Table 2 Signal detection.

Blood and lymphatic system disorders

10002034

Anaemia

4055

3609

4.10; 4.39

422

4.57

4.15; 5.04

24

4.01

2.67; 6.02

10033661

Pancytopenia

2414

2166

8.96; 9.78

236

9.13

8.02; 10.39

12

7.13

4.03; 12.63

10029354

Neutropenia

6991

6461

12.64; 13.31

474

8.18

7.45; 8.97

56

15.58

11.84; 20.49

10043554

Thrombocytopenia

4041

3653

7.65; 8.18

360

7.00

6.30; 7.78

28

8.49

5.81; 12.40

Cardiac disorders

10007636

Cardiomyopathy

900

845

12.00; 13.81

53

7.05

5.38; 9.24

2

4.10

1.02; 16.44

10048610

Cardiotoxicity

1192

1116

36.41; 41.49

67

17.96

14.10; 22.86

9

37.36

19.34; 72.17

Gastrointestinal disorders

10012735

Diarrhoea

3276

2972

1.02; 1.10

280

0.93

0.82; 1.05

24

1.25

0.83; 1.88

10028813

Nausea

4180

3636

0.98; 1.05

533

1.41

1.29; 1.54

11

0.43

0.24; 0.79

10047700

Vomiting

3284

2900

1.34; 1.45

372

1.68

1.51; 1.86

12

0.82

0.46; 1.46

General disorders and administration site conditions

10016288

Febrile neutropenia

9427

8868

41.44; 43.48

498

17.53

16.02; 19.20

61

34.68

26.63; 45.15

10028116

Mucosal inflammation

2426

2214

20.74; 22.67

197

16.18

14.04; 18.65

15

19.02

11.40; 31.75

10037660

Pyrexia

4997

4538

2.91; 3.09

405

2.45

2.22; 2.71

54

5.31

4.02; 7.01

Infections and infestations

10040047

Sepsis

3137

2940

5.82; 6.28

177

3.26

2.81; 3.78

20

5.79

3.71; 9.03

Metabolism and nutrition disorders

10059512

Apoptosis

6

6

1.91; 9.68

0

–

–

0

–

–

10057248

Cell death

12

7

0.38; 1.68

5

5.35

2.22; 12.88

0

–

–

Musculoskeletal and connective tissue disorders

10003239

Arthralgia

854

754

0.39; 0.45

99

0.51

0.42; 0.63

1

0.08

0.01; 0.57

10003988

Back pain

1018

819

0.71; 0.82

194

1.71

1.48; 1.97

5

0.67

0.28; 1.62

10005956

Bone disorder

282

237

2.28; 2.95

44

4.47

3.32; 6.01

1

1.57

0.22; 11.16

10006002

Bone pain

891

835

2.93; 3.36

52

1.79

1.37; 2.36

4

2.14

0.80; 5.72

10031264

Osteonecrosis

593

526

2.81; 3.34

65

3.49

2.74; 4.46

2

1.66

0.41; 6.65

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

10051398

Malignant neoplasm progression

2180

1795

4.16; 4.58

369

8.40

7.57; 9.32

16

5.56

3.38; 9.13

Nervous system disorders

10008190

Cerebrovascular accident

292

254

0.27; 0.34

34

0.38

0.27; 0.53

4

0.70

0.26; 1.86

10019211

Headache

1249

1094

0.35; 0.39

151

0.48

0.41; 0.57

4

0.20

0.07; 0.52

10024382

Leukoencephalopathy

153

139

6.91; 9.72

14

7.42

4.39; 12.55

0

–

–

10033775

Paraesthesia

605

507

0.62; 0.73

93

1.16

0.94; 1.42

5

0.97

0.40; 2.33

10044565

Tremor

257

223

0.25; 0.32

30

0.35

0.25; 0.50

4

0.73

0.27; 1.96

Psychiatric disorders

10002855

Anxiety

1614

1409

0.99; 1.10

204

1.42

1.23; 1.63

1

0.11

0.01; 0.75

Respiratory, thoracic and mediastinal disorders

10022611

Interstitial lung disease

1649

1355

6.44; 7.19

291

13.49

12.00; 15.17

3

2.09

0.67; 6.50

10035598

Pleural effusion

1315

1148

3.88; 4.37

162

5.36

4.59; 6.27

5

2.54

1.05; 6.12

10035664

Pneumonia

3214

2914

1.86; 2.00

278

1.70

1.51; 1.92

22

2.11

1.38; 3.22

Skin and subcutaneous tissue disorders

10033553

Palmar-plantar erythrodysaesthesia syndrome

1024

626

5.69; 6.68

384

36.14

32.60; 40.06

14

19.69

11.59; 33.44

Vascular disorders

10037377

Pulmonary embolism

1275

1143

2.34; 2.63

120

2.41

2.02; 2.89

12

3.77

2.13; 6.67