Keywords
Concomitant Medication ×
Show more Keywords
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
Selected data models

You must log in to select data models for download or further analysis.

388 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

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Concomitant Medication

- 8/19/19 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Administrative documentation, Concomitant Agent
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine (Study ID: 105377) - Logs/ Repeats - Concomitant Medication; 12-Lead/ Holter/ Telemetry ECG; 12-Lead ECG Abnormalities

- 8/16/19 - 1 form, 3 itemgroups, 35 items, 1 language
Itemgroups: Concomitant Medication, 12-Lead/ Holter/ Telemetry ECG , 12-Lead ECG Abnormalities
Study ID: 105377 Clinical Study ID: 105377 Study Title: A randomised, open-label, parallel-group design study to evaluate the pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Epilepsy

Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612 - Cycle 1

- 8/12/19 - 1 form, 8 itemgroups, 45 items, 1 language
Itemgroups: Administrative documentation, Demography, Experimental drug, Topotecan, Administration of medication, Experimental drug, Carboplatin, Administration of medication, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Urinalysis, Concomitant Agent
Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

Evaluation of Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects NCT00989625 - Logs/ Repeats - Concomitant Medication; Electronically Transferred Lab Data; Vital Signs

- 8/11/19 - 1 form, 3 itemgroups, 22 items, 1 language
Itemgroups: Concomitant Medication, Electronically Transferred Lab Data, Vital signs
Study ID: 108504 Clinical Study ID: 108504 Study Title: An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989625 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: This is a pharmacokinetic study (Treximet) Trade Name: Naproxen Sodium and Sumatriptan Study Indication: Migraine Disorders

Evaluation of Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects NCT00989625 - Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events

- 8/8/19 - 1 form, 10 itemgroups, 84 items, 1 language
Itemgroups: Logs and Repeats, Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions, Non-serious Adverse Event (AE), Serious Adverse Events (SAE), Serious Adverse Event - Concomitant Medication, Serious Adverse Event - Medical Conditions/ Risk Factors, Serious Adverse Events - Relevant diagnostic results, Serious Adverse Events - Investigational Products, Serious Adverse Events - General narrative comments, Serious Adverse Events - Non clinical
Study ID: 108504 Clinical Study ID: 108504 Study Title: An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989625 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: This is a pharmacokinetic study (Treximet) Trade Name: Naproxen Sodium and Sumatriptan Study Indication: Migraine Disorders

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events; Concomitant Medication; Electronically Transferred Lab Data; Vital Signs; 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood - GSK618334

- 8/4/19 - 1 form, 18 itemgroups, 151 items, 1 language
Itemgroups: Logs and Repeats, Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions, Non-serious Adverse Event (AE), Serious Adverse Events (SAE), Serious Adverse Event - Concomitant Medication, Serious Adverse Event - Medical Conditions/ Risk Factors, Serious Adverse Events - Relevant diagnostic results, Serious Adverse Events - Investigational Products, Serious Adverse Events - General narrative comments, Serious Adverse Events - Non clinical, Concomitant Medication, Urinalysis - Local, Electronically Transferred Lab Data, Vital signs - Semi-supine, Vital Signs - Standing, 12-Lead ECG, ECG Abnormalities, Repeat Pharmacokinetics Blood - GSK618334
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

SB-681323 in ALI/ARDS risk patients - NCT00996840 - Concomitant Medications

- 7/20/19 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative documentation, Concomitant Medications
Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form is to be filled in continously during the study and/or at the follow-up evaluation and contains information on other medication the participant has received during the course of the study.

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Concomitant Medications

- 7/12/19 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Administrative documentation, Concomitant Agent
Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Concomitant Medication

- 7/3/19 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Administrative documentation, Concomitant Agent
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer