Résultats de recherche - Portail des modèles médicaux de données (portail MDM)

Drug Safety Patient-Reported Adverse Drug Event Questionnaire Part A

- 20/09/2021 - 1 Formulaire, 19 Groupes Item, 306 Eléments de données, 1 Langue

Groupes Item: General Information, Drug use, Symptoms, Symptoms Eyes eyelids, Symptoms Ear, nose and throat swallowing, Symptoms Sweating blushing temperature flu, Symptoms Mouth lips speech, Symptoms Tongue teeth taste, Symptoms chest sleep apnea blood, Symptoms Bladder urination, Symptoms Intestines stomach vomiting, Symptoms Skin hair nails, Symptoms Genitals menopause menstruation, Symptoms Muscles bones joints, Symptoms Dizziness falling balance, Symptoms Head brain moods, Symptoms Sleep fatigue, Symptoms Eating drinking weight, Symptoms Infection edema fungal infection

Study description: Patient-Reported Adverse Drug Event Questionnaire for the evaluation of drug safety, Part A. Publication granted by Sieta de Vries. Publishing results based on the questionnaire should include the following reference: de Vries, S.T., Mol, P.G.M., de Zeeuw, D. et al. Drug Saf (2013) 36: 765. doi:10.1007/s40264-013-0036-8

Eligibility Oral Mucositis NCT01265810

- 21/01/2021 - 1 Formulaire, 2 Groupes Item, 15 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion Criteria

The objective is to assess the relieving effect of Caphosol® oral rinse on clinical outcomes which include oral intake, swallowing function and pain associated with incidence of grade ≥ 1 oral side effects and the anticancer therapy cessation in patients treated with selected targeted anticancer therapy.

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611 - Repeating Logs

- 30/10/2019 - 1 Formulaire, 8 Groupes Item, 70 Eléments de données, 1 Langue

Groupes Item: Administrative data, Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions), NON-SERIOUS ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, RELEVANT CONCOMITANT/TREATMENT MEDICATIONS, RELEVANT MEDICAL CONDITION/RISK FACTORS, 12-lead/Holter/Telemetry ECG, CONCOMITANT MEDICATION

Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

Bfarm Pharmacovigilance - Report about an adverse Drug Reaction (BERICHT ÜBER UNERWÜNSCHTE ARZNEIMITTELWIRKUNGEN)

- 11/08/2019 - 1 Formulaire, 14 Groupes Item, 55 Eléments de données, 2 Langues

Groupes Item: Basic Data, Observed adverse drug reaction, Involved Drugs, Suspected Drug, Diseases, Anamnestic Specifics, Clinical Laboratory Tests, Therapy of adverse drug reaction, Outcome of the adverse drug reaction, Causality, Informed entities, Signatory Data, Manufacturer, Signature

Der UAW-Meldebogen des Bundesinstituts für Arzneimittel und Medizinprodukte. https://www.bfarm.de/SharedDocs/Formulare/DE/Arzneimittel/Pharmakovigilanz/aa-uaw-melde-bogen.html The english translation of the german form is not an official state-approved version, but a translation by the researchers at the institute for medical informatics. Das Bundesinstitut für Arzneimittel und Medizinprodukte bittet Sie, Meldungen über unerwünschte Arzneimittelwirkungen auf dem vorliegenden Berichtsbogen BfArM 643 zu erstatten, damit eine rasche Auswertung und EDV-mäßige Bearbeitung gewährleistet ist. Je vollständiger der Berichtsbogen ausgefüllt wird, um so sicherer wird die Auswertung und Abschätzungeines Arzneimittelrisikos sein können. Unvollständige Daten sollten jedoch kein Hinderungsgrund für eine Meldung sein. Um auch bisher unbekannte Arzneimittelrisiken erfassen zu können, ist es notwendig,auch in Verdachtsfällen und beim Auftreten unerwünschter Wirkungen, die bisher nicht mit den verabreichten Arzneimitteln in Verbindung gebracht wurden, einen Berichtsbogen auszufüllen. Dem Berichtsbogen können alle Ihnen zu dieser unerwünschten Arzneimittelwirkung, insbesondere über die Symptomatik und den Verlauf zur Verfügung stehende Unterlagen (z.B. Untersuchungsbefunde,Labordaten, Sektionsprotokolle) in Kopie beigelegt werden. Füllen Sie die Angaben zur Person des Patienten bitte so vollständig wie möglich aus, da hierdurch doppelt gemeldete unerwünschte Wirkungen erkannt werden können. Geben Sie die Initialen des Patienten bitte in der Reihenfolge Name - Vorname an. Die Daten zu den verabreichten Arzneimitteln sollten so genau wie möglich, d.h. unter Berücksichtigungder vollständigen Bezeichnung (z.B. retard, forte), der Darreichungsform, der Stärke, der Dosierung und der Art der Anwendung (z.B. p.o., i.v., i.m.) angegeben werden. Das Arzneimittel, das vermutlich die unerwünschte Wirkung ausgelöst hat, sollte entsprechend gekennzeichnet werden. Alle auf dem Berichtsbogen angegebenen patienten- und arztbezogenen Daten werden den Bestimmungen des Bundesdatenschutzgesetzes entsprechend vertraulich behandelt. Weitere Vordrucke des Berichtsbogens sind beim Bundesinstitut für Arzneimittel und Medizinprodukte,Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn erhältlich.

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Treatment Completion Form

- 14/03/2019 - 1 Formulaire, 10 Groupes Item, 39 Eléments de données, 1 Langue

Groupes Item: Administrative data, Treatment Completion, Tumor Measurements, Best Tumor Response, Follow-Up Form, Disease Follow-Up Status, Notice of New Primary, Long Term Adverse Events, Adverse Events details, Additional Cancer Therapy

Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer

the Effect of Food on the Pharmacokinetics of a Tablet Formulation - 103268 - Adverse Events

- 13/03/2019 - 1 Formulaire, 14 Groupes Item, 51 Eléments de données, 1 Langue

Groupes Item: Administrative data, Serious Adverse Event, SECTION 1, Seriousness, SECTION 3: Demography Data, Document section, Section 5, Relevant Medical Conditions, Other relevant risk factors, Document section Concomitant Medications, Section 9 - Investigational Product, Details of relevant Assessments, SECTION 11 Narrative Remarks, Investigator signature

Study ID: 103268 Clinical Study ID: 103268 Study Title: An Open Label, Randomised, Single Dose, Three-way Crossover Study to Investigate the Relative Bioavailability of Two Different Formulations of GSK163090 and the Effect of Food on the Pharmacokinetics of a Tablet Formulation in Healthy Male and Female Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00536679 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK163090 capsule, fasted/fed Trade Name: N/A Study Indication: Depression; Depressive Disorder and Anxiety Disorders

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611 - Liver Event Form

- 13/03/2019 - 1 Formulaire, 11 Groupes Item, 108 Eléments de données, 1 Langue

Groupes Item: Administrative data, Liver Event, Investigational Product, Pharmacokinetics - Blood, Medical Conditions, Drug Related Liver Disease Conditions, Other Liver Disease Conditions, Other medical conditions, Alcohol Intake, Liver imaging, Liver Biopsy

Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611 - Follow-Up

- 12/03/2019 - 1 Formulaire, 12 Groupes Item, 69 Eléments de données, 1 Langue

Groupes Item: Administrative data, STATUS OF TREATMENT BLIND, STUDY CONCLUSION, PREGNANCY INFORMATION, Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions), NON-SERIOUS ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, RELEVANT CONCOMITANT/TREATMENT MEDICATIONS, RELEVANT MEDICAL CONDITION/RISK FACTORS, RELEVANT DIAGNOSTIC RESULTS, INVESTIGATIONAL PRODUCTS, GENERAL NARRATIVE COMMENTS

Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Concomitant Medication, Non-Serious Adverse Events, Study Conclusion

- 11/03/2019 - 1 Formulaire, 14 Groupes Item, 53 Eléments de données, 1 Langue

Groupes Item: Administrative data, CONCOMITANT VACCINATION, Vaccination details, CONCOMITANT MEDICATION, Medication details, NON-SERIOUS ADVERSE EVENTS, Adverse Events, STUDY CONCLUSION, PREGNANCY INFORMATION, ELIMINATION CRITERIA, SUBJECT WITHDRAWAL, INVESTIGATOR'S SIGNATURE, USE OF HUMAN SAMPLES BY GSK, INVESTIGATOR'S SIGNATURE

Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza

Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Visit "Day 21"

- 11/03/2019 - 1 Formulaire, 19 Groupes Item, 112 Eléments de données, 1 Langue

Groupes Item: Administrative data, ELIMINATION CRITERIA, CHECK FOR STUDY CONTINUATION, LABORATORY TESTS, SOLICITED ADVERSE EVENTS - LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Induration, Local Symptoms - Ecchymosis, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, General Symptoms - Temperature, General Symptoms - Fatigue, General Symptoms - Headache, General Symptoms - Myalgia, General Symptoms - Shivering, General Symptoms - Arthralgia, General Symptoms - Sweating increase, UNSOLICITED ADVERSE EVENTS

Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza

Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Visit "Day 0" Vaccination

- 11/03/2019 - 1 Formulaire, 29 Groupes Item, 196 Eléments de données, 1 Langue

Groupes Item: Administrative data, ELIMINATION CRITERIA, INFORMED CONSENT, DEMOGRAPHICS, ELIGIBILITY CHECK, INCLUSION CRITERIA, EXCLUSION CRITERIA, TREATMENT ALLOCATION, GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION, HISTORY OF INFLUENZA VACCINATION, LABORATORY TESTS, HCG URINE PREGNANCY TEST, VACCINE ADMINISTRATION, VACCINE NON-ADMINISTRATION, SOLICITED ADVERSE EVENTS - LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Induration, Local Symptoms - Ecchymosis, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, General Symptoms - Temperature, General Symptoms - Fatigue, General Symptoms - Headache, General Symptoms - Myalgia, General Symptoms - Shivering, General Symptoms - Arthralgia, General Symptoms - Sweating increase, UNSOLICITED ADVERSE EVENTS

Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Concomitant Medication, Adverse Events Forms

- 07/03/2019 - 1 Formulaire, 12 Groupes Item, 50 Eléments de données, 1 Langue

Groupes Item: Administrative data, CONCOMITANT VACCINATION, Concomitant Vaccination Details, CONCOMITANT MEDICATION, Concomitant Medications Details, NON-SERIOUS ADVERSE EVENTS, Non-Serious Adverse Events Log, STUDY CONCLUSION, OCCURRENCE OF SERIOUS ADVERSE EVENT, STATUS OF TREATMENT BLIND, ELIMINATION CRITERIA, INVESTIGATOR'S SIGNATURE

Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal

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