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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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449 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

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.

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

- 10/21/20 - 1 form, 3 itemgroups, 17 items, 1 language
Itemgroups: Administrative Data, Concomitant medications - continuous infusion, Concomitant medications - continuous infusion
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 (Continuous Infusion) Form has to be filled in each time any change in medication administered as continous infusion occurs during the Study. Please use one Instance of this Form per medication administered.

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Log

- 10/13/20 - 1 form, 9 itemgroups, 117 items, 1 language
Itemgroups: Date of visit, Assessment Date, Event Log, Status, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Concomitant Agent, Adrenal Cortex Hormones, Blood product; Supportive care, Collection of blood specimen for laboratory procedure, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Informed Consent, Withdraw (activity)
Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Chronic and concomitant medication; Concomitant vaccination

- 9/21/20 - 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

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Logs/Repeats

- 8/13/20 - 1 form, 10 itemgroups, 157 items, 1 language
Itemgroups: Event Log, Repeat, Echocardiography, Multiple gated acquisition scanning, Vital signs, Repeat, 12 lead ECG, Unscheduled, Repeat, 12 lead ECG, Abnormality, Pharmacokinetic aspects, Unscheduled, Repeat, Experimental drug, Unscheduled, Repeat, Adverse event, Repeat, Serious Adverse Event, Concomitant Agent, Repeat
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - PGx-Pharmacogenetic Research; Concomitant Medications

- 7/28/20 - 1 form, 4 itemgroups, 23 items, 1 language
Itemgroups: Administrative, PGx-Pharmacogenetic Research, Concomitant Medications, Concomitant Medications
Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Concomitant Medication

- 6/19/20 - 1 form, 3 itemgroups, 14 items, 1 language
Itemgroups: Administrative, Concomitant Medications, Concomitant Medications
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629 - Concomitant Medications

- 6/16/20 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Administrative Data, Concomintant Medications
This form documents the concomitant medications taken during the study. To be filled in continously. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Concomitant Medications - Repeating Form, Logs/Repeats 4-RF-DF

- 6/7/20 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Concomitant Medications
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitus Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias