Unexpected Adverse Drug Reaction definition

Unexpected Adverse Drug Reaction means an adverse reaction, the nature or severity of which is not consistent with the applicable product information.

Unexpected Adverse Drug Reaction means an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational medicinal product).

Unexpected Adverse Drug Reaction. ("UADR") means an ADR, the nature or severity of which is not consistent with the applicable product information

Examples of Unexpected Adverse Drug Reaction in a sentence

• An Unexpected Adverse Drug Reaction is defined as an adverse reaction, the nature or severity of which is not consistent with the applicable product information.

• Serious Adverse Event and Unexpected Adverse Drug Reaction Unanticipated risks are sometimes discovered during the course of studies.

• Unexpected Adverse Drug Reaction (abbreviated as UADR) - shall mean such adverse drug reaction the nature, severity or consequences of which are not consistent with the information laid down in the summary of the product characteristics for an authorised medicinal product or which are not consistent with available information, e.g. the investigator's brochure for an investigational medicinal product without marketing authorisation (Section 3, paragraph 4 (b) of the Act).

• Unexpected Adverse Drug Reaction: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product or package insert/summary of product characteristics for an approved product).

• Categories of incidence for Serious Adverse Event (SAE) and Unexpected Adverse Drug Reaction (ADR) are listed in Table 1.

• Requires a medical or surgical intervention to prevent a permanent impairment of a body function or permanent damage to a body structure.• Unanticipated Adverse Event (UAE) / Unexpected Adverse Drug Reaction (UADR)/or Other Unexpected Problems: Unexpected (in terms of nature, severity, or frequency) means that: 1.

• Serious Adverse Event is an event characterized by any of the following: • Death • Life-threatening condition • Hospitalization (initial/prolonged) • Disability • Congenital anomaly • Requires intervention to prevent permanent impairment or damage Unexpected Adverse Drug Reaction (ADR) is an adverse reaction the nature or severity of which is not consistent with the investigator’s brochure.

• ASME B16.9 “Factory-Made Wrought Buttwelding Fittings.” 2) Stainless steel butt weld pipe fittings shall be made of a material that matches the grade of the pipe material used.

• An Unexpected Adverse Drug Reaction is any adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator’s Brochure).

• Unexpected Adverse Drug Reaction (U-ADR): an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. the Investigator’s Brochure for an unapproved investigational product or the Product Monograph for a marketed drug).

More Definitions of Unexpected Adverse Drug Reaction

Unexpected Adverse Drug Reaction means an adverse reaction with the nature or severity not consistent with the applicable product information; CHAPTER II: APPLICATION, ASSESSMENT, INSPECTION AND REPORTING IN CLINICAL TRIALS

Unexpected Adverse Drug Reaction means an adverse reaction, the nature or severity of which is not consistent with the applicable investigational product information.

Unexpected Adverse Drug Reaction means an adverse reaction with the nature or severity not consistent with the applicable product information;

Unexpected Adverse Drug Reaction. An Adverse Drug Reaction where the nature and/or severity of the reaction is not consistent with the term or description used in the IB. Unlisted Adverse Drug Reaction: An ADR, the nature, severity, specificity or outcome of which is not consistent with the information included in the applicable CCSI or local equivalent reference label.

Unexpected Adverse Drug Reaction. An Adverse Drug Reaction where the nature and/or severity of the reaction is not consistent with the term or description used in the IB . Unlisted Adverse Drug Reaction: An ADR, the nature, severity, specificity or outcome of which is not consistent with the information included In the applicable CCSI or local equivalent reference label. · Valid Case: A case that includes each of the following minimum criteria: • An identifiable patient; • The name of the suspect Medicinal Product(s) or Clinical Study if considered related to a Clinical Study procedure/design; • An identifiable reporting source; • An event or outcome.

Unexpected Adverse Drug Reaction means an adverse reaction, the nature, severity or outcome of which is not consistent with domestic labeling, marketing authorization or the SmPC.