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Table 6 Adverse events occurring in ≥ 3 patients

From: A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients

 

Acetaminophen,

N = 53

Intravenous

Ibuprofen, N = 47

Adverse Event

N (%)

Patients

#

Events

N (%)

Patients

#

Events

Any AE1

26 (49%)

65

28 (60%)

66

Any AE, excluding infusion site reaction2

26 (49%)

65

24 (51%)

59

Infusion Site Pain

0

0

5 (11%)

7

Vomiting

3 (6%)

3

3 (6%)

4

Headache

1 (2%)

1

3 (6%)

3

Nausea

2 (4%)

2

3 (6%)

3

ALT Increased

1 (2%)

1

2 (4%)

2

AST Increased

2 (4%)

2

2 (4%)

2

Blood lactate dehydrogenase increased

3 (6%)

3

1 (2%)

1

Diarrhea

4 (8%)

4

1 (2%)

1

Hypokalemia

2 (4%)

2

1 (2%)

1

Pruritus

2 (4%)

2

1 (2%)

1

  1. N number, AE adverse event, ALT alanine transaminase, AST aspartate transaminase
  2. 1 p-value = 0.321; 2 p-value >0.999