Keywords
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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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- 9/20/21 - 1 form, 3 itemgroups, 17 items, 1 language
Itemgroups: Administrative Data, Adverse Event/Concomitant Medication/Unscheduled Assessment, 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 ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01476046 See https://clinicaltrials.gov/ct2/show/NCT01476046 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 This phase I trial primarily studies the safety and tolerability of ascending single intravenous doses of the selective TNFR1 antagonist GSK1995057 in healthy volunteers, and secondly explores the drug's pharmacodynamics, pharmacokinetics, concentration in lung epithelial lining fluid as well as its effect on immune system markers. The drug is hypothesized to be useful for Acute Lung Injury. 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 is to be filled in at the end of the study (regular follow-up or study discontinuation) and lists whether any repeated/additional investigations were performed and/or whether certain events occured in the participant, such as (Non-)Serious Adverse Events. Details about the investigations/events are recorded in different forms.
- 9/20/21 - 1 form, 33 itemgroups, 103 items, 1 language
Itemgroups: Default Itemgroup, 1. Beginning of interview, 2. Presence of Others, who might interfere, 3. Fill, if Interview has to be cancelled, 4. Reason for canceling of interview, 5. Family, 6. Current living situation, 7. Statutory supervisor, 8. Help with household through Family and Friends, 9. Do Friends and Family help with Nursing? If so, who?, 10. Do you get other help through friends and family?, 11. Would you describe one of them as your, 12. Frequency of being supported by that, 13. Description of Relationship with that person, 14. Aids, 15. Change of health insurance, 16. Additional private Health insurance, 17. Changes about care dependency, 18. Care level, 19. Is a new care level classification planned?, 20. If yes, status of classification, 21. Main service of health insurance, 22. Changes / adjustments in living circumstances, 23. Changes in living circumstances, 24. Purchaser, 25. Are changes planned?, 26. Status, 27. Frequency of leaving the house, 28. Way of attending doctor´s appointments, 29. Type of transportation in case of regular doctor´s appointments, 30. Contact to Others, 31. Interests and Hobbies, 32. Most important interests
- 9/20/21 - 1 form, 9 itemgroups, 24 items, 1 language
Itemgroups: General Information, 1. Over the past two weeks, how bothered have you been by..., 2. Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)?, 3. Over the past past two weeks, how dissatisfied or satisfied have you been with the ability of your diabetes medication(s) to...., 4. Overall, over the past two weeks, how dissatisfied or satisfied have you been with...., 5. Thinking about your diabetes medication(s) over the past two weeks...., 6. Over the past two weeks, how often has taking your diabetes medication(s) as prescribed interfered with your ability to..., 7. Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how dissatisfied or satisfied have you been with ...., 8. Overall, based on your current experiences with your diabetes medications...
- 9/20/21 - 1 form, 9 itemgroups, 24 items, 1 language
Itemgroups: General Information, 1. Over the past two weeks, how bothered have you been by..., 2. Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)?, 3. Over the past past two weeks, how dissatisfied or satisfied have you been with the ability of your diabetes medication(s) to...., 4. Overall, over the past two weeks, how dissatisfied or satisfied have you been with...., 5. Thinking about your diabetes medication(s) over the past two weeks...., 6. Over the past two weeks, how often has taking your diabetes medication(s) as prescribed interfered with your ability to..., 7. Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how dissatisfied or satisfied have you been with ...., 8. Overall, based on your current experiences with your diabetes medications...
- 9/20/21 - 1 form, 9 itemgroups, 24 items, 1 language
Itemgroups: General Information, 1. Over the past two weeks, how bothered have you been by..., 2. Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)?, 3. Over the past past two weeks, how dissatisfied or satisfied have you been with the ability of your diabetes medication(s) to...., 4. Overall, over the past two weeks, how dissatisfied or satisfied have you been with...., 5. Thinking about your diabetes medication(s) over the past two weeks...., 6. Over the past two weeks, how often has taking your diabetes medication(s) as prescribed interfered with your ability to..., 7. Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how dissatisfied or satisfied have you been with ...., 8. Overall, based on your current experiences with your diabetes medications...
- 9/20/21 - 1 form, 22 itemgroups, 159 items, 1 language
Itemgroups: Header Module, Eligibility Screening Form, Randomization, Informed Consent, Header, Vital signs and physical measurements, ECG, LVEF, HER2/neu status (local lab), Central Laboratory, Hormonal receptor status, History of primary breast cancer, Hematology and Biochemistry, History of primary cancer (continued), Sentinel nodes sampling, Primary breast cancer surgery, Axillary node dissection, Prior neo-/adjuvant chemotherapy for primary breast cancer, Previous or current cardiovascular disease, Previous or current diseases other than primary breast and cardiovascular diseases, Radiological examination, Translational Research (Appendix 5)