Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In clinical studies, 555 patients were exposed to Amyvid. Amyvid caused no serious adverse reactions in the studies and the reported adverse reactions were predominantly mild to moderate in severity. The adverse reactions reported in more than one subject within the studies are shown in Table 2.
Table 2: Adverse Reactions Reported in Clinical Trials (N=555 patients)
|Adverse Reactions||N (Percent of patients)|
|Musculoskeletal pain||4 (0.7%)|
|Blood pressure increaseda||4 (0.7%)|
|Injection site reactionb||3 (0.5%)|
|Back pain||2 (0.4%)|
|Feeling coldc||2 (0.4%)|
|Neck pain||2 (0.4%)|
|aIncludes the terms blood pressure increased and hypertension.
bIncludes the terms injection site haemorrhage, injection site irritation, and injection site pain.
cIncludes the terms feeling cold and chills.
Other adverse reactions occurred at lower frequencies and included infusion site rash, dysgeusia, pruritis, urticaria, and flushing.