- 12/18/19 - 1 form, 13 itemgroups, 44 items, 1 language
Itemgroups: Administrative documentation, Serious Adverse Event, Serious Adverse Event, Seriousness of Adverse Event, Serious Adverse Event, Demography, Serious Adverse Event, Relationships, Experimental drug, Serious Adverse Event, Etiology aspects, Serious Adverse Event, Disease, Serious Adverse Event, Risk factors, Serious Adverse Event, Concomitant Agent, Serious Adverse Event, Experimental drug, Details, Serious Adverse Event, Diagnostic Procedure, Serious Adverse Event, Comment, Serious Adverse Event, Investigator Signature
- 6/20/19 - 1 form, 19 itemgroups, 70 items, 1 language
Itemgroups: Administrative, Concomitant Medications, Concomitant Medications, Non-Serious Adverse Events, Non-Serious Adverse Events , Serious Adverse Event, Serious Adverse Event - Section 1, Serious Adverse Event - Section 2 Seriousness, Serious Adverse Event - Section 3 Demography Data, Serious Adverse Event - Section 4, Serious Adverse Event - Section 5, Serious Adverse Event - Section 6 Medical Conditions, Serious Adverse Event - Section 7, Serious Adverse Event - Section 8 Relevant Concomitant Medication, Serious Adverse Event - Section 9, Was treatment blind broken at investigational site?, Serious Adverse Event - Section 10, Serious Adverse Event - Section 11, Serious Adverse Event - lnvestigator's signature
- 4/23/19 - 1 form, 13 itemgroups, 43 items, 1 language
Itemgroups: Administrative documentation, Serious Adverse Event, Serious Adverse Event, Severity of Adverse Event, Serious Adverse Event, Demography, Serious Adverse Event, Relationship, Experimental drug, Serious Adverse Event, Causations, Disease, Serious Adverse Event, Risk factor, Serious Adverse Event, Concomitant Agent, Serious Adverse Event, Experimental drug, Serious Adverse Event, Evaluation, Details, Serious Adverse Event, Comment, Investigator Signature
- 4/19/18 - 1 form, 13 itemgroups, 61 items, 1 language
Itemgroups: Serious Adverse Events, Serious Adverse Events - Section 1: Demography, Serious Adverse Events - Section 2, Serious Adverse Events - Section 3: Possible Causes of SAE other than Investigational Product(s), Serious Adverse Events - Section 4: Seriousness, Serious Adverse Events - Section 5: Relevant Medical Conditions, Serious Adverse Events - Section 6: Other Relevant Risk Factors, Serious Adverse Events - Section 7: Details of investigational Products, Serious Adverse Events - Section 8: Relevant concomitant medication, Serious Adverse Events - Section 9: Narrative/Comments, Serious Adverse Events - Section 10: Details of relevant assessments, Serious Adverse Events - Section 11: Reporting Investigator, Serious Adverse Events: Additional or follow-up Information

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