Has the patient experienced any Adverse Events since signing the Informed Consent? Yes, specify below No Action taken with Outcome Study Drug 1=Recovered Start Date Stop Date 1=None If SAE does it Severity 2=Recovered Plausible require dd/mmm/yyyy dd/mmm/yyyy 2=Dose Reduction with sequelae AE Withdrawn Serious AE Adverse Event 1=Mild (diagnosis (if known) or relationship immediate Temporarily and Time and Time no. due to AE? (SAE)? signs/symptoms) 3=Continuing 2=Moderate to Study Drug reporting? 3=Dose Reduced (24 hour (24 hour 4=Patient Died 3=Severe (see Protocol)? clock) clock) 4=Discontinued 5=Change in AE Temporarily 6=unknown 5=Discontinued / / / / Yes Yes Yes Yes No No No No / / / / Yes Yes Yes Yes No No No No / / / / Yes Yes Yes Yes No No No No
Has the patient experienced any Adverse Events since signing the Informed Consent? Yes, specify below No AE no. Adverse Event (diagnosis (if known) or signs/symptoms) Start Date dd/mmm/yyyy and Time (24 hour clock) Stop Date dd/mmm/yyyy and Time (24 hour clock) Outcome 1=Recovered 2=Recovered with sequelae 3=Continuing 4=Patient Died 5=Change in AE 6=unknown Severity 1=Mild 2=Moderate 3=Severe Plausible relationship to Study Drug Action taken with Study Drug 1=None 2=Dose Reduction Temporarily 3=Dose Reduced 4=Discontinued Temporarily 5=Discontinued Withdrawn due to AE? Serious AE (SAE)? If SAE does it require immediate reporting? (see Protocol)? / / / / Yes Yes Yes Yes No No No No / / / / Yes Yes Yes Yes No No No No / / / / Yes Yes Yes Yes No No No No
example_case_report_form.docx