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Informações:
Falhas:
ID
42027
Descrição
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.
Palavras-chave
Versões (3)
- 19/02/2018 19/02/2018 -
- 15/03/2021 15/03/2021 - Dr. rer. medic Philipp Neuhaus
- 20/09/2021 20/09/2021 -
Titular dos direitos
Roche
Transferido a
15 de março de 2021
DOI
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Licença
Creative Commons BY-NC 3.0
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Serious Adverse Event (SAE) Cover Page rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g
Serious Adverse Event (SAE) Cover Page
- StudyEvent: ODM
Similar models
Serious Adverse Event (SAE) Cover Page
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
C2986440 (UMLS CUI [1,2])
CL Item
Male (Male)
C0086582 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Female (Female)
C0015780 (UMLS CUI-1)
(Comment:en)
(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])
CL Item
White (White)
C0007457 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Black (Black)
C0005680 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Asian or Pacific Islander (Asian or Pacific Islander)
C1531604 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Hispanic (Hispanic)
C0086409 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
American Indian or Alaskan Native (American Indian or Alaskan Native)
C1515945 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Other (Other)
C0205394 (UMLS CUI-1)
(Comment:en)
(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])
CL Item
R (R)
C0229089 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
L (L)
C0229090 (UMLS CUI-1)
(Comment:en)
(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])
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])
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])
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])
C1519255 (UMLS CUI [1,2])
Comments
Item
Additional Comments (if needed):
text
C0947611 (UMLS CUI [1])