- 4/25/17 - 1 form, 27 itemgroups, 251 items, 1 language
Itemgroups: Subject Information, Demography, Child-bearing Potential (Complete for Female Subjects Only), Pregnancy Test (Complete for Female Subjects of Child-bearing Potential Only), Local Laboratory Result Data, Medical Conditions, Urine Drug Screen, Alcohol Test, Serology - HIV/Hepatitis Screen, Physical examination, History of tobacco use, Vital signs, 12-Lead ECG, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities: A. Rhythm, 12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology, 12-Lead ECG Abnormalities: C. Conduction, 12-Lead ECG Abnormalities: D. Myocardial Infarction, 12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T), 12-Lead ECG Abnormalities: Other Abnormalities, Local laboratory result data (haematology), Local laboratory result data - (clinical chemistry), Urinalysis, Eligibility Question, Inclusion Criteria, Exclusion Criteria, Investigator Comment Log
- 4/21/17 - 1 form, 12 itemgroups, 150 items, 1 language
Itemgroups: Subject Information, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities: A. Rhythm, 12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology, 12-Lead ECG Abnormalities: C. Conduction, 12-Lead ECG Abnormalities: D. Myocardial Infarction, 12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T), 12-Lead ECG Abnormalities: Other Abnormalities, Pharmacokinetics - Blood, Local laboratory result data (Haematology), Local laboratory result data - (Clinical Chemistry), Urinalysis
- 4/8/17 - 1 form, 9 itemgroups, 42 items, 1 language
Itemgroups: Subject information, Date of assessment, Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?, Liver events, Alcohol intake, Liver disease medical conditions, Drug related liver disease conditions (All drugs including Investigational Product), Other liver disease conditions, Other medical conditions