Resultados da pesquisa - Portal para modelos de dados médicos (portal MDM)

Grupos de itens: 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.

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

- 17/10/2019 - 1 Formulário, 11 Grupos de itens, 34 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Initial AE form number, Adverse Event Diagnosis, AE Start Date/Time, AE Intensity, Relationship to Study Drug, Action Taken with Study Drug, Corrective Treatment/Therapy, AE outcome, Seriousness Criteria, 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 (non-serious) adverse events, and is to be filled in as necessary during the study. An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceuticalproduct and which does not necessarily have to have a causal relationship with this treatment. An Adverse Event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratoryfinding, for example), symptoms, or disease temporally associated with the use of a medicinal product, whetheror not considered related to the medicinal product. For a given AE, if certain information (outcome, intensity etc.) is not known at the time of the initial completionof the form, this information will be completed as soon as it is known on the same form.

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Unusual Bleeding Form

- 16/09/2019 - 1 Formulário, 3 Grupos de itens, 12 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Unusual Bleeding, Bleeding AE form Numbers

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 unusual bleeding events and is to be filled in as appropriate during the study.

Endpoint revascularisation GSK study Chronic Coronary Heart Disease NCT00799903

- 05/01/2018 - 1 Formulário, 3 Grupos de itens, 52 Elementos de dados, 1 Idioma

Grupos de itens: Coronary revascularisation, Urgent coronary revascularisation for myocardial ischemia, CEC Status

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Endpoint revascularisation - Repeating form (Scheduled visits)

RTOG-0525 AE: Adverse Event Evaluation Form NCT00304031

- 08/07/2015 - 1 Formulário, 2 Grupos de itens, 20 Elementos de dados, 1 Idioma

Grupos de itens: RTOG clinical trial administrative data, REPORT ALL CONTINUING OR NEW ADVERSE EVENTS

RTOG-0525 AE: Adverse Event Evaluation Form NCT00304031 Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FD9B3E8E-5C94-635F-E034-0003BA3F9857

AMC-061 Adverse Events Form (ADV) NCT00890747

- 16/06/2015 - 1 Formulário, 2 Grupos de itens, 19 Elementos de dados, 1 Idioma

Grupos de itens: Adverse Event Information, Comments

AMC-061 Adverse Events Form (ADV) NCT00890747 Sunitinib Malate in Treating HIV-Positive Patients With Cancer Undergoing Highly Active Antiretroviral Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=71988CF7-F8CE-68F0-E040-BB89AD4358A1

Event Monitoring Form N0577

- 09/01/2015 - 1 Formulário, 7 Grupos de itens, 32 Elementos de dados, 1 Idioma

Grupos de itens: Header Module, VITAL STATUS, Disease Follow-up Status, Notice of First Relapse/Progression in the Event Monitoring Phase, Notice of First Subsequent Treatment, Notice of New Primary, Late Adverse Events

North Central Cancer Treatment Group N0577 Event Monitoring Form Radiation Therapy or Radiation Therapy and Temozolomide or Temozolomide Alone in Treating Patients With Newly Diagnosed Anaplastic Glioma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C090D31-BB06-2FAA-E044-0003BA3F9857

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Modelos de dados selecionados

Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [Day 7 post-Op]

Outcome event death/SAE Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [Outcome event death/SAE]

Toxicity - Brain Cancer - Adverse Event Form - 2263172v3.0 - Brain Cancer - Adverse Event Form

Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619 - Adverse Event Form

Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619 - SAE Complementary Information Form

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