Polaris

Code INTENSITY as:1 = Mild2 = Moderate3 = Severex = Not applicableCode OUTCOME as:R = ResolvedS = Resolved with sequelaeN = Not resolvedCompanyCODES FOR SERIOUS ADVERSE EXPERIENCESCode ACTION TAKEN WITH TRIAL MEDICATION AS A RESULT OF THE NON-SERIOUS ADVERSE EXPERIENCE as:0 = None1 = Dosage adjusted2 = Temporarily interrupted3 = Permanently discontinuedx = Not applicableCode WITHDRAWAL as:Y = Yes, subject did withdraw from the study as a result of this serious adverse experience.N = No, subject did not withdraw from the study as a result of this serious adverse experience.Code RELATIONSHIP TO TRIAL MEDICATION as:Y = Yes, there is a reasonable possibility that the non-serious adverse experience may have been caused by the trialmedication.N = No, there is a not reasonable possibility that the non-serious adverse experience may have been caused by the trialmedication.Code SERIOUSNESS as:A = FatalB = Life-threateningC = Disabling/incapacitatingD = Hospitalization required or prolongedE = OverdoseF = Grade 4 laboratory abnormalitySAE.doc© 2004 by CRC Press LLC