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Table 3 Adverse drug reactions by preferred term

From: Real-world efficacy and safety of two doses of cabazitaxel (20 or 25 mg/m2) in patients with castration-resistant prostate cancer: results of a Japanese post-marketing surveillance study

 

All patients

Unmatched patients

All grades

Grade ≥ 3

C20

C25

All grades

Grade ≥ 3

All grades

Grade ≥ 3

N

660

190

159

Patients with any ADR

511 (77.4)

409 (62.0)

149 (78.4)

116 (61.1)

142 (89.3)*

129 (81.1)

Number of ADRs

1113

644

317

177

323

211

ADRs (Grade ≥ 3 in ≥2 patients), n (%)

 Pneumonia

6

(0.9)

5

(0.8)

2

(1.1)

2

(1.1)

2

(1.3)

1

(0.6)

 Pyelonephritis

3

(0.5)

3

(0.5)

0

 

0

 

1

(0.6)

1

(0.6)

 Sepsis

4

(0.6)

4

(0.6)

2

(1.1)

2

(1.1)

1

(0.6)

1

(0.6)

 Septic shock

3

(0.5)

3

(0.5)

0

 

0

 

1

(0.6)

1

(0.6)

 Anemiaa

99

(15.0)

58

(8.8)

22

(11.6)

12

(6.3)

25

(15.7)

15

(9.4)

 Febrile neutropenia

119

(18.0)

113

(17.1)

28

(14.7)

28

(14.7)

50

(31.5)

48

(30.2)

 Leukopeniab

74

(11.2)

48

(7.3)

23

(12.1)

13

(6.8)

18

(11.3)

15

(9.4)

 Neutropeniac

324

(49.1)

263

(39.8)

103

(54.2)

81

(42.6)

98

(61.6)

88

(55.3)

 Thrombocytopeniad

77

(11.7)

36

(5.5)

29

(15.3)

11

(5.8)

16

(10.1)

7

(4.4)

 Bone marrow failure

2

(0.3)

2

(0.3)

0

 

0

 

1

(0.6)

1

(0.6)

 Decreased appetite

49

(7.4)

11

(1.7)

17

(9.0)

3

(1.6)

10

(6.3)

2

(1.3)

 Neuropathy peripheral

10

(1.5)

2

(0.3)

4

(2.1)

2

(1.1)

2

(1.3)

0

 

 Interstitial lung disease

8

(1.2)

7

(1.1)

1

(0.5)

0

 

4

(2.5)

4

(2.5)

 Pneumonitis

2

(0.3)

2

(0.3)

0

 

0

 

0

 

0

 

 Diarrhea

66

(10.0)

21

(3.2)

21

(11.1)

5

(2.6)

16

(10.1)

6

(3.8)

 Nausea

22

(3.3)

4

(0.6)

9

(4.7)

4

(2.1)

5

(3.1)

0

 

 Vomiting

11

(1.7)

3

(0.5)

1

(0.5)

0

 

3

(1.9)

2

(1.3)

 Liver disorder

3

(0.5)

3

(0.5)

0

 

0

 

1

(0.6)

1

(0.6)

 Malaise

40

(6.1)

3

(0.5)

8

(4.2)

0

 

9

(5.7)

0

 

 Pyrexia

22

(3.3)

4

(0.6)

7

(3.7)

1

(0.5)

4

(2.5)

1

(0.6)

  1. *p < 0.01 vs C20 (Fisher’s test)
  2. C20 20 mg/m2 cabazitaxel, C25 25 mg/m2 cabazitaxel, ADR Adverse drug reaction
  3. aAnemia and hemoglobin decreased
  4. bLeukopenia and white blood cell count decreased
  5. cNeutropenia and neutrophil count decreased
  6. dThrombocytopenia and platelet count decreased
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