Table 3 Comparing safety signals of gemcitabine with or without albumin-bound paclitaxel at the PT level (The top 50 frequency of adverse drug reactions in AG treatment)

Blood and lymphatic system disorders

Neutropenia

335

266

1.11 (0.94–1.3)

1.1 (1.45)

Anaemia

316

209

1.33 (1.12–1.59)

1.32 (10.18)

Thrombocytopenia

297

292

0.89 (0.75–1.05)

0.89 (2.04)

Febrile neutropenia**

182

65

2.47 (1.86–3.29)

2.45 (41.59)

Leukopenia

130

110

1.03 (0.8–1.34)

1.03 (0.07)

Pancytopenia

75

50

1.31 (0.92–1.88)

1.31 (2.25)

Thrombotic microangiopathy

49

300

0.14 (0.1–0.19)

0.14 (219.79)

Disseminated intravascular coagulation**

49

20

2.15 (1.28–3.62)

2.14 (8.7)

Gastrointestinal disorders

Diarrhoea

254

116

1.94 (1.55–2.42)

1.92 (35.49)

Vomiting

226

106

1.88 (1.49–2.37)

1.87 (29.44)

Nausea

224

138

1.43 (1.15–1.77)

1.42 (10.81)

Abdominal pain*

193

76

2.24 (1.72–2.93)

2.22 (37.12)

Constipation*

86

26

2.91 (1.87–4.51)

2.9 (24.89)

Colitis**

56

22

2.23 (1.36–3.66)

2.23 (10.73)

Gastrointestinal haemorrhage

55

53

0.91 (0.62–1.33)

0.91 (0.25)

Stomatitis*

53

12

3.88 (2.07–7.26)

3.87 (20.85)

Upper gastrointestinal haemorrhage**

46

9

4.49 (2.2–9.17)

4.47 (20.35)

Ascites

46

53

0.76 (0.51–1.13)

0.76 (1.88)

General disorders and administration site conditions

Pyrexia

318

141

2 (1.64–2.44)

1.97 (47.92)

Fatigue

221

111

1.76 (1.4–2.21)

1.74 (23.74)

Asthenia

145

90

1.42 (1.09–1.84)

1.41 (6.7)

Oedema peripheral

113

73

1.36 (1.01–1.83)

1.35 (4.16)

General physical health deterioration

94

49

1.68 (1.19–2.38)

1.68 (8.9)

Infections and infestations

Sepsis**

224

71

2.79 (2.14–3.65)

2.76 (61.38)

Pneumonia**

168

62

2.39 (1.78–3.2)

2.37 (36.3)

Biliary tract infection**

69

3

20.24 (6.37–64.33)

20.13 (52.44)

Septic shock

54

32

1.48 (0.95–2.29)

1.48 (3.11)

Infection*

49

20

2.15 (1.28–3.62)

2.14 (8.7)

Respiratory, thoracic and mediastinal disorders

Dyspnoea

132

61

1.9 (1.4–2.58)

1.89 (17.76)

Interstitial lung disease

94

121

0.68 (0.52–0.89)

0.68 (8.04)

Pneumonitis

84

72

1.02 (0.74–1.4)

1.02 (0.02)

Pleural effusion

73

94

0.68 (0.5–0.92)

0.68 (6.25)

Pulmonary embolism

54

59

0.8 (0.55–1.16)

0.8 (1.4)

Nervous system disorders

Peripheral neuropathy

188

123

1.34 (1.07–1.69)

1.34 (6.43)

Neurotoxicity

59

30

1.72 (1.11–2.68)

1.72 (6.04)

Cerebrovascular accident**

58

16

3.18 (1.83–5.54)

3.17 (18.72)

Paraesthesia*

49

6

7.17 (3.07–16.75)

7.15 (28.34)

Investigations

Platelet count decreased

96

44

1.92 (1.34–2.74)

1.91 (13.16)

Neutrophil count decreased*

87

32

2.39 (1.59–3.59)

2.38 (18.81)

White blood cell count decreased

50

25

1.75 (1.08–2.84)

1.75 (5.38)

Weight decreased

46

39

1.03 (0.67–1.58)

1.03 (0.02)

Metabolism and nutrition disorders

Decreased appetite

125

67

1.64 (1.22–2.21)

1.63 (10.79)

Dehydration*

114

45

2.23 (1.58–3.15)

2.22 (21.72)

Hepatobiliary disorders

Cholangitis

108

51

1.86 (1.33–2.6)

1.85 (13.71)

Hypertransaminasaemia

49

22

1.95 (1.18–3.23)

1.95 (7.04)

Skin and subcutaneous tissue disorders

Alopecia

91

44

1.82 (1.27–2.61)

1.81 (10.82)

Rash

53

70

0.66 (0.46–0.95)

0.66 (5.21)

Renal and urinary disorders

Acute kidney injury

86

94

0.8 (0.6–1.07)

0.8 (2.24)

Vascular disorders

Hypotension*

64

16

3.51 (2.03–6.08)

3.5 (22.95)

Cardiac disorders

Atrial fibrillation**

49

15

2.87 (1.61–5.11)

2.86 (13.92)