ID
43850
Beschrijving
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 #: FVF4170g 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
Trefwoorden
Versies (2)
- 25-06-17 25-06-17 -
- 20-09-21 20-09-21 -
Houder van rechten
Genentech, Inc.
Geüploaded op
20 september 2021
DOI
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Licentie
Creative Commons BY-NC 3.0
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SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4170G Macular Edema NCT00473382
SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4170G Macular Edema NCT00473382
Beschrijving
SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36)
Beschrijving
Adverse Event
Beschrijving
AE_RAW_TERM [AERAW]
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
AE_LOCATION [AELOC]
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2826797
- UMLS CUI [1,2]
- C0015392
Beschrijving
AE_ONSET_DT [AEODT]
Datatype
date
Maateenheden
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2985916
Beschrijving
AE_RESOLVE_DT [AERDT]
Datatype
date
Maateenheden
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2985918
Beschrijving
AE_INTENSITY [AEINT]
Datatype
integer
Alias
- UMLS CUI [1]
- C2985921
Beschrijving
AE_CAUSE_STUDY_DRUG [AETX]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1706742
- UMLS CUI [1,2]
- C0304229
Beschrijving
AE_CAUSE_CONCUR_DX [AECDX1]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschrijving
AE_CAUSE_CONCUR_DX [AECDX2]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschrijving
AE_CAUSE_CONCUR_DX [AECDX3]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschrijving
AE_CAUSE_CONCUR_DX [AECDX4]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschrijving
AE_CAUSE_CONCUR_DX [AECDX5]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschrijving
AE_CAUSE_CONCUR_DX [AECDX6]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschrijving
AE_CAUSE_CONCUR_DX [AECDX7]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschrijving
AE_CAUSE_CONCUR_DX [AECDX8]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschrijving
AE_CAUSE_CONCUR_DX [AECDX9]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschrijving
AE_ACTION_STUDY_DRUG [AEACTX]
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1608430
Beschrijving
AE_TX_MEDICATIONS [AETXMD1]
Datatype
boolean
Alias
- UMLS CUI [1]
- C2981656
Beschrijving
AE_TX_MEDICATIONS [AETXMD2]
Datatype
boolean
Alias
- UMLS CUI [1]
- C2981656
Beschrijving
AE_TX_MEDICATIONS [AETXMD3]
Datatype
boolean
Alias
- UMLS CUI [1]
- C2981656
Beschrijving
AE_TX_MEDICATIONS [AETXMD4]
Datatype
boolean
Alias
- UMLS CUI [1]
- C2981656
Beschrijving
Serious AE
Beschrijving
Death
Datatype
boolean
Alias
- UMLS CUI [1]
- C1306577
Beschrijving
Date of Death
Datatype
date
Maateenheden
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C1148348
Beschrijving
Autopsy
Datatype
integer
Alias
- UMLS CUI [1]
- C4274690
Beschrijving
Life-threatening
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826244
Beschrijving
hospitalization
Datatype
boolean
Alias
- UMLS CUI [1]
- C0745041
Beschrijving
Admission date
Datatype
date
Alias
- UMLS CUI [1]
- C1302393
Beschrijving
Disability
Datatype
boolean
Alias
- UMLS CUI [1]
- C0231170
Beschrijving
congenital anomaly
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826727
Beschrijving
subject in danger
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C2164151
Beschrijving
Relevant Diagnostic Tests Performed
Beschrijving
Tests
Beschrijving
Diagnostic Test
Datatype
text
Alias
- UMLS CUI [1]
- C0430022
Beschrijving
Date
Datatype
date
Maateenheden
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0011008
Beschrijving
test result
Datatype
text
Alias
- UMLS CUI [1]
- C0456984
Beschrijving
test result pending
Datatype
boolean
Alias
- UMLS CUI [1]
- C2711509
Beschrijving
Additional Case Details:
Similar models
SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4170G Macular Edema NCT00473382
C2986440 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1608430 (UMLS CUI [1,2])
C2164151 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])