Skip to main content

Table 2 ADRs reported for Japanese patients with GD according to MedDRA version 22.1

From: Long-term safety and effectiveness of velaglucerase alfa in Gaucher disease: 6-year interim analysis of a post-marketing surveillance in Japan

 

Total (N = 30)

Type 2 GD (N = 11)

Age < 4 years (N = 6)

Treatment-naïve (N = 7)

Patients with ADRs, n (%)

7 (23.3)

7 (63.6)

5 (83.3)

2 (28.6)

ADRs, n

14

14

10

3

Patients with serious ADRs, n (%)

5 (16.7)

1 (9.1)

1 (16.7)

1 (14.3)

Serious ADRs, n

10

2

2

2

Type of ADR

    

 Antibody test positive

2

2

1

0

 Pyrexia

2

2

2

1

 Vomiting

2

2

1

0

 Aspartate aminotransferase increased

1

1

1

0

 Erythema

1

1

1

0

 Gastric hypomotility

1

1

1

1

 Hyperchlorhydria

1

1

1

1

 Myoclonus

1

1

0

0

 Rash

1

1

0

0

 Swelling of eyelid

1

1

1

0

 Tachycardia

1

1

1

0

  1. The different forms of ADR are presented for patients, following treatment with velaglucerase alfa, showing the results for all patients as well as the results for those with type 2 GD, those < 4 years of age and those who were treatment naïve
  2. ADR adverse drug reaction, GD Gaucher disease, MedDRA Medical Dictionary for Regulatory Activities