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HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Concomitant Medications

- 12.07.19 - 1 Formular, 2 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Concomitant Agent
Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Concomitant Medication

- 03.07.19 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Concomitant Agent
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Concomitant Medication

- 03.07.19 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Concomitant Agent
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - Concomitant Medication

- 03.07.19 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Concomitant Agent
Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Diary Card - Dose 1

- 21.06.19 - 1 Formular, 17 Itemgruppen, 139 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, General symptom, Vaccination, General symptom, Other, Pharmaceutical Preparations
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Diary Card - Dose 2

- 21.06.19 - 1 Formular, 17 Itemgruppen, 139 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, General symptom, Vaccination, General symptom, Other, Pharmaceutical Preparations
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Diary Card - Dose 3

- 21.06.19 - 1 Formular, 17 Itemgruppen, 139 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, General symptom, Vaccination, General symptom, Other, Pharmaceutical Preparations
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503 - Concomitant Medications; Non-Serious Adverse Events; Serious Adverse Events

- 20.06.19 - 1 Formular, 19 Itemgruppen, 70 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Concomitant Medications, Concomitant Medications, Non-Serious Adverse Events, Non-Serious Adverse Events , Serious Adverse Event, Serious Adverse Event - Section 1, Serious Adverse Event - Section 2 Seriousness, Serious Adverse Event - Section 3 Demography Data, Serious Adverse Event - Section 4, Serious Adverse Event - Section 5, Serious Adverse Event - Section 6 Medical Conditions, Serious Adverse Event - Section 7, Serious Adverse Event - Section 8 Relevant Concomitant Medication, Serious Adverse Event - Section 9, Was treatment blind broken at investigational site?, Serious Adverse Event - Section 10, Serious Adverse Event - Section 11, Serious Adverse Event - lnvestigator's signature
Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia

Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039 - Medication - Final Analysis

- 14.06.19 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Medication, Medication details
Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria This study (Malaria-039 / NCT00323622 / GlaxoSmithKline Study ID 104297) is a two-year follow-up to Malaria-026 and consists of three clinic visits: Visit 1 / Informed Consent Visit at Visit 7 of Malaria-026 (i.e. 21 months post vaccine dose 1 in Malaria-026). Visit 2 / Interim Analysis 12 months +/- 1 month after Visit 1. Visit 3 / Final Analysis 24 months +/- 1 month after Visit 1. See https://clinicaltrials.gov/ct2/show/NCT00323622 This form is to be completed at Visit 3.

Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039 - Medication - Interim Analysis

- 12.06.19 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Medication, Medication details
Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria This study (Malaria-039 / NCT00323622 / GlaxoSmithKline Study ID 104297) is a two-year follow-up to Malaria-026 and consists of three clinic visits: Visit 1 / Informed Consent Visit at Visit 7 of Malaria-026 (i.e. 21 months post vaccine dose 1 in Malaria-026). Visit 2 / Interim Analysis 12 months +/- 1 month after Visit 1. Visit 3 / Final Analysis 24 months +/- 1 month after Visit 1. See https://clinicaltrials.gov/ct2/show/NCT00323622 This form is to be completed at Visit 2.

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Concomitant Vaccination

- 26.05.19 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: Administrative Documentation, Concomitant Agent, Vaccination
Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 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 Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463 - Concomitant Vaccination

- 26.05.19 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: Administrative Documentation, Concomitant Agent, Vaccination
Study ID: 105910 Clinical Study ID: 105910 Study Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00320463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: DTPa-HBV-IPV/Hib vaccine Trade Name: N/A Study Indication: Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

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