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Multiple Myeloma and Plasma Cell Neoplasm NCT00522392 Eligibility - E1A05 Registration Worksheet (step 1) - 2948474v1.0 - E1A05 Registration Worksheet (step 1)

- 17/09/2021 - 1 Formulário, 3 Grupos de itens, 26 Elementos de dados, 1 Idioma
Grupos de itens: Eligibility, Demographic Data Required For Patient Registration, I have reviewed the above data and agree the date are accurate and correct
E1A05 Registration Worksheet (step 1) Bortezomib and Dexamethasone With or Without Lenalidomide in Treating Patients With Multiple Myeloma Previously Treated With Dexamethasone Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=74CCB3AB-1EF3-A75A-E040-BB89AD431F27

Multiple Myeloma and Plasma Cell Neoplasm NCT00602641 Eligibility - E1A06 Registration Worksheet (Step 1) - 2762148v1.0 - E1A06 Registration Worksheet (Step 1)

- 17/09/2021 - 1 Formulário, 3 Grupos de itens, 27 Elementos de dados, 1 Idioma
Grupos de itens: Eligibility, Demographic Data Required For Patient Registration, I have reviewed the above data and agree the date are accurate and correct
E1A06 Registration Worksheet (Step 1) Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=510B294D-430D-4275-E044-0003BA3F9857

Multiple Myeloma and Plasma Cell Neoplasm NCT00644228 Registration - Southwest Oncology Group S0777 Registration Worksheet - Not for OPEN - 2697089v1.0 - Southwest Oncology Group S0777 Registration Worksheet - Not for OPEN

- 17/09/2021 - 1 Formulário, 10 Grupos de itens, 45 Elementos de dados, 1 Idioma
Grupos de itens: Protocol Information, For SWOG Institutions:, For Non-SWOG Institutions:, Patient Information, Race, Demographic Information, Stratification Questions, Indicate how the patient answered the following questions on the consent form, Patient Eligibility, Comments (notes from Confirmation of Registration):
Southwest Oncology Group S0777 Registration Worksheet - Not for OPEN Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3EFCA54F-811F-2D21-E044-0003BA3F9857

EBMT Multiple Myeloma - 16pp EBMT Multiple Myeloma 10PCD

- 10/04/2021 - 1 Formulário, 19 Grupos de itens, 214 Elementos de dados, 1 Idioma
Grupos de itens: GENERAL INFORMATION, PATIENT, DISEASE, PLASMA CELL DISORDERS (INCLUDING MULTIPLE MYELOMA), PRE-HSCT TREATMENT, HSCT, STATUS OF DISEASE AT COLLECTION, DISEASE STATUS AT HSCT, ADDITIONAL TREATMENT POST-HSCT, STATUS OF DISEASE AT 100 DAYS AFTER HSCT, FORMS TO BE FILLED IN, PLASMA CELL DISORDERS (INCLUDING MULTIPLE MYELOMA), PATIENT LAST SEEN, GRAFT VERSUS HOST DISEASE (GvHD) SINCE LAST REPORT, OTHER COMPLICATIONS SINCE LAST REPORT, ADDITIONAL THERAPIES SINCE LAST FOLLOW UP, FIRST EVIDENCE OF RELAPSE OR PROGRESSION SINCE LAST HSCT, LAST DISEASE AND PATIENT STATUS, ADDITIONAL NOTES IF APPLICABLE
Bacteria:S. pneumoniae, Other gram positive (i.e.: other streptococci, staphylococci, listeria …), Haemophilus influenzae, Other gram negative (i.e.: E. coli klebsiella, proteus, serratia, pseudomonas …), Legionella sp, Mycobacteria sp, Other Fungi: Candida sp, Aspergillus sp, Pneumocystis carinii, Other Parasites: Toxoplasma gondii, Other Viruses: HSV, VZV, EBV,CMV, HHV-6,RSV, Other respiratory virus (influenza, parainfluenza, rhinovirus), Adenovirus, HBV, HCV, HIV, Papovavirus, Parvovirus,Other

EBMT PLASMA CELL DISORDERS (INCLUDING MULTIPLE MYELOMA)

- 10/04/2021 - 1 Formulário, 8 Grupos de itens, 91 Elementos de dados, 1 Idioma
Grupos de itens: PLASMA CELL DISORDERS (INCLUDING MULTIPLE MYELOMA), PATIENT LAST SEEN, GRAFT VERSUS HOST DISEASE (GvHD) SINCE LAST REPORT, OTHER COMPLICATIONS SINCE LAST REPORT, ADDITIONAL THERAPIES SINCE LAST FOLLOW UP, FIRST EVIDENCE OF RELAPSE OR PROGRESSION SINCE LAST HSCT, LAST DISEASE AND PATIENT STATUS, ADDITIONAL NOTES IF APPLICABLE
Bacteria:S. pneumoniae, Other gram positive (i.e.: other streptococci, staphylococci, listeria …), Haemophilus influenzae, Other gram negative (i.e.: E. coli klebsiella, proteus, serratia, pseudomonas …), Legionella sp, Mycobacteria sp, Other Fungi: Candida sp, Aspergillus sp, Pneumocystis carinii, Other Parasites: Toxoplasma gondii, Other Viruses: HSV, VZV, EBV,CMV, HHV-6,RSV, Other respiratory virus (influenza, parainfluenza, rhinovirus), Adenovirus, HBV, HCV, HIV, Papovavirus, Parvovirus,Other

Eligibility Multiple Myeloma NCT01177683

- 22/01/2021 - 1 Formulário, 2 Grupos de itens, 14 Elementos de dados, 1 Idioma
Grupos de itens: Inclusion Criteria, Exclusion Criteria
Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01177683

Eligibility Multiple Myeloma NCT02248428

- 26/10/2020 - 1 Formulário, 2 Grupos de itens, 13 Elementos de dados, 1 Idioma
Grupos de itens: Inclusion Criteria, Exclusion Criteria
Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02248428

Eligibility Multiple Myeloma NCT01241708

- 05/10/2020 - 1 Formulário, 2 Grupos de itens, 10 Elementos de dados, 1 Idioma
Grupos de itens: Inclusion Criteria, Exclusion Criteria
Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01241708

Eligibility High-risk Smoldering Multiple Myeloma NCT01484275

- 07/06/2020 - 1 Formulário, 2 Grupos de itens, 12 Elementos de dados, 1 Idioma
Grupos de itens: Inclusion Criteria, Exclusion Criteria
A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01484275

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Cycle 2 Day 1 - Vital Signs; SRT501 Administration; Study Treatment Compliance (Issue); New Adverse Events and Concomitant Treatment

- 30/10/2019 - 1 Formulário, 6 Grupos de itens, 21 Elementos de dados, 1 Idioma
Grupos de itens: Administrative, Visit Date, Vital Signs, SRT501 Administration, Study Treatment Compliance (Issue), New Adverse Events and Concomitant Treatment
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - SRT501, Monotherapy, Cycle__ Day 1 - Visit Date; Vital Signs; SRT501 Administration; Study Treatment Compliance (Issue); New Adverse Events and Concomitant Treatment

- 30/10/2019 - 1 Formulário, 6 Grupos de itens, 21 Elementos de dados, 1 Idioma
Grupos de itens: Administrative, Visit Date, Vital Signs, SRT501 Administration, Study Treatment Compliance (Issue), New Adverse Events and Concomitant Treatment
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Cycle 1 Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 30/10/2019 - 1 Formulário, 19 Grupos de itens, 82 Elementos de dados, 1 Idioma
Grupos de itens: Administrative, Visit Date, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Results, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, PK Sampling - Plasma Samples, Study Treatment Compliance (Return) , New Adverse Events and Concomitant Treatment
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

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