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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    1. 1.2. Medical History
    1. 1.3. Physical Examination
    1. 1.4. Assessment Score
    1. 1.5. Apparative Diagnostics
    1. 1.6. Laboratory
    1. 1.7. Pathology/Histology
    1. 1.8. Consent
    1. 1.9. Therapy
    1. 1.10. Operative Report
    1. 1.11. Adverse Event
    1. 1.12. Follow-Up
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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Pancreatic Cancer NCT00058149 Follow-Up - Hematology/Chemistry Form - 2048132v3.0 - Hematology/Chemistry Form

- 1/21/15 - 1 form, 2 itemgroups, 31 items, 1 language
Itemgroups: Header, Hematology and Chemistry
Hematology/Chemistry Form A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65D4877-9B57-427A-E034-0003BA0B1A09

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Physical Examination, Laboratory Results Hematology/ Chemistry Follow- Up

- 1/31/22 - 1 form, 8 itemgroups, 44 items, 1 language
Itemgroups: Date of physical examination, Visit Week physical examination, B- Symptoms, Physical Examination, Organ/ System, Visit Week laboratory, Hematology, Chemistry
Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Follow-up AMLSG 21-13 DRKS00007189 NCT02013648 Akute myeloische Leukämie (AML) - Follow-up AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

- 11/17/21 - 1 form, 5 itemgroups, 22 items, 1 language
Itemgroups: Follow-up, Concomitant Disease, Therapy, Allogenic Transplantation, Signature
Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel(TM)) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)

Breast Cancer NCT01101438 Follow-Up - NCIC MA.32 Telephone Follow-Up Report - 3025096v1.0 - NCIC MA.32 Telephone Follow-Up Report

- 9/27/21 - 1 form, 5 itemgroups, 17 items, 1 language
Itemgroups: TIMING OF REPORT - TELEPHONE FOLLOW-UP, METFORMIN/PLACEBO ADMINISTRATION, SERIOUS ADVERSE EVENT - QUESTION, ADVERSE EVENTS ON TREATMENT - QUESTION, ADVERSE EVENTS
NCIC MA.32 Telephone Follow-Up Report A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81DC7457-3943-EA84-E040-BB89AD43055B

Follow-Up - Phase II Lung Cancer - Advanced Disease Follow-Up Form - 2399268v1.0 - Phase II Lung Cancer - Advanced Disease Follow-Up Form

- 9/27/21 - 1 form, 9 itemgroups, 36 items, 1 language
Itemgroups: CRF Header, Form Administration, Lung: Vital Status, Lung: Disease Follow-Up Status, Lung: Notice of Progression/Site, Lung: Subsequent Non-Protocol Therapy, Lung: Notice of New Primary, Lung: Long-Term Toxicity, Comments
Phase II Consortium Phase II Lung Cancer - Advanced Disease Follow-Up Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF8E0C9E-44F2-3242-E034-0003BA3F9857

Follow-Up - Phase II Lung Cancer - Localized Disease Follow-Up Form - 2402852v1.0 - Phase II Lung Cancer - Localized Disease Follow-Up Form

- 9/27/21 - 1 form, 9 itemgroups, 38 items, 1 language
Itemgroups: CRF Header, Form Administration, Lung: Vital Status, Lung: Disease Follow-Up Status, Lung: Notice of Progression/Site, Lung: Subsequent Non-Protocol Therapy, Lung: Notice of New Primary, Lung: Long-Term Toxicity, Comments
Phase II Consortium Phase II Lung Cancer - Localized Disease Follow-Up Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=00212490-27A3-4F0A-E044-0003BA3F9857

Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039 - Visit 3: Laboratory Tests

- 9/27/21 - 1 form, 4 itemgroups, 12 items, 1 language
Itemgroups: Administrative data, Blood Sample for Antibodies to CS, Blood Sample for Antibodies to HBs, Blood Sample for Hematocrit
Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria This study (Malaria-039 / NCT00323622 / GlaxoSmithKline Study ID 104297) is a two-year follow-up to Malaria-026 and consists of three clinic visits: Visit 1 / Informed Consent Visit at Visit 7 of Malaria-026 (i.e. 21 months post vaccine dose 1 in Malaria-026). Visit 2 / Interim Analysis 12 months +/- 1 month after Visit 1. Visit 3 / Final Analysis 24 months +/- 1 month after Visit 1. See https://clinicaltrials.gov/ct2/show/NCT00323622 This form is to be completed at/after Visit 3.

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 12, Year 9) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 28 items, 1 language
Itemgroups: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 11, Year 8) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 28 items, 1 language
Itemgroups: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 10, Year 7) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 29 items, 1 language
Itemgroups: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 9, Year 6) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 29 items, 1 language
Itemgroups: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880 - Follow-Up Visit und Unscheduled Visit Form

- 9/20/21 - 1 form, 3 itemgroups, 34 items, 1 language
Itemgroups: Administrative Data, Vital Signs, Physical Examination
This ODM file contains a form for the documention required at the follow-up and unscheduled visits. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia

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