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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 3 Prior to next Course (Day 25 - 28) - Vital Signs; Tumor Marker (CA-125); Laboratory Tests; Lesion Assessment Record

- 9/1/19 - 1 form, 9 itemgroups, 40 items, 1 language
Itemgroups: Administrative, Vital Signs, Tumor Marker (CA-125), Laboratory Tests - Haematology, Laboratory Tests - Haematology , Laboratory Tests - Chemistry, Laboratory Tests - Chemistry , Lesion Assessment, Lesion Assessment Record
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 3 (Day 8 ) - Vital Signs; Hematology; Administration of Study Medications

- 9/1/19 - 1 form, 7 itemgroups, 44 items, 1 language
Itemgroups: Administrative, Day 8 Vital Signs, Hematology, Hematology, Day 8 Administration of Study Medications, Topotecan Administration, Gemicitabine Administration
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 3 (Day 15 ) - Vital Signs; Hematology; Administration of Study Medications

- 9/1/19 - 1 form, 7 itemgroups, 44 items, 1 language
Itemgroups: Administrative, Day 15 Vital Signs, Hematology, Hematology, Day 15 Administration of Study Medications, Topotecan Administration, Gemcitabine Administration
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 3 (Day 1) - Eligibility; Vital Signs; Administration of Study Medications

- 9/1/19 - 1 form, 6 itemgroups, 44 items, 1 language
Itemgroups: Administrative, Eligibility, Vital Signs, Administration of Study Medications, Topotecan Administration, Gemcitabine Administration
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 2 Prior to next Course (Day 25 - 28) - Vital Signs; Tumor Marker (CA-125); Laboratory Tests; Lesion Assessment Record

- 8/30/19 - 1 form, 9 itemgroups, 40 items, 1 language
Itemgroups: Administrative, Vital Signs, Tumor Marker (CA-125), Laboratory Tests - Haematology, Laboratory Tests - Haematology , Laboratory Tests - Chemistry, Laboratory Tests - Chemistry , Lesion Assessment, Lesion Assessment Record
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 2 Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log

- 8/30/19 - 1 form, 7 itemgroups, 22 items, 1 language
Itemgroups: Administrative, Review of Disease Status, Therapeutic Interventions, End of Course Eligibility, Unscheduled Laboratory Tests - Hematology, Unscheduled Laboratory Tests - Hematology, Therapeutic Interventions
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 2 (Day 15 ) - Vital Signs; Hematology; Administration of Study Medications

- 8/30/19 - 1 form, 7 itemgroups, 44 items, 1 language
Itemgroups: Administrative, Day 15 Vital Signs, Hematology, Hematology, Day 15 Administration of Study Medications, Topotecan Administration, Gemcitabine Administration
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 1 (Day 15 ) - Vital Signs; Hematology; Administration of Study Medications

- 8/30/19 - 1 form, 7 itemgroups, 44 items, 1 language
Itemgroups: Administrative, Day 15 Vital Signs, Hematology, Hematology, Day 15 Administration of Study Medications, Topotecan Administration, Gemcitabine Administration
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 2 (Day 1) - Eligibility; Vital Signs; Administration of Study Medications

- 8/30/19 - 1 form, 6 itemgroups, 44 items, 1 language
Itemgroups: Administrative, Eligibility, Vital Signs, Administration of Study Medications, Topotecan Administration, Gemcitabine Administration
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 2 (Day 8 ) - Vital Signs; Hematology; Administration of Study Medications

- 8/30/19 - 1 form, 7 itemgroups, 44 items, 1 language
Itemgroups: Administrative, Day 8 Vital Signs, Hematology, Hematology, Day 8 Administration of Study Medications, Topotecan Administration, Gemicitabine Administration
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 1 Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log

- 8/30/19 - 1 form, 7 itemgroups, 22 items, 1 language
Itemgroups: Administrative, Review of Disease Status, Therapeutic Interventions, End of Course Eligibility, Unscheduled Laboratory Tests - Hematology, Unscheduled Laboratory Tests - Hematology, Therapeutic Interventions
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 1 Prior to next Course (Day 25 - 28) - Vital Signs; Tumor Marker (CA-125); Laboratory Tests; Lesion Assessment Record

- 8/29/19 - 1 form, 9 itemgroups, 40 items, 1 language
Itemgroups: Administrative, Vital Signs, Tumor Marker (CA-125), Laboratory Tests - Haematology, Laboratory Tests - Haematology , Laboratory Tests - Chemistry, Laboratory Tests - Chemistry , Lesion Assessment, Lesion Assessment Record
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

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