ID
43850
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 #: 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
Keywords
Versions (2)
- 6/25/17 6/25/17 -
- 9/20/21 9/20/21 -
Copyright Holder
Genentech, Inc.
Uploaded on
September 20, 2021
DOI
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License
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
Description
SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36)
Description
Adverse Event
Description
AE_RAW_TERM [AERAW]
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
AE_LOCATION [AELOC]
Data type
integer
Alias
- UMLS CUI [1,1]
- C2826797
- UMLS CUI [1,2]
- C0015392
Description
AE_ONSET_DT [AEODT]
Data type
date
Measurement units
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2985916
Description
AE_RESOLVE_DT [AERDT]
Data type
date
Measurement units
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2985918
Description
AE_INTENSITY [AEINT]
Data type
integer
Alias
- UMLS CUI [1]
- C2985921
Description
AE_CAUSE_STUDY_DRUG [AETX]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1706742
- UMLS CUI [1,2]
- C0304229
Description
AE_CAUSE_CONCUR_DX [AECDX1]
Data type
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX2]
Data type
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX3]
Data type
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX4]
Data type
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX5]
Data type
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX6]
Data type
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX7]
Data type
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX8]
Data type
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX9]
Data type
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_ACTION_STUDY_DRUG [AEACTX]
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1608430
Description
AE_TX_MEDICATIONS [AETXMD1]
Data type
boolean
Alias
- UMLS CUI [1]
- C2981656
Description
AE_TX_MEDICATIONS [AETXMD2]
Data type
boolean
Alias
- UMLS CUI [1]
- C2981656
Description
AE_TX_MEDICATIONS [AETXMD3]
Data type
boolean
Alias
- UMLS CUI [1]
- C2981656
Description
AE_TX_MEDICATIONS [AETXMD4]
Data type
boolean
Alias
- UMLS CUI [1]
- C2981656
Description
Serious AE
Description
Death
Data type
boolean
Alias
- UMLS CUI [1]
- C1306577
Description
Date of Death
Data type
date
Measurement units
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C1148348
Description
Autopsy
Data type
integer
Alias
- UMLS CUI [1]
- C4274690
Description
Life-threatening
Data type
boolean
Alias
- UMLS CUI [1]
- C2826244
Description
hospitalization
Data type
boolean
Alias
- UMLS CUI [1]
- C0745041
Description
Admission date
Data type
date
Alias
- UMLS CUI [1]
- C1302393
Description
Disability
Data type
boolean
Alias
- UMLS CUI [1]
- C0231170
Description
congenital anomaly
Data type
boolean
Alias
- UMLS CUI [1]
- C2826727
Description
subject in danger
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C2164151
Description
Relevant Diagnostic Tests Performed
Description
Tests
Description
Diagnostic Test
Data type
text
Alias
- UMLS CUI [1]
- C0430022
Description
Date
Data type
date
Measurement units
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0011008
Description
test result
Data type
text
Alias
- UMLS CUI [1]
- C0456984
Description
test result pending
Data type
boolean
Alias
- UMLS CUI [1]
- C2711509
Description
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])