ID
43849
Beschreibung
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
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- 25.06.17 25.06.17 -
- 20.09.21 20.09.21 -
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Genentech, Inc.
Hochgeladen am
20. September 2021
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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
Beschreibung
SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36)
Beschreibung
Adverse Event
Beschreibung
AE_RAW_TERM [AERAW]
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
AE_LOCATION [AELOC]
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2826797
- UMLS CUI [1,2]
- C0015392
Beschreibung
AE_ONSET_DT [AEODT]
Datentyp
date
Maßeinheiten
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2985916
Beschreibung
AE_RESOLVE_DT [AERDT]
Datentyp
date
Maßeinheiten
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2985918
Beschreibung
AE_INTENSITY [AEINT]
Datentyp
integer
Alias
- UMLS CUI [1]
- C2985921
Beschreibung
AE_CAUSE_STUDY_DRUG [AETX]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1706742
- UMLS CUI [1,2]
- C0304229
Beschreibung
AE_CAUSE_CONCUR_DX [AECDX1]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschreibung
AE_CAUSE_CONCUR_DX [AECDX2]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschreibung
AE_CAUSE_CONCUR_DX [AECDX3]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschreibung
AE_CAUSE_CONCUR_DX [AECDX4]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschreibung
AE_CAUSE_CONCUR_DX [AECDX5]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschreibung
AE_CAUSE_CONCUR_DX [AECDX6]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschreibung
AE_CAUSE_CONCUR_DX [AECDX7]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschreibung
AE_CAUSE_CONCUR_DX [AECDX8]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschreibung
AE_CAUSE_CONCUR_DX [AECDX9]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1706742
Beschreibung
AE_ACTION_STUDY_DRUG [AEACTX]
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1608430
Beschreibung
AE_TX_MEDICATIONS [AETXMD1]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2981656
Beschreibung
AE_TX_MEDICATIONS [AETXMD2]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2981656
Beschreibung
AE_TX_MEDICATIONS [AETXMD3]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2981656
Beschreibung
AE_TX_MEDICATIONS [AETXMD4]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2981656
Beschreibung
Serious AE
Beschreibung
Death
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1306577
Beschreibung
Date of Death
Datentyp
date
Maßeinheiten
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C1148348
Beschreibung
Autopsy
Datentyp
integer
Alias
- UMLS CUI [1]
- C4274690
Beschreibung
Life-threatening
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826244
Beschreibung
hospitalization
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0745041
Beschreibung
Admission date
Datentyp
date
Alias
- UMLS CUI [1]
- C1302393
Beschreibung
Disability
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0231170
Beschreibung
congenital anomaly
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826727
Beschreibung
subject in danger
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C2164151
Beschreibung
Relevant Diagnostic Tests Performed
Beschreibung
Tests
Beschreibung
Diagnostic Test
Datentyp
text
Alias
- UMLS CUI [1]
- C0430022
Beschreibung
Date
Datentyp
date
Maßeinheiten
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0011008
Beschreibung
test result
Datentyp
text
Alias
- UMLS CUI [1]
- C0456984
Beschreibung
test result pending
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2711509
Beschreibung
Additional Case Details:
Ähnliche Modelle
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])