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Serious Adverse Event (SAE)

4 Formulär  
Serious Adverse Event (SAE) Section 1
Beskrivning

Serious Adverse Event (SAE) Section 1

Event
Beskrivning

Diagnosis Only

Datatyp

text

Alias
UMLS CUI [1]
C1519255
Start date
Beskrivning

Start date

Datatyp

date

Måttenheter
  • Day Month Year
Alias
UMLS CUI [1]
C2697888
Day Month Year
Start time
Beskrivning

Start time

Datatyp

time

Alias
UMLS CUI [1]
C1301880
Outcome
Beskrivning

Outcome

Datatyp

integer

Alias
UMLS CUI [1]
C1705586
End date
Beskrivning

End date

Datatyp

date

Måttenheter
  • Day Month Year
Alias
UMLS CUI [1]
C0806020
Day Month Year
End time
Beskrivning

End time

Datatyp

time

Alias
UMLS CUI [1]
C1522314
Maximum intensity
Beskrivning

Maximum intensity

Datatyp

text

Alias
UMLS CUI [1]
C1710066
Action Taken with lnvestigational Product
Beskrivning

Action Taken with lnvestigational Product

Datatyp

integer

Alias
UMLS CUI [1]
C1704758
Did the subject withdraw from study as a result of this SAE?
Beskrivning

Withdrawl

Datatyp

boolean

Alias
UMLS CUI [1]
C0422727
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Beskrivning

Relationship to Investigational product

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
SECTION 2 Seriousness
Beskrivning

SECTION 2 Seriousness

Seriousness SAE
Beskrivning

Seriousness (specify reason(s) for considering this a SAE, ttl all that apply

Datatyp

integer

Alias
UMLS CUI [1]
C1710056
SECTION 3 Demography Data
Beskrivning

SECTION 3 Demography Data

Demography Data
Beskrivning

Demography Data

Datatyp

integer

Alias
UMLS CUI [1]
C0011298
Date of birth
Beskrivning

Date of birth

Datatyp

date

Måttenheter
  • Day Month Year
Alias
UMLS CUI [1]
C0421451
Day Month Year
Sex
Beskrivning

Sex

Datatyp

integer

Alias
UMLS CUI [1]
C0079399
SECTION 4
Beskrivning

SECTION 4

Investigational Product
Beskrivning

If lnvestigational Product(s) was Stopped

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
SECTION 5
Beskrivning

SECTION 5

Possible Causes of SAE
Beskrivning

Possible Causes of SAE

Datatyp

integer

Alias
UMLS CUI [1,1]
C3828190
UMLS CUI [1,2]
C1519255
SECTION 6
Beskrivning

SECTION 6

Medical Conditions
Beskrivning

RELEVANT Medical Conditions

Datatyp

integer

Alias
UMLS CUI [1]
C0012634
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Beskrivning

Medical history

Datatyp

text

Alias
UMLS CUI [1]
C0262926
Date of Onset
Beskrivning

Date of Onset

Datatyp

date

Alias
UMLS CUI [1]
C0574845
Condition Present at Time of the SAE?
Beskrivning

Condition Present at Time of the SAE?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
If No, Date of Last Occurrence
Beskrivning

If No, Date of Last Occurrence

Datatyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0011008
SECTION 7
Beskrivning

SECTION 7

Other RELEVANT Risk Factors
Beskrivning

provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)

Datatyp

text

Alias
UMLS CUI [1]
C0035648
SECTION 8 RELEVANT Concomitant Medications
Beskrivning

SECTION 8 RELEVANT Concomitant Medications

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C2347852
Drug Name
Beskrivning

Drug Name

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Dose
Beskrivning

Dose

Datatyp

integer

Alias
UMLS CUI [1]
C3174092
Unit
Beskrivning

Unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beskrivning

Frequency

Datatyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beskrivning

Route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Taken Prior to Study?
Beskrivning

Taken Prior to Study?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beskrivning

Stop Date

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Beskrivning

Ongoing Medication?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beskrivning

Reason for Medication

Datatyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
SECTION 9: Drug Details
Beskrivning

SECTION 9: Drug Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C1522508
Start Date Investigational Product (from REDUCE study)
Beskrivning

Start Date Investigational Product

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013230
Stop Date Investigational Product (from REDUCE study)
Beskrivning

Stop Date Investigational Product

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013230
Start Date Prescription Dutasteride
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date Prescription Dutasteride
Beskrivning

Stop Date

Datatyp

date

Alias
UMLS CUI [1]
C0806020
SECTION 10: Details of RELEVANT Assessments
Beskrivning

SECTION 10: Details of RELEVANT Assessments

Alias
UMLS CUI-1
C0220825
Details of Relevant Assessments
Beskrivning

Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range.

Datatyp

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
SECTION 11: Narrative Remarks
Beskrivning

SECTION 11: Narrative Remarks

Investigator's signature
Beskrivning

Investigator's signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's name
Beskrivning

Investigator's name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Narrative Remarks
Beskrivning

Provide a brief narrative description of the SAE and details of treatment given.

Datatyp

text

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Similar models

Serious Adverse Event (SAE)

4 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Serious Adverse Event (SAE) Section 1
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])
Outcome
Code List
Outcome
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])
Action Taken with lnvestigational Product
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 Group
SECTION 2 Seriousness
Item
Seriousness SAE
integer
C1710056 (UMLS CUI [1])
Seriousness SAE
Code List
Seriousness SAE
CL Item
Results in death (1)
C1320832 (UMLS CUI-1)
(Comment:en)
CL Item
Results in disability/incapacity (2)
C0231170 (UMLS CUI-1)
(Comment:en)
CL Item
Is life-threatening (3)
C1517874 (UMLS CUI-1)
(Comment:en)
CL Item
Requires hospitalisation or prolongation of Congenital anomaly/birth defect (4)
C0019993 (UMLS CUI-1)
(Comment:en)
CL Item
 (5)
(Comment:en)
CL Item
Other, specify _______________________existing hospitalisation (see definition) (6)
C0522473 (UMLS CUI-1)
C3840932 (UMLS CUI-2)
(Comment:en)
CL Item
 (7)
(Comment:en)
Item Group
SECTION 3 Demography Data
Demography Data
Item
Demography Data
integer
C0011298 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item Group
SECTION 4
Item
Investigational Product
integer
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
If lnvestigational Product(s) was Stopped
Code List
Investigational Product
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
Item Group
SECTION 5
Item
Possible Causes of SAE
integer
C3828190 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Possible Causes of SAE
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)
Item Group
SECTION 6
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])
Item Group
SECTION 7
Other RELEVANT Risk Factors
Item
Other RELEVANT Risk Factors
text
C0035648 (UMLS CUI [1])
Item Group
SECTION 8 RELEVANT Concomitant Medications
C1828479 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
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])
Item Group
SECTION 9: Drug Details
C0013227 (UMLS CUI-1)
C1522508 (UMLS CUI-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])
Item Group
SECTION 10: Details of RELEVANT Assessments
C0220825 (UMLS CUI-1)
Details of Relevant Assessments
Item
Details of Relevant Assessments
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SECTION 11: Narrative Remarks
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Narrative Remarks
Item
Narrative Remarks
text
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