Table 5 Adverse drug reactions observed in at least two patients in either group (safety-analysis set)

Safety-analysis set, n

166

36

146

1401

173

778

Patients with any adverse drug reaction, n (%)

34 (20.48)

16 (44.44)

20 (13.70)

289 (20.63)

35 (20.23)

131 (16.84)

Number of adverse drug reactions

49

23

25

396

44

163

Adverse drug reactions, n (%)

 Diarrhea

2 (1.20)

3 (8.33)

6 (4.11)

54 (3.85)

10 (5.78)

36 (4.63)

 Serum ferritin increased

6 (3.61)

4 (11.11)

2 (1.37)

43 (3.07)

10 (5.78)

29 (3.73)

 Constipation

0 (0.00)

2 (5.56)

3 (2.05)

28 (2.00)

1 (0.58)

11 (1.41)

 Hemoglobin increased

2 (1.20)

0 (0.00)

1 (0.68)

31 (2.21)

0 (0.00)

0 (0.00)

 Nausea

1 (0.60)

0 (0.00)

0 (0.00)

18 (1.28)

1 (0.58)

10 (1.29)

 Hyperferritinemia

1 (0.60)

2 (5.56)

1 (0.68)

10 (0.71)

3 (1.73)

8 (1.03)

 Hypertension

1 (0.60)

1 (2.78)

0 (0.00)

11 (0.79)

1 (0.58)

3 (0.39)

 Abdominal discomfort

1 (0.60)

0 (0.00)

0 (0.00)

11 (0.79)

0 (0.00)

3 (0.39)

 Abdominal distension

2 (1.20)

0 (0.00)

0 (0.00)

7 (0.50)

0 (0.00)

3 (0.39)

 Feces discolored

1 (0.60)

0 (0.00)

0 (0.00)

11 (0.79)

0 (0.00)

0 (0.00)

 Polycythemia

2 (1.20)

0 (0.00)

0 (0.00)

10 (0.71)

0 (0.00)

0 (0.00)

 Decreased appetite

0 (0.00)

0 (0.00)

1 (0.68)

5 (0.36)

1 (0.58)

3 (0.39)

 Pruritus

0 (0.00)

0 (0.00)

0 (0.00)

5 (0.36)

0 (0.00)

3 (0.39)

 Vomiting

0 (0.00)

0 (0.00)

0 (0.00)

7 (0.50)

1 (0.58)

0 (0.00)

 Feces soft

0 (0.00)

0 (0.00)

0 (0.00)

6 (0.43)

0 (0.00)

2 (0.26)

 Abdominal pain

1 (0.60)

0 (0.00)

1 (0.68)

3 (0.21)

1 (0.58)

1 (0.13)

 Hepatic function abnormal

0 (0.00)

0 (0.00)

0 (0.00)

1 (0.07)

2 (1.16)

3 (0.39)

 Blood iron increased

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

1 (0.58)

2 (0.26)

 Gastroesophageal reflux disease

0 (0.00)

0 (0.00)

1 (0.68)

3 (0.21)

1 (0.58)

0 (0.00)

 Red blood cell count increased

1 (0.60)

0 (0.00)

0 (0.00)

4 (0.29)

0 (0.00)

0 (0.00)

 Renal impairment

0 (0.00)

0 (0.00)

0 (0.00)

0 (0.00)

0 (0.00)

5 (0.64)

 Hyperphosphatemia

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

2 (0.26)

 Hypocalcemia

0 (0.00)

0 (0.00)

2 (1.37)

1 (0.07)

1 (0.58)

0 (0.00)

 Abdominal pain upper

0 (0.00)

0 (0.00)

0 (0.00)

1 (0.07)

1 (0.58)

1 (0.13)

 Acute myocardial infarction

0 (0.00)

0 (0.00)

0 (0.00)

3 (0.21)

0 (0.00)

0 (0.00)

 Anemia

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

1 (0.13)

 Arrhythmia

0 (0.00)

0 (0.00)

2 (1.37)

1 (0.07)

0 (0.00)

0 (0.00)

 Back pain

1 (0.60)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Blood calcium decreased

1 (0.60)

1 (2.78)

0 (0.00)

1 (0.07)

0 (0.00)

0 (0.00)

 Cardiac failure congestive

0 (0.00)

0 (0.00)

1 (0.68)

2 (0.14)

0 (0.00)

0 (0.00)

 Cerebral infarction

0 (0.00)

0 (0.00)

0 (0.00)

3 (0.21)

0 (0.00)

0 (0.00)

 Death

0 (0.00)

1 (2.78)

0 (0.00)

1 (0.07)

0 (0.00)

1 (0.13)

 Feeling abnormal

1 (0.60)

0 (0.00)

0 (0.00)

1 (0.07)

0 (0.00)

1 (0.13)

 Hematocrit increased

1 (0.60)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Hemoglobin decreased

2 (1.20)

0 (0.00)

0 (0.00)

1 (0.07)

0 (0.00)

0 (0.00)

 Headache

1 (0.60)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Hyperuricemia

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

1 (0.13)

 Hypophosphatemia

1 (0.60)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Malaise

0 (0.00)

1 (2.78)

0 (0.00)

1 (0.07)

1 (0.58)

0 (0.00)

 Shunt occlusion

1 (0.60)

0 (0.00)

0 (0.00)

1 (0.07)

0 (0.00)

1 (0.13)

 Blood phosphorus increased

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

1 (0.58)

0 (0.00)

 Transferrin saturation increased

0 (0.00)

0 (0.00)

0 (0.00)

3 (0.21)

0 (0.00)

0 (0.00)

 Nephrogenic anemia

1 (0.60)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Abdominal pain lower

1 (0.60)

0 (0.00)

0 (0.00)

1 (0.07)

0 (0.00)

0 (0.00)

 Angina pectoris

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Arthralgia

0 (0.00)

0 (0.00)

0 (0.00)

1 (0.07)

0 (0.00)

1 (0.13)

 Blood parathyroid hormone increased

0 (0.00)

1 (2.78)

0 (0.00)

0 (0.00)

0 (0.00)

1 (0.13)

 Blood pressure decreased

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Blood pressure increased

0 (0.00)

0 (0.00)

0 (0.00)

1 (0.07)

0 (0.00)

1 (0.13)

 Bronchitis

1 (0.60)

0 (0.00)

0 (0.00)

1 (0.07)

0 (0.00)

0 (0.00)

 Cerebellar infarction

0 (0.00)

0 (0.00)

0 (0.00)

1 (0.07)

0 (0.00)

1 (0.13)

 Eosinophilia

0 (0.00)

0 (0.00)

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.26)

 Frequent bowel movements

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Gastric ulcer

0 (0.00)

0 (0.00)

0 (0.00)

1 (0.07)

0 (0.00)

1 (0.13)

 Gastrointestinal disorder

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Hypercholesterolemia

0 (0.00)

0 (0.00)

0 (0.00)

1 (0.07)

0 (0.00)

1 (0.13)

 Insomnia

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Muscle spasms

0 (0.00)

0 (0.00)

0 (0.00)

1 (0.07)

1 (0.58)

0 (0.00)

 Musculoskeletal pain

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Nasopharyngitis

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Oedema

0 (0.00)

0 (0.00)

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.26)

 Pain in extremity

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Peritonitis

0 (0.00)

0 (0.00)

0 (0.00)

1 (0.07)

1 (0.58)

0 (0.00)

 Stomatitis

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Shunt stenosis

0 (0.00)

0 (0.00)

0 (0.00)

2 (0.14)

0 (0.00)

0 (0.00)

 Peripheral arterial occlusive disease

2 (1.20)

0 (0.00)

0 (0.00)

0 (0.00)

0 (0.00)

0 (0.00)