| Definitions |
Any unfavorable or unintended disease, sign, or symptom (including an abnormal laboratory finding) that is temporally associated with the use of a medical treatment or procedure, and that may or may not be considered related to the medical treatment or procedure. Such events can be related to the intervention, dose, route of administration, patient, or caused by an interaction with another drug(s) or procedure(s).
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| ALT_DEFINITION |
Any unfavorable or unintended disease, sign, or symptom (including an abnormal laboratory finding) that is temporally associated with the use of a medical treatment or procedure, and that may or may not be considered related to the medical treatment or procedure. Such events can be related to the intervention, dose, route of administration, patient, or caused by an interaction with another drug(s) or procedure(s). An unexpected medical problem that happens during treatment with a drug or other therapy. Adverse effects do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe. Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. an adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A] See also serious adverse event, serious adverse experience. Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. [Modified from ICH E2A] Synonyms: side effect, adverse experience. See also serious adverse event, serious adverse experience. (CDISC glossary) Any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. EXAMPLE(S): death, back pain, headache, pulmonary embolism, heart attack OTHER NAME(S): NOTE(S): The BRIDG SCC has a GForge Tracker Issue (#31893) indicating a need to validate the requirement that every AdverseEvent be described by a SafetyReportVersion. Any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. EXAMPLE(S): death, back pain, headache, pulmonary embolism, heart attack
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| DEFINITION |
Any unfavorable or unintended disease, sign, or symptom (including an abnormal laboratory finding) that is temporally associated with the use of a medical treatment or procedure, and that may or may not be considered related to the medical treatment or procedure. Such events can be related to the intervention, dose, route of administration, patient, or caused by an interaction with another drug(s) or procedure(s).
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