- 3/25/20 - 1 form, 14 itemgroups, 102 items, 1 language
Itemgroups: Log Status, Non-Serious Adverse Event, Serious Adverse Event - Type of Report, Serious Adverse Event - Randomisation, Serious Adverse Event, Serious Adverse Event - Seriousness, Serious Adverse Event - Relevant Concomitant/ Treatment Medications, Serious Adverse Event - Relevant Medical Conditions/Risk Factors, Serious Adverse Event - Relevant Diagnostic Results, Serious Adverse Event - Rechallenge, Serious Adverse Event - Investigational Product Double Blind Phase, Serious Adverse Event - Investigational Product Open Label Phase, Serious Adverse Event - General Narrative Comments, Serious Adverse Event - Non Clinical
- 5/1/19 - 1 form, 16 itemgroups, 137 items, 1 language
Itemgroups: Logs ad Repeats, Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions, Non-serious Adverse Event (AE), Serious Adverse Events (SAE), Serious Adverse Event - Concomitant Medication, Serious Adverse Event - Medical Conditions/ Risk Factors, Serious Adverse Events - Relevant diagnostic results, Serious Adverse Events - Investigational Products, Serious Adverse Events - General narrative comments, Serious Adverse Events - Non clinical, Concomitant Medication, Electronically Transferred Lab Data, Vital signs, 12-Lead ECG, ECG Abnormalities, Repeat Pharmacokinetics Blood - GW856553