ID
43849
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 (2)
- 25/06/2017 25/06/2017 -
- 20/09/2021 20/09/2021 -
Détendeur de droits
Genentech, Inc.
Téléchargé le
20 septembre 2021
DOI
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Creative Commons BY-NC 3.0
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SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4168G Macular Edema NCT00473330
SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4168G Macular Edema NCT00473330
Description
SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36)
Description
Adverse Event
Description
AE_RAW_TERM [AERAW]
Type de données
text
Alias
- UMLS CUI [1]
- C0877248
Description
AE_LOCATION [AELOC]
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2826797
- UMLS CUI [1,2]
- C0015392
Description
AE_ONSET_DT [AEODT]
Type de données
date
Unités de mesure
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2985916
Description
AE_RESOLVE_DT [AERDT]
Type de données
date
Unités de mesure
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2985918
Description
AE_INTENSITY [AEINT]
Type de données
integer
Alias
- UMLS CUI [1]
- C2985921
Description
AE_CAUSE_STUDY_DRUG [AETX]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1706742
- UMLS CUI [1,2]
- C0304229
Description
AE_CAUSE_CONCUR_DX [AECDX1]
Type de données
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX2]
Type de données
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX3]
Type de données
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX4]
Type de données
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX5]
Type de données
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX6]
Type de données
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX7]
Type de données
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX8]
Type de données
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_CAUSE_CONCUR_DX [AECDX9]
Type de données
boolean
Alias
- UMLS CUI [1]
- C1706742
Description
AE_ACTION_STUDY_DRUG [AEACTX]
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1608430
Description
AE_TX_MEDICATIONS [AETXMD1]
Type de données
boolean
Alias
- UMLS CUI [1]
- C2981656
Description
AE_TX_MEDICATIONS [AETXMD2]
Type de données
boolean
Alias
- UMLS CUI [1]
- C2981656
Description
AE_TX_MEDICATIONS [AETXMD3]
Type de données
boolean
Alias
- UMLS CUI [1]
- C2981656
Description
AE_TX_MEDICATIONS [AETXMD4]
Type de données
boolean
Alias
- UMLS CUI [1]
- C2981656
Description
Serious AE
Description
Death
Type de données
boolean
Alias
- UMLS CUI [1]
- C1306577
Description
Date of Death
Type de données
date
Unités de mesure
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C1148348
Description
Autopsy
Type de données
integer
Alias
- UMLS CUI [1]
- C4274690
Description
Life-threatening
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826244
Description
hospitalization
Type de données
boolean
Alias
- UMLS CUI [1]
- C0745041
Description
Admission date
Type de données
date
Alias
- UMLS CUI [1]
- C1302393
Description
Disability
Type de données
boolean
Alias
- UMLS CUI [1]
- C0231170
Description
congenital anomaly
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826727
Description
subject in danger
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C2164151
Description
Relevant Diagnostic Tests Performed
Description
Tests
Description
Diagnostic Test
Type de données
text
Alias
- UMLS CUI [1]
- C0430022
Description
Date
Type de données
date
Unités de mesure
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0011008
Description
test result
Type de données
text
Alias
- UMLS CUI [1]
- C0456984
Description
test result pending
Type de données
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 FVF4168G Macular Edema NCT00473330
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])