Adverse events classified by body system using MedDRA, based on the incidence, severity, and causality to study treatment

(1) The event is clearly related to other factors, such as a subject’s clinical state, therapeutic interventions or concomitant medications.
(2) The event was most likely produced by other factors, such as a subject’s clinical state, therapeutic interventions or concomitant medications, and does not follow a known response pattern to the study drug.
(3) The event has a reasonable temporal relationship to the study drug administration and follows a known response pattern to the study drug. However, a potential alternate etiology may be responsible for the event. The effect of drug withdrawal is unclear. Re-challenge information is unclear or lacking.
(4) The event follows a reasonable temporal sequence from the time of drug administration, and follows a known response pattern to the study drug and cannot be reasonably explained by non drug related factors. There is a reasonable response to withdrawal of the drug. Re-challenge information is not available or advisable.
(5) The event follows a temporal sequence from the time of drug administration and follows a known response pattern to the study drug. Either occurs immediately following the study drug administration, improves on stopping the drug, or reappears on repeat exposure.