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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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- 10/30/19 - 1 form, 19 itemgroups, 82 items, 1 language
Itemgroups: Administrative,Visit Date,Was a physical examination performed?,Physical Examination,Vital Signs,12-Lead ECG,ECG Results,ECG Findings,Hematology,Hematology ,Clinical Chemistry, Coagulation and Electrolytes,Clinical Chemistry, Coagulation and Electrolytes ,Urinalysis dipstick results,Urinalysis microscopy results,Urinalysis microscopy results ,Serum beta-hCG Pregnancy Test,PK Sampling - Plasma Samples,Study Treatment Compliance (Return) ,New Adverse Events and Concomitant Treatment
- 10/26/19 - 1 form, 12 itemgroups, 61 items, 1 language
Itemgroups: Administrative Data,Liver Event Seriousness,Notification Liver,Liver Chemistry reaching stopping criteria,Liver Events Clinical,Investigational Product Liver,Pharmakokinetics Liver,Liver disease medical conditions,Drug related liver disease conditions,Other Liver Disease,Other medical conditions,Alcohol Intake at Onset of Liver Event
Study ID: 110951 Clinical Study ID: 110951 Study Title: A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of intravenously infused GSK1995057 in healthy subjects. Patient Level Data: Study Listed on Identifier: NCT01476046 See Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: N/A, Placebo Trade Name: N/A Study Indication: Respiratory Disorders The single-centre study consists of two parts A and B with seven cohorts/ten subcohorts in total. Part A includes ascending doses of the investigational product given to subjects negative or positive for pre-existing human anti-heavy chain variable domain (HAVH) antibodies (Cohorts 1 to 3 with Subcohorts 1a, 2a and 3a negative for HAVH and 1b, 2b, 3b positive for HAVH). Part B includes only subjects negative for HAVH, with ascending doses given to Cohorts 4 to 6. Cohort 7 receives the same dose as Cohort 6, but whereas the other Cohorts are single-blinded, Cohort 7 is open-label and additionally receives a bronchoalveolar lavage (BAL). The study consists of a Screening Visit (up to 56 days before Day 1, the day of the drug administration), Visits on Day -1, 1, 2, 3, 5, 7, 14, 28 and Follow-Up Visits on Day 57 and 85. This form contains general information on any Liver Event happening during the study, including whether and when a pharmacokinetic sample has been obtained as well as information on the subject's general and liver-related medical conditions and alcohol intake. There are seperate forms for Imaging and Biopsy in case of a Liver Event.

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