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Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Screening - Toxicities Related to Previous Radiotherapy for SCLC; 12-Lead Electrocardiogram; Diagnostic Studies for Tumor Assessment; Ongoing Medical Conditions Associated with SCLC; Significant Medical/Surgical History and Physical Examination

- 17-04-21 - 1 Formulier, 9 Itemgroepen, 20 Data-elementen, 1 Taal
Itemgroepen: Administrative, Toxicities related to previous Radiotherapy for SCLC, Toxicities related to previous Radiotherapy for SCLC, 12-Lead Electrocardiogram, Diagnostic Studies for Tumor Assessment, Ongoing Medical Conditions Associated with SCLC, Ongoing Medical Conditions Associated with SCLC, Significant Medical/ Surgical History and Physical Examination, Significant Medical/ Surgical History and Physical Examination
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

GSK Study ID 104864-201 Post-Treatment Follow-Up - Post Treatment Follow-Up

- 15-03-21 - 1 Formulier, 18 Itemgroepen, 68 Data-elementen, 1 Taal
Itemgroepen: Identification Numbers, Post Treatment Follow-Up, Health Care Resource Utilization , If Yes to Hospitalization, FACT-An, Stem Cell Transplant (SCT) Follow-Up, If ’Yes’ please indicate chemotherapy regimen/agents below, Total body irradiation, Signature-Name of Person, Patient Assignment Sheet, Patient Assignment Sheet, Patient Log, Patient Log , Month of Report, Outcome, Form D, Laboratory Reference Ranges, Referance Range
Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Pathology Report

- 31-12-19 - 1 Formulier, 6 Itemgroepen, 20 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Primary, Histology Type, Histologic Grade, Specimens, Secondary
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Study Medication

- 16-08-19 - 1 Formulier, 3 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Body Weight, Body Surface Area, Topotecan; Therapeutic radiology procedure
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Screening

- 16-08-19 - 1 Formulier, 12 Itemgroepen, 75 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Demography, Vital signs, Rectal Carcinoma, Medical History, Rectal Carcinoma, Operative Surgical Procedures, Previous, 12 lead ECG, Rectal Carcinoma, Evaluation, Diagnostic procedure, Disease, Relationships, Rectal Carcinoma, Medical History; History of surgical procedures; Physical Examination, Pharmaceutical Preparations, Previous; Concomitant Agent, Inclusion, Exclusion Criteria
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612 - Cycle 7

- 13-08-19 - 1 Formulier, 4 Itemgroepen, 17 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Clinical Trials, Status, Experimental drug, Topotecan, Administration of medication, Experimental drug, Topotecan, Administration of medication
Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian 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: HycamtinTM Study Indication: Ovarian Cancer

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - GOG Toxicity Case Summary

- 15-03-19 - 1 Formulier, 12 Itemgroepen, 55 Data-elementen, 2 Talen
Itemgroepen: Administrative data, Demographics, Description, Protocol Treatment, Drugs and Doses for this Course, Cumulative Totals to Date, Serious Adverse Event, Pretreatment Counts for this Course, Nadir Counts, GOG #, Quality of Life Cover Sheet (Investigator's details), Time of Today's Assessment
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Treatment Completion Form

- 14-03-19 - 1 Formulier, 10 Itemgroepen, 39 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Treatment Completion, Tumor Measurements, Best Tumor Response, Follow-Up Form, Disease Follow-Up Status, Notice of New Primary, Long Term Adverse Events, Adverse Events details, Additional Cancer Therapy
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Common Toxicity Report

- 14-03-19 - 1 Formulier, 2 Itemgroepen, 15 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Common Toxicity Report
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent on Persistent Carcinoma of the Cervix - 103369 - Drug Dose Form

- 14-03-19 - 1 Formulier, 6 Itemgroepen, 38 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Investigational Product, Drug Dose, Tumor Measurements, Best Tumor Response, Pre-treatment Hematologies and Chemistries
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

GSK Study ID 104864-201-Pre-Next Course (Course 02) - Pre-Next Course

- 24-04-18 - 1 Formulier, 12 Itemgroepen, 36 Data-elementen, 1 Taal
Itemgroepen: Identification Numbers, Serious Adverse Experiences, 12-Lead Electrocardiogram, Echocardiogram or Multiple Gated Acquisition Scanning (MUGA), If Yes for the obtained Ejection Fraction, Chest X-Ray, Supportive Therapy (Including Erythropoietin), If Yes to Supportive Therapy (Including Erythropoietin), Supportive Anti-Infective Therapy, If Yes to Supportive Anti-Infective Therapy, Concominant Medication, If Yes to Concominant Medication
Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

GSK Study ID 104864-201-Medication (next Course) - Medication

- 24-04-18 - 1 Formulier, 12 Itemgroepen, 61 Data-elementen, 1 Taal
Itemgroepen: Identification Numbers, Topotecan and Ara-C Study Medication Record, Topotecan Administration, Ara-C Administration, Idarubicin and Ara-C Study Medication Record, Idarubicin Administration, Ara-C Administration, Dose Reduction, Retreatment Interval, G-CSF Study Medication Record, Vital Signs-TAG Regiment only, Vital Signs-IDAG Regiment only
Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

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