- 2021-09-20 - 1 Formulär, 16 Item-grupper, 156 Dataelement, 1 Språk
Item-grupper: Date of visit, Assessment Date, Adverse Event; Concomitant Agent; Evaluation, Repeat, Liver, Adverse Event, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Laboratory Procedures, Vital signs, Pharmacokinetic aspect, Blood, Repeat, Pulmonary function tests, Repeat, Holter Electrocardiography, Repeat, Holter Electrocardiography, Abnormality, Repeat, Telemetry, Repeat, Telemetry, Abnormality, Repeat, 12 lead ECG, Abnormality, Repeat, 12 lead ECG
- 2020-01-09 - 1 Formulär, 19 Item-grupper, 77 Dataelement, 1 Språk
Item-grupper: Administrative, Adverse Events, Adverse Event - Intensity Changes, Serious Adverse Event, Randomisation, Adverse Event - Seriousness, Relevant Concomitant/Treatment Medications, Lab Sequence Number, Relevant Diagnostic Results, Adverse Events - Rechallenge, General Narrative Comments, Possible suicidality-related adverse event - Section 1, Possible suicidality-related adverse event - Section 2, Possible suicidality-related adverse event - Section 3 , Possible suicidality-related adverse event - Section 4 , Possible suicidality-related adverse event - Section 5 , Possible suicidality-related adverse event - Section 6 , Possible suicidality-related adverse event - Section 7 , Possible suicidality-related adverse event - Section 8
- 2020-01-05 - 1 Formulär, 11 Item-grupper, 103 Dataelement, 1 Språk
Item-grupper: Date of visit, Adverse Event, Liver, Experimental drug, Liver, Pharmacokinetic aspects, Liver, Liver, Adverse Event, Disease, Liver, Adverse Event, Disease, Drug-related disorder, Liver, Adverse Event, Liver diseases, Other, Liver, Adverse Event, Disease, Other, Liver, Adverse Event, Alcohol consumption, Liver, Adverse Event, Imaging of liver, Liver, Adverse Event, Biopsy of liver
- 2019-10-30 - 1 Formulär, 24 Item-grupper, 92 Dataelement, 1 Språk
Item-grupper: Administrative, Investigational Product, Status of Treatment Blind, Consent for Pharmacogenetic Research, PGx - Blood Sample Collection (DNA), PGx - Withdrawal of Consent, PGx - Blood Sample Destruction, Concomitant Medications, Concomitant Medications , Non-Serious Adverse Events, Non-Serious Adverse Events , Serious Adverse Events, Serious Adverse Events - Section 1, Serious Adverse Events - Section 2 (Seriousness), Serious Adverse Events - Section 3 (Demography Data), Serious Adverse Events - Section 4, Serious Adverse Events - Section 5 (Possible Cause of SAE), Serious Adverse Events - Medical Conditions, Serious Adverse Events - Section 7 (Other relevant Risk Factors), Serious Adverse Events - Section 8 (Relevant Concomitant Medication), Serious Adverse Events - Section 9 (Details of Investigational Product(s)), Serious Adverse Events - Section 10 ( Details of relevant Assessments), Serious Adverse Events - Section 11 (Narrative Remarks), Serious Adverse Events - Investigator's signature
- 2019-09-23 - 1 Formulär, 18 Item-grupper, 67 Dataelement, 1 Språk
Item-grupper: Administrative , Haematology , Clinical Chemistry , Plasma Concentrations of AEDs , Adverse Experiences and Concomitant Medication, Admission Criteria, Randomisation, Compliance Record, Adverse Experiences, Adverse Experiences, Concomitant AED Medication, Concomitant AED Medication , Emergency AED Therapy used irregularly as required, Emergency AED Therapy used irregularly as required, Concomitant Medication other than AEDs, Concomitant Medication other than AEDs , Seizure Record, Atypical Absence Seizures (1 Hour Count)

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