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Table 4 Statistical table of adverse events (N = 72)

From: A study on the pharmacokinetic bioequivalence of oral tablet formulations of riluzole among healthy volunteers utilizing HPLC-MS/MS

Adverse events

Test preparation

Reference preparation

Cases

Absolute freuquency*(%)

Relative frequency**(%)

Cases

Absolute freuquency*(%)

Relative frequency**(%)

Total AEs

31

18(25.0)

-

39

23(31.9)

-

Various inspections

29

17(23.6)

93.5

32

22(30.6)

82

Elevation of gamma glutamyltransferase

2

2(2.8)

6.5

0

0(0.0)

0

Elevation of alanine aminotransferase

6

6(8.3)

19.4

7

7(9.7)

18

Depression of red blood cell count

0

0(0.0)

0

1

1(1.4)

2.6

Elevation of conjugated bilirubin

3

3(4.2)

9.7

0

0(0.0)

0

Urine white blood cell positive

1

1(1.4)

3.2

2

2(2.8)

5.1

Depression of globulin

1

1(1.4)

3.2

0

0(0.0)

0

Elevation of aspartate aminotransferase

2

2(2.8)

6.5

1

1(1.4)

2.6

Extended QT interval on electrocardiogram

2

2(2.8)

6.5

0

0(0.0)

 

ST segment depression on electrocardiogram

0

0(0.0)

0

1

1(1.4)

2.6

Abnormal ST segment on electrocardiogram

0

0(0.0)

0

1

1(1.4)

2.6

Changes in ST-T segment of electrocardiogram

1

1(1.4)

3.2

1

1(1.4)

2.6

Decreased heart rate

1

1(1.4)

3.2

3

2(2.8)

5.1

Elevation of blood bilirubin

2

2(2.8)

6.5

0

0(0.0)

0

Elevation of blood triglycerides

1

1(1.4)

3.2

3

3(4.2)

7.7

Depression of hemoglobin

1

1(1.4)

3.2

1

1(1.4)

2.6

Depression of blood potassium

0

0(0.0)

0

1

1(1.4)

2.6

Depression of blood sodium

0

0(0.0)

0

1

1(1.4)

2.6

Elevation of blood uric acid

3

3(4.2)

9.7

3

3(4.2)

7.7

Depression of blood glucose

0

0(0.0)

0

1

1(1.4)

2.6

Elevation of blood glucose

1

1(1.4)

3.2

0

0(0.0)

0

Depression of blood pressure

2

2(2.8)

6.5

5

5(6.9)

12.8

AEs of neurological disorders

0

0(0.0)

0

2

2(2.8)

5.1

 Dizzy

0

0(0.0)

0

2

2(2.8)

5.1

AEs of gastrointestinal system

0

0(0.0)

0

1

1(1.4)

2.6

 Nausea

0

0(0.0)

0

1

1(1.4)

2.6

AEs of heart organ

2

2(2.8)

6.5

3

2(2.8)

5.1

 Nodal rhythm

0

0(0.0)

0

1

1(1.4)

2.6

 Indoor conduction disorder

1

1(1.4)

3.2

0

0(0.0)

0

 Sinus tachycardia

1

1(1.4)

3.2

2

2(2.8)

5.1

AEs of Eye organ

0

0(0.0)

 

1

1(1.4)

 

 Amaurosis

0

0(0.0)

 

1

1(1.4)

 
  1. AE, adverse events; QT interval, the time interval between the beginning of the Q wave and the end of the T wave on the electrocardiogram; ST segment, reflects the potential changes in each part of the ventricle during the period from the end of depolarization to the beginning of repolarization; ST-T segment is the repolarization process of the ventricular muscle, reflecting the myocardial blood supply or myocardial damage
  2. Absolute freuquency* is ratio of the number of subjects experiencing adverse events to the total number of subjects(N = 72); relative frequency** is ratio of the number of adverse events in subjects to the total number of cases occurring after taking the test preparation or reference preparation
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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