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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    1. 1.2. Medical History
    1. 1.3. Physical Examination
    1. 1.4. Assessment Score
    1. 1.5. Apparative Diagnostics
    1. 1.6. Laboratory
    1. 1.7. Pathology/Histology
    1. 1.8. Consent
    1. 1.9. Therapy
    1. 1.10. Operative Report
    1. 1.11. Adverse Event
    1. 1.12. Follow-Up
  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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SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 6/8/17 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: Patient administration, SUBJECT ELIGIBILITY, Eligibility Criteria Not Met
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

Eligibility Hepatocellular Carcinoma NCT02149771

- 9/20/21 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Combination Treatment for Advanced Liver Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02149771

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Eligibility Criteria

- 9/20/21 - 1 form, 4 itemgroups, 40 items, 1 language
Itemgroups: Administrative Data, Eligibility Question, Inclusion Criteria, Exclusion Criteria
This ODM-file contains the eligibility criteria. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Eligibility Acute Myeloid Leukemia NCT02034227

- 9/20/21 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Safety, Tolerability Study of SG2000 in the Treatment of Advanced Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia; ODM derived from: http://clinicaltrials.gov/show/NCT02034227

Eligibility Pulmonary Arterial Hypertension NCT01841762

- 6/23/21 - 1 form, 2 itemgroups, 28 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
SYMPHONY: A Study of Macitentan in Pulmonary Arterial Hypertension to Validate the PAH-SYMPACT; ODM derived from: https://clinicaltrials.gov/show/NCT01841762

Eligibility Type 2 Diabetes Glycemia-Lowering Medication NCT01794143

- 6/23/21 - 1 form, 2 itemgroups, 36 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01794143

Eligibility Type 2 Diabetes Weight Loss NCT01601574

- 6/23/21 - 1 form, 2 itemgroups, 39 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Weight Loss Study for People With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01601574

Eligibility Posttraumatic Stress Disorders Multiple Sclerosis NCT01743664

- 6/15/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
The Efficacy of EMDR in Patients With PTSD in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01743664

Eligibility Polyarticular-course Juvenile Idiopathic Arthritis (JIA) NCT01550003

- 1/22/21 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Pediatric Arthritis Study of Certolizumab Pegol; ODM derived from: https://clinicaltrials.gov/show/NCT01550003

Eligibility Rheumatoid Arthritis NCT01197534

- 1/22/21 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.; ODM derived from: https://clinicaltrials.gov/show/NCT01197534

Eligibility Oral Mucositis NCT01265810

- 1/21/21 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
The objective is to assess the relieving effect of Caphosol® oral rinse on clinical outcomes which include oral intake, swallowing function and pain associated with incidence of grade ≥ 1 oral side effects and the anticancer therapy cessation in patients treated with selected targeted anticancer therapy.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Eligibility Criteria

- 12/4/20 - 1 form, 4 itemgroups, 40 items, 1 language
Itemgroups: Administrative Data, Eligibility Question, Inclusion Criteria, Exclusion Criteria
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia To assess any further potential impact on subject eligibility with regard to safety, the investigator must refer to the study document(s) for detailed information regarding warnings, precautions, contraindications, adverse events, and other significant data pertaining to the investigational product(s) being used in this study, please refer to the Clinical Investigator Brochure for more detailed information [GSK Document Number UM2005/00217/00]. This form has to be filled out at the Screening Visit.

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