Reset filter
Keywords
SKF104864A ×
Show more Keywords
Table of contents
  1. 1. Estudo clínico
    1. 1.1. Inclusão/exclusão
    1. 1.2. Anamnese
    1. 1.3. Exame físico
    1. 1.4. Score
    1. 1.5. Diagnóstico com aparelhos
    1. 1.6. Laboratório
    1. 1.7. Patologia/histologia
    1. 1.8. Esclarecimento/consentimento
    1. 1.9. Terapia
    1. 1.10. Relatório da operação
    1. 1.11. Evento indesejado
    1. 1.12. Seguimento
  2. 2. Documentação de rotina
  3. 3. Estudos de registo/coortes
  4. 4. Garantia da qualidade
  5. 5. Padrão de dados
  6. 6. Questionário do paciente
  7. 7. Especialidade médica
Selected data models

You must log in to select data models for download or further analysis.

19 Search results.
Relevance Rating New first Old first

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

- 04/05/2021 - 1 form, 7 itemgroups, 36 items, 1 language
Itemgroups: Administrative, Laboratory Reference Ranges, Laboratory Reference Ranges , Concomitant Medication - Continued, Adverse Experiences (Non-serious), Adverse Experiences (Non-serious), Investigator's Signature (Adverse Experience)
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) - Module 2 - Pre-Next Course: Serious Adverse Experiences; Vital Signs; 12-Lead ECG

- 29/04/2021 - 1 form, 4 itemgroups, 14 items, 1 language
Itemgroups: 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

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Module 2 - Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

- 28/04/2021 - 1 form, 4 itemgroups, 21 items, 1 language
Itemgroups: Administrative, Laboratory Tests - Haematology, Laboratory Tests - Blood Chemistry, Laboratory Tests - Urinalysis
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) - Regimen 1 and Regimen 2: Days 1 - 5 - Weight/ Body Surface Area; Topotecan Study Medication Record; Pre-Cisplatin Hydration Record; Cisplatin Study Medication Record; Post-Cisplatin Hydration Record; Post-Cisplatin Dosing; Etoposide Study Medication Record; Vital Signs

- 28/04/2021 - 1 form, 9 itemgroups, 51 items, 1 language
Itemgroups: Administrative, Weight/Body Surface Area (Regimen 1, Regimen 2), Topotecan Study Medication Record (Regimen 1, Regimen 2), Day 5 Pre-Cisplatin Hydration Record (Regimen 1), Day 5 Cisplatin Study Medication Record (Regimen 1), Day 5 Post-Cisplatin Hydration Record (Regimen 1), Day 5 Vital Signs, Post-Cisplatin Dosing (Regimen 1), Etoposide Study Medication Record (Regimen 1, Regimen 2), Day 5 Vital Signs, Post-Etoposide Dosing (Regimen 2)
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) - Module 2 - Regimen 1 and Regimen 2: Days 1 - 5 - Weight/ Body Surface Area; Topotecan Study Medication Record; Pre-Cisplatin Hydration Record; Cisplatin Study Medication Record; Post-Cisplatin Hydration Record; Post-Cisplatin Dosing; Etoposide Study Medication Record; Vital Signs

- 28/04/2021 - 1 form, 13 itemgroups, 63 items, 1 language
Itemgroups: Administrative, Course Delay (Regimen 1, Regimen 2), Weight/Body Surface Area (Regimen 1, Regimen 2), Topotecan Study Medication Record (Regimen 1, Regimen 2), Topotecan Study Medication Record (Regimen 1, Regimen 2), Day 5 Pre-Cisplatin Hydration Record (Regimen 1), Day 5 Cisplatin Study Medication Record (Regimen 1), Cisplatin Study Medication Record, Day 5 Post-Cisplatin Hydration Record (Regimen 1), Day 5 Vital Signs, Post-Cisplatin Dosing (Regimen 1), Etoposide Study Medication Record (Regimen 2), Etoposide Study Medication Record , Day 5 Vital Signs, Post-Etoposide Dosing (Regimen 2)
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) - Concomitant Medication; Adverse Experiences (Non-serious); Course Conclusion

- 27/04/2021 - 1 form, 7 itemgroups, 31 items, 1 language
Itemgroups: 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

- 27/04/2021 - 1 form, 4 itemgroups, 14 items, 1 language
Itemgroups: 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

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

- 21/04/2021 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: Administrative, Laboratory Tests - Haematology, Laboratory Tests - Blood Chemistry, Laboratory Tests - Urinalysis
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) - Eligibility Criteria

- 20/04/2021 - 1 form, 5 itemgroups, 27 items, 1 language
Itemgroups: Administrative, Inclusion Criteria, Exclusion Criteria, Inclusion/ Exclusion, Investigator's Signature
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) - Screening - Prior an Concomitant Medication; Telephone Randomisation

- 18/04/2021 - 1 form, 4 itemgroups, 13 items, 1 language
Itemgroups: Administrative, Prior and Concomitant Medication, Prior and Concomitant Medication , Telephone Randomisation
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) - 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

- 17/04/2021 - 1 form, 9 itemgroups, 20 items, 1 language
Itemgroups: 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

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

- 31/12/2019 - 1 form, 6 itemgroups, 20 items, 1 language
Itemgroups: 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 

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial