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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Ocular History and Risk Factors

- 12/12/20 - 1 modulo, 3 itemgroups, 17 elementi, 1 linguaggio
Itemgroups: Administrative Data, ocular history and risk factors, cataract risk factors
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, a follow-up visit, a logs and repeats visit, a PGx visit and a visit for the common CRF. 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 This form has to be filled out at the Screening Visit.

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Immune Mediated Disease Report; General Medical History; Relevant Risk Factors; Neurological Events; Myasthenia Gravis; Uveitis (Report Final and Annex Report 2 Final)

- 02/11/20 - 1 modulo, 31 itemgroups, 114 elementi, 1 linguaggio
Itemgroups: Administrative, IMD Report, General Medical History, General Medical History , Relevant risk factors, Neurological Events, Neurological Events - Signs and Symptoms, Neurological Events - Signs and Symptoms - Seizures, Neurological Events - Signs and Symptoms, Neurological Events - Other signs and symptoms, Neurological Events - Other signs and symptoms , Neurological Events - Diagnostic Test Results, Neurological Events - Other Diagnostic Test Results , Neurological Events - Other Diagnostic Test Results , Neurological Events - Other diagnostic Procedure, Myasthenia Gravis, Myasthenia Gravis - Signs and symptoms (supporting the final diagnosis), Myasthenia Gravis - Other Signs and symptoms, Myasthenia Gravis - Other Signs and symptoms , Myasthenia Gravis - Diagnostic Test Results, Myasthenia Gravis - Other Diagnostic Test Results , Myasthenia Gravis - Other Diagnostic Test Results , Myasthenia Gravis - Other diagnostic Procedure , Uveitis, Uveitis - Signs and symptoms (supporting the final diagnosis), Uveitis - Other Signs and symptoms , Uveitis - Other Signs and symptoms , Uveitis - Diagnostic Test Results , Uveitis - Other Diagnostic Test Results , Uveitis - Other Diagnostic Test Results , Uveitis - Other diagnostic Procedure
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055 - Screen - Medical / surgical procedures; Risk Factors; Vital Signs; History of Tobacco Use; Alcohol intake

- 10/01/20 - 1 modulo, 10 itemgroups, 31 elementi, 1 linguaggio
Itemgroups: Medical/ surgical procedures - Right Eye, Medical/ surgical procedures - Left Eye , Other ocular surgeries and procedures, Risk Factors, Vital Signs, First sitting BP reading, Second sitting BP reading , Third sitting BP reading , History of Tobacco Use, Alcohol intake
Study ID: 110852 Clinical Study ID: 110852 Study Title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01134055 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib eye drops, ranibizumab intravitreal injection, placebo Trade Name: pazopanib, ranibizumab Study Indication: Macular Degeneration

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Follow-UP Serious Adverse Event Form

- 30/11/18 - 1 modulo, 10 itemgroups, 61 elementi, 1 linguaggio
Itemgroups: Randomisation, Serious Adverse Event Entry, Seriousness, Relevant Concomitant/Treatment Medication, Relevant Medical Conditions/Risk Factors, Relevant Diagnosis Results, Rechallenge, Investigational Product, General narrative comments, Non Clinical
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Vaccination against pneumonia and otitis media, NCT00466947 - Medical history, Physical Examination, Risk factors, Vaccination history

- 17/10/18 - 1 modulo, 4 itemgroups, 28 elementi, 1 linguaggio
Itemgroups: Administrative data, MEDICAL HISTORY / PHYSICAL EXAMINATION, MedDRA System Organ Class, RISK FACTORS, Vaccination history
Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00466947; https://clinicaltrials.gov/ct2/show/NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains general medical history, physical examination, risk factors and vaccination history. It has to be filled in for Visit 1 for all workbooks.

GSK Study to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects 102587 - Serious Adverse Event, Relevant Concomitant Treatment/Medications/Results

- 24/04/18 - 1 modulo, 3 itemgroups, 26 elementi, 1 linguaggio
Itemgroups: Relevant concomitant/treatment medications, Relevant medical conditions/Risk factors, Relevant diagnostic results
Study ID: 102587 Clinical Study ID: EGF102587 Study Title: A Single-Dose, Open-Label, Randomized, Three-Way Cross-Over Study in Healthy Subjects to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib (GW572016) Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tykerb,Tycerb,Tyverb; Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Breast Documentation part: Serious Adverse Event, Relevant Concomitant Treatment/Medications/Results

Baseline study (T0) – Risk Factors / Sonography in angiology / Randomization VTETumor02 Prophylactic Treatment of Thromboembolism with Enoxaparin EudraCT number: 2007-002036-28 - Baseline study (T0) – Risk Factors / Sonography in angiology / Randomization

- 13/09/16 - 1 modulo, 4 itemgroups, 51 elementi, 1 linguaggio
Itemgroups: Comorbidity, risk factor Thrombosis, Ultrasonography, registration; Randomization
Study documentation part: Baseline study (T0) – Risk Factors / Sonography in angiology / Randomization, VTETumor02. This is a prospective, randomized, controlled, unicentric, open study on prophylactic treatment of thromboembolism with Enoxaparin in non-surgical oncology patients under systemic antineoplastic therapy. Principal Investigator Prof. Dr. Max E. Scheulen, Clinic and Polyclinic for Internal medicine (Tumor research), University Hospital of Essen, Germany. EudraCT number: 2007-002036-28, Version 0.6 vom 06.08.09.

Year 5 Medical & Personal History Cardiovascular Health Study (CHS)

- 25/08/16 - 1 modulo, 10 itemgroups, 330 elementi, 1 linguaggio
Itemgroups: Medical History, Medical History: Women only, Medical History: Myocardical Infarction, Medical History: Angina, Medical History: Congestive heart failure, Medical History: Intermittent claudication, Medical History: Cerebrovascular accident, Medical History: Transient ischemic attack, Medical History: Other conditions, Date of interview
Documentation part: Record 29 Year 5 Medical & Personal History The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

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