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Table 4 The list of adverse drug reactions

From: Nalfurafine hydrochloride for refractory pruritus in peritoneal dialysis patients: a phase III, multi-institutional, non-controlled, open-label trial

 

2.5-μg administration period

5-μg administration period

5-μg administration period + follow-up period

Treatment period + follow-up period

N = 37

N = 35

N = 35

N = 37

Adverse drug reactions

Number of patients (%)

Number of patients (%)

Number of patients (%)

Number of patients (%)

Insomnia

3 (8.1)

2 (5.7)

2 (5.7)

5 (13.5)

Dizziness

1 (2.7)

0 (0.0)

0 (0.0)

1 (2.7)

Hypoaesthesia

1 (2.7)

0 (0.0)

0 (0.0)

1 (2.7)

Somnolence

3 (8.1)

0 (0.0)

0 (0.0)

3 (8.1)

Restless legs syndrome

0 (0.0)

1 (2.9)

1 (2.9)

1 (2.7)

Constipation

1 (2.7)

0 (0.0)

0 (0.0)

1 (2.7)

Gastrooesophageal reflux disease

0 (0.0)

1 (2.9)

1 (2.9)

1 (2.7)

Vomiting

1 (2.7)

1 (2.9)

1 (2.9)

2 (5.4)

Hypoaesthesia oral

1 (2.7)

0 (0.0)

0 (0.0)

1 (2.7)

Hepatic function abnormal

1 (2.7)

0 (0.0)

0 (0.0)

1 (2.7)

Drug eruption

1 (2.7)

0 (0.0)

0 (0.0)

1 (2.7)

Pruritus

1 (2.7)

0 (0.0)

0 (0.0)

1 (2.7)

Rash

1 (2.7)

0 (0.0)

0 (0.0)

1 (2.7)

Haematuria

1 (2.7)

0 (0.0)

0 (0.0)

1 (2.7)

Asthenia

1 (2.7)

0 (0.0)

0 (0.0)

1 (2.7)

Feeling hot

1 (2.7)

0 (0.0)

0 (0.0)

1 (2.7)

Aspartate aminotransferase increased

0 (0.0)

0 (0.0)

1 (2.9)

1 (2.7)

Blood prolactin increased

2 (5.4)

2 (5.7)

3 (8.6)

5 (13.5)

Blood testosterone free decreased

2 (5.4)

1 (2.9)

1 (2.9)

3 (8.1)