ID
27452
Description
Study ID: 103094 Clinical Study ID: ARI103094 Study Title: ARI103094-Follow-Up Study for REDUCE Study Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00883909 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Neoplasms, Prostate
Keywords
Versions (2)
- 11/15/17 11/15/17 -
- 11/26/17 11/26/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 15, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Concomitant Medications GSK study Prostatic neoplasms NCT00883909
Concomitant Medications GSK study Prostatic neoplasms NCT00883909
Description
Intake of concomitant Medications
Description
Check that either the YES or NO box at the top of the page is selected. • If NO is selected, check that no applicable concomitant medications are present. • If YES is selected, check that at least one applicable concomitant medication is present. If YES, record below.
Data type
text
Description
Record of Concomitant Medications
Description
Check that the drug name (trade name preferred) is spelled correctly. If medication is given to treat a serious adverse event (SAE), then the event must be recorded on the SERIOUS ADVERSE EVENT page(s).
Data type
text
Description
Dose
Data type
float
Description
Units
Data type
text
Description
Frequency
Data type
text
Description
Route
Data type
text
Description
Check that either the ‘Date started’ is completed or ‘started Pre-Follow Up Study’ is completed. At least one must be completed, but it is acceptable if both are completed. • If both ‘Date started’ and ‘started Pre-Follow Up Study’ are completed, check that the start date is pre-study.
Data type
date
Description
Check that either the ‘Date started’ is completed or ‘started Pre-Follow Up Study’ is completed. At least one must be completed, but it is acceptable if both are completed. • If both ‘Date started’ and ‘started Pre-Follow Up Study’ are completed, check that the start date is pre-study.
Data type
boolean
Description
Check that either the ‘Date stopped’ box is completed or the ‘continued Post-Follow Up Study’ is completed. Only one must be completed. • Check that the drug start date is before or equal to the drug stop date.
Data type
date
Description
Check that either the ‘Date stopped’ box is completed or the ‘continued Post-Follow Up Study’ is completed. Only one must be completed.
Data type
boolean
Description
Indication
Data type
text
Description
Prophylaxis
Data type
text
Description
If the concomitant medication was taken for a serious adverse event (SAE), check that the event is entered on the SERIOUS ADVERSE EVENT page(s) and that the dates are consistent with the event.
Data type
text