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Concomitant Medication ×
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Inhaltsverzeichnis
  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
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- 21.04.18 - 1 Formular, 14 Itemgruppen, 133 Datenelemente, 1 Sprache
Itemgruppen: Adverse Events, Concomitant Medication, Demographics, Disease Characteristics, Disposition, ECG, Laboratory, Laboratory Data, Medical History, Patient Reported Outcome, Substance Use, Surgery, Tumor Response, Vital Signs
- 13.02.19 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Concomitant Medication, Concomitant Medication
Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of this form is to document any concimtant medication, the subject has received during the study. It should be filled out at each visit/contact. At each study visit/contact, the investigator should question the subject 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 the study vaccines/ comparator and ending 30 days after administration of the study vaccines/ comparator 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. - Any treatments and/or medications specifically contraindicated, e.g., any immunoglobulins, other blood products and any immune modifying drugs administered within 3 months or at any time during the study period are to be recorded with generic n-me 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. - A prophylactic medication is a medication administered in the absence of ANY symptom and in anticipation of a reaction to the vaccination (e.g. an anti-pyretic is considered to be prophylactic when it is given in the absence of fever [rectal temperature < 38°C] and any other symptom, to prevent fever from occurring). Any concomitant medication administered prophylactically in anticipation of reaction to the vaccination must be recorded in the CRF with generic name of the medication (trade names are allowed for combination drugs only), total daily dose, route of administration, start and end dates of treatment and coded as ‘Prophylactic’. - Concomitant medication administered for the treatment of an AE or SAE within the follow-up period for adverse events must be recorded in the CRF with generic name of the medication (trade names are allowed for combination drugs only), medical indication (including which AE/SAE), 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 Report Form. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1 Visit 1 and 2 are part of the study: "Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373"
- 13.02.19 - 1 Formular, 3 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Concomitant Vaccination, Concomitant Vaccination Record
- 07.02.19 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Concomitant Medication, Concomitant Medication
Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of this form is to document any concimtant medication, the subject has received during the study. It should be filled out at each visit/contact. At each study visit/contact, the investigator should question the subject 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 the study vaccines/ comparator and ending 30 days after administration of the study vaccines/ comparator 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. - Any treatments and/or medications specifically contraindicated, e.g., any immunoglobulins, other blood products and any immune modifying drugs administered within 3 months or at any time during the study period are to be recorded with generic n-me 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. - A prophylactic medication is a medication administered in the absence of ANY symptom and in anticipation of a reaction to the vaccination (e.g. an anti-pyretic is considered to be prophylactic when it is given in the absence of fever [rectal temperature < 38°C] and any other symptom, to prevent fever from occurring). Any concomitant medication administered prophylactically in anticipation of reaction to the vaccination must be recorded in the CRF with generic name of the medication (trade names are allowed for combination drugs only), total daily dose, route of administration, start and end dates of treatment and coded as ‘Prophylactic’. - Concomitant medication administered for the treatment of an AE or SAE within the follow-up period for adverse events must be recorded in the CRF with generic name of the medication (trade names are allowed for combination drugs only), medical indication (including which AE/SAE), 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 Report Form. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1
- 07.02.19 - 1 Formular, 3 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Concomitant Vaccination, Concomitant Vaccination Record
Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of this form is to document any concimtant vaccination, the subject has received during the study. It should be filled out at each visit/contact. At each study visit/contact, the investigator should question the subject about any vaccination(s) taken. - Any vaccine not foreseen in the study protocol administered in the period beginning 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) preceding the dose of study vaccines and ending 30 days after administration of the study vaccines, and in the period beginning 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) preceding the last study visit at Day 180 is to be recorded with trade name, route of administration and date(s) of administration. - Any Flu vaccine administered during the study period is to be recorded with trade name, route of administration and date(s) of administration. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1
- 24.01.19 - 1 Formular, 3 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Concomitant Medication, Concomitant Medication Record
Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders The purpose of this form is to document the subjects concomitant medication. Check that either ’Yes’ or ’No’ box at the top of the page has been completed. • Ensure that the spelling of the Drug Name(s) is correct (use of Trade Names is preferred). • Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. • It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. • It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit. • Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. • It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’. • Ensure that the ’Reason for Medication’ is recorded on one of the following pages using the same terms: • Medical Conditions • Non-Serious Adverse Events • Serious Adverse Events Form