Serious Adverse Event (SAE) Cover Page

Serious Adverse Event (SAE) Cover Page
Beschreibung

Serious Adverse Event (SAE) Cover Page

Alias
UMLS CUI-1
C1519255
Initial Report Date:
Beschreibung

Report Date

Datentyp

date

Alias
UMLS CUI [1]
C1302584
Follow-up Report Date:
Beschreibung

Report Date Follow-up

Datentyp

date

Alias
UMLS CUI [1,1]
C1302584
UMLS CUI [1,2]
C1522577
Principal Investigator:
Beschreibung

Principal Investigator

Datentyp

text

Alias
UMLS CUI [1]
C1521895
Reporter:
Beschreibung

Reporter

Datentyp

text

Alias
UMLS CUI [1]
C1709908
Reporter Telephone #:
Beschreibung

Telephone number

Datentyp

integer

Alias
UMLS CUI [1]
C1515258
Reporter FAX #:
Beschreibung

Fax number

Datentyp

integer

Alias
UMLS CUI [1]
C1549619
Investigator Number
Beschreibung

Investigator Number

Datentyp

text

Alias
UMLS CUI [1]
C2826689
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beschreibung

Subject Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Sex:
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Weight in kg:
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight in lb
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • lb
Alias
UMLS CUI [1]
C0005910
lb
Date of Birth:
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Race:
Beschreibung

Race

Datentyp

text

Alias
UMLS CUI [1]
C0034510
If other, specify
Beschreibung

Other

Datentyp

text

Alias
UMLS CUI [1]
C0205394
Study Drug:
Beschreibung

Study Drug

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Route: intravitreal
Beschreibung

Route intravitreal

Datentyp

boolean

Alias
UMLS CUI [1]
C1517572
Study Eye:
Beschreibung

Study Eye

Datentyp

text

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0015392
Kit # (most recent injection):
Beschreibung

Kit number

Datentyp

text

Study Treatment Start Date:
Beschreibung

Therapy start date

Datentyp

date

Alias
UMLS CUI [1]
C3173309
Time Administered:
Beschreibung

Time Administered

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1533734
Last Treatment Prior to SAE:
Beschreibung

Therapy end date

Datentyp

date

Alias
UMLS CUI [1]
C1531784
Time Administered:
Beschreibung

Time Administered

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1533734
Study Treatment Continuing:
Beschreibung

Treatment Continuing

Datentyp

boolean

Alias
UMLS CUI [1]
C1553904
If the study treatment was interrupted due to SAE and then restarted, did the primary SAE recur?
Beschreibung

recur SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C1519255
This fax cover sheet is for (Primary Serious Adverse Event):
Beschreibung

Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Onset Date
Beschreibung

Onset Date

Datentyp

date

Alias
UMLS CUI [1]
C2985916
Is this event sight threatening?
Beschreibung

Visual Impairment

Datentyp

boolean

Alias
UMLS CUI [1]
C3665347
Date event met serious criteria:Date event met serious criteria:
Beschreibung

date Serious Adverse Event

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1519255
Additional Comments (if needed):
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611

Ähnliche Modelle

Serious Adverse Event (SAE) Cover Page

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Serious Adverse Event (SAE) Cover Page
C1519255 (UMLS CUI-1)
Report Date
Item
Initial Report Date:
date
C1302584 (UMLS CUI [1])
Report Date Follow-up
Item
Follow-up Report Date:
date
C1302584 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
Principal Investigator
Item
Principal Investigator:
text
C1521895 (UMLS CUI [1])
Reporter
Item
Reporter:
text
C1709908 (UMLS CUI [1])
Telephone number
Item
Reporter Telephone #:
integer
C1515258 (UMLS CUI [1])
Fax number
Item
Reporter FAX #:
integer
C1549619 (UMLS CUI [1])
Investigator Number
Item
Investigator Number
text
C2826689 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Item
Sex:
text
C0079399 (UMLS CUI [1])
Code List
Sex:
CL Item
Male (Male)
C0086582 (UMLS CUI-1)
(Comment:en)
CL Item
Female (Female)
C0015780 (UMLS CUI-1)
(Comment:en)
Weight
Item
Weight in kg:
float
C0005910 (UMLS CUI [1])
Weight
Item
Weight in lb
float
C0005910 (UMLS CUI [1])
Date of Birth
Item
Date of Birth:
date
C0421451 (UMLS CUI [1])
Item
Race:
text
C0034510 (UMLS CUI [1])
Code List
Race:
CL Item
White (White)
C0007457 (UMLS CUI-1)
(Comment:en)
CL Item
Black (Black)
C0005680 (UMLS CUI-1)
(Comment:en)
CL Item
Asian or Pacific Islander (Asian or Pacific Islander)
C1531604 (UMLS CUI-1)
(Comment:en)
CL Item
Hispanic (Hispanic)
C0086409 (UMLS CUI-1)
(Comment:en)
CL Item
American Indian or Alaskan Native (American Indian or Alaskan Native)
C1515945 (UMLS CUI-1)
(Comment:en)
CL Item
Other (Other)
C0205394 (UMLS CUI-1)
(Comment:en)
Other
Item
If other, specify
text
C0205394 (UMLS CUI [1])
Study Drug
Item
Study Drug:
text
C0304229 (UMLS CUI [1])
Route intravitreal
Item
Route: intravitreal
boolean
C1517572 (UMLS CUI [1])
Item
Study Eye:
text
C0008972 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
Code List
Study Eye:
CL Item
R (R)
C0229089 (UMLS CUI-1)
(Comment:en)
CL Item
L (L)
C0229090 (UMLS CUI-1)
(Comment:en)
Kit number
Item
Kit # (most recent injection):
text
Therapy start date
Item
Study Treatment Start Date:
date
C3173309 (UMLS CUI [1])
Time Administered
Item
Time Administered:
time
C0040223 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Therapy end date
Item
Last Treatment Prior to SAE:
date
C1531784 (UMLS CUI [1])
Time Administered
Item
Time Administered:
time
C0040223 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Treatment Continuing
Item
Study Treatment Continuing:
boolean
C1553904 (UMLS CUI [1])
Item
If the study treatment was interrupted due to SAE and then restarted, did the primary SAE recur?
text
C0034897 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
If the study treatment was interrupted due to SAE and then restarted, did the primary SAE recur?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Applicable (Not Applicable)
Serious Adverse Event
Item
This fax cover sheet is for (Primary Serious Adverse Event):
text
C1519255 (UMLS CUI [1])
Onset Date
Item
Onset Date
date
C2985916 (UMLS CUI [1])
Visual Impairment
Item
Is this event sight threatening?
boolean
C3665347 (UMLS CUI [1])
date Serious Adverse Event
Item
Date event met serious criteria:Date event met serious criteria:
date
C0011008 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Comments
Item
Additional Comments (if needed):
text
C0947611 (UMLS CUI [1])