ࡱ>  bjbj 8xxxw l%%%8]%*p4=q #*%*%*%*%*%*%*+.N%*^ qq^ ^ %*=4:*,#,#,#^ =#*,#^ #*,#,#:'(,(hP9HH%p!^S( *P*0*](R.!.(.(`-,#I-1%*%*"X*^ ^ ^ ^ . : STUDY NAMESite Number: Pt_ID: ________________ ________________Visit Date: __ __ / __ __ __ / 2 0 __ __ d d m m m y y y y  Visit Type (circle one): Screening Baseline Visit 1 Visit 2 Visit 3 Visit 4Visit 5 Completion Visit CATEGORYNormal Or AbnormalIF Abnormal, Describe belowChange from baseline General Appearance FORMCHECKBOX Normal  FORMCHECKBOX Abnormal  FORMCHECKBOX Not Examined FORMCHECKBOX Yes  FORMCHECKBOX  No  FORMCHECKBOX  NA HEENT FORMCHECKBOX Normal  FORMCHECKBOX Abnormal  FORMCHECKBOX Not Examined FORMCHECKBOX Yes  FORMCHECKBOX  No  FORMCHECKBOX  NA Neck FORMCHECKBOX Normal  FORMCHECKBOX Abnormal  FORMCHECKBOX Not Examined FORMCHECKBOX Yes  FORMCHECKBOX  No  FORMCHECKBOX  NA Chest and Lungs FORMCHECKBOX Normal  FORMCHECKBOX Abnormal  FORMCHECKBOX Not Examined FORMCHECKBOX Yes  FORMCHECKBOX  No  FORMCHECKBOX  NA Cardiovascular FORMCHECKBOX Normal  FORMCHECKBOX Abnormal  FORMCHECKBOX Not Examined FORMCHECKBOX Yes  FORMCHECKBOX  No  FORMCHECKBOX  NAAbdomen FORMCHECKBOX Normal  FORMCHECKBOX Abnormal  FORMCHECKBOX Not Examined FORMCHECKBOX Yes  FORMCHECKBOX  No  FORMCHECKBOX  NA Genitourinary FORMCHECKBOX Normal  FORMCHECKBOX Abnormal  FORMCHECKBOX Not Examined FORMCHECKBOX Yes  FORMCHECKBOX  No  FORMCHECKBOX  NA Rectal FORMCHECKBOX Normal  FORMCHECKBOX Abnormal  FORMCHECKBOX Not Examined FORMCHECKBOX Yes  FORMCHECKBOX  No  FORMCHECKBOX  NA Musculoskeletal FORMCHECKBOX Normal  FORMCHECKBOX Abnormal  FORMCHECKBOX Not Examined FORMCHECKBOX Yes  FORMCHECKBOX  No  FORMCHECKBOX  NALymph Nodes FORMCHECKBOX Normal  FORMCHECKBOX Abnormal  FORMCHECKBOX Not Examined  FORMCHECKBOX Yes  FORMCHECKBOX  No  FORMCHECKBOX  NAExtremities/Skin FORMCHECKBOX Normal  FORMCHECKBOX Abnormal  FORMCHECKBOX Not Examined FORMCHECKBOX Yes  FORMCHECKBOX  No  FORMCHECKBOX  NANeurological FORMCHECKBOX Normal  FORMCHECKBOX Abnormal  FORMCHECKBOX Not Examined FORMCHECKBOX Yes  FORMCHECKBOX  No  FORMCHECKBOX  NAOther:__________ FORMCHECKBOX Normal  FORMCHECKBOX Abnormal  FORMCHECKBOX Not Examined FORMCHECKBOX Yes  FORMCHECKBOX  No  FORMCHECKBOX  NA Note: For follow-up PE, if a body system category changes from Normal at baseline to Abnormal at follow-up due to a new disease/condition, or a preexisting disease/condition worsens from the baseline, an adverse event form should be completed to report the change. 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