![.](tbl_spacer.png) 0 Table of Contents |
![.](tbl_spacer.png) ![.](tbl_vjoin.png) 1 AdverseEvents for Clinical Research Home Page |
![.](tbl_spacer.png) ![.](tbl_vjoin.png) 2 Background and Workflow |
![.](tbl_spacer.png) ![.](tbl_vjoin-open.png) 3 Real World examples |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.1 Cancer Clinical Trial Example |
![.](tbl_spacer.png) ![.](tbl_vjoin.png) 4 Security Note |
![.](tbl_spacer.png) ![.](tbl_vjoin.png) 5 Useful Downloads |
![.](tbl_spacer.png) ![.](tbl_vjoin.png) 6 IG Change History |
![.](tbl_spacer.png) ![.](tbl_vjoin_end-open.png) 7 Artifacts Summary |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.1 Adverse Event Clinical Research |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.2 Adverse Event Grade |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.3 Adverse Event Severity |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.4 Adverse event caused subject to discontinue the study |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.5 Criteria reviewed in determining serious adverse event |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.6 ClinicalTrialSignificantAdverseEvent |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.7 Patient reported AE during research study |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.8 adverse-event-compass-ex1 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.9 adverse-event-compass-ex1a |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.10 adverse-event-compass-ex1b |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.11 adverse-event-compass-ex2 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.12 AdverseEventFromProcedureNotStudyDrug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.13 SeriousAdverseEventResearchStudy |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.14 NonSeriousAdverseEventResearchStudyMed |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.15 adverse-event-device-death |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.16 Serious Adverse Event |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.17 ClinicalTrialSubject5 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.18 AEHepaticFailure |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.19 AEHepaticFailurecomplication |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.20 Janet Patient |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.21 Breast Cancer Trial |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.22 Janet weight Observation |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.23 Janet Blood Pressure Observation |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.24 Janet Tylenol PM med |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.25 Janet allergy med |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.26 Janet pill for water retention med not known |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.27 Medication Administration for bresentrik |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.28 Medication is bresentrik |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.29 Medication Request for bresentrik |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.30 Medication Administration of Med0301 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.31 Medication Request for discontinued clinical trial medication ABC |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.32 Medication Request for discontinued clinical trial medication 0301 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.33 Problem |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.34 patient-example-kaitlyn-b |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.35 practitioner-oncology-nurse-jane |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.36 practitioner-owen-oncologist |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.37 medication-request-example-kadcyla |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.38 medication-request-example-tucatinib |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.39 medication-administration-kadcyla |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.40 medication-administration-tucatinib |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.41 clinical-trial-example-compass |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.42 clinical-trial-example-subject |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.43 medication-administration-kadcyla-reduced |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.44 medication-administration-tucatinib-reduced |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.45 medication-request-example-zofran |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.46 GIBleed |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.47 research-study-XYZ |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.48 study-medication-ABC |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.49 study-medication-administration-ABC |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.50 procedure-upper-endoscopy |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.51 research-study-DISNEY |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.52 study-medication-MMD |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.53 study-medication-administration-MMD |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.54 medication-tylenol |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.55 medication-administration-tylenol |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.56 research-study-acme |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.57 clinical-trial-acme-subject |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.58 clinical-trial-acme-procedure |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.59 study-medication-administration-WBY |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.60 medication-contrast-dye |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.61 medication-administration-contrast-dye |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.62 medication-forhives |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.63 medication-administration-forhives |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.64 AEModeratehives |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.65 resstudy-medication-WBY |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.66 Patient MOUMIC |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.67 AEHeadache |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.68 Example patient SLP |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.69 Device - Infuser that exploded |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.70 clinical-trial-example-subject1 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.71 medication-administration-kadcyla1 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 7.72 medication-request-example-kadcyla1 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin_end.png) 7.73 patient-example-kaitlyn-b1 |