□ Adverse experience AE + SAE SAE □ Serious Adverse Experiences (please (SAE) print clearly) ____/_____/_____ ____:______ Specify reason(s) for considering this a □ Onset Date and Time serious AE. Mark all that apply: Day Month Year Hour : min □ □ End Date and Time. fatal ____/_____/_____ ____:______ □ Day Month Year Hour : min (If ongoing please leave blank) life threatening Outcome □ Resolved □ disabling/incapacitating □ Ongoing □ results in hospitalization (excluding □ elective surgery or routine clinical Died procedures) Experience course. □No. □ □ hospitalization prolonged Intermittent of episodes □ □ congenital abnormality Constant □ (maximum). Intensity □ cancer Mild □ overdose □ Moderate □ □ Investigator considers serious or a Severe significant hazard, contra- indication, side effect or precaution. Action Taken with Respect □ □ □ Did the SAE abate? Yes No None to Ozone treatment If ozone was interrupted, stopped or □ dose reduced: Dose reduced Was ozone reintroduced □ □ □ (or dose increased)? Yes No Interrupted/restarted □ □ If yes, did SAE Yes No □ Stopped Relationship to Ozone Assessment □ Not related The SAE is probably associated treatment □ with: Unlikely □ □ Protocol design or procedures (but Suspected not ozone) □ ______________ Probable Please specify: □ Corrective Therapy If ‘Yes’ □ □ Another condition (e.g. Condition Yes No Record details in Concomitant under study, inter-current illness) Medication section ______________ Please specify: Was the patient withdrawn due □ □ Yes No □ to this specific AE? Another drug ______________ Please specify: Physician Signature: _____________________________________ Date: _____________ Place: __________
□ Adverse experience □ Serious Adverse Experiences (SAE) (please print clearly) AE + SAE SAE □ Onset Date and Time ____/_____/_____ ____:______ Day Month Year Hour : min Specify reason(s) for considering this a serious AE. Mark all that apply: □ fatal □ life threatening □ disabling/incapacitating □ results in hospitalization (excluding elective surgery or routine clinical procedures) □ hospitalization prolonged □ congenital abnormality □ cancer □ overdose □ Investigator considers serious or a significant hazard, contra- indication, side effect or precaution. □ End Date and Time. (If ongoing please leave blank) ____/_____/_____ ____:______ Day Month Year Hour : min Outcome □ Resolved □ Ongoing □ Died Experience course. □ Intermittent □No. of episodes □ Constant Intensity (maximum). □ Mild □ Moderate □ Severe Action Taken with Respect to Ozone treatment □ None □ Dose reduced □ Interrupted/restarted □ Stopped Did the SAE abate? □ Yes □ No If ozone was interrupted, stopped or dose reduced: Was ozone reintroduced (or dose increased)? □ Yes □ No If yes, did SAE □ Yes □ No Relationship to Ozone treatment □ Not related □ Unlikely □ Suspected □ Probable Assessment The SAE is probably associated with: □ Protocol design or procedures (but not ozone) Please specify: ______________ □ Another condition (e.g. Condition under study, inter-current illness) Please specify: ______________ □ Another drug Please specify: ______________ Corrective Therapy If ‘Yes’ Record details in Concomitant Medication section □ Yes □ No Was the patient withdrawn due to this specific AE? □ Yes □ No Physician Signature: _____________________________________ Date: _____________ Place: __________
ISCO3-REC-00-03-Att-II-III-IV.docx