Serious Adverse Experience definition

Serious Adverse Experience means any Adverse Experience associated with the use of any of Aldurazyme that results in one or more of the following outcomes: death; a life-threatening experience; required or prolonged inpatient hospitalization; persistent or significant disability or incapacity; a congenital anomaly or defect; or the occurrence of an important medical event that may jeopardize the health of a Patient or subject, and may require medical or surgical intervention to prevent one of the outcomes listed above.

Serious Adverse Experience means any experience that suggests a significant hazard, contraindication, side effect or precaution, or any experience that is fatal or life threatening, Is permanently disabling, requires or prolongs inpatient hospitalization, or is a congenital anomaly, cancer or overdose. Unexpected adverse experience is one not identified in nature, specificity, severity or frequency in a current investigator brochure for Compound, or in CUBIST's labeling for Product.

Serious Adverse Experience means any [REDACTED – commercially sensitive information].

Examples of Serious Adverse Experience in a sentence

• In any event, each Party shall notify the other Party within [*] of any Serious Adverse Experience (as set forth in 21 CFR 314.80).

• In addition to the foregoing, the Parties shall update the current guidelines and procedures to govern receipt, processing, assessment and submission of Aldurazyme Adverse Experience and Serious Adverse Experience reports to the FDA, the European Commission and other regulatory authorities within sixty (60) days after the Effective Date.

• Furthermore, upon Sponsor's reasonable request, DCR shall promptly investigate any such Serious Adverse Experience and shall submit follow-up reports of new information in a timely manner.

• A Serious Adverse Experience or Event (SAE) is any AE that occurring at any dose results in any of the following outcomes: death, life-threatening adverse toxicity experience, inpatient hospitalization or prolongation of existing hospitalization (excluding hospitalization for elective procedures or transfusions), a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.

• The designated reporting form [Sponsor or CTCC provided Serious Adverse Experience Notification Form (SAEN) or MedWatch Form] must be completed for all Serious Adverse Experiences regardless of causality or expectedness.

More Definitions of Serious Adverse Experience

Serious Adverse Experience means any Adverse Experience which is any one or more of the following: fatal; life threatening; disabling or incapacitating; results in hospitalization or prolongation of hospitalization; requires intervention to prevent permanent impairment/damage; or otherwise suggests a significant hazard, contraindication, side effect or precaution that may be associated with the use of ADJUVANTS or PRODUCTS or COMBINATIONS.

Serious Adverse Experience shall have the meaning of Serious Adverse Drug Experience set forth in 21 CFR 314.80.

Serious Adverse Experience means any experience that suggests a significant hazard, contraindication, side effect, or precaution. With respect to human clinical experience, a serious adverse drug experience includes any experience that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer, or overdose.

Serious Adverse Experience means any adverse event associated with the use of Product in humans (whether or not considered drug-related) that gives rise at any dose to one or more of the following: death, threat to life, new or prolonged in-patient hospitalization, permanent, persistent or significant disability or incapacitation, overdose, congenital abnormality, a congenital anomaly or birth defect or any other serious event or laboratory abnormality which is thought by the reporting physician to be serious or associated with relevant clinical signs or symptoms; and

Serious Adverse Experience or “Serious AE” shall have the meaning set forth in the SDEA.

Serious Adverse Experience refers to an experience that has any serious adverse effect on health or safety or any life-threatening problem caused by, or associated with, a Device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a Device that relates to the rights, safety, or welfare of subjects. Any untoward event which occurs regardless of its causality, including any side effect, injury, toxicity or sensitivity reaction during the testing of protocol treatments (whether or not considered Device-related), will be designated as an unanticipated adverse effect and recorded on the adverse events page of the Case Report Form (CRF).

Serious Adverse Experience means any experience that suggests a significant hazard, contraindication, side effect, or precaution. With respect to human clinical experience, a serious adverse drug experience includes any experience that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer, or overdose. With respect to results obtained from tests in laboratory animals, a serious adverse drug experience includes any experience suggesting a significant risk for human subjects, including any finding of mutagenicity, teratogenicity, or carcinogenicity.