Serious Adverse Drug Reaction definition

Serious Adverse Drug Reaction. (“SADR”) shall have the meanings provided to such terms in the International Conference on Harmonization (“ICH”) guideline for industry on Clinical Safety Data Management (E2A, Definitions and Standards for Expedited Reporting).

Serious Adverse Drug Reaction means an adverse drug reaction that requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. (réaction indésirable grave à une drogue)

Serious Adverse Drug Reaction. ("SADR") means an ADR having the characteristics described in 1.2.

Examples of Serious Adverse Drug Reaction in a sentence

• An event may qualify for expedited reporting to worldwide regulatory authorities if it is a Serious Adverse Event, Serious Adverse Drug Reaction or Suspected Unexpected Serious Adverse Reaction (SUSAR) in line with relevant legislation, including the European Commission Clinical Trials Directive (2001/20/EC).

• Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) is any untoward medical occurrence that at any dose:1.

• A Serious Adverse Event (SAE) which is considered related to the protocol treatment is defined as a Serious Adverse Drug Reaction (SADR).

• Serious Adverse Drug Reaction (abbreviated as SADR) – shall mean such adverse drug reaction which results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity or is demonstrated as a congenital anomaly or birth defect in offsprings, (Section 3, paragraph 4 (a) of the Act).

• Serious Adverse Drug Reaction (SADR):An adverse drug reaction (ADR) is an adverse event for which a causal relationship (Possible/Probable relation) between the study drug and the occurrence of the event is suspected.

More Definitions of Serious Adverse Drug Reaction

Serious Adverse Drug Reaction shall have the meanings provided to such terms in the ICH guideline for industry on Clinical Safety Data Management (E2A, Definitions and Standards for Expedited Reporting).

Serious Adverse Drug Reaction means any adverse drug reaction which —

Serious Adverse Drug Reaction means a noxious and unintended response to a drug that occurs at any dose: • congenital anomaly/birth defect and suspected transmission of any infectious disease • Results in death, • Is life-threatening (NOTE: The term “life-threatening” in the definition of “serious” refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/ reaction which hypothetically might have caused death if it were more severe), • Requires inpatient hospitalization or results in prolongation of existing hospitalization, • Results in persistent or significant disability/incapacity Safety Report covered by the Agreement is those arising from use of the Product(s) within the terms of the marketing and those arising from the use outside the terms of the marketing authorization. Serious Unexpected Adverse Drug Reaction: a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the drug.

Serious Adverse Drug Reaction and "Serious Adverse Event" shall have the meaning given at 21 C.F.R. 314.80 or 21 C.F.R. 312.32, as applicable, and the ICH guidelines.

Serious Adverse Drug Reaction. (‘SADR’) shall mean any untoward medical occurrence that, at any dose:

Serious Adverse Drug Reaction means a noxious and unintended response to a drug that occurs at any dose and that requires in-

Serious Adverse Drug Reaction an ADR occurring at any dose that results in one of more of the following: congenital anomaly/birth defect and suspected transmission of any infectious disease, results in death, is life-threatening (The term “life-threatening” in the definition of “serious” refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/ reaction which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, other medically important condition that may put the patient at risk or may require medical or surgical intervention to prevent one of the above conditions.