Zoekresultaten - Portaal voor medische datamodellen (MDM-portaal)

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Concomitant Medication; Adverse Experiences (Non-serious); Course Conclusion

- 27-04-21 - 1 Formulier, 7 Itemgroepen, 31 Data-elementen, 1 Taal

Itemgroepen: Administrative, Concomitant Medication, Adverse Experiences (Non-serious), Adverse Experiences (Non-serious), Investigator's Signature (Adverse Experience), Course Conclusion, Investigator's Signature (Study Conclusion)

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

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Pre-Next Course: Serious Adverse Experiences; Vital Signs; 12-Lead ECG

- 27-04-21 - 1 Formulier, 4 Itemgroepen, 14 Data-elementen, 1 Taal

Itemgroepen: Administrative, Serious Adverse Experiences, Vital Signs , 12-Lead Electrocardiogram

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

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Log

- 26-04-21 - 1 Formulier, 9 Itemgroepen, 117 Data-elementen, 1 Taal

Itemgroepen: Date of visit, Assessment Date, Event Log, Status, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Concomitant Agent, Adrenal Cortex Hormones, Blood product; Supportive care, Collection of blood specimen for laboratory procedure, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Informed Consent, Withdraw (activity)

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Anal Cancer NCT00324415 Toxicity - AMC-045 Type III Adverse Event Reporting Form (TAE) - 2516535v1.0 - AMC-045 Type III Adverse Event Reporting Form (TAE)

- 13-04-21 - 1 Formulier, 3 Itemgroepen, 7 Data-elementen, 1 Taal

Itemgroepen: Administrative, Severe Adverse Event (Grade 3), Comments

AMC-045 Type III Adverse Event Reporting Form (TAE) Cisplatin, Fluorouracil, Cetuximab, and Radiation Therapy in Treating Patients With HIV and Stage I, Stage II, or Stage III Anal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1C146B28-823F-583B-E044-0003BA3F9857

Quality assurance Follow-up Heart Transplant (AQUA) - Quality assurance Follow-up Heart Transplant (AQUA)

- 13-04-21 - 1 Formulier, 3 Itemgroepen, 23 Data-elementen, 2 Talen

Itemgroepen: Follow-up(auszufüllen nach 1, 2 und 3 Jahren), Überlebensstatus des Empfängers, Gegenwärtige Immunsuppression

Documentation form for quality assurance in German Health Care by the Institute for Applied Quality Improvement and Research in Health Care (Aqua), https://www.aqua-institut.de/en/home. Internal Aqua form version: HTXFU Specification 2015 V02

Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758 - Infection Summary; Concomitant Medications and Transfusions; Adverse Experiences

- 29-03-21 - 1 Formulier, 9 Itemgroepen, 48 Data-elementen, 1 Taal

Itemgroepen: Administrative, Infection Summary, Infection Summary - Culture information, Infection Summary - Anti-infective, Infection Summary - Anti-infective , Concomitant Medications and Transfusions, Adverse Experiences, Adverse Experiences, Adverse Experiences - Investigator Signature

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

End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 15-03-21 - 1 Formulier, 4 Itemgroepen, 32 Data-elementen, 2 Talen

Itemgroepen: Medications, Adverse Events, Transfusion history during the entry study, Conclusion of the Study and Termination

Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

SAE documentation AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - SAE documentation AIEOP-BFM ALL 2009 NCT01117441

- 15-03-21 - 1 Formulier, 4 Itemgroepen, 39 Data-elementen, 1 Taal

Itemgroepen: Patient Information, Therapy, Severe adverse event, Identification and Signature

Study Description Stamm: International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Documentation. Clinical Trial Number: NCT01117441.

inital & follow-up report serious adverse events starting dose of ropinirole Parkinson's Disease 101468/166

- 15-03-21 - 1 Formulier, 6 Itemgroepen, 32 Data-elementen, 1 Taal

Itemgroepen: time of documentation, patient information, adverse event, study drug, patient information, principal investigator

Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Concomitant Medications and Transfusions and Adverse Experiences

- 15-03-21 - 1 Formulier, 5 Itemgroepen, 27 Data-elementen, 1 Taal

Itemgroepen: Administrative, Concomitant Medications and Transfusions, Adverse event, Adverse event, Investigator Signature

Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Serious Adverse Event

- 15-03-21 - 1 Formulier, 10 Itemgroepen, 29 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Demographic Information, Description, Study Drug, Hospitalization, Death, Previous and Concomitant Medication, Medical History and Concomitant Disease, SAE Follow-Up Information, Investigator & Monitor

Study ID: 103414 Clinical Study ID: 103414 Study Title: A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal surgery Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00038961 https://clinicaltrials.gov/ct2/show/NCT00038961 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Fondaparinux Sodium Trade Name: Fondaparinux Sodium Study Indication: Thrombosis This phase III placebo-controlled trial studies the efficacy and safety of Fondaparinux as an additional prevention measure of venous thromboembolic events (VTE) in patients above the age of 40 with intermediate or high VTE risk undergoing abdominal surgery. The study consists of a Screening Visit (Visit 0), the baseline visit on Day 1, the day of the surgery (Visit 1), the treatment period (denoted in its entirety as Visit 2) consisting of administration of Fondaparinux (2.5mg subcutaneously once daily) or placebo starting on Day 1 and continuing at least up to Day 5, possibly up to Day 9, in parallel to intermittent pneumatic compression and possibly elastic stockings, followed by a mandatory bilateral venography no longer than 24 hours after study drug cessation, and finally a Follow-up Visit (Visit 3) on Day 30 +/- 2. This form contains information on serious adverse events, and is to be filled in as necessary during the study, in addition to the AE form, and consists of a complimentary part and a follow-up part.

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Logs and Repeats - Logs and Repeats; Non-Serious Adverse Events; Serious Adverse Events

- 09-03-21 - 1 Formulier, 13 Itemgroepen, 87 Data-elementen, 1 Taal

Itemgroepen: Logs and Repeats - Date of visit/assessment, Logs and Repeats - Adverse Event/Concomitant Medication/Repeat Assessment Check Questions, Non-Serious Adverse Event, Serious Adverse Event - Type of Report, Serious Adverse Event - Randomisation, Serious Adverse Event, Serious Adverse Event - Serious, Serious Adverse Event - Relevant Concomitant/Treatment Medications, Serious Adverse Event - Relevant Medical Conditions/Risk Factors, Serious Adverse Event - Relevant Diagnostic Results, Serious Adverse Event - Investigational Products, Serious Adverse Event - General Narrative Comments, Serious Adverse Event - No clinical

Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

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