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Table 3 Adverse reactions

From: Efficacy, safety and feasibility of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric patients receiving moderately and highly emetogenic chemotherapy – results of a non-interventional observation study

 

Fosaprepitant group

Control group

p-value

 

N = 112 courses

N = 116 courses

 

n (%)

n (%)

Laboratory markers

 Increase ALT (n.v. ≤ 39 U/L)

  ≥ 1.5 x normal value

7 (6.3)

6 (5.2)

0.9481

  ≥ 2.5 x normal value

7 (6.3)

8 (6.9)

0.8439

 Increase AST (n.v. ≤ 59 U/L)

  ≥ 1.5 x normal value

7 (6.3)

5 (4.3)

0.7195

  ≥ 2.5 x normal value

1 (0.9)

3 (2.6)

0.6390

 Increase total bilirubin (n.v. ≤ 1.1 mg/dL)

  ≥ 1.5 x normal value

1 (0.9)

2 (1.7)

> 0.9999

  ≥ 2.5 x normal value

0 (0.0)

1 (0.9)

> 0.9999

 Increase creatinine (n.v. ≤ 0.7 mg/dL)

  ≥ 1.5 x normal value

0 (0.0)

3 (2.6)

0.2577

  ≥ 2.5 x normal value

0 (0.0)

0 (0.0)

 Increase urea (n.v. ≤ 46 mg/dL)

  ≥ 1.5 x normal value

1 (0.9)

0 (0.0)

0.986

  ≥ 2.5 x normal value

0 (0.0)

1 (0.9)

> 0.9999

 Decrease potassium (n.v. ≥ 3.4 mmol/L - 4.9 mmol/L)

  < 3.4 mmol/L

4 (3.6)

6 (5.2)

0.7897

  < 2.4 mmol/L

0 (0.0)

0 (0.0)

 Decrease calcium (n.v. ≥ 2.0 mmol/L - 2.6 mmol/L)

  < 2.0 mmol/L

12 (10.7)

7 (6.0)

0.2397

  < 1.8 mmol/L

0 (0.0)

0 (0.0)

 Decrease sodium (n.v. 134–145 mmol/L)

  < 134 mmol/L

14 (12.5)

23 (19.8)

0.1867

  < 130 mmol/L

2 (1.8)

1 (0.9)

0.9756

Adverse reactions

   

 Exanthema

1 (0.9)

0 (0.0)

0.3302

 Sweating

3 (2.7)

2 (1.7)

0.6228

 Fever

5 (4.5)

10 (8.6)

0.2864

 Loss of appetite

3 (2.7)

2 (1.7)

0.2057

 Diarrhea

15 (13.4)

14 (12.1)

0.6228

 Obstipation

4 (3.6)

3 (2.6)

0.7642

  1. The occurrence of clinical and laboratory adverse reactions was not significantly different (p > 0.05) between both study groups
  2. Abbreviations: ALT alanine aminotransferase, AST aspartate aminotransferase, mg/dL milligram per deciliter, mmol/L millimol per liter, n sample size, n.v. normal value, No. number, U/L Units per liter