ID
27681
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 26, 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
Alias
- UMLS CUI-1
- C2347852
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
Alias
- UMLS CUI [1]
- C2347852
Description
Record of Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
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
Alias
- UMLS CUI [1]
- C0013227
Description
Dose
Data type
float
Alias
- UMLS CUI [1]
- C3174092
Description
Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Frequency
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
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
Alias
- UMLS CUI [1]
- C3173309
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
Alias
- UMLS CUI [1]
- C0016441
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
Alias
- UMLS CUI [1]
- C1531784
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
Alias
- UMLS CUI [1]
- C0016441
Description
Indication
Data type
text
Alias
- UMLS CUI [1]
- C3146298
Description
Prophylaxis
Data type
text
Alias
- UMLS CUI [1]
- C0199176
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
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C1519255
Similar models
Concomitant Medications GSK study Prostatic neoplasms NCT00883909
C0750480 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])