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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)