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Meningococcal Infections Vaccination in children NCT00196976 - Diary Card Part 2 Vaccination 2 3-5 years of age

- 08.11.17 - 1 Formular, 7 Itemgruppen, 64 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Fever, Irritability, Drowsiness, Loss of appetite, Other general symptoms, Medication

Study ID: 103533 Clinical Study ID: 103533 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Concomitant Medication

- 06.11.17 - 1 Formular, 1 Itemgruppe, 7 Datenelemente, 1 Sprache

Itemgruppe: Concomitant Medication

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) 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: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Concomitant Medication (Follow-Up)

Meningococcal Infections Vaccination in children NCT00196976 - Diary Card Part 2 Vaccination 1 12-14 months of age

- 03.11.17 - 1 Formular, 8 Itemgruppen, 66 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, Fever, Irritability, Drowsiness, Loss of appetite, Other general symptoms, Medication

Study ID: 103533 Clinical Study ID: 103533 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal

Meningococcal Infections Vaccination in children NCT00196976 - Diary Card Part 2 Vaccination 2 12-14 months of age

- 03.11.17 - 1 Formular, 8 Itemgruppen, 66 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, Fever, Irritability, Drowsiness, Loss of appetite, Other general symptoms, Medication

Study ID: 103533 Clinical Study ID: 103533 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal

Meningococcal Infections Vaccination in children NCT00196976 - Workbook 2 Other medical information

- 03.11.17 - 1 Formular, 5 Itemgruppen, 16 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Concomitant Vaccination, Concomitant Vaccination, Medication, Medication

Study ID: 103533 Clinical Study ID: 103533 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal

Meningococcal Infections Vaccination in children NCT00196976 - Workbook 1 Other medical information

- 03.11.17 - 1 Formular, 5 Itemgruppen, 15 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Concomitant Vaccination, Concomitant Vaccination, Medication, Medication

Study ID: 103533 Clinical Study ID: 103533 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Screening

- 03.11.17 - 1 Formular, 1 Itemgruppe, 6 Datenelemente, 1 Sprache

Itemgruppe: Concomitant Medication

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) 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: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Screening

Pharmacokinetics of a new unmarketed formulation of ropinirole Follow-up 101468/199 - Follow-up

- 27.10.17 - 1 Formular, 10 Itemgruppen, 92 Datenelemente, 1 Sprache

Itemgruppen: Pregnancy test, Physical examination, 12-lead ECG, Vital signs, Laboratory Result Data Haematology, Laboratory Result Data Clinical Chemistry, Urinalysis, Dipstick Test, Status of Treatment Blind, Investigational Product Discontinuation - Ropinirole, Concomitant Medications

Study ID: 101468/199 Clinical Study ID: 101468/199 Study Title: An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome Documentation part (Visit Description): Follow-up

L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 2 Visit 5 Month 3

- 24.10.17 - 1 Formular, 13 Itemgruppen, 52 Datenelemente, 1 Sprache

Itemgruppen: General information, Flexible Dose Start Date and Current Dose Level, Vital signs, Concomitant Medication, Adverse Experiences, Study Medication Compliance, Concomitant medication, Details of Concomitant Medication, Levodopa rescue, Details of Ledopa Rescue Therapy, Adverse Experiences, Details on adverse experiences, Patient Continuation/Withdrawal

Study ID: 101468/125 Clinical Study ID: SKF-101468/125 Study Title: A double-blind, multicentre, flexible dose, L-dopa controlled study of ropinirole to investigate A) neuroprotective effect as measured by 3D PET scanning, and B) ophthalmological safety, in patients with early Parkinson’s disease 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: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Concomitant Medication

- 23.10.17 - 1 Formular, 3 Itemgruppen, 10 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Concomitant Medication, CONCOMITANT MEDICATION

Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

concomitant medication Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 18.10.17 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache

Itemgruppen: administrative data, concomitant medication, concomitant medication

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

Follow-Up GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18.10.17 - 1 Formular, 8 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: General Information, RLS RATING SCALE, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, LABORATORY EVALUATION, URINE DIPSTICK

Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). 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: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the mandatory 7 day follow-up assessment form.

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