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ADVERSE EVENT REPORTINGADVERSE EVENT REPORTING
 
 
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Any untoward medical occurrence in a patient or clinical investigation subjectadministered a pharmaceutical product andwhich does not necessarily have to have acausal relationship with this treatment.
 ADVERSE EVENT
 
 
ADVERSE EVENT(CONTD)
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Thus an AE can be any unfavourable andThus an AE can be any unfavourable andunintended sign, symptom , or diseaseunintended sign, symptom , or diseasetemporally associated with the use of temporally associated with the use of medicinal product, whether or notmedicinal product, whether or notconsidered related to the medicinalconsidered related to the medicinal product. product.
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