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 any adverse drug reaction which —

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)

Examples of Serious Adverse Drug Reaction in a sentence

• Golf writers and tour operators from several foreign countries were present for the week and hopes are high for increased international golf tourism.

• Within 90 days after the Effective Date, the Parties shall begin to negotiate in good faith a process and procedures for sharing Adverse Drug Reaction and Serious Adverse Drug Reaction information which shall be documented in a pharmacovigilance agreement with respect to the Licensed Product (the “Pharmacovigilance Agreement”).

• 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 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 Event (SAE) or Serious Adverse Drug Reaction (Serious ADR): Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect or requires medical or surgical interventions to prevent any of the above outcomes.

More Definitions of Serious Adverse Drug Reaction

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

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

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: a. results in death, b. is life-threatening, c. requires in-patient hospitalisation or prolongation of existing hospitalisation, d. results in persistent or significant disability/incapacity, e. is a congenital anomaly/birth defect, and/or f. is a medically (or clinically) important event or reaction.

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.