Adverse Drug Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Adverse Drug Event means any untoward medical occurrence in a patient or clinical investigation subject administered with the Product, including any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the Product, whether or not considered related to the Product. Affected Obligations is defined in clause 21.1(a)(ii).
Adverse Drug Event means an injury resulting from the use of a drug.
Examples of Adverse Drug Event in a sentence
Disclaimer: The suggestions are made by the pharmacist submitting the Significant Adverse Drug Event Report.
Disclaimer: These suggestions are made by the pharmacist submitting the Significant Adverse Drug Event Report.
For the purpose of this guideline, "SAHPRA" refers to the South African Health Products Regulatory Authority, hereafter referred to as the Authority, and “NADEMC” refers to the National Adverse Drug Event Monitoring Centre.
Evaluating Adverse Drug Event Reporting in Administrative Data from Emergency Departments: A Validation Study.
Granulocyte colony-stimulating factor-associated aortitis in the Japanese Adverse Drug Event Report database.
More Definitions of Adverse Drug Event
Adverse Drug Event means an unexpected and undesired incident that results in patient injury or death or an adverse outcome for a patient, including injury or complication.
Adverse Drug Event means any noxious, unintended, or untoward medical occurrence in a patient or clinical investigation subject associated with the use of a medicinal or investigational product, whether or not related to the medicinal or investigational product.
Adverse Drug Event means any experience with any of the Finished Products which may adversely impact the Marketing Authorization and which shall include any unfavorable, unusual or unwanted signs, symptoms, or laboratory values (whether or not considered drug related) experienced by a patient or customer that may be attributable to the Active Pharmaceutical Ingredient.
Adverse Drug Event means:
Adverse Drug Event. (ADE) shall mean any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action.
Adverse Drug Event or "ADE" means an injury from a medicine or lack of an intended medicine.
Adverse Drug Event means any unwanted medical occurrence in a subject to whom a drug is administered and includes an occurrence which is not caused by or related to the drug;