Event
Item
Event
text
C1519255 (UMLS CUI [1])
Start date
Item
Start date
date
C2697888 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Recovered (1)
C2826210 (UMLS CUI-1)
(Comment:en)
CL Item
Recovering (2)
C1709864 (UMLS CUI-1)
(Comment:en)
CL Item
Not resolved (3)
C1709277 (UMLS CUI-1)
(Comment:en)
CL Item
Resolved with sequelae (4)
C1709862 (UMLS CUI-1)
(Comment:en)
CL Item
Fatal (5)
C1302234 (UMLS CUI-1)
(Comment:en)
End date
Item
End date
date
C0806020 (UMLS CUI [1])
End time
Item
End time
time
C1522314 (UMLS CUI [1])
Maximum intensity
Item
Maximum intensity
text
C1710066 (UMLS CUI [1])
Item
Action Taken with lnvestigational Product
integer
C1704758 (UMLS CUI [1])
Code List
Action Taken with lnvestigational Product
CL Item
lnvestigational withdrawn (1)
C2349954 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
(Comment:en)
CL Item
dose reduced (2)
C1707814 (UMLS CUI-1)
(Comment:en)
CL Item
dose increased (3)
C1707810 (UMLS CUI-1)
(Comment:en)
CL Item
dose not changed (4)
C0178602 (UMLS CUI-1)
C0443172 (UMLS CUI-2)
(Comment:en)
CL Item
dose interrupted (5)
C1512900 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
(Comment:en)
CL Item
not applicable (6)
C1272460 (UMLS CUI-1)
(Comment:en)
Withdrawl
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C0422727 (UMLS CUI [1])
Relationship to Investigational product
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item
Investigational Product
integer
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Investigational Product
CL Item
Unknown at this time (3)
Item
Possible Causes of SAE
integer
C3828190 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Possible Causes of SAE
CL Item
Disease under study (1)
C0012634 (UMLS CUI-1)
(Comment:en)
CL Item
Concomitant medication (2)
C2347852 (UMLS CUI-1)
(Comment:en)
CL Item
Medical condition (3)
C1699700 (UMLS CUI-1)
(Comment:en)
CL Item
Activity related to study participation (e.g., procedures) (4)
C2348568 (UMLS CUI-1)
(Comment:en)
CL Item
Lack of efficacy (5)
C0235828 (UMLS CUI-1)
(Comment:en)
CL Item
Other, specify ______________________ (6)
C2911685 (UMLS CUI-1)
C1521902 (UMLS CUI-2)
(Comment:en)
CL Item
Withdrawal of investigational product(s) (7)
C2349954 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
(Comment:en)
RELEVANT Medical Conditions
Item
Medical Conditions
integer
C0012634 (UMLS CUI [1])
Medical history
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0262926 (UMLS CUI [1])
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
If No, Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Other RELEVANT Risk Factors
Item
Other RELEVANT Risk Factors
text
C0035648 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start Date Investigational Product
Item
Start Date Investigational Product (from REDUCE study)
date
C0808070 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Stop Date Investigational Product
Item
Stop Date Investigational Product (from REDUCE study)
date
C0806020 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Start Date
Item
Start Date Prescription Dutasteride
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date Prescription Dutasteride
date
C0806020 (UMLS CUI [1])
Details of Relevant Assessments
Item
Details of Relevant Assessments
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])