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Table 2 Signal strength of adverse events of pertuzumab at the system organ class (SOC) level in FAERS database

From: A disproportionality analysis of adverse events associated to pertuzumab in the FDA Adverse Event Reporting System (FAERS)

System Organ Class (SOC)

Cases Reporting SOC

ROR

PRR (χ2)

IC (IC025)

EBGM  (EBGM 05)

Blood and lymphatic system disorders

848

3.73 (3.48-4.00) a

3.57 (68673.87) a

1.84 (1.71) a

3.57 (3.37) a

Cardiac disorders

645

1.91 (1.76–2.06) a

1.87 (16674.70)

0.90 (0.83) a

1.87 (1.75)

Gastrointestinal disorders

2104

1.80 (1.72–1.89) a

1.69 (145491.33)

0.75 (0.72) a

1.69 (1.62)

Respiratory, thoracic and mediastinal disorders

1088

1.63 (1.53–1.73) a

1.58 (30352.29)

0.66 (0.62) a

1.58 (1.50)

Skin and subcutaneous tissue disorders

1132

1.42 (1.34–1.51) a

1.39 (19323.01)

0.47 (0.45) a

1.39 (1.32)

Hepatobiliary disorders

171

1.42 (1.22–1.65) a

1.41 (457.89)

0.50 (0.43) a

1.41 (1.25)

Vascular disorders

414

1.38 (1.25–1.52) a

1.37 (2273.62)

0.45 (0.41) a

1.37 (1.26)

Metabolism and nutrition disorders

393

1.29 (1.17–1.43) a

1.28 (1378.17)

0.36 (0.32) a

1.28 (1.18)

Investigations

1067

1.25 (1.18–1.34) a

1.24 (7998.15)

0.31 (0.29) a

1.24 (1.17)

Infections and infestations

961

1.25 (1.17–1.34) a

1.24 (6480.47)

0.31 (0.29) a

1.24 (1.17)

Immune system disorders

190

1.12 (0.97–1.29)

1.12 (75.71)

0.16 (0.14) a

1.12 (0.99)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

464

1.06 (0.97–1.17)

1.06 (131.92)

0.09 (0.08) a

1.06 (0.98)

  1. ROR Reporting odds ratio, CI Confidence interval, PRR Proportional reporting ratio, χ Chi-squared, IC Information component, IC025 The lower limit of 95% CI of the IC, EBGM Empirical Bayesian geometric mean, EBGM05 The lower limit of 95% CI of EBGM
  2. aIndicates statistically significant signals in algorithm