ID

42027

Description

Study part: Serious Adverse Event (SAE) Cover Page. A Phase III, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) In Subjects With Minimally Classic Or Occult Subfoveal Neovascular Age-Related Macular Degeneration.

Keywords

Versions (3)
  1. 2/19/18 2/19/18 -
  2. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
  3. 9/20/21 9/20/21 -
Copyright Holder

Roche

Uploaded on

March 15, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Serious Adverse Event (SAE) Cover Page rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g

English

Serious Adverse Event (SAE) Cover Page

1 forms  
Serious Adverse Event (SAE) Cover Page
Description

Serious Adverse Event (SAE) Cover Page

Alias
UMLS CUI-1
C1519255
Initial Report Date:
Description

Report Date

Data type

date

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

Report Date Follow-up

Data type

date

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

Principal Investigator

Data type

text

Alias
UMLS CUI [1]
C1521895
Reporter:
Description

Reporter

Data type

text

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

Telephone number

Data type

integer

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

Fax number

Data type

integer

Alias
UMLS CUI [1]
C1549619
Investigator Number
Description

Investigator Number

Data type

text

Alias
UMLS CUI [1]
C2826689
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Subject Initials
Description

Subject Initials

Data type

text

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

Gender

Data type

text

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

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight in lb
Description

Weight

Data type

float

Measurement units
  • lb
Alias
UMLS CUI [1]
C0005910
lb
Date of Birth:
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Race:
Description

Race

Data type

text

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

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Study Drug:
Description

Study Drug

Data type

text

Alias
UMLS CUI [1]
C0304229
Route: intravitreal
Description

Route intravitreal

Data type

boolean

Alias
UMLS CUI [1]
C1517572
Study Eye:
Description

Study Eye

Data type

text

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

Kit number

Data type

text

Study Treatment Start Date:
Description

Therapy start date

Data type

date

Alias
UMLS CUI [1]
C3173309
Time Administered:
Description

Time Administered

Data type

time

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

Therapy end date

Data type

date

Alias
UMLS CUI [1]
C1531784
Time Administered:
Description

Time Administered

Data type

time

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

Treatment Continuing

Data type

boolean

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

recur SAE

Data type

text

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

Serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1519255
Onset Date
Description

Onset Date

Data type

date

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

Visual Impairment

Data type

boolean

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

date Serious Adverse Event

Data type

date

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

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Serious Adverse Event (SAE) Cover Page

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Gender
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])
Race
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])
Study Eye
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])
recur SAE
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])
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