ID

42027

Descripción

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.

Palabras clave

Versiones (3)
  1. 19/2/18 19/2/18 -
  2. 15/3/21 15/3/21 - Dr. rer. medic Philipp Neuhaus
  3. 20/9/21 20/9/21 -
Titular de derechos de autor

Roche

Subido en

15 de marzo de 2021

DOI

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Licencia

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

Inglés

Serious Adverse Event (SAE) Cover Page

1 formularios  
Serious Adverse Event (SAE) Cover Page
Descripción

Serious Adverse Event (SAE) Cover Page

Alias
UMLS CUI-1
C1519255
Initial Report Date:
Descripción

Report Date

Tipo de datos

date

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

Report Date Follow-up

Tipo de datos

date

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

Principal Investigator

Tipo de datos

text

Alias
UMLS CUI [1]
C1521895
Reporter:
Descripción

Reporter

Tipo de datos

text

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

Telephone number

Tipo de datos

integer

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

Fax number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1549619
Investigator Number
Descripción

Investigator Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2826689
Subject Number
Descripción

Subject Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Subject Initials
Descripción

Subject Initials

Tipo de datos

text

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

Gender

Tipo de datos

text

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

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight in lb
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • lb
Alias
UMLS CUI [1]
C0005910
lb
Date of Birth:
Descripción

Date of Birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Race:
Descripción

Race

Tipo de datos

text

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

Other

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394
Study Drug:
Descripción

Study Drug

Tipo de datos

text

Alias
UMLS CUI [1]
C0304229
Route: intravitreal
Descripción

Route intravitreal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1517572
Study Eye:
Descripción

Study Eye

Tipo de datos

text

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

Kit number

Tipo de datos

text

Study Treatment Start Date:
Descripción

Therapy start date

Tipo de datos

date

Alias
UMLS CUI [1]
C3173309
Time Administered:
Descripción

Time Administered

Tipo de datos

time

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

Therapy end date

Tipo de datos

date

Alias
UMLS CUI [1]
C1531784
Time Administered:
Descripción

Time Administered

Tipo de datos

time

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

Treatment Continuing

Tipo de datos

boolean

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

recur SAE

Tipo de datos

text

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

Serious Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Onset Date
Descripción

Onset Date

Tipo de datos

date

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

Visual Impairment

Tipo de datos

boolean

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

date Serious Adverse Event

Tipo de datos

date

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

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Serious Adverse Event (SAE) Cover Page

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

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