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Table 3 The 50 most common adverse events for combination therapy at the preferred term (PT) level

From: The real-world safety profile of pemetrexed and platinum with or without pembrolizumab: insights from a comparative analysis of FAERS database

PT name

N

ROR(95%Cl)

PRR((χ2)

EBGM(EBGM05)

IC(IC025)

Pancytopenia*

355

7.80(6.90–8.81)

7.65(1517.80)

5.90(5.33)

2.56(2.39)

Acute Kidney Injury*

294

3.54(3.13–4.01)

3.49(452.52)

3.14(2.83)

1.65(1.47)

Neutropenia*

281

2.82(2.49–3.20)

2.79(287.60)

2.58(2.33)

1.37(1.19)

Anaemia

273

1.78(1.57–2.01)

1.76(84.15)

1.71(1.54)

0.77(0.59)

Diarrhoea

272

0.66(0.58–0.75)

0.67(45.42)

0.68(0.61)

-0.57(-0.74)

Febrile Neutropenia

213

2.18(1.89–2.51)

2.16(121.55)

2.06(1.83)

1.04(0.83)

Nausea

204

0.82(0.71–0.94)

0.82(7.88)

0.83(0.73)

-0.27(-0.48)

Interstitial Lung Disease

204

1.46(1.27–1.69)

1.46(27.61)

1.43(1.27)

0.51(0.30)

Death

197

0.29(0.26–0.34)

0.30(324.54)

0.31(0.28)

-1.68(-1.89)

Pyrexia

189

1.05(0.91–1.22)

1.05(0.44)

1.05(0.93)

0.07(-0.15)

Thrombocytopenia

188

1.97(1.70–2.29)

1.96(81.73)

1.88(1.66)

0.91(0.69)

Pneumonitis

181

1.41(1.21–1.64)

1.41(20.09)

1.38(1.22)

0.47(0.24)

Vomiting

173

1.09(0.93–1.27)

1.09(1.21)

1.08(0.95)

0.12(-0.11)

Fatigue

170

0.68(0.59–0.80)

0.69(23.92)

0.70(0.61)

-0.52(-0.75)

Tubulointerstitial Nephritis*

159

7.84(6.53–9.40)

7.77(689.24)

5.97(5.12)

2.58(2.32)

General Physical Health Deterioration

157

2.05(1.74–2.42)

2.04(76.81)

1.95(1.70)

0.97(0.73)

Pneumonia

156

0.86(0.73–1.01)

0.86(3.59)

0.86(0.75)

-0.21(-0.45)

Rash

154

0.53(0.45–0.62)

0.53(62.77)

0.54(0.48)

-0.88(-1.11)

Asthenia

153

0.97(0.82–1.14)

0.97(0.18)

0.97(0.84)

-0.05(-0.29)

Drug Ineffective

139

0.92(0.78–1.09)

0.92(0.85)

0.93(0.80)

-0.11(-0.36)

Dyspnoea

124

0.59(0.49–0.71)

0.59(33.80)

0.61(0.52)

-0.72(-0.99)

Renal Impairment

116

2.26(1.86–2.74)

2.25(73.06)

2.13(1.81)

1.09(0.81)

Decreased Appetite

111

0.60(0.50–0.73)

0.60(28.29)

0.62(0.53)

-0.70(-0.98)

Colitis

110

2.25(1.85–2.74)

2.24(68.92)

2.13(1.80)

1.09(0.80)

Hepatitis*

105

3.81(3.10–4.70)

3.80(184.05)

3.38(2.84)

1.75(1.45)

Sepsis

100

1.81(1.48–2.22)

1.81(33.40)

1.74(1.47)

0.80(0.50)

Renal Failure

98

2.47(2.01–3.05)

2.46(76.71)

2.31(1.94)

1.21(0.90)

Hypothyroidism

95

1.79(1.45–2.21)

1.79(30.39)

1.72(1.45)

0.79(0.48)

Renal Tubular Necrosis*

90

13.54(10.4-17.63)

13.47(638.14)

8.65(6.94)

3.11(2.76)

Platelet Count Decreased

87

1.19(0.96–1.48)

1.19(2.51)

1.18(0.98)

0.24(-0.08)

Mucosal Inflammation*

84

3.02(2.40–3.80)

3.01(99.13)

2.76(2.28)

1.47(1.13)

Pulmonary Embolism

79

1.43(1.14–1.79)

1.42(9.41)

1.40(1.16)

0.48(0.15)

Pleural Effusion

76

0.83(0.66–1.04)

0.83(2.56)

0.84(0.69)

-0.26(-0.59)

Toxic Epidermal Necrolysis*

72

6.61(5.07–8.61)

6.59(261.08)

5.27(4.22)

2.40(2.02)

Blood Creatinine Increased

71

1.58(1.24–2.02)

1.58(14.17)

1.54(1.26)

0.62(0.27)

Myocarditis*

69

3.06(2.38–3.94)

3.05(83.42)

2.80(2.26)

1.48(1.12)

Immune-Mediated Enterocolitis*

69

3.36(2.60–4.33)

3.35(98.44)

3.03(2.45)

1.60(1.23)

Septic Shock

66

2.45(1.89–3.16)

2.44(50.43)

2.29(1.85)

1.20(0.83)

Immune-Mediated Lung Disease*

66

3.61(2.78–4.68)

3.59(105.97)

3.22(2.59)

1.69(1.31)

Toxicity To Various Agents

64

2.40(1.86–3.11)

2.40(47.04)

2.26(1.82)

1.18(0.80)

Malaise

64

0.70(0.55–0.90)

0.71(7.66)

0.71(0.58)

-0.48(-0.85)

Nephritis*

63

8.10(6.06–10.83)

8.07(283.73)

6.14(4.81)

2.62(2.21)

Leukopenia

62

1.39(1.07–1.79)

1.38(6.22)

1.36(1.10)

0.44(0.070)

Hepatic Function Abnormal

61

0.91(0.70–1.17)

0.91(0.55)

0.91(0.74)

-0.13(-0.51)

Constipation

60

0.55(0.43–0.71)

0.55(21.22)

0.56(0.46)

-0.82(-1.20)

Haemophagocytic Lymphohistiocytosis*

60

8.76(6.49–11.84)

8.74(292.08)

6.49(5.05)

2.70(2.28)

Pruritus

58

0.59(0.46–0.77)

0.59(15.90)

0.60(0.49)

-0.73(-1.11)

Immune-Mediated Hepatic Disorder*

58

4.32(3.26–5.73)

4.31(122.87)

3.76(2.97)

1.91(1.50)

Respiratory Failure

57

0.90(0.69–1.18)

0.90(0.55)

0.91(0.73)

-0.14(-0.53)

Cough

56

0.55(0.42–0.72)

0.55(19.60)

0.57(0.45)

-0.82(-1.21)

  1. Asterisks (*) indicate that the signal is statistically significant in all four formulas. Abbreviations: N, the number of reports; ROR, reporting odds ratio; PRR, proportional reporting ratio; EBGM, empirical Bayesian geometric mean; EBGM05, the lower limit of the 95% CI of EBGM; IC, information component; IC025, the lower limit of the 95% CI of the IC; CI, confidence interval; PT, preferred term
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BMC Cancer

ISSN: 1471-2407

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