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Investigator data Log GSK study Prostatic neoplasms NCT00883909

- 26/11/2017 - 1 formulario, 3 itemgroups, 8 items, 1 idioma
Itemgroups: Administrative data, Investigator Comment, Investigator Statement
Study ID: 103094 Clinical Study ID: ARI103094 Study Title: ARI103094-Follow-Up Study for REDUCE Study Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00883909 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Neoplasms, Prostate CRF Seiten: 934-977

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 End of Treatment - CRFs Cabazitaxel Prostate Cancer NCT01308580 End of Treatment

- 25/05/2017 - 1 formulario, 7 itemgroups, 46 items, 1 idioma
Itemgroups: End of Treatment, Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Ciruclating free plasma DNA - Blood Sampling, Electrocardiogram
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (Survival Follow-up) - Radium 223 Dichloride (Alpharadin) - Survival Follow-up

- 30/03/2017 - 1 formulario, 2 itemgroups, 7 items, 1 idioma
Itemgroups: Survival Assessment, End of Survival Follow-up
This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product. NCT01618370

Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (Last Visit) - Radium 223 Dichloride (Alpharadin) - Last Visit

- 30/03/2017 - 1 formulario, 2 itemgroups, 4 items, 1 idioma
Itemgroups: Last Visit, Death
This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product. NCT01618370

Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (End of Study Treatment) - Radium 223 Dichloride (Alpharadin) - End of Study Treatment

- 20/03/2017 - 1 formulario, 1 itemgroup, 6 items, 1 idioma
Itemgroup: End of Study Treatment
This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product. NCT01618370

Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (End of Treatment Visit) - Radium 223 Dichloride (Alpharadin) - End of Treatment Visit

- 20/03/2017 - 1 formulario, 7 itemgroups, 45 items, 1 idioma
Itemgroups: Subject Visit, Assessment of Disease Progression, Vital Signs, BPI-SF, ECOG Performance Status, Hematology (with DBC), General Chemistry - Serum
This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product. NCT01618370

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

- 13/08/2019 - 1 formulario, 3 itemgroups, 8 items, 1 idioma
Itemgroups: Administrative documentation, Clinical Research, End, Investigator Signature, Confirmation
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

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Study Conclusion

- 12/07/2019 - 1 formulario, 2 itemgroups, 5 items, 1 idioma
Itemgroups: Administrative documentation, Conclusion, Clinical Research
Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects GSK102587 - Follow-up

- 16/04/2018 - 1 formulario, 5 itemgroups, 63 items, 1 idioma
Itemgroups: Vital Signs, Drug and Alcohol Screen, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis
Study ID: 102587 Clinical Study ID: EGF102587 Study Title: A Single-Dose, Open-Label, Randomized, Three-Way Cross-Over Study in Healthy Subjects to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib (GW572016) Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tykerb,Tycerb,Tyverb; Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Breast Documentation part: Follow-up

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Withdrawal / Study Conclusion NCT00078572

- 18/05/2017 - 1 formulario, 9 itemgroups, 77 items, 1 idioma
Itemgroups: Withdrawal / Study Conclusion, Physical Exam (Vital Signs, Weight, Height), ECOG Performance Status, Cardiac Assessments Screening, Hematology, Clinical Chemistry, Response Assessment, Confirmatory Scan, Endpoint Evaluation : Investigator
XELODA and Lapatinib Advanced or Metastatic Breast Cancer Study ID: 100151 Clinical Study ID: EGF100151 Study Title: A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer Clinicaltrials.gov Identifier: NCT00078572 https://clinicaltrials.gov/ct2/show/NCT00078572 Procedure: Withdrawal / Study Conclusion Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Breast Cancer; Neoplasms, Breast

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Study Conclusion

- 03/07/2019 - 1 formulario, 2 itemgroups, 7 items, 1 idioma
Itemgroups: Administrative documentation, Conclusion, Clinical Research
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical 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: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Study Conclusion

- 03/07/2019 - 1 formulario, 2 itemgroups, 7 items, 1 idioma
Itemgroups: Administrative documentation, Conclusion, Clinical Research
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical 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: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

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