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Klinische Studie, Phase II [Dokumenttyp] ×
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Inhaltsverzeichnis
  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
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Eligibility Renal Cell Carcinoma NCT01147536

- 26.08.18 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Immune Response Following Treatment of Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence; ODM derived from: https://clinicaltrials.gov/show/NCT01147536

Oral GW786034 treatment for ovarian cancer NCT00281632 - Unscheduled Visit

- 30.05.18 - 1 Formular, 7 Itemgruppen, 50 Datenelemente, 1 Sprache
Itemgruppen: Header, Vital signs, Electronically transferred laboratory data, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, 12 LEAD ECG
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Oral GW786034 treatment for ovarian cancer NCT00281632 - Post-Treatment Assessments

- 16.05.18 - 1 Formular, 12 Itemgruppen, 54 Datenelemente, 1 Sprache
Itemgruppen: Header, Vital signs, ECOG Performance Status Scale, Electronically transferred laboratory data, Physical examination, serum pregnancy test, CONCOMITANT MEDICATIONS, ADVERSE EVENTS, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, 12 LEAD ECG
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Oral GW786034 treatment for ovarian cancer NCT00281632 - Visit description: Treatment Period 3. Day 1

- 15.05.18 - 1 Formular, 15 Itemgruppen, 64 Datenelemente, 1 Sprache
Itemgruppen: Header, Vital signs, ECOG Performance Status, Electronically transferred lab data - CA-125, Physical examination, Concomitant Medication, Adverse Events, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, Pharmacokinetics Blood, Investigational Product, Biomarker sample(s), investigational product, Treatment Confirmation
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Oral GW786034 treatment for ovarian cancer NCT00281632 - Visit description: Treatment Period 2. Day 1

- 15.05.18 - 1 Formular, 16 Itemgruppen, 74 Datenelemente, 1 Sprache
Itemgruppen: Header, Vital signs, ECOG Performance Status, Electronically transferred lab data - CA-125, Physical examination, Concomitant Medication, Adverse Events, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, Pharmacokinetics Blood, Investigational Product, Biomarker sample(s), investigational product, Investigational Product, Treatment Confirmation
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Oral GW786034 treatment for ovarian cancer NCT00281632 - Visit description: Treatment Period 1. Day 8

- 14.05.18 - 1 Formular, 5 Itemgruppen, 38 Datenelemente, 1 Sprache
Itemgruppen: Header, Vital signs, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, investigational product
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Oral GW786034 treatment for ovarian cancer NCT00281632 - Visit description: Treatment Period 1. Day 1

- 04.05.18 - 1 Formular, 15 Itemgruppen, 68 Datenelemente, 1 Sprache
Itemgruppen: Header, Vital signs, ECOG Performance Status, Electronically transferred lab data - CA-125, Physical examination, Concomitant Medication, Adverse Events, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, tumour tissue sample collection, consent for tumour genetic research, Withdrawal of consent, tumour sample destruction, Biomarker sample(s)
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Oral GW786034 treatment for ovarian cancer NCT00281632 - Screening

- 14.04.18 - 1 Formular, 24 Itemgruppen, 129 Datenelemente, 2 Sprachen
Itemgruppen: Header, Eligibility Question, Demography, Physical examination, Disease Characteristics, Metastatic Disease Site, local laboratory, Residual toxicities related to previous therapy for cancer, Residual toxicities, Cancer related current medical conditions, Medical Conditions, non-cancer related medical conditions, Medical Conditions, Prior anti-cancer therapy, Prior anti-cancer therapy - medication, Prior anti-cancer therapy - radiotherapy, Vital signs, ECOG Performance Status Scale, 12 LEAD ECG, 12-lead ECG Abnormalities, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, Electronically transferred laboratory data
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Oral GW786034 treatment for ovarian cancer NCT00281632 - Screening Eligibility Criteria

- 14.04.18 - 1 Formular, 3 Itemgruppen, 31 Datenelemente, 1 Sprache
Itemgruppen: Header, Inclusion Criteria, Exclusion Criteria
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Concomitant Therapy GIMEMA CML0408 NCT00769327 - Concomitant Therapy

- 29.11.17 - 1 Formular, 1 Itemgruppe, 4 Datenelemente, 2 Sprachen
Itemgruppe: Concomitant pharmacological therapies
RATIONALE: Nilotinib and imatinib m esylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Concomitant Therapy Form.

Visit 13 GIMEMA CML0408 NCT00769327 - Visit 13

- 29.11.17 - 1 Formular, 5 Itemgruppen, 56 Datenelemente, 2 Sprachen
Itemgruppen: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Molecular Biology (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 13 Form

Visit 5 GIMEMA CML0408 NCT00769327 - Visit 5

- 29.11.17 - 1 Formular, 4 Itemgruppen, 44 Datenelemente, 2 Sprachen
Itemgruppen: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 5 Form