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Table of contents
  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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899 Search results.

Quality assurance Follow-up Heart Transplant (AQUA) - Quality assurance Follow-up Liver Transplant (AQUA)

- 9/27/19 - 1 form, 2 itemgroups, 16 items, 2 languages
Itemgroups: Follow-up(auszufüllen nach 1, 2 und 3 Jahren), Überlebensstatus des Empfängers
Documentation form for quality assurance in German Health Care by the Institute for Applied Quality Improvement and Research in Health Care (Aqua), https://www.aqua-institut.de/en/home. Internal Aqua form version: HTXFU Specification 2015 V02

REGIMS Multiple Sclerosis Immunotherapy Registry Version 2016 - Follow Up Adverse Events

- 12/7/17 - 9 forms, 14 itemgroups, 50 items, 2 languages
Itemgroups: Angaben zum unerwünschtes Ereignis, Weitere Angaben zum unerwünschtes Ereignis, Einstufung des Ereignisses, Ausgang, Kausalität (UE & MS-Medikation), MS-Medikation, Kausalität (UE & Begleitmedikation), Begleitmedikation, Schwerwiegende unerwünschte Ereignisse, Patientenangaben, Behandlung, Relevante Vorerkrankung / Symptome, Ergebnisse der relevanten Diagnostischen Untersuchungen, Kontaktdaten des Berichterstatters
REGIMS is a registry of the administration, adverse events and benefit of immunotherapeutic agents in patients with Multiple Sclerosis. REGIMS is a project from the Institute of Epidemiology and Social Medicine of the University of Muenster, publication granted by Prof. Dr. Berger. For further information (in German), please view http://campus.uni-muenster.de/index.php?id=6075 or http://www.kompetenznetz-multiplesklerose.de/aktuelle-studien/regims. REGIMS ist ein Immuntherapieregister zur Verbesserung der Arzneimittelsicherheit in der Multiple Sklerose Therapie innerhalb des krankheitsbezogenen Kompetenznetzes MS. Das primäre Ziel von REGIMS ist die Erfassung der Häufigkeit, Charakteristika und Auswirkungen von Nebenwirkungen aktueller und neuer Immuntherapien in der klinischen Routinebehandlung der MS. Sekundäre Ziele sind die Auswertung von Faktoren, die a) mit Nebenwirkungen und b) mit guter Therapie-Adhärenz assoziiert sind. Optional können bei Zustimmung der Patienten Blutproben für die Biobank des KKNMS gesammelt werden. Patienten mit Multipler Sklerose (MS) weisen trotz des chronischen Verlaufs eine große Heterogenität klinischer Symptome, in Befunden der Bildgebung sowie pathophysiologischen Prozessen auf. Faktoren, die zur individuellen Krankheitsprognose beitragen sind kaum bekannt, jedoch hat die Einführung neuer Substanzen die Therapiemöglichkeiten der MS in den letzten Jahren deutlich erweitert. Die Anwendung sogenannter Immuntherapeutika (inklusive der neuen Substanzklasse der Biologika) bietet in der MS-Therapie eine Reihe von Chancen, birgt aber auch Risiken.

Follow Up Main Sheet

4 itemgroups, 15 items31

Follow Up Pregnancy Part 1

5 itemgroups, 24 items31

Follow Up Medication Change

3 itemgroups, 11 items31

Follow Up Pregnancy Part 2

5 itemgroups, 21 items31
4 more forms meeting the search are available in the detailed view.

CDASH Adverse Event - Adverse Event

- 3/9/20 - 1 form, 2 itemgroups, 18 items, 2 languages
Itemgroups: General information, Details Adverse Event
translated and modified from CDASH Adverse Event 2011-10-24 http://www.cdisc.org/

NCI Standard Adverse Event/Serious Adverse Event CTCAE v3 Template - 2748814v1.0 - NCI Standard Adverse Event/Serious Adverse Event CTCAE v3 Template

- 2/5/19 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: Mandatory Adverse Event Questions, Conditional Adverse Event Questions, Optional Adverse Event Questions, Optional Serious Adverse Event Questions
The collection of CDEs used in the Adverse Events/Serious Adverse Events module. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4D0BC7DD-57DD-63BE-E044-0003BA3F9857

Breast Cancer Adverse Event NCT00382070 - rade 2 and 3 Adverse Event Report Breast Cancer NCT00382070 NSABP B-42

- 4/1/15 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Header, Adverse event
NSABP Protocol B-42 - Grade 2 and 3 Adverse Event (AE) Report Form Worksheet Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer NCT00382070 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17ADF05F-DB75-341D-E044-0003BA3F9857

REGIMS - SUE Report

- 6/25/15 - 1 form, 10 itemgroups, 43 items, 2 languages
Itemgroups: SUE, Patientenangaben, SUE: Beschreibung, SUE: Behandlung, SUE: Ausgang, SUE: MS-Medikation, SUE: Begleitmedikation, SUE: Relevante Vorerkrankung / Sypmtome, Ergebnisse der relevanten Diagnostischen Untersuchungen, Kontaktdaten des Berichterstatters
Schwerwiegendes unerwünschtes Ereignis (SUE) in der Therapie SUE Berichtsformular Bitte ausfüllen und faxen oder senden an: Westfälische Wilhelms-Universität Münster, Institut für Epidemiologie und Sozialmedizin, Albert-Schweitzer-Campus 1, Gebäude 03, 48149 Münster Fax: (0251) 83-55300, E-Mail: regims@uni-muenster.de http://epi.uni-muenster.de

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883 - Adverse Events; Demography; Height Weight; ECG

- 4/6/20 - 1 form, 7 itemgroups, 85 items, 1 language
Itemgroups: Administrative, Adverse Events, Serious Adverse Events, Demography, Height Weight, ECG, ECG Holter
Study ID: 111314 Clinical Study ID: 111314 Study Title: A first-time-in-human, three-part, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00857883 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1521498 or placebo Study Indication: Obesity

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Log Status; Non-Serious Adverse Events; Serious Adverse Events

- 3/25/20 - 1 form, 14 itemgroups, 102 items, 1 language
Itemgroups: Log Status, Non-Serious Adverse Event, Serious Adverse Event - Type of Report, Serious Adverse Event - Randomisation, Serious Adverse Event, Serious Adverse Event - Seriousness, Serious Adverse Event - Relevant Concomitant/ Treatment Medications, Serious Adverse Event - Relevant Medical Conditions/Risk Factors, Serious Adverse Event - Relevant Diagnostic Results, Serious Adverse Event - Rechallenge, Serious Adverse Event - Investigational Product Double Blind Phase, Serious Adverse Event - Investigational Product Open Label Phase, Serious Adverse Event - General Narrative Comments, Serious Adverse Event - Non Clinical
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

FHIR v4.0.1 - Resource Medicinal Product Undesirable Effect (0)

- 3/18/20 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: MedicinalProductUndesirableEffect (0)
https://www.hl7.org/fhir/resourcelist.html (accessed at 06.02.2020) This form contains an incomplete implementation of the FHIR Resource Medicinal Product Undesirable Effect (0). After preliminary review, it contains the data elements that request clinical information.

FHIR v4.0.1 - Resource Adverse Event (0)

- 3/10/20 - 1 form, 1 itemgroup, 16 items, 1 language
Itemgroup: AdverseEvent
The form corresponds to an incomplete version of FHIR Resource AdverseEvent, v4.0.1. It contains all data elements that query a medical issue. The file was created for analysis purposes. https://www.hl7.org/fhir/resourcelist.html 02.01.2020

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Liver events

- 3/5/20 - 1 form, 9 itemgroups, 42 items, 1 language
Itemgroups: Administrative data, Liver event, Investigational product (Liver), Pharmacokinetics (Liver PK), Liver disease medical conditions, Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake
Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the liver events form. It has to be filled in if a liver event occurs during the study.

Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055 - Subject Logs - Log Status; Concomitant Medications; Non-Serious Adverse Event; Serious Adverse Events

- 2/24/20 - 1 form, 15 itemgroups, 131 items, 1 language
Itemgroups: Date of Visit/ Assessment, Log Status, Concomitant Medications, Non-Serious Adverse Event, Serious Adverse Event - Type of Report, Serious Adverse Event - Randomisation, Serious Adverse Event, Serious Adverse Event - Intensity Changes, Serious Adverse Event - Seriousness, Serious Adverse Event - Relevant Concomitant/ Treatment Medications, Serious Adverse Events - Relevant Medical Conditions/ Risk Factors, Serious Adverse Event - Relevant Diagnostic Results, Serious Adverse Event - Rechallenge, Serious Adverse Event - Investigational Product, Serious Adverse Event - Non clinical
Study ID: 110852 Clinical Study ID: 110852 Study Title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01134055 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib eye drops, ranibizumab intravitreal injection, placebo Trade Name: pazopanib, ranibizumab Study Indication: Macular Degeneration