- 11/15/19 - 1 form, 18 itemgroups, 72 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 Possible Causes of SAE Other Than Investigational Product(s),Serious Adverse Event - Section 6 Relevant medical Conditions,Serious Adverse Event - Section 7 Other relevant Risk Factors,Serious Adverse Event - Section 8 Relevant Concomitant Medications,Serious Adverse Event - Section 9 Details of Investigational Product(s),Serious Adverse Event - Section 10 Details of relevant Assessments,Serious Adverse Event - Section 11 Narrative Remarks,Investigator's signature

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