Yes No Has the participant/subject had any adverse events during the study? Table 1 Record diagnoses (if known) or signs/symptoms the participant/subject experienced during the study that qualify as adverse events Date and Date of Investigator Serious SAE Form Adverse Time of Action Taken Outcomes Attributed to the IRB Resolution Severity Assessment of Other Action Taken Adverse Adverse Event(s) Onset with Study Intervention Event Notified Causality Event? Event? Data to be fillen in by Recovered/Resolved site None Recovered/Resolved With Mild Unrelated Study Intervention Sequelae Moderate Unlikely Interrupted None Not Recovering/Resolving No No No No Severe Reasonable Study Intervention Non-Study resolved Not Recovered/Not Yes Yes Yes Yes Life-threatening Possibility Discontinued Treatment Required Resolved Fatal/Death Definite Study Intervention Fatal Modified Unknown Data to be fillen in by Recovered/Resolved site None Recovered/Resolved With Mild Unrelated Study Intervention Sequelae Moderate Unlikely Interrupted None Not Recovering/Resolving No No No No Severe Reasonable Study Intervention Non-Study resolved Not Recovered/Not Yes Yes Yes Yes Life-threatening Possibility Discontinued Treatment Required Resolved Fatal/Death Definite Study Intervention Fatal Modified Unknown Data to be fillen in by Recovered/Resolved site None Recovered/Resolved With Mild Unrelated Study Intervention Sequelae Moderate Unlikely Interrupted None Not Recovering/Resolving No No No No Severe Reasonable Study Intervention Non-Study resolved Not Recovered/Not Yes Yes Yes Yes Life-threatening Possibility Discontinued Treatment Required Resolved Fatal/Death Definite Study Intervention Fatal Modified Unknown
Has the participant/subject had any adverse events during the study? Yes No Table 1 Record diagnoses (if known) or signs/symptoms the participant/subject experienced during the study that qualify as adverse events Adverse Event(s) Date and Time of Onset Date of Resolution Severity Investigator Assessment of Causality Action Taken with Study Intervention Other Action Taken Outcomes Attributed to the Event Serious Adverse Event? Adverse Event? IRB Notified SAE Form Data to be fillen in by site Not resolved Mild Moderate Severe Life-threatening Fatal/Death Unrelated Unlikely Reasonable Possibility Definite None Study Intervention Interrupted Study Intervention Discontinued Study Intervention Modified None Non-Study Treatment Required Recovered/Resolved Recovered/Resolved With Sequelae Recovering/Resolving Not Recovered/Not Resolved Fatal Unknown No Yes No Yes No Yes No Yes Data to be fillen in by site Not resolved Mild Moderate Severe Life-threatening Fatal/Death Unrelated Unlikely Reasonable Possibility Definite None Study Intervention Interrupted Study Intervention Discontinued Study Intervention Modified None Non-Study Treatment Required Recovered/Resolved Recovered/Resolved With Sequelae Recovering/Resolving Not Recovered/Not Resolved Fatal Unknown No Yes No Yes No Yes No Yes Data to be fillen in by site Not resolved Mild Moderate Severe Life-threatening Fatal/Death Unrelated Unlikely Reasonable Possibility Definite None Study Intervention Interrupted Study Intervention Discontinued Study Intervention Modified None Non-Study Treatment Required Recovered/Resolved Recovered/Resolved With Sequelae Recovering/Resolving Not Recovered/Not Resolved Fatal Unknown No Yes No Yes No Yes No Yes
F0009_Adverse_Events.docx