- 15/11/19 - 1 modulo, 18 itemgroups, 72 elementi, 1 linguaggio
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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