Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Clinical Studies Experience
Anaphylaxis and anaphylactoid reactions were the most common serious reactions observed following VASOVIST injection administration [see WARNINGS AND PRECAUTIONS].
In all clinical trials evaluating VASOVIST (gadofosveset trisodium injection for intravenous use) with MRA, a total of 1,676 (1379 patients and 297 healthy subjects) were exposed to various doses VASOVIST (gadofosveset trisodium injection for intravenous use) . The mean age of the 1379 patients who received VASOVIST (gadofosveset trisodium injection for intravenous use) was 63 years (range 18 to 91 years); 66% (903) were men and 34% (476) were women. In this population, there were 80% (1100) Caucasian, 8% (107) Black, 12% (159) Hispanic, 1% (7) Asian, and < 1% (6) patients of other racial or ethnic groups. Table 2 shows the most common adverse reactions ( ≥ 1%) experienced by subjects receiving VASOVIST (gadofosveset trisodium injection for intravenous use) at a dose of 0.03 mmol/kg.
Table 2 Common Adverse Reactions in 802 Subjects Receiving VASOVIST (gadofosveset trisodium injection for intravenous use) at 0.03 mmol/kg
|Preferred Term||n (%)|
|Injection site bruising||19 (2)|
|Burning sensation||17 (2)|
|Venipuncture site bruise||17 (2)|
|Dizziness (excluding vertigo)||8 (1)|
|Feeling cold||7 (1)|
Because post-marketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The profile of adverse reactions identified during the post-marketing experience outside the United States was similar to that observed during the clinical studies experience.