Pregnancy ×
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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
Selected data models

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- 9/30/20 - 1 form, 2 itemgroups, 54 items, 1 language
Itemgroups: Instructions, Belief
- 6/6/20 - 1 form, 14 itemgroups, 167 items, 1 language
Itemgroups: Date of visit, Vital signs, 12 lead ECG, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Urinalysis, Laboratory Procedures, Hormones, Laboratory Procedures, Free Testosterone Measurement, Laboratory Procedures, Prolactin measurement, Nervous system structure, Evaluation, Ophthalmic examination and evaluation, Blinded Clinical Study, Status, Pregnancy, Information, Conclusion, Clinical Research
- 5/26/20 - 1 form, 6 itemgroups, 45 items, 1 language
Itemgroups: Administrative Data, Mother's relevant medical/family history, Father's Relevant Medical/Family History, Drug Exposures, Subject withdrawal, Reporting Investigator Information
Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Pregnancy Notification Form is used to report pregnancy to GSK in specific cases specified by the Protocol. This form should be completed according to the protocol reporting requirements. Complete this form for each subject or subject’s partner who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. Original pages should remain with the subject’s Case Report Form. Note: This form does not routinely need to be completed for subject’s partner pregnancy unless there is specific instruction to do so stated in the protocol.