ID
24117
Description
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus
Mots-clés
Versions (1)
- 25/07/2017 25/07/2017 -
Détendeur de droits
Genentech, Inc.
Téléchargé le
25 juillet 2017
DOI
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Licence
Creative Commons BY-NC 3.0
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RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 24) CRFs Roche FVF4168G Macular Edema NCT00473330
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 24) CRFs Roche FVF4168G Macular Edema NCT00473330
Description
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 24)
Description
[Central foveal thickness (CFT) is 250 μm with < 50 μm reduction from the prior month’s measurement, and laser treatment not received by the subject in the past 3 months.]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C1512693
Description
TX_RECEIVED (TXREC)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0743733
Description
If Yes (Administered):
Type de données
date
Unités de mesure
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C4255413
Description
TREATMENT_TIME (TXTM)
Type de données
time
Unités de mesure
- 24 hr clock
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C4255413
Description
TREATMENT_TYPE (TXTYP)
Type de données
integer
Alias
- UMLS CUI [1]
- C1275681
- UMLS CUI [2]
- C1275682
Description
LASER_BURNS (LSRBRN)
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0332708
- UMLS CUI [1,2]
- C0449788
Description
LASER_POWER (LSRPWR)
Type de données
integer
Unités de mesure
- mW
Alias
- UMLS CUI [1,1]
- C0023089
- UMLS CUI [1,2]
- C3854080
Description
LASER_DURATION (LSRDUR)
Type de données
integer
Unités de mesure
- seconds
Alias
- UMLS CUI [1,1]
- C0023089
- UMLS CUI [1,2]
- C0449238
Description
If No (Not Administered): If protocol specified anatomical and timeframe criteria for the rescue laser treatment were met but the rescue laser was NOT administered, select one or more reasons below and / or provide other reasons, if applicable:
Type de données
text
Description
INDICATE_REASON (NDRSN1)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C1275950
Description
INDICATE_REASON (NDRSN2)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0333101
Description
INDICATE_REASON (NDRSN3)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0154828
Description
INDICATE_REASON (NDRSN4)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C4049512
Description
INDICATE_REASON (NDRSN5)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0749657
Description
INDICATE_REASON (NDRSN6)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C3840932
Description
OTHER_SPECIFY [OTHSP]
Type de données
text
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C3840932
Similar models
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 24) CRFs Roche FVF4168G Macular Edema NCT00473330
C2986440 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,2])
C4255413 (UMLS CUI [1,2])
C4255413 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C3854080 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C1275950 (UMLS CUI [1,2])
C0333101 (UMLS CUI [1,2])
C4049512 (UMLS CUI [1,2])
C0749657 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])