders

1

1

P-8/M6

  
  1. MSC, Mesenchymal stem cell; M, Month; W, Week; N, Number of events