Suchergebnisse - Portal für Medizinische Datenmodelle (MDM-Portal)

Adverse events LenaMain-Study - Adverse Events CTC

- 17.03.16 - 1 Formular, 1 Itemgruppe, 24 Datenelemente, 1 Sprache

Itemgruppe: Adverse Events

A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma. Protocol-Code: RV-MM-PI-280 EudraCT-Number: 2007-003945-33 Author: Claus Schreiber Review: Gerd Felder Approval of CRF: Prof. Dr. med. G. Kobbe (LKP) Release for MDM: Prof. Gattermann, Düsseldorf (26.1.2016) Principal Investigator „LenaMain“-Studie: Prof. Roland Fenk, Düsseldorf Coordinating center for clinical trial Medical faculty of University Hospital Heinrich-Heine-University Scientific Director: Herr Dr. J. Grebe Moorenstrasse 5 40225 Düsseldorf Tel.: +49 (0) 211-81-19701 Fax: +49 (0) 211-81-19702

On-Study - Adverse Events - 2804058v1.0 - Adverse Events

- 09.01.15 - 1 Formular, 3 Itemgruppen, 22 Datenelemente, 1 Sprache

Itemgruppen: DCP Template Header, Adverse Events, DCP Template Footer

The Division of Cancer Prevention's adverse events case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C3563B2-CBFA-3E8F-E044-0003BA3F9857

Ewing Study SAE DRKS00003588 - SAE

- 04.08.14 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 2 Sprachen

Itemgruppen: Show identification of patient, SAE

EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

Rotavirus Vaccine RIX4414 Study NCT00289172 - Serious Adverse Event

- 13.04.18 - 1 Formular, 14 Itemgruppen, 51 Datenelemente, 1 Sprache

Itemgruppen: Header, Serious adverse event, Seriousness, Demography data, SECTION 4, SECTION 5, Relevant Medical Conditions, Other relevant risk factors, Document section Concomitant Medications, Details of investigational product, Details of relevant Assessments, Narrative Remarks, Investigator's signature, follow-up information SAE

A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Study ID:103792 Clinical Study ID:103792 Study Title: A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:NCT00289172 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: BIO ROTA; Rotarix Study Indication: Infections, Rotavirus CRF Seiten: 375-430

Rotavirus Vaccine RIX4414 Study NCT00289172 - gastroenteritis, concomitant vaccination, medication and non-serious adverse events

- 13.04.18 - 1 Formular, 8 Itemgruppen, 38 Datenelemente, 2 Sprachen

Itemgruppen: Header, Gastroenteritis Episodes, Gastroenteritis protocol, Concomitant Vaccination, Concomitant Vaccination, Medication, Medication, Non-serious Adverse Events

A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Study ID:103792 Clinical Study ID:103792 Study Title: A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:NCT00289172 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: BIO ROTA; Rotarix Study Indication: Infections, Rotavirus CRF Seiten: 375-430

On-Study - AE and Conmed Evaluation - 2803423v1.0 - AE and Conmed Evaluation

- 09.01.15 - 1 Formular, 3 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: DCP Template Header, AE and Conmed Evaluation Form, DCP Template Footer

The Division of Cancer Prevention's AE and conmed evaluation case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C1255DF-0CBA-43D9-E044-0003BA3F9857

Ewing Study Event date DRKS00003588 - Event date

- 04.08.14 - 1 Formular, 1 Itemgruppe, 2 Datenelemente, 2 Sprachen

Itemgruppe: Event date

EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Serious Adverse Event (SAE)

- 24.05.20 - 1 Formular, 16 Itemgruppen, 67 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Serious Adverse Event, SECTION 1, SECTION 2: Seriousness, SECTION 3 Demography Data, SECTION 4 If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?, SECTION 5 Possible Causes of SAE Other Than Investigational Product(s), SECTION 6 RELEVANT Medical Conditions, SECTION 7 Other RELEVANT Risk Factors, SECTION 8 RELEVANT Concomitant Medications, SECTION 9 Details of Investigational Product(s) - Treatment Period 1, SECTION 9 Details of Investigational Product(s) - Treatment Period 2, SECTION 10 Details of relevant Assessments, SECTION 11 Narrative Remarks, Investigator's name and signature, SECTION 12: Additional/Follow-Up Information

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Serious adverse event (SAE) Form has to be filled in whenever such events occur during the study.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Non-serious adverse events (AE)

- 24.05.20 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Non-serious adverse events (AE)

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Non-serious adverse events (AE) Form has to be filled in whenever such events occur during the study. If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.

Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857 - Serious adverse events, Form D and Vitals

- 26.02.18 - 1 Formular, 8 Itemgruppen, 47 Datenelemente, 1 Sprache

Itemgruppen: Administration, Serious adverse experience, Form D, Orthostatic vital signs, Dose and meal information, Medical Procedures, Concomitant Medication, Adverse experiences

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome; Restless Legs Syndrome (RLS)

Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857 - Non-serious adverse events and study conclusion

- 26.02.18 - 1 Formular, 5 Itemgruppen, 19 Datenelemente, 1 Sprache

Itemgruppen: Administration, Adverse experience, Pregnancy information, Study conclusion, Administration Investigator

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome; Restless Legs Syndrome (RLS)

Serious adverse events GSK study Prostatic neoplasms NCT00883909

- 26.11.17 - 1 Formular, 14 Itemgruppen, 58 Datenelemente, 1 Sprache

Itemgruppen: administrative data, Serious adverse event, Serious adverse event, SAE, Demography data, Recurrence of SAE, Causes of SAE, Relevant Medical Conditions, risk factors, concomitant medication, Drug Details, Assessments, Remarks, information Investigator

Study ID: 103094 Clinical Study ID: ARI103094 Study Title: ARI103094-Follow-Up Study for REDUCE Study Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00883909 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Neoplasms, Prostate

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