Engelsk

Serious Adverse Event (SAE)- Form

5 Formulär  
GENERAL INFORMATION
Beskrivning

GENERAL INFORMATION

Alias
UMLS CUI-1
C1508263
Date to submitted to BMS:
Beskrivning

Date to submitted to BMS

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Name of institution:
Beskrivning

Name of institution

Datatyp

text

Alias
UMLS CUI [1]
C1301943
Address:
Beskrivning

Address

Datatyp

text

Alias
UMLS CUI [1]
C1442065
Country:
Beskrivning

Country

Datatyp

text

Alias
UMLS CUI [1]
C0454664
Date of birth:
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Gender at birth:
Beskrivning

Gender at birth

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Race:
Beskrivning

Race

Datatyp

text

Alias
UMLS CUI [1]
C0034510
If "Other", please specify:
Beskrivning

If "Other", please specify

Datatyp

text

Alias
UMLS CUI [1]
C2348235
SERIOUS ADVERSE EVENT (SAE)- INITIAL REPORT
Beskrivning

SERIOUS ADVERSE EVENT (SAE)- INITIAL REPORT

Alias
UMLS CUI-1
C1519255
Ctc code:
Beskrivning

Ctc code

Datatyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C1516728
Event:
Beskrivning

Event

Datatyp

text

Alias
UMLS CUI [1]
C0441471
If "Other", please specify:
Beskrivning

If "Other", please specify

Datatyp

text

Alias
UMLS CUI [1]
C2348235
Onset date and time:
Beskrivning

Onset date and time

Datatyp

datetime

Alias
UMLS CUI [1]
C0011008
Resolution date and time:
Beskrivning

Resolution date and time

Datatyp

datetime

Alias
UMLS CUI [1]
C0011008
CTC grade:
Beskrivning

CTC grade

Datatyp

text

Alias
UMLS CUI [1]
C2985911
Relationship to study drug:
Beskrivning

Relationship to study drug

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Action taken regarding study drug
Beskrivning

Action taken regarding study drug

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Outcome:
Beskrivning

Outcome

Datatyp

text

Alias
UMLS CUI [1]
C1705586
Treatment required?
Beskrivning

Treatment required?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512698
UMLS CUI [1,2]
C1514873
Date of death:
Beskrivning

Date of death

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0011065
Cause of death:
Beskrivning

Cause of death

Datatyp

text

Alias
UMLS CUI [1]
C0007465
SERIOUS ADVERSE EVENT (SAE)- FOLLOW-UP REPORT
Beskrivning

SERIOUS ADVERSE EVENT (SAE)- FOLLOW-UP REPORT

Alias
UMLS CUI-1
C1519255
Description of serious adverse event/ relevant medical history; If unrelated to study drug, specify cause:
Beskrivning

Description of serious adverse event/ relevant medical history; If unrelated to study drug, specify cause.

Datatyp

text

Alias
UMLS CUI [1]
C1519255
Study drug:
Beskrivning

Study drug

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Phase:
Beskrivning

Phase

Datatyp

text

Alias
UMLS CUI [1]
C0205390
Suspect drug:
Beskrivning

Suspect drug

Datatyp

boolean

Alias
UMLS CUI [1]
C0013227
Therapy start date:
Beskrivning

Therapy start date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Therapy stop date:
Beskrivning

Therapy stop date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1947925
Total dose daily:
Beskrivning

Total dose daily

Datatyp

float

Alias
UMLS CUI [1]
C3174092
No of course:
Beskrivning

No of course

Datatyp

integer

Alias
UMLS CUI [1]
C0750729
Route:
Beskrivning

Route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Concomitant medication (exclude any medication used to treat the SAE):
Beskrivning

Concomitant medication

Datatyp

text

Alias
UMLS CUI [1]
C2347852
Concomitant medication therapy start date:
Beskrivning

Concomitant medication therapy start date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Concomitant medication therapy stop date:
Beskrivning

Concomitant medication therapy stop date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Laboratory test (Relevant to SAE only):
Beskrivning

Laboratory test (Relevant to SAE only)

Datatyp

text

Alias
UMLS CUI [1]
C0022885
Date of test:
Beskrivning

Date of test

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Results:
Beskrivning

Results

Datatyp

text

Alias
UMLS CUI [1]
C2826772
Baseline:
Beskrivning

Baseline

Datatyp

text

Alias
UMLS CUI [1]
C1442488
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Similar models

Serious Adverse Event (SAE)- Form

5 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
GENERAL INFORMATION
C1508263 (UMLS CUI-1)
Date
Item
Date to submitted to BMS:
date
C0011008 (UMLS CUI [1])
Institution
Item
Name of institution:
text
C1301943 (UMLS CUI [1])
Address
Item
Address:
text
C1442065 (UMLS CUI [1])
Country
Item
Country:
text
C0454664 (UMLS CUI [1])
birth date
Item
Date of birth:
date
C0421451 (UMLS CUI [1])
Item
Gender at birth:
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender at birth:
CL Item
Female (1)
CL Item
Male (2)
Item
Race:
text
C0034510 (UMLS CUI [1])
Race
Code List
Race:
CL Item
White (1)
CL Item
Black (2)
CL Item
Asian (3)
CL Item
American indian or Alaska native (4)
CL Item
Native Hawaiian or other pacific islander (5)
CL Item
Other race (6)
Specification
Item
If "Other", please specify:
text
C2348235 (UMLS CUI [1])
Item Group
SERIOUS ADVERSE EVENT (SAE)- INITIAL REPORT
C1519255 (UMLS CUI-1)
Ctc code
Item
Ctc code:
text
C0805701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Item
Event:
text
C0441471 (UMLS CUI [1])
Event
Code List
Event:
CL Item
Death (1)
CL Item
Life threatening (2)
CL Item
Cancer (3)
CL Item
Congenital anomaly (4)
CL Item
Hospitalization/ Prolongation (5)
CL Item
Persistent/ Significant disability (6)
CL Item
Important medical event (7)
CL Item
Drug dependency/ Abuse (8)
CL Item
Other (9)
specification
Item
If "Other", please specify:
text
C2348235 (UMLS CUI [1])
date and time
Item
Onset date and time:
datetime
C0011008 (UMLS CUI [1])
date and time
Item
Resolution date and time:
datetime
C0011008 (UMLS CUI [1])
CTC grade
Item
CTC grade:
text
C2985911 (UMLS CUI [1])
Item
Relationship to study drug:
text
C0013227 (UMLS CUI [1])
Drug
Code List
Relationship to study drug:
CL Item
Certain (1)
CL Item
Probable (2)
CL Item
Possible (3)
CL Item
Not likely (4)
CL Item
Not related (5)
Item
Action taken regarding study drug
text
C0013227 (UMLS CUI [1])
drug
Code List
Action taken regarding study drug
CL Item
None (1)
CL Item
Reduced (2)
CL Item
Increased (3)
CL Item
Interrupted (4)
CL Item
Discontinued (5)
Item
Outcome:
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome:
CL Item
Did not resolve (1)
CL Item
Resolved (2)
CL Item
Resolved W/ Sequela (3)
CL Item
Unknown (4)
CL Item
Death (5)
Treatment required
Item
Treatment required?
boolean
C1512698 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
death date
Item
Date of death:
date
C0011008 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Death cause
Item
Cause of death:
text
C0007465 (UMLS CUI [1])
Item Group
SERIOUS ADVERSE EVENT (SAE)- FOLLOW-UP REPORT
C1519255 (UMLS CUI-1)
SERIOUS ADVERSE EVENT
Item
Description of serious adverse event/ relevant medical history; If unrelated to study drug, specify cause:
text
C1519255 (UMLS CUI [1])
Drug
Item
Study drug:
text
C0013227 (UMLS CUI [1])
Item
Phase:
text
C0205390 (UMLS CUI [1])
Phase
Code List
Phase:
CL Item
Lead in (1)
CL Item
Blinded (2)
CL Item
Open (3)
Drug
Item
Suspect drug:
boolean
C0013227 (UMLS CUI [1])
start date
Item
Therapy start date:
date
C0808070 (UMLS CUI [1])
stop date
Item
Therapy stop date:
date
C0011008 (UMLS CUI [1,1])
C1947925 (UMLS CUI [1,2])
dose
Item
Total dose daily:
float
C3174092 (UMLS CUI [1])
course
Item
No of course:
integer
C0750729 (UMLS CUI [1])
Route
Item
Route:
text
C0013153 (UMLS CUI [1])
Concomitant medication
Item
Concomitant medication (exclude any medication used to treat the SAE):
text
C2347852 (UMLS CUI [1])
start date
Item
Concomitant medication therapy start date:
date
C0808070 (UMLS CUI [1])
stop date
Item
Concomitant medication therapy stop date:
date
C0011008 (UMLS CUI [1])
Laboratory test
Item
Laboratory test (Relevant to SAE only):
text
C0022885 (UMLS CUI [1])
date
Item
Date of test:
date
C0011008 (UMLS CUI [1])
Result
Item
Results:
text
C2826772 (UMLS CUI [1])
Baseline
Item
Baseline:
text
C1442488 (UMLS CUI [1])
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