life-threatening adverse event

life-threatening adverse event

In the context of a clinical trail, any adverse drug response that the investigator believes places the patient or subject at immediate risk of death from the reaction as it occurred. This does not include a reaction that might have caused death had it occurred in a more severe form.
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The Code of Federal Regulations* defines a serious adverse event associated with using a biologic product in humans as any of the following: death, life-threatening adverse event, inpatient hospitalization or prolongation of an existing hospitalization, persistent or substantial disability/incapacity, congenital anomaly/birth defect, or an important medical event that requires medical or surgical intervention to avert one of these outcomes.
With a cumulative dosing exposure of 149 months, no drug-related severe or life-threatening adverse events were observed.
Additionally, the study will consider other measures of functional recovery, biomarker data and clinical outcomes, including hospitalization, mortality, life-threatening adverse events and post-stroke complications, such as infection.
Intravenous ferric carboxymaltose as per total correction dose (maximum 1500 mg) was administered to all women and they found that mean haemoglobin levels significantly increased over a period of 3 weeks after Ferric carboxymaltose administration and no serious life-threatening adverse events were observed.
For the first-line treatment of epilepsy, drugs such as phenytoin (PHT), carbamazepine (CBZ), valproic acid, and lamotrigine are commonly used antiepileptic drugs (AEDs) that may give rise to cutaneous reactions ranging from a skin rash to unexpected life-threatening adverse events. AEDs have been recognized as being among the most common medications associated with severe cutaneous adverse reactions, with relative risks reported to be 15%, 11%, 13%, and less than 5% for phenobarbital, CBZ, PHT, and oxcarbazepine, respectively.
However, it has been implicated in some grave and life-threatening adverse events, such as thrombocytopenia, hypersensitivity reaction, and prolonged QT interval on electrocardiography [3].
Incidence and management of life-threatening adverse events during cardiac catheterization for congenital heart disease.
Furthermore, there were no differences in the number of serious, life-threatening adverse events between the testosterone and placebo arms of the study.
She explains that consumers may not know exactly what they are getting when buying such antiviral products on the Internet from an unfamiliar company, adding that patients who buy prescription drugs from web sites operating unlawfully are at increased risk of suffering life-threatening adverse events.
The FDA recently warned that unapproved use of Infuse had been linked to serious and life-threatening adverse events. Kohl and Grassley have written letters to Medtronic officials asking for records relating to consulting contracts it has with physicians for Infuse Bone Graft.
"The magnitude of the safety signal associated with using Chantix is alarming both in terms of severity of injury and the number of different serious, life-threatening adverse events associated with this dangerous drug," said Kristian Rasmussen of Birmingham, Alabama, the chair of AAJ's new Chantix litigation group.
In December, the FDA issued a public health advisory about fentanyl patches, warning that the agency has continued to receive reports of fatalities and life-threatening adverse events related to fentanyl overdoses in cases where the fentanyl patch was used to treat pain in opioid-naive patients; and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, or exposed the patch to a heat source, such as a heating pad (INTERNAL MEDICINE NEWS, Feb.