ID
27452
Beschrijving
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
Trefwoorden
Versies (2)
- 15-11-17 15-11-17 -
- 26-11-17 26-11-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 november 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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Concomitant Medications GSK study Prostatic neoplasms NCT00883909
Concomitant Medications GSK study Prostatic neoplasms NCT00883909
Beschrijving
Intake of concomitant Medications
Beschrijving
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.
Datatype
text
Beschrijving
Record of Concomitant Medications
Beschrijving
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).
Datatype
text
Beschrijving
Dose
Datatype
float
Beschrijving
Units
Datatype
text
Beschrijving
Frequency
Datatype
text
Beschrijving
Route
Datatype
text
Beschrijving
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.
Datatype
date
Beschrijving
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.
Datatype
boolean
Beschrijving
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.
Datatype
date
Beschrijving
Check that either the ‘Date stopped’ box is completed or the ‘continued Post-Follow Up Study’ is completed. Only one must be completed.
Datatype
boolean
Beschrijving
Indication
Datatype
text
Beschrijving
Prophylaxis
Datatype
text
Beschrijving
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.
Datatype
text