Zoekresultaten - Portaal voor medische datamodellen (MDM-portaal)

Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664 - Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7

- 23-05-18 - 1 Formulier, 4 Itemgroepen, 56 Data-elementen, 1 Taal

Itemgroepen: Dosimetric Dose - Day 0, Vital Signs, Therapy Dose - Day 7, Vital Signs

https://clinicaltrials.gov/show/NCT00989664 Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7 Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Interim Visit HOMe aFers 1 NCT02905539

- 29-12-17 - 1 Formulier, 12 Itemgroepen, 40 Data-elementen, 1 Taal

Itemgroepen: Administrative data, Adverse events, Pre- and concomitant therapy, Vital parameters, Physical Examination, Collection of biological samples_interim visit, Signature for interim visit, Medical history, Intercurrent diseases, Adverse events, Serious adverse events, Pre- and concomitant therapy

Interim visit form Interimsvisite NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Visit 5 HOMe aFers 1 NCT02905539

- 29-12-17 - 1 Formulier, 12 Itemgroepen, 49 Data-elementen, 1 Taal

Itemgroepen: Administrative data, Adverse events, Pre- and concomitant therapy, Questionnaire 1, Questionnaire 2, Questionnaire 3, Vital parameters, Anthropometric Data, Physical Examination, 12-lead ECG, Collection of biological samples_visit 5, Signature for visit 5

Visit 5 form Visite 5 NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Visit 4 HOMe aFers 1 NCT02905539

- 23-12-17 - 1 Formulier, 10 Itemgroepen, 39 Data-elementen, 1 Taal

Itemgroepen: Administrative data, Adverse events, Pre- and concomitant therapy, Vital parameters, Physical Examination, 12-lead ECG, 24-hour ECG, Echocardiography, Collection of biological samples_visit 4, Signature for visit 4

Visit 4 form Visite 4 NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Visit 3 HOMe aFers 1 NCT02905539

- 22-12-17 - 1 Formulier, 6 Itemgroepen, 18 Data-elementen, 1 Taal

Itemgroepen: Administrative data, Adverse events, Pre- and concomitant therapy, Vital parameters, Collection of biological samples_Visit 3, Signature for visit 3

Visit 3 form Visite 3 NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Visit 2 after study drug administration HOMe aFers 1 NCT02905539

- 17-12-17 - 1 Formulier, 3 Itemgroepen, 6 Data-elementen, 1 Taal

Itemgroepen: Adverse events, Collection of biological samples_visit 2_after study drug administration, Signature for Visit 2

Visit 2 after study drug administration form Visite 2 – nach Verabreichung der Studienmedikation NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Visit 2 study drug administration form HOMe aFers 1 NCT02905539

- 17-12-17 - 1 Formulier, 2 Itemgroepen, 9 Data-elementen, 1 Taal

Itemgroepen: Reconstitution, Surveillance protocol

Visit 2 study drug administration form Visite 2 – Verabreichung der Studienmedikation NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Visit 2 before study drug administration HOMe aFers 1 NCT02905539

- 17-12-17 - 1 Formulier, 11 Itemgroepen, 33 Data-elementen, 1 Taal

Itemgroepen: Administrative data, Intercurrent diseases, Concomitant therapy, Questionnaire 1, Questionnaire 2, Questionnaire 3, Vital parameters, Anthropometric Data, 12-lead ECG, Echocardiography, Collection of biological samples_Visit 2_ before study drug administration

Visit 2 before study drug administration form Visite 2 - vor Verabreichung der Studienmedikation NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Visit 1 Screening Visit HOMe aFers 1 NCT02905539

- 17-12-17 - 1 Formulier, 13 Itemgroepen, 51 Data-elementen, 1 Taal

Itemgroepen: Screening visit, Consent for participation in the study, Demographic Data, Medical History, Pre- and concomitant therapy, Questionnaire, Vital parameters, Anthropometric Data, Physical Examination, 12-lead ECG, 24-hour ECG, Collection of biological samples_visit 1, Signature for visit 1 (screening visit)

Visit 1 Screening Visit form NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes