Search results - Portal of Medical Data Models (MDM-Portal)

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Module 1 - Screening (Demography; Vital Signs; History of Small Cell Lung Cancer; Previous Radiotherapy for Small Cell Lung Cancer; Previous Radiotherapy for Small Cell Lung Cancer

- 4/8/21 - 1 form, 8 itemgroups, 29 items, 1 language

Itemgroups: Administrative, Demography, Vital Signs, History of Small Cell Lung Cancer, Previous Surgical Procedures for Small Cell Lung Cancer, Previous Surgical Procedures for Small Cell Lung Cancer , Previous Radiotherapy for Small Cell Lung Cancer, Previous Radiotherapy for Small Cell Lung Cancer

lung Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758 - Patient Enrollment/ Patient Eligibility - Demographics; General Medical History; Prior Therapy; History of Lymphoma

- 3/18/21 - 1 form, 13 itemgroups, 46 items, 1 language

Itemgroups: Administrative, Demographics (Enrollment), Investigator Signature, For Coulter Use Only, Demographics (General Medical History), Medical History Date, General Medical History, Prior Therapy, Prior Radiation Therapy, History of Lymphoma, Lymphoma Cell Type, Lymphoma Grade , History of Lymphoma

Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Screening - Subject Identification; Demography; Disease Characteristics; Status at Screening; Anti-Cancer Therapy; Anti-Cancer Radiotherapy; Medical Conditions

- 3/15/21 - 1 form, 12 itemgroups, 64 items, 1 language

Itemgroups: Inform Screening, Subject number, Date of Visit/ Assessment, Local Laboratories, Subject identification, Demography, Disease Characteristics, Metastatic Disease, Status at Screening, Anti-Cancer Therapy, Anti-Cancer Therapy , Medical Conditions

Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Informed Consent; Optional Translational Research and other Research; Demographics; Cutaneous Melanoma: Disease chracteristics (Annex Report 2 Final)

- 10/27/20 - 1 form, 5 itemgroups, 18 items, 1 language

Itemgroups: Administrative, Informed Consent, Optional Translational Research and other Research, Demographics, Cutaneous Melanoma: Disease chracteristics

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

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Informed Consent; Optional Translational Research and other Research; Demographics; Cutaneous Melanoma: Disease chracteristics

- 8/18/20 - 1 form, 5 itemgroups, 17 items, 1 language

Itemgroups: Administrative, Informed Consent, Optional Translational Research and other Research, Demographics, Cutaneous Melanoma: Disease chracteristics

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

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use

- 6/12/20 - 1 form, 5 itemgroups, 15 items, 1 language

Itemgroups: Administrative, Demography, Medical Conditions, Alcohol intake, History of Tobacco Use

Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Demography

- 2/14/20 - 1 form, 3 itemgroups, 15 items, 1 language

Itemgroups: Administrative data, Demography, Geographic ancestry

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the demography form. It has to be filled in for screening.

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Pregnancy Notification Form

- 11/21/18 - 1 form, 4 itemgroups, 38 items, 1 language

Itemgroups: Administrative data, Demography, Pregnancy Information, Important Note

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877 - Informed consent, demography

- 11/16/18 - 1 form, 4 itemgroups, 15 items, 1 language

Itemgroups: Administrative data, Informed consent, Demography, Demography for Females

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma 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: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the informed consent form and demography of subject. It has to be filled in for Session 1.

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