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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
  7. 7. Medical Specialty
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Eligibility Hepatitis B, Chronic NCT01023217

- 9/27/21 - 1 form, 2 itemgroups, 25 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir; ODM derived from: https://clinicaltrials.gov/show/NCT01023217

Eligibility Hepatitis B, Chronic NCT00435825

- 9/27/21 - 1 form, 2 itemgroups, 7 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).; ODM derived from: https://clinicaltrials.gov/show/NCT00435825

Eligibility Hepatitis B, Chronic NCT00436163

- 9/27/21 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg-Positive Chronic Hepatitis B (CHB).; ODM derived from: https://clinicaltrials.gov/show/NCT00436163

Eligibility Hepatitis B, Chronic NCT00917761

- 9/27/21 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Entecavir and Pegasys Sequential Therapy Versus Pegasys for HBeAg Negative Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00917761

Eligibility Hepatitis B, Chronic NCT00921180

- 9/27/21 - 1 form, 2 itemgroups, 20 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Entecavir and Pegasys Sequential Therapy Versus Pegasys for HBeAg Positive Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00921180

Eligibility Hepatitis B, Chronic NCT00718887

- 9/27/21 - 1 form, 2 itemgroups, 19 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Suboptimal Responders to Adefovir Switching to Entecavir; ODM derived from: https://clinicaltrials.gov/show/NCT00718887

Eligibility Hepatitis B Virus NCT00960518

- 9/27/21 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
TACE and Adefovir Compared With Transarterial Chemoembolization (TACE) Alone for Hepatitis B Virus (HBV)-Related Unresectable Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT00960518

Eligibility Hepatocellular Carcinoma NCT00862082

- 9/27/21 - 1 form, 2 itemgroups, 19 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Randomized Phase 1/2 Open-Label Trial of PR104 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT00862082

Eligibility Hepatocellular Carcinoma NCT00669136

- 9/27/21 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00669136

Eligibility Hepatocellular Carcinoma NCT01686880

- 9/27/21 - 1 form, 2 itemgroups, 19 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Y90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver; ODM derived from: https://clinicaltrials.gov/show/NCT01686880

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

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