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TABLE 4

AE Reported While Children Received Therapy for TB Infection

CategorySymptom3HP (n = 281), No. (%)9H (n = 234), No. (%)4R (n = 124), No. (%)
No events N/A 257 (91.5) 202 (86.3) 118 (95.2) 
Any AE N/A 24 (8.5) 32 (13.7) 6 (4.8) 
Constitutional Decreased appetite 5 (1.8) 3 (1.3) 
Fatigue 1 (0.4) 
Gastrointestinal Abdominal pain 5 (1.8) 14 (6.0) 3 (2.4) 
Nausea and/or vomiting 5 (1.8) 4 (1.7) 1 (0.8) 
Hepatotoxicitya 2 (0.9) 
Dermatologic Rash 4 (1.4) 3 (1.3) 1 (0.8) 
Pruritus 1 (0.4) 
Neurologic Headache 6 (2.1) 1 (0.4) 
Dizziness 3 (1.1) 
Other Anxiety with the health department worker 2 (0.7) 3 (1.3) 1 (0.8) 
Myalgias 1 (0.4) 1 (0.4) 
Unrelated to medicationsb 1 (0.4) 1 (0.4) 
Symptom severityc Grade 1 24 (8.5) 27 (11.5) 6 (4.8) 
Grade 2 4 (1.7) 
Grade 4 1 (0.4) 
Not documented N/A 2 (0.7) 18 (7.7) 8 (6.5) 
CategorySymptom3HP (n = 281), No. (%)9H (n = 234), No. (%)4R (n = 124), No. (%)
No events N/A 257 (91.5) 202 (86.3) 118 (95.2) 
Any AE N/A 24 (8.5) 32 (13.7) 6 (4.8) 
Constitutional Decreased appetite 5 (1.8) 3 (1.3) 
Fatigue 1 (0.4) 
Gastrointestinal Abdominal pain 5 (1.8) 14 (6.0) 3 (2.4) 
Nausea and/or vomiting 5 (1.8) 4 (1.7) 1 (0.8) 
Hepatotoxicitya 2 (0.9) 
Dermatologic Rash 4 (1.4) 3 (1.3) 1 (0.8) 
Pruritus 1 (0.4) 
Neurologic Headache 6 (2.1) 1 (0.4) 
Dizziness 3 (1.1) 
Other Anxiety with the health department worker 2 (0.7) 3 (1.3) 1 (0.8) 
Myalgias 1 (0.4) 1 (0.4) 
Unrelated to medicationsb 1 (0.4) 1 (0.4) 
Symptom severityc Grade 1 24 (8.5) 27 (11.5) 6 (4.8) 
Grade 2 4 (1.7) 
Grade 4 1 (0.4) 
Not documented N/A 2 (0.7) 18 (7.7) 8 (6.5) 

Adapted from American Academy of Pediatrics. Tuberculosis. In: Kimberlin DW, Brady MT, Jackson MA, Long SS, eds. Red Book 2015: Report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015:804–830.1 Percent may sum to >100% because some children reported >1 symptom. For 28 children, the frequency of AEs could not be accurately quantitated; for this reason, the denominators in the column headers differ from those in Table 1. Percentages reflect within-column percentages. N/A, not applicable.

a

Asparate or alanine aminotransferase >2.5 times the upper limit of normal by age.

b

3HP group (1: death from stroke in a child with lupus and idiopathic thrombocytopenic purpura); 9H (hematochezia as a result of Meckel’s diverticulum).

c

Grading system used by the US Department of Health and Human Services for AEs.15 Grade 1: mild; asymptomatic or mild symptoms only requiring clinical or diagnostic observations, but no intervention. Grade 2: moderate; minimal, local, or noninvasive interventions indicated; some limitation in activities of daily living. Grade 3: severe or medically significant without being life-threatening, requiring hospitalization, limiting activities of daily living. Grade 4: life-threatening. Grade 5: death related to AE.

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