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Table 1 Summary of observational studies (n=10) and ADRs incidence rate

From: Pharmacovigilance and incidence of adverse drug reactions in hospitalized pediatric patients: a mini systematic review

Studies (year) (reference)

Country

Study design

Pediatrics population studied (n)

Duration of study

Incidence of ADRs % (n)

Gallagher RM et al. (2011) [22]

UK

Prospective

822

2 weeks

3.3% (27)

Gallagher RM et al. (2012) [23]

UK

Prospective

6821

1 year

3.6% (249)

Khan LM et al. (2013) [16]

Saudi Arabia

Retrospective-Prospective

1200

1 year

6.3% (76)

Dash M et al. (2015) [29]

India

Prospective cohort

500

1 year

25.4% (127)

Gholami K et al. (2015) [24]

Iran

Prospective

658

6 months

4.1% (27)

Rivas AB et al. (2016) [28]

Spain

Prospective cohort

313

1 year

17.2% (116)

Salas Rdl et al. (2016) [30]

Colombia

Prospective cohort

772

6 months

20.2% (156)

Kurian J et al. (2016) [25]

India

Prospective

1082

6 months

5.9% (64)

Vázquez-Alvarez AO et al. (2017) [27]

Mexico

Prospective cross-sectional

1083

6 months

1.7% (19)

Sindhu AR et al. (2019) [26]

India

Prospective

200

6 months

7.5% (15)