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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
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Visit 24 (Week 240) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/18/22 - 1 form, 10 itemgroups, 41 items, 1 language
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 24 (Week 240)

Unsceduled relapse assessment visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/18/22 - 1 form, 10 itemgroups, 41 items, 1 language
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Relapse assessment, Subject Identification, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Unsceduled relapse assessment visit

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Physical Examination, Laboratory Results Hematology/ Chemistry Week 7 (Visit 6)

- 2/18/22 - 1 form, 6 itemgroups, 38 items, 1 language
Itemgroups: Date of physical examination, B- Symptoms, Physical Examination, Organ/ System, 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

Visit 8 (Week 32) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/17/22 - 1 form, 10 itemgroups, 41 items, 1 language
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 8 (Week 32)

Visit 20 (Week 192) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/17/22 - 1 form, 10 itemgroups, 42 items, 1 language
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 20 (Week 192)

Visit 10 (Week 72): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/17/22 - 1 form, 9 itemgroups, 31 items, 1 language
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 10 (Week 72)

Visit 22 (Week 216): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/17/22 - 1 form, 9 itemgroups, 31 items, 1 language
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 22 (Week 216)

Visit 14 (Week 120): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/4/22 - 1 form, 9 itemgroups, 31 items, 1 language
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 14 (Week 120)

Visit 18 (Week 168): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/4/22 - 1 form, 9 itemgroups, 31 items, 1 language
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 18 (Week 168)

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

SHORT STAY RECORD ID NOTE-ENDO - HIS

- 9/27/21 - 1 form, 4 itemgroups, 94 items, 2 languages
Itemgroups: SHORT STAY RECORD ID NOTE-ENDO, Chief Complaint, Physical Exam, Prior Medical History
Form from HIS OpenVista

Visit V5_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79 - Visit V5 (Day 140 + - 14)

- 9/27/21 - 1 form, 8 itemgroups, 49 items, 1 language
Itemgroups: Visit, Physical examination, Medical Examination Rhinoscope, Spirometry; Peak Expiratory Flow, Medication, Hematology, Biochemistry, medication Demand
Study part: Visit V5 (Day 140 + - 14). Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

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