Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Identifier, Hospitals
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomization, Numbers
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Serious Adverse Event, During, Clinical Trials
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Serious Adverse Event, Diagnosis, Signs and Symptoms
Item
Event
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
Serious Adverse Event, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
Serious Adverse Event, End Date
Item
End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
[X] Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
integer
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
[1] Investigational product(s) withdrawn (1)
CL Item
[2] Dose reduced (2)
CL Item
[3] Dose increased (3)
CL Item
[4] Dose not changed (4)
CL Item
[5] Dose interrupted (5)
CL Item
[X] Not applicable (6)
Serious Adverse Event, Withdrawal by Subject
Item
Withdrawal - Did the subject withdraw from study as a result of this SAE?
boolean
C1519255 (UMLS CUI [1,1])
C1710677 (UMLS CUI [1,2])
Serious Adverse Event, Relationships, Investigational New Drugs
Item
Relationship to Investigational Product(s)) - Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Serious Adverse Event, Fatal, Autopsy
Item
If FATAL, was a post-mortem/autopsy performed?
boolean
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Item
Seriousness (specify reason(s) for considering this a SAE, mark all that apply)
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Code List
Seriousness (specify reason(s) for considering this a SAE, mark all that apply)
CL Item
[A] result in death (1)
CL Item
[B] Is life-threatening (2)
CL Item
[C] Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
[D] Results in disability/incapacity (4)
CL Item
[E] Congenital anomaly/birth defect (5)
CL Item
[F] other, specify___________________________________ (6)
Item
If investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
If investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item
Possible causes of SAE Other Than Investigational Product(s), mark all that apply:
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Code List
Possible causes of SAE Other Than Investigational Product(s), mark all that apply:
CL Item
Disease under study (1)
CL Item
Medical condition(s) specify_____________________(record in Section 6) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) specify_________________(record in section 8) (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify_________________________________________________ (7)
Medical History; Hypersensitivity; Operative Surgical Procedures
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0262926 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Disease, Date of Onset
Item
Date of Onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Disease, During, Serious Adverse Event
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Disease, Occurrence, Date in time
Item
If NO, Date of Last Occurrence
date
C0012634 (UMLS CUI [1,1])
CC2745955 (UMLS CUI [1,2])
Serious Adverse Event, Risk Factors, Medical History, Family History
Item
Provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
text
C1519255 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0241889 (UMLS CUI [1,4])
Serious Adverse Event, Concomitant Agent, Medication Name
Item
Drug Name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Medication Dose
Item
Dose
integer
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Unit of Measure
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent,, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Prior Medication Usage
Item
Taken Prior to Study?
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826257 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, End Date
Item
Stop Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Concomitant Medication Ongoing
Item
Ongoing Medication?
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Indication
Item
Reason for Medication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item
Part 1 - Investigational Product
text
C0304229 (UMLS CUI [1])
Code List
Part 1 - Investigational Product
CL Item
Dutasteride (Dutasteride)
Item
Treatment Period
integer
C0087111 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Code List
Treatment Period
Therapeutic Procedure, Groups
Item
Treatment Group (A, B or C)
text
C0087111 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
Experimental Drug, Start Date
Item
Start Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Part 2 - Investigational Product
text
C0304229 (UMLS CUI [1])
Code List
Part 2 - Investigational Product
CL Item
Testosterone (Testosterone)
CL Item
Dutasteride (loading) (Dutasteride (loading))
CL Item
Dutasteride (Dutasteride)
CL Item
Testosterone (Testosterone)
CL Item
Dutasteride (repeat dose) (Dutasteride (repeat dose))
Therapeutic Procedure, Period
Item
Treatment Period
text
C0087111 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Experimental Drug, Start Date
Item
Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Experimental Drug, End Date
Item
Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event, Evaluation
Item
Provide details of any other tests/procedures which were carried out to diagnose or onfirm the SAE e.g., laboratory data with units and normal range
text
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Serious Adverse Event, Comment
Item
Narrative Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Investigator signature
Item
Investigator's signature (confirming that the data on the SAE pages are accurate and complete)
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])