GAMMAGARD LIQUID - IV Administration
Protecting life's moments with an established tolerability profile1
|(381/400) of non-serious adverse reactions (ARs) reported in this study were considered mild (217) or moderate (164).
(The remaining 5% [19/400] were rated severe)
|of non-serious ARs were mild (n=217)
Mild ARs were defined as transient discomfort that resolves spontaneously or with minimal intervention
|of non-serious ARS were moderate (n=164)
Moderate ARs were defined as limited impairment of function that resolves spontaneously or with minimal intervention with no sequelae
|of non-serious ARs were severe (n=19)
All 19 severe ARs resolved without complications or hospitalization
Severe ARs were defined as marked impairment of function or can lead to temporary inability to resume normal life pattern; requires prolonged intervention or results in sequelae
- One subject withdrew from the study due to a non-serious adverse experience (papular rash)
- Fifteen adverse reactions in 8 subjects were serious. Of these, two episodes of aseptic meningitis in one patient were deemed possibly related to the infusion of GAMMAGARD LIQUID
Reference: 1. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [Prescribing Information]. Westlake Village, CA: Baxalta US Inc.
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