| Question | Response |
|---|---|
| Adverse Event Identifier | |
| Has the subject recently received a blood transfusion or traveled to an area with Endemic Hepatitis or other infectious disease? | No Yes Unknown |
| Does the subject have signs or symptoms consistent with Hepatitis? | No Yes Unknown |
| Has the subject recently experienced occupational or toxic exposure? | No Yes Unknown |
| Has the subject had a recent increase in alcohol use? | No Yes Unknown |
| Has the subject had a recent increase in recreational drug use? | No Yes Unknown |
| Have any local labs been performed that pertain to this event? | No Yes Unknown |
| Indicate the most severe Hepatobiliary AESI experienced by the Subject. | Elevation in ALT >= 3X and <5X ULN and the total bilirubin is <2X ULN ALT or AST >=3X ULN and total bilirubin >=2X ULN Total bilirubin >= 3.0 mg/dl (regardless of ALT values) ALT or AST >= 5X ULN Total bilirubin >= 2X ULN and <3.0 mg/dl with no jaundice and ALT, AST < ULN |
| Has there been a serological evaluation for viral hepatitis A, B, or C, and Anti-Nuclear Antibodies (ANA), Anti-Smooth Muscle Antibody (ASMA), and Prothrombin Time, (International normalize ratio [INR])? | No Yes Unknown |
| Has a gastrointestinal or hepatobiliary consult occurred? | No Yes Unknown |
| Did the patient have any other additional required procedures? | No Yes Unknown |
| If yes, Specify the other additional required procedures |