Follow up - Serious Adverse Event Form

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Identifier, Hospitals

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Randomisation Number
Description

Randomization, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Serious Adverse Event (SAE)
Description

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
Did the subject experience a serious adverse event during the study?
Description

Serious Adverse Event, During, Clinical Trials

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Event
Description

Serious Adverse Event, Diagnosis, Signs and Symptoms

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0037088
Start Date
Description

Serious Adverse Event, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Outcome
Description

Serious Adverse Event, Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End Date
Description

Serious Adverse Event, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Maximum Intensity
Description

Serious Adverse Event, Seriousness of Adverse Event

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Action Taken with Investigational Product(s) as a Result of the SAE
Description

Serious Adverse Event, Action Taken with Study Treatment

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704758
Withdrawal - Did the subject withdraw from study as a result of this SAE?
Description

Serious Adverse Event, Withdrawal by Subject

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710677
Relationship to Investigational Product(s)) - Is there a reasonable possibility the SAE may have been caused by the investigational product?
Description

Serious Adverse Event, Relationships, Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013230
If FATAL, was a post-mortem/autopsy performed?
Description

Serious Adverse Event, Fatal, Autopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0004398
Seriousness
Description

Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Seriousness (specify reason(s) for considering this a SAE, mark all that apply)
Description

Serious Adverse vent, Seriousness of Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Demography Data
Description

Demography Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1704791
Date of birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
If investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Description

Serious Adverse Event, Experimental Drug

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Possible Causes
Description

Possible Causes

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0085978
Possible causes of SAE Other Than Investigational Product(s), mark all that apply:
Description

Serious Adverse Event, Causations

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
Relevant Medical Conditions
Description

Relevant Medical Conditions

Alias
UMLS CUI-1
C0012634
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Description

Medical History; Hypersensitivity; Operative Surgical Procedures

Data type

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0020517
UMLS CUI [3]
C0543467
Date of Onset
Description

Disease, Date of Onset

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Condition Present at Time of the SAE?
Description

Disease, During, Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1519255
If NO, Date of Last Occurrence
Description

Disease, Occurrence, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
CC2745955
Other Relevant Risk Factors
Description

Other Relevant Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0035648
Provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
Description

Serious Adverse Event, Risk Factors, Medical History, Family History

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0262926
UMLS CUI [1,4]
C0241889
Relevant Concomitant Medications
Description

Relevant Concomitant Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
Drug Name
Description

Serious Adverse Event, Concomitant Agent, Medication Name

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2360065
Dose
Description

Serious Adverse Event, Concomitant Agent, Medication Dose

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3174092
Unit
Description

Serious Adverse Event, Concomitant Agent, Unit of Measure

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519795
Frequency
Description

Serious Adverse Event, Concomitant Agent,, Frequencies

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439603
Route
Description

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0013153
Taken Prior to Study?
Description

Serious Adverse Event, Concomitant Agent, Prior Medication Usage

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826257
Start Date
Description

Serious Adverse Event, Concomitant Agent, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0808070
Stop Date
Description

Serious Adverse Event, Concomitant Agent, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0806020
Ongoing Medication?
Description

Serious Adverse Event, Concomitant Agent, Concomitant Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826666
Reason for Medication
Description

Serious Adverse Event, Concomitant Agent, Indication

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0392360
Details of Investigational Product(s)
Description

Details of Investigational Product(s)

Alias
UMLS CUI-1
C0013230
Part 1 - Investigational Product
Description

Experimental Drug

Data type

text

Alias
UMLS CUI [1]
C0304229
Treatment Period
Description

Therapeutic Procedure, Period

Data type

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1948053
Treatment Group (A, B or C)
Description

Therapeutic Procedure, Groups

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0441833
Start Date of Dose
Description

Experimental Drug, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Part 2 - Investigational Product
Description

Experimental Drug

Data type

text

Alias
UMLS CUI [1]
C0304229
Treatment Period
Description

Therapeutic Procedure, Period

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1948053
Start Date
Description

Experimental Drug, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Stop Date
Description

Experimental Drug, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Details of Relevant Assessments
Description

Details of Relevant Assessments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0220825
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
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0220825
Narrative Remarks
Description

Narrative Remarks

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Narrative Remarks
Description

Serious Adverse Event, Comment

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Investigator's confirmation
Description

Investigator's confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0008961
Investigator's signature (confirming that the data on the SAE pages are accurate and complete)
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Investigator Signature, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's name (print)
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892

Similar models

Follow up - Serious Adverse Event Form

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
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])
Item Group
Serious Adverse Event (SAE)
C1519255 (UMLS CUI-1)
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])
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
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
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
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 Group
Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
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 Group
Demography Data
C1519255 (UMLS CUI-1)
C1704791 (UMLS CUI-2)
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Investigational Product
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
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
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
Possible Causes
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
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)
Item Group
Relevant Medical Conditions
C0012634 (UMLS CUI-1)
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])
Item Group
Other Relevant Risk Factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-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])
Item Group
Relevant Concomitant Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
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 Group
Details of Investigational Product(s)
C0013230 (UMLS CUI-1)
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
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
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
Lupron (Lupron)
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])
Item Group
Details of Relevant Assessments
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-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])
Item Group
Narrative Remarks
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
Narrative Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Investigator's confirmation
C0750484 (UMLS CUI-1)
C0008961 (UMLS CUI-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])