TABLE 4

Adverse events

Type of adverse eventNo. (%)P value
Children (n = 30)Adults (n = 30)
Anya15 (50)19 (63)0.29c
Vomiting8 (26.7)9 (30)0.77c
Nausea1 (3.3)6 (20)0.10b
Dizziness2 (6.7)4 (13.3)0.67b
Abdominal pain2 (6.7)3 (10)1.00b
Headache1 (3.3)3 (10)0.61b
Fever3 (10)00.23b
Increased creatinine levels
    Grade 1 (>ULNd, ≤1.5 × ULN)4 (13.3)6 (20)0.48c
    Grade 2 or higher (>1.5 ULN)00
Other7 (23.3)10 (33.3)0.56c
  • a Individuals presenting with at least one adverse event over the total of individuals in each study group.

  • b χ2 test.

  • c Fisher exact test.

  • d ULN, upper limit of normal.