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Number and Percentage of Patients With Adverse Events in the Placebo-controlled Study1
NAGLAZYME (galsulfase) (n=19)
Placebo (n=20*)
Adverse Event
Patients, n(%)
Patients, n(%)
All
19 (100)
20 (100)
Abdominal Pain
9 (47)
7 (35)
Ear Pain
8 (42)
4 (20)
Arthralgia
8 (42)
5 (25)
Pain
6 (32)
1 (5)
Conjunctivitis
4 (21)
0
Dyspnea
4 (21)
2 (10)
Rash
4 (21)
2 (10)
Chills
4 (21)
0
Chest Pain
3 (16)
1 (5)
Pharyngitis
2 (11)
0
Areflexia
2 (11)
0
Corneal Opacity
2 (11)
0
Gastroenteritis
2 (11)
0
Hypertension
2 (11)
0
Malaise
2 (11)
0
Nasal Congestion
2 (11)
0
Umbilical Hernia
2 (11)
0
Hearing Impairment
2 (11)
0
*One of the 20 patients in the placebo group dropped out after week 4 infusion.
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