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Table 3 Common adverse events (>10%) reported by maximum grade of severity

From: Two-year long safety and efficacy of deferasirox film-coated tablets in patients with thalassemia or lower/intermediate risk MDS: phase 3 results from a subset of patients previously treated with deferasirox in the ECLIPSE study

AEs (N = 53)

 System organ class

  Preferred term

Overall, n (%)

Mild, n (%)

Moderate, n (%)

Severe, n (%)

Number of patients with at least one event

52 (98.1)

11 (20.8)

27 (50.9)

14 (26.4)

 Infections and infestations

40 (75.5)

15 (28.3)

21 (39.6)

4 (7.5)

  Rhinitis

8 (15.1)

8 (15.1)

0

0

  Gastroenteritis

7 (13.2)

6 (11.3)

0

1 (1.9)

  Pharyngitis

7 (13.2)

4 (7.5)

3 (5.7)

0

  Urinary tract infection

6 (11.3)

3 (5.7)

3 (5.7)

0

 Gastrointestinal disorders

36 (67.9)

24 (45.3)

12 (22.6)

0

  Diarrhea

14 (26.4)

11 (20.8)

3 (5.7)

0

  Nausea

12 (22.6)

9 (17.0)

3 (5.7)

0

  Vomiting

12 (22.6)

9 (17.0)

3 (5.7)

0

  Upper abdominal pain

11 (20.8)

7 (13.2)

4 (7.5)

0

  Abdominal pain

10 (18.9)

7 (13.2)

3 (5.7)

0

 General disorders and administration site conditions

24 (45.3)

16 (30.2)

8 (15.1)

0

  Asthenia

10 (18.9)

8 (15.1)

2 (3.8)

0

  Influenza

9 (17.0)

3 (5.7)

6 (11.3)

0

  Pyrexia

13 (24.5)

7 (13.2)

6 (11.3)

0

 Respiratory, thoracic and mediastinal disorders

20 (37.7)

13 (24.5)

7 (13.2)

0

  Cough

12 (22.6)

9 (17.0)

3 (5.7)

0

  Oropharyngeal pain

9 (17.0)

6 (11.3)

3 (5.7)

0

 Investigationsa

17 (32.1)

6 (11.3)

9 (17.0)

2 (3.8)

  Urine protein/creatinine ratio increased

8 (15.1)

5 (9.4)

1 (1.9)

2 (3.8)

 Musculoskeletal and connective tissue disorders

17 (32.1)

14 (26.4)

1 (1.9)

2 (3.8)

  Musculoskeletal pain

6 (11.3)

6 (11.3)

0

0

 Nervous system disorders

16 (30.2)

10 (18.9)

5 (9.4)

1 (1.9)

  Headache

14 (26.4)

9 (17.0)

4 (7.5)

1 (1.9)

  1. Proportion of patients with AEs > 10% reported by preferred term and grouped by system organ class
  2. AE adverse event
  3. aAbnormal laboratory values reported as AEs