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- 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
- 3/13/17 - 1 form, 13 itemgroups, 46 items, 1 language
Itemgroups: General Information, Section 1, Section 2 Seriousness, Section 3 Demography Data, Section 4, Section 5, Section 6 Relevant Medical Conditions, Section 7 Other RELEVANT Risk Factors, Section 8 RELEVANT Concomitant Medications, Section 9 Details of Investigation Product(s), Section 10 Details of RELEVANT Assessments, Section 11 Narrative Remarks, Investigator's signature