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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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157 Search results.

26672_Common Data Elements Myeloid Leukemia (MDS AML CML) - Global Disease Course

- 4/21/18 - 13 forms, 3 itemgroups, 11 items, 1 language
Itemgroups: Global Disease Course, Red Cell Transfusion, Platelet Cell Transfusion
Common Data Elements Myeloid Leukemia (MDS, AML, CML) for use in clinical routine and clinical trial documentation. https://www.ncbi.nlm.nih.gov/pubmed/27577388

Physical Examination/Follow up

3 itemgroups, 14 items31

Administrative/Demographic Details

1 itemgroup, 11 items31

Apparatus-based Diagnostics

1 itemgroup, 4 items31

Medical History

3 itemgroups, 9 items31
8 more forms meeting the search are available in the detailed view.

10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010 - Concomitant Medication

- 8/28/19 - 1 form, 3 itemgroups, 14 items, 1 language
Itemgroups: Administrative documentation, Concomitant Medication, Concomitant Medication Details
Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains information on concomitant medication the subject has received, which should be recorded at the Interim Analysis at/after Visit 6 and at the End of Study Analysis at/after Visit 10. At each study visit/contact, the investigator should question the subject's parent(s)/guardian(s) about any medication(s) taken. All concomitant medication, with the exception of vitamins and/or dietary supplements, administered at ANY time during the period starting with administration of each dose of the study vaccines and ending one month (minimum 30 days) after each dose of the study vaccines are to be recorded with generic name of the medication (trade names are allowed for combination drugs, i.e. multi-component drugs), medical indication, total daily dose, route of administration, start and end dates of treatment. Anti-retroviral therapy taken at any time during the entire study period is to be recorded with generic name of the medication (trade names are allowed for combination drugs only), medical indication, total daily dose, route of administration, start and end dates of treatment. Any treatments and/or medications specifically contraindicated, e.g., any immunoglobulins, other blood products and any immune modifying drugs administered since birth or at any time during the study period are to be recorded with generic name of the medication (trade names are allowed for combination drugs only), medical indication, total daily dose, route of administration, start and end dates of treatment. During the period starting with the administration of each dose of the study vaccines and ending one month (minimum 30 days) after each dose of the study vaccines, concomitant medication administered for the treatment of a non-serious AE must be recorded with generic name of the medication (trade names are allowed for combination drugs only), medical indication (including which AE), total daily dose, route of administration, start and end dates of treatment. Similarly, concomitant medication administered for the treatment of an SAE, at any time, must be recorded on the SAE Form, as applicable.

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Screening - Subject Identification; Demography; Disease Characteristics; Status at Screening; Anti-Cancer Therapy; Anti-Cancer Radiotherapy; Medical Conditions

- 8/14/19 - 1 form, 12 itemgroups, 64 items, 1 language
Itemgroups: Inform Screening, Subject number, Date of Visit/ Assessment, Local Laboratories, Subject identification, Demography, Disease Characteristics, Metastatic Disease, Status at Screening, Anti-Cancer Therapy, Anti-Cancer Therapy , Medical Conditions
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

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

- 8/11/19 - 1 form, 14 itemgroups, 55 items, 2 languages
Itemgroups: 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.

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Screening - Medical and Surgical History; Disease Stage at Study Entry; Classification of Disease at Study Entry; Cancer related Surgical History; Previous Anti-Neoplastic Therapy

- 2/27/19 - 1 form, 9 itemgroups, 26 items, 1 language
Itemgroups: Adminstrative, Does the subject have any clinically significant medical or surgical history?, Medical and Surgical History, Disease Stage at Study Entry, Classification of Disease at Study Entry, Did the subject have previous cancer related surgical history?, Cancer related Surgical History, Previous Anti-Neoplastic Therapy, Previous Anti-Neoplastic Therapy
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Multiple sclerosis studies NCT02461069 NCT02419378 - Visit 1 (Screening) Part 2/2, Lab; Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

- 1/29/19 - 18 forms, 7 itemgroups, 40 items, 1 language
Itemgroups: Date of blood sampling, Hematology, Liver Function, Renal function, Medical Examination, Expanded disability status scale (EDSS), Signature
Screening, Baseline and Visit 1 CRFs of DIMAT-MS and ALAIN studies for semantic analysis of Multiple Sclerosis study documentation. Provided by Prof. Dr. Luisa Klotz of the Department of Neurology of the University Hospital Muenster.

Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

7 itemgroups, 31 items31

Eligibility Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

3 itemgroups, 31 items31

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

2 itemgroups, 48 items31

Screening: Medical History Multiple Sclerosis ALAIN01 NCT02419378

2 itemgroups, 5 items31
13 more forms meeting the search are available in the detailed view.

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Infusion Record Dosimetric Dose - Day 0 (Visit 2)

- 8/18/18 - 1 form, 9 itemgroups, 32 items, 1 language
Itemgroups: Date administered, HAMA, Time started, Time finished, Doses, Infusion rate, Record Vital Signs, Adverse Experience, Compliance
Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Prior Therapy

- 8/18/18 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Prior Therapy, Pharmaceutical Preparations, Therapeutic radiology procedure; Before
Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755 - Prior Therapy

- 7/12/18 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Administrative Data, xxx
Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin Please record all prior therapies for NHL (e.g. chemotherapy, immunotherapy, steroidal therapy).

CDASH Drug accountability(1) - Drug accountability (1)

- 6/20/18 - 1 form, 3 itemgroups, 5 items, 1 language
Itemgroups: General information, Study Treatment – Returned Amount, Study Treatment – Dispensed Amount
modified from http://www.cdisc.org

CDASH Drug accountability (2) - Drug accountability (2)

- 6/20/18 - 1 form, 4 itemgroups, 8 items, 1 language
Itemgroups: Study Treatment – Returned, Study Treatment – Returned Amount, Study Treatment – Dispensed, Study Treatment – Dispensed Amount
modified from http://www.cdisc.org

CDASH Drug accountability (3) - Drug accountability (3)

- 6/20/18 - 1 form, 2 itemgroups, 5 items, 1 language
Itemgroups: General information, Study Treatment
modified from http://www.cdisc.org