Dr Manocha discusses adverse events in medicine and how they relate to meditation in this excerpt from his thesis:
The International Conference on Harmonisation adopted a definition of adverse events (AEs) designed to facilitate systematic recording of all untoward events occurring in clinical trials. An AE does not necessarily require a plausible association; rather its definition requires only that it may be reasonably associated with the treatment. AEs can be non-serious or serious (SAE). SAEs are defined as any adverse event that results, in requirement for hospitalization, results in persistent or significant incapacity, causes a congenital anomaly, is life threatening or results in death. Since many research trials are blinded, data and safety monitoring boards have been proposed as mechanisms to monitor safety of trial participants.
Many trials report AEs with insufficient detail to allow meaningful analysis and consideration. While guidelines for the reporting of AEs in general and for particular classes of drugs are now emerging, there are none for complimentary and alternative medicines, let alone meditation. Therefore, in order to determine whether guidelines for meditation AEs are necessary and for what pattern of AE the guidelines should be prepared, a review of adverse events associated with meditation is necessary.