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. 2014 Dec 18;8(12):e3412. doi: 10.1371/journal.pntd.0003412

Table 1. Safety comparison between PVRV and PCECV with Zagreb or Essen regimen on different age group.

Age groups for PVRV Age groups for PCECV P
<5 5∼18 19∼60 >60 Total <5 5∼18 19∼60 >60 Total
Zagreb Patients Number 16 19 32 17 84 21 26 33 31 111 0.539d
Local AEsa 4 9 3 7 23 4 4 4 12 24 0.352c
Pain 2 8 2 6 18 1 3 3 9 16
Induration 2 1 0 1 4 2 0 0 0 2
Edema 0 0 1 0 1 0 0 0 1 1
Tenderness 0 0 0 0 0 1 1 1 1 4
Systemic AEsb 8 2 2 2 14 12 4 2 3 21 0.685c
Fever (°C) 7 1 1 1 10 9 1 1 1 12 0.039
37.1∼37.5 5 1 0 0 6 1 0 0 0 1
37.6∼39.0 2 0 0 1 3 7 1 1 1 10
>39.0 0 0 1 0 1 1 0 0 0 1
Malaise 0 1 1 0 2 0 1 1 2 4
Allergy 0 0 0 0 0 1 1 0 0 2
Essen Patients Number 18 18 28 17 81 26 25 33 27 111 0.900d
Local AEsa 3 7 2 4 16 4 10 3 8 25 0.644c
Pain 1 5 0 2 8 0 7 2 5 14
Induration 1 1 0 1 3 2 1 0 1 4
Edema 0 0 1 1 2 1 1 1 1 4
Tenderness 1 1 1 0 3 0 1 0 1 2
Systemic AEsb 6 2 1 2 11 10 2 1 2 15 0.989c
Fever (°C) 5 2 1 1 9 6 1 1 1 9 0.494c
37.1∼37.5 4 1 0 0 5 2 1 0 0 3
37.6∼39.0 1 1 1 1 4 4 1 1 1 7
>39.0 0 0 0 0 0 0 0 0 0 0
Malaise 0 0 0 1 1 0 1 0 1 2
Allergy 0 0 0 0 0 2 0 0 0 2
a

Local adverse events (AEs) included pain, induration, edema, tendemess, and erythema in this study, but only top 4 AEs were listed.

b

Systemic AEs included fever, malaise, allergy, restlessness, nausea and vomiting in this study, but only top 3 AEs were listed.

c

By χ2 test for comparison of total patients with AEs between PVRV and PCECV.

d

By χ2 test for comparison of patients number in different age groups between PVRV and PCECV.