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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - AED Plasma Concentration - Baseline Week 4 and 6, Laboratory Comments - Baseline Week 4 and 6 and Study Continuation Record - Baseline Study Week 8

- 11.10.18 - 1 Formular, 11 Itemgruppen, 20 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Laboratory test finding, Laboratory Results; Clinical Significance; Unexpected, Antiepileptic Agents; plasma concentration , Laboratory test finding, Laboratory Results; Clinical Significance; Unexpected, Antiepileptic Agents; plasma concentration , Study Subject Participation Status | Assessment Date, Study Subject Participation Status | Inclusion | Exclusion Criteria, Study Subject Participation Status | Inclusion; Seizures; Baseline, Study Subject Participation Status | Clinical Trial Eligibility Criteria
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Vital Signs/ Weight/ Physical Examination, Neurological Examination, Electrocardiogram - Baseline Study Week 8

- 08.10.18 - 1 Formular, 16 Itemgruppen, 56 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Physical Examination Date, Vital signs | Body Weight, Physical Examination, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Electroencephalography, Electrocardiography
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Seizure record - Baseline, Treatment Phase, Taper and Follow- up and innumerable seizure activity record - Study week 1 through Taper and Follow-up

- 08.10.18 - 1 Formular, 5 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Seizures; Records | Baseline, Seizures; Records | Treatment Epoch, Seizures; Records | follow-up, seizure activity
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

ICHOM Parkinson's Disease - First Doctor's Visit Form

- 04.09.18 - 1 Formular, 3 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Patient ID, Demographic factors, Baseline clinical status
PARKINSON‘S DISEASE DATA COLLECTION Version 2.2.1 Revised April 10th, 2017 www.ichom.org Conditions Covered: Idiopathic Parkinson’s Disease Treatment Approaches: Pharmacotherapy | Behavioral Therapy | Exercise-Based Therapy | Deep Brain Stimulation | Infusion/Injection-Based Delivery This ODM-file contains a form to be administered at the first visit to the doctor with Parkinson's disease. Mainly Patient-reported, some items may alternatively have a clinical reporting source. Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. TEST StudyFor example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc. Survey used: Movement Disorder Society (MDS-UPDRS), Part I: Non-Motor Aspects of Experiences of Daily Living (nM- EDL). Both clinical- and patient-reported portions; Part II: Motor Aspects of Experiences of Daily Living (M-EDL). Patient-reported: The MDS-UPDRS requires a license (by International Parkinson’s and Movement Disorders Society), therefore the used items are not integrated into this version of the Parkinson's Disease Standard Set. International Parkinson’s and Movement Disorders Society (IPMDS) Non-motor symptoms questionnaire (NMSQ): The NMSQ requires a license. However, in ICHOM's Parkinson's Disease Standard Set only one question derived from 2 NMSQ items is used. Parkinson’s Disease Quality of Life Questionnaire (PDQ-8): The PDQ-8 requires a license (by Innovation, Oxford University), therefore the used items are not integrated into this version of the Parkinson's Disease Standard Set. ICHOM was endorsed for this standard set by the International Association for Parkinsonism and Related Disorders. De Roos P, Bloem BR, Kelley TA, et al. A Consensus Set of Outcomes for Parkinson’s Disease from the International Consortium for Health Outcomes Measurement. Journal of Parkinson’s disease. 2017;7(3):533-543. doi:10.3233/JPD-161055.

ICHOM Low Back Pain - Administrative Form (30 days after index hospitalization)

- 31.08.18 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: Patient ID, Acute Complications of Treatment
LOW BACK PAIN DATA COLLECTION Version 2.0.3 Revised August 24th, 2017 www.ichom.org Conditions: Lumbar Disc Herniation | Lumbar Stenosis | Lumbar Spondylolisthesis | Degenerative Scoliosis | Adult Idiopathic Scoliosis | Degenerative Disc Disorder | Other Degenerative Lumbar Disorders | Mechanical, Acute, and Chronic Lumbar Back Pain and Back-Related Leg Pain Conditions Not Covered: Individuals < 18 Years of Age | Spinal Infection | Spinal Tumor | Spinal Fractures | Traumatic Dislocation | Congenital Scoliosis Documented as >20 Degrees, Moderate, Large, or Severe Treatment Approaches: Conservative Therapy (e.g. physical therapy, chiropractic, drug therapy, injections, etc.) | Surgical Therapy (e.g. spinal fusion, decompression, or discectomy) This ODM-file contains an Adminstrative Form, to be reported within 30 days after index hospitalization. Use of the following Scores: ODI - Oswestry Disability Index Version 2.1a: The ODI is free for all health care organizations, but a license is needed for use (therefore not included in this version of the standard set). Please visit eprovide: https://eprovide.mapi-trust.org/ NPRS - Numerical Pain Rating Scale: The NPRS is free for all health care organizations, and a license is not needed. EQ-5D-3L - EuroQol‐5D descriptive system (EQ-­5D‐3L) and visual analogue scale (EQ-­VAS): The EQ-5D-3L is free for non-profits and academic research, but a license is needed for use (therefore not included in this version of the standard set). https://euroqol.org/support/how-to-obtain-eq-5d/ Publication: R Carter Clement, Adina Welander, Caleb Stowell, Thomas D Cha, John L Chen, Michelle Davies, Jeremy C Fairbank, Kevin T Foley, Martin Gehrchen, Olle Hagg, Wilco C Jacobs, Richard Kahler, Safdar N Khan, Isador H Lieberman, Beth Morisson, Donna D Ohnmeiss, Wilco C Peul, Neal H Shonnard, Matthew W Smuck, Tore K Solberg, Bjorn H Stromqvist, Miranda L Van Hooff, Ajay D Wasan, Paul C Willems, William Yeo & Peter FRitzell (2015) A proposed set of metrics for standardized outcome reporting in the management of low back pain, Acta Orthopaedica, 86:5, 523-533 ICHOM received an endorsement of Arthritis Research UK for the development of this standard set.

ICHOM Low Back Pain - Clinical Follow-up Form (Disease recurrence)

- 31.08.18 - 1 Formular, 2 Itemgruppen, 3 Datenelemente, 1 Sprache
Itemgruppen: Patient ID, Acute Complications of Treatment
LOW BACK PAIN DATA COLLECTION Version 2.0.3 Revised August 24th, 2017 www.ichom.org Conditions: Lumbar Disc Herniation | Lumbar Stenosis | Lumbar Spondylolisthesis | Degenerative Scoliosis | Adult Idiopathic Scoliosis | Degenerative Disc Disorder | Other Degenerative Lumbar Disorders | Mechanical, Acute, and Chronic Lumbar Back Pain and Back-Related Leg Pain Conditions Not Covered: Individuals < 18 Years of Age | Spinal Infection | Spinal Tumor | Spinal Fractures | Traumatic Dislocation | Congenital Scoliosis Documented as >20 Degrees, Moderate, Large, or Severe Treatment Approaches: Conservative Therapy (e.g. physical therapy, chiropractic, drug therapy, injections, etc.) | Surgical Therapy (e.g. spinal fusion, decompression, or discectomy) This ODM-file contains a clinical follow-up form to document disease recurrence, to be reported when occurs. Use of the following Scores: ODI - Oswestry Disability Index Version 2.1a: The ODI is free for all health care organizations, but a license is needed for use (therefore not included in this version of the standard set). Please visit eprovide: https://eprovide.mapi-trust.org/ NPRS - Numerical Pain Rating Scale: The NPRS is free for all health care organizations, and a license is not needed. EQ-5D-3L - EuroQol‐5D descriptive system (EQ-­5D‐3L) and visual analogue scale (EQ-­VAS): The EQ-5D-3L is free for non-profits and academic research, but a license is needed for use (therefore not included in this version of the standard set). https://euroqol.org/support/how-to-obtain-eq-5d/ Publication: R Carter Clement, Adina Welander, Caleb Stowell, Thomas D Cha, John L Chen, Michelle Davies, Jeremy C Fairbank, Kevin T Foley, Martin Gehrchen, Olle Hagg, Wilco C Jacobs, Richard Kahler, Safdar N Khan, Isador H Lieberman, Beth Morisson, Donna D Ohnmeiss, Wilco C Peul, Neal H Shonnard, Matthew W Smuck, Tore K Solberg, Bjorn H Stromqvist, Miranda L Van Hooff, Ajay D Wasan, Paul C Willems, William Yeo & Peter FRitzell (2015) A proposed set of metrics for standardized outcome reporting in the management of low back pain, Acta Orthopaedica, 86:5, 523-533 ICHOM received an endorsement of Arthritis Research UK for the development of this standard set.

ICHOM Low Back Pain - Baseline Clinical Variables

- 31.08.18 - 1 Formular, 5 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: Patient ID, Baseline Clinical Factors, Prior Treatment, Procedure, Acute Complications of Treatment
LOW BACK PAIN DATA COLLECTION Version 2.0.3 Revised August 24th, 2017 www.ichom.org Conditions: Lumbar Disc Herniation | Lumbar Stenosis | Lumbar Spondylolisthesis | Degenerative Scoliosis | Adult Idiopathic Scoliosis | Degenerative Disc Disorder | Other Degenerative Lumbar Disorders | Mechanical, Acute, and Chronic Lumbar Back Pain and Back-Related Leg Pain Conditions Not Covered: Individuals < 18 Years of Age | Spinal Infection | Spinal Tumor | Spinal Fractures | Traumatic Dislocation | Congenital Scoliosis Documented as >20 Degrees, Moderate, Large, or Severe Treatment Approaches: Conservative Therapy (e.g. physical therapy, chiropractic, drug therapy, injections, etc.) | Surgical Therapy (e.g. spinal fusion, decompression, or discectomy) This ODM-file contains Baseline Clinical Variables to be assessed at baseline and/or during index visit or hospitalization for procedure. Use of the following Scores: ODI - Oswestry Disability Index Version 2.1a: The ODI is free for all health care organizations, but a license is needed for use (therefore not included in this version of the standard set). Please visit eprovide: https://eprovide.mapi-trust.org/ NPRS - Numerical Pain Rating Scale: The NPRS is free for all health care organizations, and a license is not needed. EQ-5D-3L - EuroQol‐5D descriptive system (EQ-­5D‐3L) and visual analogue scale (EQ-­VAS): The EQ-5D-3L is free for non-profits and academic research, but a license is needed for use (therefore not included in this version of the standard set). https://euroqol.org/support/how-to-obtain-eq-5d/ Publication: R Carter Clement, Adina Welander, Caleb Stowell, Thomas D Cha, John L Chen, Michelle Davies, Jeremy C Fairbank, Kevin T Foley, Martin Gehrchen, Olle Hagg, Wilco C Jacobs, Richard Kahler, Safdar N Khan, Isador H Lieberman, Beth Morisson, Donna D Ohnmeiss, Wilco C Peul, Neal H Shonnard, Matthew W Smuck, Tore K Solberg, Bjorn H Stromqvist, Miranda L Van Hooff, Ajay D Wasan, Paul C Willems, William Yeo & Peter FRitzell (2015) A proposed set of metrics for standardized outcome reporting in the management of low back pain, Acta Orthopaedica, 86:5, 523-533 ICHOM received an endorsement of Arthritis Research UK for the development of this standard set.

ICHOM Low Back Pain - Baseline Patient-reported Variables

- 31.08.18 - 1 Formular, 5 Itemgruppen, 30 Datenelemente, 1 Sprache
Itemgruppen: Patient ID, Demographic Factors, Baseline functional Status, Baseline Clinical Factors, Prior Treatment
LOW BACK PAIN DATA COLLECTION Version 2.0.3 Revised August 24th, 2017 www.ichom.org Conditions: Lumbar Disc Herniation | Lumbar Stenosis | Lumbar Spondylolisthesis | Degenerative Scoliosis | Adult Idiopathic Scoliosis | Degenerative Disc Disorder | Other Degenerative Lumbar Disorders | Mechanical, Acute, and Chronic Lumbar Back Pain and Back-Related Leg Pain Conditions Not Covered: Individuals < 18 Years of Age | Spinal Infection | Spinal Tumor | Spinal Fractures | Traumatic Dislocation | Congenital Scoliosis Documented as >20 Degrees, Moderate, Large, or Severe Treatment Approaches: Conservative Therapy (e.g. physical therapy, chiropractic, drug therapy, injections, etc.) | Surgical Therapy (e.g. spinal fusion, decompression, or discectomy) This ODM-file contains Baseline patient-reported Variables to be assessed at baseline, with use of the following Scores: ODI - Oswestry Disability Index Version 2.1a: The ODI is free for all health care organizations, but a license is needed for use (therefore not included in this version of the standard set). Please visit eprovide: https://eprovide.mapi-trust.org/ NPRS - Numerical Pain Rating Scale: The NPRS is free for all health care organizations, and a license is not needed. EQ-5D-3L - EuroQol‐5D descriptive system (EQ-­5D‐3L) and visual analogue scale (EQ-­VAS): The EQ-5D-3L is free for non-profits and academic research, but a license is needed for use (therefore not included in this version of the standard set). https://euroqol.org/support/how-to-obtain-eq-5d/ Publication: R Carter Clement, Adina Welander, Caleb Stowell, Thomas D Cha, John L Chen, Michelle Davies, Jeremy C Fairbank, Kevin T Foley, Martin Gehrchen, Olle Hagg, Wilco C Jacobs, Richard Kahler, Safdar N Khan, Isador H Lieberman, Beth Morisson, Donna D Ohnmeiss, Wilco C Peul, Neal H Shonnard, Matthew W Smuck, Tore K Solberg, Bjorn H Stromqvist, Miranda L Van Hooff, Ajay D Wasan, Paul C Willems, William Yeo & Peter FRitzell (2015) A proposed set of metrics for standardized outcome reporting in the management of low back pain, Acta Orthopaedica, 86:5, 523-533 ICHOM received an endorsement of Arthritis Research UK for the development of this standard set.

Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; Study ID: 104574 - Baseline Form

- 28.08.18 - 1 Formular, 5 Itemgruppen, 62 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Patient Information, Clinical Assessment Pre-Randomization, Pre-Randomization Laboratory Tests, Patient History
Study ID: 104574 Clinical Study ID: AR1104574 Study Title: A randomized blinded pilot trial of fondaparinux sodium (Arixtra®) versus unfractionated heparin in addition to standard therapy in a broad range of patients undergoing percutaneous coronary intervention (ASPIRE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thromboembolism

ICHOM Chronic Kidney Disease - Baseline Characteristics, Baseline Condition Factors and Treatment-specific Variables (administrative / clinical)

- 27.07.18 - 1 Formular, 4 Itemgruppen, 43 Datenelemente, 1 Sprache
Itemgruppen: Patient ID, Baseline Characteristics, Baseline Condition Factors, Treatment-specific
CHRONIC KIDNEY DISEASE DATA COLLECTION REFERENCE GUIDE Version 1.0.0 Revised October 25th, 2017 www.ichom.org Conditions: Chronic Kidney Disease Stage G3a/A3 | Chronic Kidney Disease StageG 3b/A2/A3 | Chronic Kidney Disease Stage G4 | Chronic Kidney Disease Stage G5 (KDIGO 2012 Stages) Treatment Approaches: Pre-RRT = Pre-Renal Replacement Therapy | HD = Haemodialysis | PD = Peritoneal Dialysis | Tx = Renal Transplantation | CC = Conservative Care This ODM-file contains Baseline Characteristics, Baseline Condition factors and Treatment-specific variables, clinical or administrative. To be collected at Baseline Visit. Surveys used: The OptumTM SF-36v2® Health Survey: The SF-36v2 Health Survey requires a license agreement prior to the use or reprodution of the tool. Information on how to obtain a license can be found here: bit.ly/SF36LIC . The scoring guide for the SF36v2 is only available upon a license agreement being made. Due to the requirement of a license the Score cannot be found in this version of the standard set. PROMIS-Global Health and PROMIS-29: Free for use in clinical practice and a license is not required. Information http://www.nihpromis.org/measures/translations . The scoring guides for the two PROMIS Scores can be found at bit.ly/PROMISGLOBALSCORE and bit.ly/PROMIS29SCORE . RAND-36: Free for use in clinical practice and a license is not required. The RAND-36 is available in English and Arabic. https://www.rand.org/health/surveys_tools/mos/36-item-short-form.html . The Scoring guide can be found at bit.ly/RAND36Score .

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Baseline Visit

- 19.04.18 - 1 Formular, 5 Itemgruppen, 23 Datenelemente, 1 Sprache
Itemgruppen: Vital Signs, Psychiatric Evaluation, Pharmacokinetic Sampling, Atypical Antipsychotic Dosing, Quality of Life Assessment
Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Baseline Visit.

REGIMS Registry Baseline - Baseline Main Sheet

- 27.02.18 - 3 Formulare, 25 Itemgruppen, 116 Datenelemente, 2 Sprachen
Itemgruppen: Ein-Ausschlusskriterien, Patientendaten, Krankheitsspezifische Angaben, EDSS-Score vor 12 Monaten, Heutige Scores der Funktionssysteme, Frühere verlaufsmodifizierende MS-Therapien, Aktuelle MS-Therapie, WeitereErkrankungen, Herz- / Kreislauferkrankungen, Stoffwechselerkrankungen, Infektionserkrankungen, Gastrointestinale Erkrankungen, Neurologische / Psychiatrische Erkrankungen, Allergien, Urogenitale Erkrankungen, Autoimmunerkrankungen, Blutbild / Labor, Allgemeine Symptome, Operation, Krebserkrankungen, Welche Therapien wurden aufgrund der Krebserkrankung durchgeführt?, Andere Erkrankung, Keine Vorerkrankungen aus diesen obigen Krankheitsgruppen/Erkrankungen bekannt, Schwangerschaft, Biologisches Material (z.B. Blut)
Baseline items for semantic analysis of the Multiple sclerosis immunotherapy registry REGIMS of the Institute of Epidemiology and Social Medicine of the University Hospital Münster provided by Prof. Dr. Klaus Berger and Dr. Maximov Stanislav.