Table 3 Adverse events on treatment with osimertinib

Patient

155 (100%)

–

–

–

–

–

Without adverse events

76 (49.0%)

–

–

–

–

–

With adverse events

79 (51.0%)

29

32

14

2

2

1. Blood and lymphatic system disorders

Anemia

4 (2.6%)

2

2

0

0

0

2. Cardiac disorders

Chest pain - cardiac

1 (0.6%)

1

0

0

0

0

Heart failure

1 (0.6%)

0

0

1

0

0

Sinus bradycardia

1 (0.6%)

1

0

0

0

0

3. Congenital, familial and genetic disorders

Congenital, familial and genetic disorders - Other, specify

1 (0.6%)

0

1

0

0

0

4. Ear and labyrinth disorders

Hearing impaired

1 (0.6%)

0

1

0

0

0

5. Endocrine disorders

Cushingoid

1 (0.6%)

1

0

0

0

0

6. Eye disorders

Dry eye

2 (1.3%)

2

0

0

0

0

Extraocular muscle paresis

1 (0.6%)

0

1

0

0

0

Eye disorders - other, specify

1 (0.6%)

0

1

0

0

0

Keratitis

1 (0.6%)

1

0

0

0

0

Watering eyes

1 (0.6%)

1

0

0

0

0

7. Gastrointestinal disorders

Abdominal pain

1 (0.6%)

1

0

0

0

0

Colitis

1 (0.6%)

0

1

0

0

0

Diarrhea

24 (15.5%)

16

8

0

0

0

Dry mouth

1 (0.6%)

1

0

0

0

0

Gastrointestinal disorders - other, specify

4 (2.6%)

1

2

1

0

0

Gingival pain

1 (0.6%)

0

0

1

0

0

Mucositis oral

10 (6.5%)

6

3

1

0

0

Nausea

9 (5.8%)

6

2

1

0

0

Vomiting

5 (3.2%)

4

1

0

0

0

8. General disorders and administration site conditions

Edema limbs

1 (0.6%)

1

0

0

0

0

Fatigue

16 (10.3%)

10

2

4

0

0

General disorders and administration site conditions - other, specify

1 (0.6%)

0

1

0

0

0

Pain

1 (0.6%)

1

0

0

0

0

11. Infections and infestations

Conjunctivitis

2 (1.3%)

1

1

0

0

0

Eye infection

1 (0.6%)

0

1

0

0

0

Fungemia

1 (0.6%)

0

1

0

0

0

Joint infection

1 (0.6%)

0

0

1

0

0

Nail infection

1 (0.6%)

1

0

0

0

0

Paronychia

6 (3.9%)

4

1

1

0

0

Rash pustular

2 (1.3%)

0

2

0

0

0

13. Investigations

Lipase increased

1 (0.6%)

0

0

1

0

0

Lymphocyte count decreased

1 (0.6%)

0

0

1

0

0

Neutrophil count decreased

3 (1.9%)

0

3

0

0

0

Platelet count decreased

8 (5.2%)

3

4

0

0

1

Serum amylase increased

1 (0.6%)

1

0

0

0

0

White blood cell decreased

1 (0.6%)

0

1

0

0

0

14. Metabolism and nutrition disorders

Anorexia

7 (4.5%)

5

0

2

0

0

15. Musculoskeletal and connective tissue disorders

Arthralgia

2 (1.3%)

2

0

0

0

0

Back pain

1 (0.6%)

1

0

0

0

0

Bone pain

1 (0.6%)

1

0

0

0

0

Flank pain

1 (0.6%)

1

0

0

0

0

Generalized muscle weakness

1 (0.6%)

1

0

0

0

0

17. Nervous system disorders

Cognitive disturbance

1 (0.6%)

0

0

1

0

0

Dizziness

3 (1.9%)

3

0

0

0

0

Dysgeusia

2 (1.3%)

2

0

0

0

0

Headache

1 (0.6%)

1

0

0

0

0

Paresthesia

2 (1.3%)

1

1

0

0

0

19. Psychiatric disorders

Agitation

1 (0.6%)

1

0

0

0

0

Anxiety

2 (1.3%)

2

0

0

0

0

Confusion

1 (0.6%)

1

0

0

0

0

22. Respiratory, thoracic and mediastinal disorders

Cough

1 (0.6%)

0

1

0

0

0

Dyspnoea

7 (4.5%)

3

2

1

1

0

Pneumonitis

4 (2.6%)

2

0

0

1

1

Respiratory, thoracic and mediastinal disorders - other, specify

2 (1.3%)

1

1

0

0

0

23. Skin and subcutaneous tissue disorders

Dry skin

2 (1.3%)

1

1

0

0

0

Nail changes

1 (0.6%)

1

0

0

0

0

Palmar-plantar erythrodysesthesia syndrome

2 (1.3%)

0

1

1

0

0

Pruritus

4 (2.6%)

3

1

0

0

0

Rash acneiform

12 (7.7%)

9

3

0

0

0

Rash maculo-papular

3 (1.9%)

2

1

0

0

0

Skin and subcutaneous tissue disorders - other, specify

11 (7.1%)

7

4

0

0

0

26. Vascular disorders

Thromboembolic event

3 (1.9%)

1

1

1

0

0

Vascular disorders - other, specify

1 (0.6%)

0

0

1

0

0