Adverse Event v1.00 This file contains the metadata, events, and data for REDCap project "Adverse Event v1.00". Adverse Event v1.00 1 0 0 4 Record ID API token from source project Number of Study Arms Subjects At Risk Per Study Arm Study Arm Names Unique Event Name Subject ID Direct Mapping Subject ID Alternate Mapping Date of Adverse Event Direct Mapping Date of Adverse Event Alternate Mapping Description of events Direct Mapping Description of events Alternate Mapping Location Direct Mapping Location Alternate Mapping Severity Direct Mapping Severity Alternate Mapping Expectedness Direct Mapping Expectedness Alternate Mapping Relatedness Direct Mapping Relatedness Alternate Mapping Changes-Corrective Action Direct Mapping Changes-Corrective Action Alternate Mapping Date Reported to PHRC, if available Direct Mapping Date Reported to PHRC, if available Alternate Mapping Adverse Event Type Direct Mapping Adverse Event Type Alternate Mapping Assessment Type Direct Mapping Assessment Type Alternate Mapping Additional Description Additional Description Alternate Mapping Organ System Name Direct Mapping Organ System Name Alternate Mapping Source Vocabulary Direct Mapping Source Vocabulary Alternate Mapping Adverse Event Term Direct Mapping Adverse Event Term Alternate Mapping Specify Study Arm Direct Mapping Specify Study Arm Alternate Mapping Affected Direct Mapping Affected Alternate Mapping IRB Custom field 1 Direct Mapping IRB Custom field 1 Alternate Mapping IRB Custom field 2 Direct Mapping IRB Custom field 2 Direct Mapping IRB Custom field 3 Direct Mapping IRB Custom field 3 Alternate Mapping IRB Custom field 4 Direct Mapping IRB Custom field 4 Alternate Mapping IRB Custom field 5 Direct Mapping IRB Custom field 5 Direct Mapping Complete? Subject ID Subject ID details Date of Adverse Event Date of Adverse Event: Details Description of events Description of events: Details Location Location: Details Severity Severity: Details Expectedness Expectedness: Details Relatedness Relatedness: Details Requires Changes / Corrective Action Requires Changes / Corrective Action: Details Date Reported to PHRC, if available Date Reported to PHRC, if available: Details Adverse Event Type Adverse Event Type: Details Assessment Type Assessment Type: Details Additional Description Additional Description: Details Organ System Name Organ System Name: Details Source Vocabulary Source Vocabulary: Details AE Term AE Term: Details Specify Study Arm Specify Study Arm: Details Record: Details Administrator Notes IRB Custom Field 1 IRB Custom Field 1: Details IRB Custom Field 2 IRB Custom Field 2: Details IRB Custom Field 3 IRB Custom Field 3: Details IRB Custom Field 4 IRB Custom Field 4: Details IRB Custom Field 5 IRB Custom Field 5: Details Complete? Subject ID Date of Adverse Event Description of events Location Severity Expectedness Relatedness Requires Changes / Corrective Action Date Reported to PHRC, if available Complete? Adverse Event Type Assessment Type Additional Description Organ System Name Source Vocabulary AE Term Complete? Number of Events: Number of Subjects Affected: Number of Subjects at Risk Complete? Incomplete Unverified Complete No Data Available Internal External Temp No Data Available Serious Non-Serious No Data Available Expected Unexpected No Data Available Relates Possibly Related Unrelated No Data Available Serious Other No Data Available Systematic Assessment Non-systematic Assessment No Data Available Blood and Lymphatic System Disorders Cardiac Disorders Congenital, Familial and Genetic Disorders Ear and Labyrinth Disorders Endocrine Disorders Eye Disorders Gastrointestinal Disorders General Disorders Hepatobiliary Disorders Immune System Disorders Infections and Infestations Injury, Poisoning and Procedural Complications Investigations Metabolism and Nutrition Disorders Musculoskeletal and Connective Tissue Disorders Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps) Nervous System Disorders Pregnancy, Puerperium and Perinatal Conditions Product Issues Psychiatric Disorders Renal and Urinary Disorders Reproductive System and Breast Disorders Respiratory, Thoracic and Mediastinal Disorders Skin and Subcutaneous Tissue Disorders Social Circumstances Surgical and Medical Procedures Vascular Disorders Incomplete Unverified Complete Internal (Partners) External (Coordinating Sites) Serious Non-Serious Expected Unexpected Relates Possibly Related Unrelated Incomplete Unverified Complete Serious Other No Data Available Systematic Assessment Non-systematic Assessment No Data Available Blood and Lymphatic System Disorders Cardiac Disorders Congenital, Familial and Genetic Disorders Ear and Labyrinth Disorders Endocrine Disorders Eye Disorders Gastrointestinal Disorders General Disorders Hepatobiliary Disorders Immune System Disorders Infections and Infestations Injury, Poisoning and Procedural Complications Investigations Metabolism and Nutrition Disorders Musculoskeletal and Connective Tissue Disorders Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps) Nervous System Disorders Pregnancy, Puerperium and Perinatal Conditions Product Issues Psychiatric Disorders Renal and Urinary Disorders Reproductive System and Breast Disorders Respiratory, Thoracic and Mediastinal Disorders Skin and Subcutaneous Tissue Disorders Social Circumstances Surgical and Medical Procedures Vascular Disorders Incomplete Unverified Complete Incomplete Unverified Complete