PDF PhUSE US Connect 2018 Adverse Event Analysis -One step
PhUSE US Connect 2018
Adverse Event Analysis ? One step forward!
- Anuja Rasal
05June2018
Disclaimer -
All views and opinions documented here are those of the author and do not necessarily represent the opinion, recommendation and practices of Syneos Health.
Adverse Events
An adverse event (AE) is 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.
Adverse Event (AE) occurring in a subject can be elaborately referred as ? - Any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporarily associated with the use of a drug, without any judgment about causality or relationship to the drug. - An event that can arise from any use of the drug (e.g., off-label use, use in combination with another drug) and from any route of administration, formulation, or dose, including an overdose.
? 2018 All rights reserved | Confidential | For Syneos HealthTM use only
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Agenda
? Categories and Definitions ? Safety Analysis ? Adverse Event Analysis
? Types of Analysis ? Conventional AE analysis
? Categorical Analysis of Adverse events ? Exposure adjusted AE analysis ? AE's of Special Interest and their Analysis
? Start Day of AE's ? Duration of AE's ? Tier-based Analysis of AE's
? Safety Signal Detection ? Conclusion
? 2018 All rights reserved | Confidential | For Syneos HealthTM use only
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