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  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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456 Search results.

EHR4CR CTE Data Inventory

- 4/21/18 - 1 form, 14 itemgroups, 133 items, 1 language
Itemgroups: Adverse Events, Concomitant Medication, Demographics, Disease Characteristics, Disposition, ECG, Laboratory, Laboratory Data, Medical History, Patient Reported Outcome, Substance Use, Surgery, Tumor Response, Vital Signs
Data Inventory for Clinical Trial Execution in the EHR4CR project. https://www.ncbi.nlm.nih.gov/pubmed/27875988 DOI for citation: 10.21961/MDM:17994

Physician letter (short)

- 7/17/16 - 1 form, 3 itemgroups, 302 items, 1 language
Itemgroups: Current episode, Diagnosis, Current medication
derived from http://www.arztbriefmanager.de/ (Dr. Wolfram Arends, Tutzing, Germany)

CDASH Concomitant Medication - Concomitant medication

- 6/20/18 - 1 form, 2 itemgroups, 9 items, 2 languages
Itemgroups: General information, Details
translated and modified from CDASH 2011-10-24 http://www.cdisc.org

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Running Logs and End of Study - Status of Treatment Blind; Pharmacogenetic Research; Concomitant Medications

- 1/13/21 - 1 form, 8 itemgroups, 30 items, 1 language
Itemgroups: Administrative, Status of Treatment Blind, Pharmacogenetic Research - Consent for PGx-Pharmacogenetic Research, Pharmacogenetic Research - Blood Sample Collection (DNA), Pharmacogenetic Research - Withdrawal of consent, Pharmacogenetic Research - Blood Sample Destruction, Concomitant Medications, Concomitant Medications
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Concomitant Medications

- 1/9/21 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative Data, Concomitant Medications
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document documents the concomitant medication taken during the study.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Concomitant medication

- 1/9/21 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Administrative Data, Concomitant Medications
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out, if concomitant medication has been taken by subject during the study.

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Logs/ Repeats - Concomitant Medication; 12-Lead/ Holter/ Telemetry ECG; Vital Signs; 12-Lead ECG Abnormalities

- 12/7/20 - 1 form, 4 itemgroups, 43 items, 1 language
Itemgroups: Concomitant Medication, 12-Lead /Holter/Telemetry ECG, Vital Signs, 12-Lead ECG Abnormalities
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Logs and Repeats - Adverse Event/ Concomitant Medication/ Repeat Assessment Check Question; Non-Serious Adverse Events; Serious Adverse Events

- 12/7/20 - 1 form, 13 itemgroups, 92 items, 1 language
Itemgroups: Date of Visit/ Assessment, Adverse Event/ Concomitant Medication/ Repeat Assessment Check Questions, Non-Serious Adverse Event, Serious Adverse Event - Type of Report, Serious Adverse Event - Randomisation, Serious Adverse Event, Serious Adverse Event - Seriousness, Serious Adverse Event - Relevant Concomitant/ Treatment Medications, Serious Adverse Events - Relevant Medical Conditions/ Risk Factors, Serious Adverse Event - Relevant Diagnostic Results, Serious Adverse Event - Investigational Product, General Narrative Comments, Serious Adverse Event - Non clinical
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Adverse Events/ Serious Adverse Events; Prior and Concomitant Medications/ Non-drug Therapies

- 11/29/20 - 1 form, 15 itemgroups, 57 items, 1 language
Itemgroups: Administrative, Adverse Events, Adverse Events/ Serious Adverse Events - Section 1, Adverse Events/ Serious Adverse Events - Section 2 (Seriousness), Adverse Events/ Serious Adverse Events - Section 3 (Demography Data), Adverse Events/ Serious Adverse Events - Section 4, Adverse Events/ Serious Adverse Events - Section 5, Adverse Events/ Serious Adverse Events - Section 6 (Medical Conditions), Adverse Events/ Serious Adverse Events - Section 7 (Other RELEVANT Risk Factors) , Adverse Events/ Serious Adverse Events - Section 8 (RELEVANT Concomitant Medications) , Adverse Events/ Serious Adverse Events - Section 9 (Details of Investigational Product(s)) , Adverse Events/ Serious Adverse Events - Section 10 (Details of RELEVANT ASSESSMENTS) , Adverse Events/ Serious Adverse Events - Section 11 (Narrative Remarks), Prior and Concomitant Medications/Non-drug Therapies , Prior and Concomitant Medications/Non-drug Therapies
Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Chronic and concomitant medication; Concomitant vaccination (Report Final and Annex Report 2 Final)

- 11/2/20 - 1 form, 5 itemgroups, 14 items, 1 language
Itemgroups: Administrative, Chronic and concomitant medication, Chronic and concomitant medication , Concomitant Vaccination, Concomitant Vaccination
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550 - COPD and concomitant medication

- 11/1/20 - 1 form, 4 itemgroups, 38 items, 1 language
Itemgroups: Administrative Data, COPD Prior concomitant medications, COPD concomitant medications, Concomitant medications
Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (COPD and concomitant medication) is to be filled out continuously during the study whenever applicable.

Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858 - Concomitant Medications (Non-Continuous Infusion)

- 10/21/20 - 1 form, 3 itemgroups, 19 items, 1 language
Itemgroups: Administrative Data, No concomitant medications, Concomitant medications, except for continuous infusions
Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 - See https://clinicaltrials.gov/ct2/show/NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. The Concomitant Medications (Non-Continuous Infusion) Form has to be filled in each time any change in medication (except for those administered as a continuous infusion) occurs during the Study. Please use one Instance of this Form per medication administered.