Keywords
Adverse event ×
Show more Keywords
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
Selected data models

You must log in to select data models for download or further analysis.

891 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.

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

CDASH Adverse Event - Adverse Event

- 6/20/18 - 1 form, 2 itemgroups, 18 items, 2 languages
Itemgroups: General information, Details
translated and modified from CDASH Adverse Event 2011-10-24 http://www.cdisc.org/

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

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - Logs and Repeats

- 1/15/20 - 1 form, 16 itemgroups, 156 items, 1 language
Itemgroups: Date of visit, Assessment Date, Adverse Event; Concomitant Agent; Evaluation, Repeat, Liver, Adverse Event, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Laboratory Procedures, Vital signs, Pharmacokinetic aspect, Blood, Repeat, Pulmonary function tests, Repeat, Holter Electrocardiography, Repeat, Holter Electrocardiography, Abnormality, Repeat, Telemetry, Repeat, Telemetry, Abnormality, Repeat, 12 lead ECG, Abnormality, Repeat, 12 lead ECG
Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532) - Adverse Events

- 1/9/20 - 1 form, 19 itemgroups, 77 items, 1 language
Itemgroups: Administrative, Adverse Events, Adverse Event - Intensity Changes, Serious Adverse Event, Randomisation, Adverse Event - Seriousness, Relevant Concomitant/Treatment Medications, Lab Sequence Number, Relevant Diagnostic Results, Adverse Events - Rechallenge, General Narrative Comments, Possible suicidality-related adverse event - Section 1, Possible suicidality-related adverse event - Section 2, Possible suicidality-related adverse event - Section 3 , Possible suicidality-related adverse event - Section 4 , Possible suicidality-related adverse event - Section 5 , Possible suicidality-related adverse event - Section 6 , Possible suicidality-related adverse event - Section 7 , Possible suicidality-related adverse event - Section 8
Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - Liver Event

- 1/5/20 - 1 form, 11 itemgroups, 103 items, 1 language
Itemgroups: Date of visit, Adverse Event, Liver, Experimental drug, Liver, Pharmacokinetic aspects, Liver, Liver, Adverse Event, Disease, Liver, Adverse Event, Disease, Drug-related disorder, Liver, Adverse Event, Liver diseases, Other, Liver, Adverse Event, Disease, Other, Liver, Adverse Event, Alcohol consumption, Liver, Adverse Event, Imaging of liver, Liver, Adverse Event, Biopsy of liver
Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

Brain Penetration by [Carbonyl-11C] GSK1034702; 110771 - Serious Adverse Event (SAE)

- 12/18/19 - 1 form, 13 itemgroups, 44 items, 1 language
Itemgroups: Administrative documentation, Serious Adverse Event, Serious Adverse Event, Seriousness of Adverse Event, Serious Adverse Event, Demography, Serious Adverse Event, Relationships, Experimental drug, Serious Adverse Event, Etiology aspects, Serious Adverse Event, Disease, Serious Adverse Event, Risk factors, Serious Adverse Event, Concomitant Agent, Serious Adverse Event, Experimental drug, Details, Serious Adverse Event, Diagnostic Procedure, Serious Adverse Event, Comment, Serious Adverse Event, Investigator Signature
Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.

Brain Penetration by [Carbonyl-11C] GSK1034702; 110771 - Non-Serious Adverse Events (AE)

- 12/18/19 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Administrative documentation, Non-serious Adverse Event
Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.

Brain Penetration by [Carbonyl-11C] GSK1034702; 110771 - Liver Events Assessment

- 12/17/19 - 1 form, 2 itemgroups, 3 items, 1 language
Itemgroups: Administrative documentation, Liver, Adverse event, Evaluation
Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.