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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 groupControl groupp-value
 N = 112 coursesN = 116 courses
 n (%)n (%)
Laboratory markers
 Increase ALT (n.v. ≤ 39 U/L)
  ≥ 1.5 x normal value7 (6.3)6 (5.2)0.9481
  ≥ 2.5 x normal value7 (6.3)8 (6.9)0.8439
 Increase AST (n.v. ≤ 59 U/L)
  ≥ 1.5 x normal value7 (6.3)5 (4.3)0.7195
  ≥ 2.5 x normal value1 (0.9)3 (2.6)0.6390
 Increase total bilirubin (n.v. ≤ 1.1 mg/dL)
  ≥ 1.5 x normal value1 (0.9)2 (1.7)> 0.9999
  ≥ 2.5 x normal value0 (0.0)1 (0.9)> 0.9999
 Increase creatinine (n.v. ≤ 0.7 mg/dL)
  ≥ 1.5 x normal value0 (0.0)3 (2.6)0.2577
  ≥ 2.5 x normal value0 (0.0)0 (0.0)
 Increase urea (n.v. ≤ 46 mg/dL)
  ≥ 1.5 x normal value1 (0.9)0 (0.0)0.986
  ≥ 2.5 x normal value0 (0.0)1 (0.9)> 0.9999
 Decrease potassium (n.v. ≥ 3.4 mmol/L - 4.9 mmol/L)
  < 3.4 mmol/L4 (3.6)6 (5.2)0.7897
  < 2.4 mmol/L0 (0.0)0 (0.0)
 Decrease calcium (n.v. ≥ 2.0 mmol/L - 2.6 mmol/L)
  < 2.0 mmol/L12 (10.7)7 (6.0)0.2397
  < 1.8 mmol/L0 (0.0)0 (0.0)
 Decrease sodium (n.v. 134–145 mmol/L)
  < 134 mmol/L14 (12.5)23 (19.8)0.1867
  < 130 mmol/L2 (1.8)1 (0.9)0.9756
Adverse reactions   
 Exanthema1 (0.9)0 (0.0)0.3302
 Sweating3 (2.7)2 (1.7)0.6228
 Fever5 (4.5)10 (8.6)0.2864
 Loss of appetite3 (2.7)2 (1.7)0.2057
 Diarrhea15 (13.4)14 (12.1)0.6228
 Obstipation4 (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