Table 3 Disproportionality analysis at PT level (n > 3)

Blood and lymphatic system disorders

 Thrombocytopenia

22

8.01 (5.26—12.20)

7.92 (133.09)

7.91 (5.56)

2.98 (1.32)

 Febrile neutropenia

14

7.71 (4.56—13.05)

7.65 (81.01)

7.65 (4.92)

2.94 (1.27)

 Neutropenia

12

2.85 (1.61—5.02)

2.83 (14.28)

2.83 (1.76)

1.50 (-0.16)

 Leukopenia

9

7.17 (3.72—13.81)

7.14 (47.52)

7.14 (4.12)

2.84 (1.17)

 Anaemia

7

1.56 (0.74—3.28)

1.56 (1.40)

1.56 (0.84)

0.64 (-1.03)

 Myelosuppression

4

3.77 (1.41—10.05)

3.76 (8.10)

3.76 (1.65)

1.91 (0.24)

Caediac disorders

 Tachycardia

9

4.23 (2.19—8.14)

4.21 (22.04)

4.21 (2.43)

2.07 (0.41)

 Bradycardia

4

3.02 (1.13—8.07)

3.02 (5.41)

3.02 (1.33)

1.59 (-0.07)

EYE DISORDERS

 Ocular hyperaemia

4

3.42 (1.28—9.12)

3.41 (6.83)

3.41 (1.50)

1.77 (0.10)

Gastrointestinal disorders

 Nausea

21

1.13 (0.73—1.73)

1.12 (0.29)

1.12 (0.78)

0.17 (-1.50)

 Vomiting

12

1.11 (0.63—1.97)

1.11 (0.14)

1.11 (0.69)

0.15 (-1.51)

 Diarrhoea

11

0.63 (0.35—1.15)

0.64 (2.32)

0.64 (0.39)

-0.65 (-2.32)

 Stomatitis

10

6.07 (3.26—11.30)

6.04 (42.06)

6.04 (3.59)

2.59 (0.93)

 Ascites

9

13.38 (6.95—25.77)

13.31 (102.41)

13.30 (7.68)

3.73 (2.07)

 Abdominal pain

6

1.09 (0.49—2.42)

1.09 (0.04)

1.09 (0.56)

0.12 (-1.55)

 Anal ulcer

5

227.51 (93.91—551.20)

226.82 (1106.31)

223.24 (106.46)

7.80 (6.13)

 Constipation

4

0.72 (0.27—1.91)

0.72 (0.44)

0.72 (0.32)

-0.48 (-2.15)

General disorders and administration site conditions

 Chills

13

4.53 (2.62—7.81)

4.50 (35.43)

4.50 (2.85)

2.17 (0.50)

 Oedema peripheral

12

5.77 (3.27—10.18)

5.73 (46.93)

5.73 (3.56)

2.52 (0.85)

 Fatigue

10

0.47 (0.25—0.88)

0.47 (5.93)

0.47 (0.28)

-1.08 (-2.75)

 Pyrexia

10

1.15 (0.62—2.13)

1.15 (0.19)

1.15 (0.68)

0.20 (-1.47)

 Mucosal inflammation

8

12.70 (6.34—25.44)

12.64 (85.73)

12.63 (7.06)

3.66 (1.99)

 Chest pain

7

1.84 (0.88—3.88)

1.84 (2.70)

1.84 (0.99)

0.88 (-0.79)

 Pain

7

0.36 (0.17—0.75)

0.36 (7.96)

0.36 (0.19)

-1.47 (-3.13)

 Malaise

7

0.65 (0.31—1.37)

0.65 (1.29)

0.65 (0.35)

-0.61 (-2.28)

 Aeneralised oedema

5

19.99 (8.30—48.12)

19.93 (89.79)

19.90 (9.54)

4.31 (2.65)

 Oedema

5

4.34 (1.80—10.45)

4.33 (12.82)

4.33 (2.08)

2.11 (0.45)

Hepatobiliary disorders

 Hepatic function abnormal

4

4.35 (1.63—11.60)

4.34 (10.29)

4.34 (1.91)

2.12 (0.45)

Immune system disorders

 Hypersensitivity

10

1.96 (1.05—3.65)

1.96 (4.68)

1.96 (1.16)

0.97 (-0.70)

 Anaphylactic shock

6

10.09 (4.53—22.50)

10.06 (48.94)

10.05 (5.14)

3.33 (1.66)

 Anaphylactic reaction

5

3.63 (1.51—8.73)

3.62 (9.50)

3.62 (1.74)

1.86 (0.19)

Infections and infestations

 Paronychia

27

243.39 (165.86—357.16)

239.41 (6303.27)

235.42 (170.80)

7.88 (6.21)

 Pneumonia

16

1.91 (1.17—3.12)

1.90 (6.84)

1.90 (1.26)

0.92 (-0.74)

 Skin infection

9

27.44 (14.24—52.87)

27.30 (227.59)

27.24 (15.74)

4.77 (3.10)

 Cellulitis

8

6.44 (3.22—12.91)

6.42 (36.59)

6.41 (3.59)

2.68 (1.01)

 Infection

7

1.74 (0.83—3.65)

1.73 (2.18)

1.73 (0.93)

0.79 (-0.87)

 Folliculitis

7

22.80 (10.85—47.93)

22.71 (145.06)

22.67 (12.18)

4.50 (2.83)

 Sepsis

6

2.23 (1.00—4.98)

2.23 (4.06)

2.23 (1.14)

1.16 (-0.51)

 Erysipelas

5

38.10 (15.82—91.77)

37.99 (179.60)

37.89 (18.16)

5.24 (3.57)

 Rash pustular

4

33.09 (12.39—88.37)

33.01 (123.89)

32.94 (14.48)

5.04 (3.37)

 Urinary tract infection

4

0.87 (0.33—2.32)

0.87 (0.08)

0.87 (0.38)

-0.20 (-1.87)

Injury, poisoning and procedural complications

 Infusion related reaction

175

93.69 (80.06—109.63)

83.82 (14,253.87)

83.33 (73.06)

6.38 (4.71)

 Administration related reaction

8

2018.82 (960.90—4241.46)

2009.00 (14,049.05)

1758.00 (944.59)

10.78 (9.07)

Investigations

 Oxygen saturation decreased

22

13.04 (8.56—19.87)

12.88 (241.09)

12.87 (9.05)

3.69 (2.02)

 Heart rate increased

6

2.48 (1.11—5.54)

2.48 (5.30)

2.48 (1.27)

1.31 (-0.36)

 Alanine aminotransferase increased

5

3.87 (1.61—9.31)

3.86 (10.61)

3.86 (1.85)

1.95 (0.28)

 White blood cell count decreased

5

1.59 (0.66—3.81)

1.58 (1.08)

1.58 (0.76)

0.66 (-1.00)

 Blood pressure increased

5

1.19 (0.50—2.87)

1.19 (0.16)

1.19 (0.57)

0.25 (-1.41)

 Blood creatinine increased

5

3.25 (1.35—7.82)

3.24 (7.75)

3.24 (1.55)

1.70 (0.03)

Metabolism and nutrition disorders

 Hypokalaemia

12

10.71 (6.07—18.90)

10.64 (104.79)

10.63 (6.61)

3.41 (1.74)

 Hypoalbuminaemia

10

55.33 (29.68—103.15)

55.00 (528.16)

54.79 (32.53)

5.78 (4.11)

 Hypocalcaemia

5

10.72 (4.45—25.79)

10.69 (43.89)

10.68 (5.12)

3.42 (1.75)

 Hhyponatraemia

7

5.23 (2.49—10.98)

5.21 (23.82)

5.21 (2.80)

2.38 (0.71)

 Decreased appetite

4

0.66 (0.25—1.76)

0.66 (0.71)

0.66 (0.29)

-0.60 (-2.27)

Musculoskeletal and connective tissue disorders

 Back pain

7

1.23 (0.59—2.59)

1.23 (0.30)

1.23 (0.66)

0.30 (-1.37)

 Pain in extremity

5

0.69 (0.29—1.67)

0.69 (0.67)

0.69 (0.33)

-0.53 (-2.19)

 Myalgia

5

1.36 (0.57—3.28)

1.36 (0.48)

1.36 (0.65)

0.45 (-1.22)

 Arthralgia

5

0.43 (0.18—1.03)

0.43 (3.79)

0.43 (0.21)

-1.22 (-2.88)

 Musculoskeletal pain

4

4.31 (1.62—11.51)

4.30 (10.15)

4.30 (1.89)

2.11 (0.44)

Neoplasms benign, malignant and unspecified

 Pyogenic granuloma

5

483.08 (197.84—1179.58)

481.61 (2318.67)

465.70 (220.64)

8.86 (7.18)

Nervous system disorders

 Syncope

8

3.49 (1.74—7.00)

3.48 (14.17)

3.48 (1.95)

1.80 (0.13)

 Dizziness

5

0.43 (0.18—1.04)

0.44 (3.69)

0.44 (0.21)

-1.20 (-2.87)

Renal and urinary disorders

 Renal impairment

4

1.65 (0.62—4.40)

1.65 (1.02)

1.65 (0.72)

0.72 (-0.95)

Respiratory, thoracic and mediastinal disorders

 Dyspnoea

44

3.20 (2.37—4.32)

3.14 (64.74)

3.14 (2.44)

1.65 (-0.02)

 Pneumonitis

30

39.69 (27.65—56.99)

38.99 (1107.86)

38.88 (28.73)

5.28 (3.61)

 Pulmonary embolism

24

13.69 (9.14—20.48)

13.50 (277.82)

13.49 (9.63)

3.75 (2.09)

 Pleural effusion

9

6.67 (3.46—12.84)

6.64 (43.09)

6.63 (3.83)

2.73 (1.06)

 Pneumothorax

8

19.26 (9.61—38.60)

19.17 (137.64)

19.15 (10.70)

4.26 (2.59)

 Respiratory failure

8

4.97 (2.48—9.96)

4.95 (25.26)

4.95 (2.77)

2.31 (0.64)

 Interstitial lung disease

7

5.45 (2.59—11.45)

5.43 (25.30)

5.43 (2.92)

2.44 (0.77)

 Cough

5

0.64 (0.26—1.53)

0.64 (1.03)

0.64 (0.31)

-0.65 (-2.31)

 Throat irritation

5

4.63 (1.92—11.13)

4.62 (14.17)

4.62 (2.21)

2.21 (0.54)

 Pulmonary oedema

5

4.84 (2.01—11.65)

4.83 (15.19)

4.83 (2.32)

2.27 (0.60)

 Acute respiratory failure

4

7.55 (2.83—20.14)

7.53 (22.66)

7.53 (3.31)

2.91 (1.24)

Skin and subcutaneous tissue disorders

 Rash

85

7.45 (5.99—9.27)

7.12 (450.03)

7.12 (5.93)

2.83 (1.16)

 Dermatitis acneiform

17

120.17 (74.37—194.18)

118.94 (1971.64)

117.95 (78.95)

6.88 (5.21)

 Pruritus

6

0.60 (0.27—1.34)

0.60 (1.58)

0.60 (0.31)

-0.73 (-2.40)

 Skin ulcer

6

8.98 (4.03—20.03)

8.95 (42.38)

8.95 (4.57)

3.16 (1.49)

 Skin fissures

5

9.27 (3.85—22.30)

9.24 (36.74)

9.24 (4.43)

3.21 (1.54)

 Skin toxicity

5

32.95 (13.68—79.36)

32.86 (154.09)

32.78 (15.71)

5.03 (3.37)

 Acne

5

1.54 (0.64—3.70)

1.54 (0.94)

1.54 (0.74)

0.62 (-1.05)

 Dry skin

5

1.06 (0.44—2.55)

1.06 (0.02)

1.06 (0.51)

0.08 (-1.58)

 Scab

4

13.05 (4.89—34.82)

13.02 (44.35)

13.01 (5.72)

3.70 (2.03)

 Skin reaction

4

11.53 (4.32—30.76)

11.50 (38.33)

11.49 (5.05)

3.52 (1.85)

 Skin disorder

4

4.27 (1.60—11.40)

4.26 (10.00)

4.26 (1.88)

2.09 (0.42)

 Vasculitic rash

4

240.98 (89.58—648.22)

240.39 (937.57)

236.37 (103.28)

7.88 (6.21)

Vascular disorders

 Deep vein thrombosis

15

14.43 (8.68—24.00)

14.31 (185.64)

14.30 (9.34)

3.84 (2.17)

 Flushing

13

6.88 (3.98—11.87)

6.83 (64.74)

6.83 (4.32)

2.77 (1.10)

 Hypotension

11

2.23 (1.23—4.03)

2.22 (7.40)

2.22 (1.35)

1.15 (-0.52)

 Hypertension

9

1.71 (0.89—3.29)

1.71 (2.64)

1.71 (0.99)

0.77 (-0.90)

 Embolism

6

33.79 (15.14—75.40)

33.67 (189.77)

33.59 (17.16)

5.07 (3.40)

 Thrombosis

4

1.96 (0.73—5.22)

1.95 (1.86)

1.95 (0.86)

0.97 (-0.70)