at nighttime [15:30 msec were noted in 64 (29%) subjects. Forty-six out of 64 subjects with QTc prolongations were further evaluated and 39% (18/46) showed associated cardiac rhythm changes. The effects of concomitant drugs were not studied. Adverse Reactions Clinical Trials Experience A total of 1716 subjects were evaluated in pre-market clinical trials of activated Definity . In this group, 1063 (61.9%) were male and 653 (38.1%) were female, 1328 (77.4%) were White, 258 (15.0%) were Black, 74 (4.3%) were Hispanic, and 56 (3.3%) were classified as other racial or ethnic groups. The mean age was 56.1 years (range 18 to 93). Of these, 144 (8.4%) had at least one adverse reaction (Table 6.1). There were 26 serious adverse events and 15 (0.9%) subjects discontinued because of an adverse event. Deaths and Serious Adverse Events Among the 1716 activated Definity patients, 19 (1.1%) suffered serious cardiopulmonary adverse events including eight deaths. The deaths occurred several days after activated Definity administration and appeared to be related to the course of underlying disease. Of the 11 other serious adverse events, which appeared within days of the drug administration (2-15 days), all appeared to be a progression underlying cardiac and non-cardiac disease. However, a role for Definity in the initiation or course of these adverse events cannot be ruled out. Discontinuations There were 15 discontinuations reported with a mean age of 41.5 years. Nine of these patients were discontinued after the first injection. One patient experienced a hypersensitivity reaction with urticaria and pruritus and all the other patients experienced dizziness, chest pain, dyspnea or back pain. These adverse reactions appeared within minutes (1 15 min) of the drug administration and were of moderate intensity resolving usually without treatment within minutes or hours after onset. For all adverse reactions, the overall incidence of adverse experiences was similar for the] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Ultrasound contrast media Related Drugs ultrasound contrast media perflutren , Optison Echocardiography perflutren , Optison , More... Definity Rating 1 User Review 1 User Review Not Rated - Be the first! continual
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