Stichworte
Klinische Studie, Phase III [Dokumenttyp] ×
Zeige mehr Stichworte
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
Ausgewählte Datenmodelle

Sie müssen eingeloggt sein, um mehrere Datenmodelle auszuwählen und diese herunterzuladen oder zu analysieren.

- 23.01.19 - 1 Formular, 19 Itemgruppen, 107 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, General Medical History / Physical Examination, Meningococcal Vaccination History, Hib Vaccination History, Disease History, Laboratory Tests - Blood, Medication, Vaccine Administration, Vaccine Administration - Vaccine 1, Vaccine Administration - Vaccine 2, Reason for non-administration, Unsolicited Adverse Events, Telephone Contact, Study Conclusion
- 15.01.19 - 1 Formular, 12 Itemgruppen, 40 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Migraine Symptoms, Date and Time Study Medication Taken, Details of Migraine Headache Pain and Symptoms, ALLODYNIA QUESTIONNAIRE (Complete at time of dosing), Details of Work Ability, ALLODYNIA QUESTIONNAIRE (Complete 2 hours after dosing), Recurrence, Medications Taken, Productivity, Productivity: Affect of Migraine Attack on work and non-work related activities, PATIENT PERCEPTION OF MIGRAINE QUESTIONNAIRE - REVISED (PPMQ-R)
This ODM file contains the form for the subject diary. To be filled out throughout the study. Study ID: 101999 Clinical Study ID: 101999 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 Subject Diary Instructions: Important Reminders: • All Pages: It is very important that you complete the diary information as accurately as possible and in a timely manner. Page 1: • Do NOT treat any headache with study medication until study personnel call you about your lab and ECG results. • Enter the date and time your migraine headache pain started and the date and time you took study medication. • Take the study medication ONLY within one hour of the start of migraine head pain and ONLY if your headache pain is still MILD. • If you wake up with mild migraine headache pain, you should take the study medication as soon as possible after awakening. • If you wake up with moderate or severe headache pain, you should NOT take the study medication to treat the headache. You should not use the study medication to treat your migraine headache if you have used: • nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil or Motrin), naproxen (Aleve), aspirin (exception is aspirin not exceeding 325mg if taken for cardiovascular health) within 24 hours before taking study medication • an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide within 24 hours before taking study medication • a triptan (such as Imitrex, Zomig, Maxalt, Relpax, Amerge, Axert, or Frova) within 24 hours before taking study medication • medications for nausea or vomiting, narcotics, or other headache medications within 24 hours before taking study medication • any other pain medications (such as Tylenol or acetaminophen) within 6 hours before taking study medication Page 2: Complete this page at time of dosing with study medication and 30 minutes, 1 hour, 2 hours, and 4 hours after taking study medication. Page 3: Complete this page at time of dosing with study medication. Page 4: Complete this page at time of dosing with study medication and at 2 and 4 hours after dosing with study medication. Page 5: Complete this page at 2 hours after dosing with study medication. Page 6: Complete this page at 24 hours after taking study medication. Page 7: Complete this page. You should not use a medication for pain, nausea, or vomiting within 2 hours after taking study medication. If you have migraine pain from 2 to 24 hours after taking the study medication, you may take other headache medication that the study doctor has told you is acceptable to use. These include Tylenol (acetaminophen), drugs for nausea or vomiting, and narcotics. Pages 8, 9 - 12: Complete these pages 24 hours after taking study medication. • Contact the investigator if you feel any unusual symptoms after taking the study medication. • Ask the investigator if you are unsure of the above instructions. GENERAL INSTRUCTIONS FOR DIARY COMPLETION • Use black ink and print neatly and legibly. • If you make a mistake, draw a single line through the incorrect entry. • Do not 'write over' or erase an incorrect entry, or re-copy the original page. • Do not use correction materials (such as correction fluid or tape) on this diary card. DATE • Record dates in DD MMM YY format (for example: 15 JAN 04). • Use the first three letters of each month as the abbreviation for the months (e.g., JAN, FEB, MAR). TIME • Record time in 24-hour clock format unless specified otherwise, per conversion chart below. a.m. Midnight = 00:00 1:00 = 01:00 2:00 = 02:00 3:00 = 03:00 4:00 = 04:00 5:00 = 05:00 6:00 = 06:00 7:00 = 07:00 8:00 = 08:00 9:00 = 09:00 10:00 = 10:00 11:00 = 11:00 p.m. Noon = 12:00 1:00 = 13:00 2:00 = 14:00 3:00 = 15:00 4:00 = 16:00 5:00 = 17:00 6:00 = 18:00 7:00 = 19:00 8:00 = 20:00 9:00 = 21:00 10:00 = 22:00 11:00 = 23:00 Note: Midnight = 00:00 is the start of the new day, not the end of the previous day. Page 1: Migraine Symptoms - Date and Time Study Medication Taken Page 2: Details of Migraine Headache Pain and Symptoms Page 3: Allodynia Questionnaire (Complete at time of dosing) Page 4: Details of WOrk Ability Page 5: Allodynia Questionnaire (Complete 2 hours after dosing) Page 6: Recurrence Page 7: Medications Taken Page 8: Productivity Page 9: PPMQ-R Reminder to Site Personnel: Upon return of the completed diary, review the diary with the subject and address discrepancies while the subject is in the clinic. Subject Reminder: Take the study medication ONLY within one hour of the start of migraine head pain and ONLY if your headache pain is still MILD.
- 11.01.19 - 1 Formular, 13 Itemgruppen, 73 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Temperature Log, Reminder, Rash / Exanthem, Rash Event Log, Parotid/Salivary Gland Swelling Events, Febrile Convulsions - Suspected Signs of Meningitis, Concomitant Vaccination, Concomitant Vaccination Details, Concomitant Medications, Concomitant Medications Details, Non-Serious Adverse Events, Non-Serious Adverse Events Log