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43849
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 #: 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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Versies (2)
- 25-06-17 25-06-17 -
- 20-09-21 20-09-21 -
Houder van rechten
Genentech, Inc.
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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 FVF4168G Macular Edema NCT00473330
SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4168G Macular Edema NCT00473330
Similar models
SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4168G Macular Edema NCT00473330
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
PT
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
PTINIT
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
VDT
Item
Report Date:
date
C1302584 (UMLS CUI [1,1])
Item Group
SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36)
CL Item
Serious (1)
CL Item
Non-Serious Expedited (2)
AE_RAW_TERM [AERAW]
Item
PRIMARY SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT (SAE/AE)
text
C0877248 (UMLS CUI [1])
Item
Ocular AEs only indicate eye affected:
integer
C2826797 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,2])
CL Item
Right (1)
CL Item
Left (2)
AE_ONSET_DT [AEODT]
Item
ONSET
date
C2985916 (UMLS CUI [1])
AE_RESOLVE_DT [AERDT]
Item
RESOLUTION
date
C2985918 (UMLS CUI [1])
CL Item
Mild (1 )
CL Item
Moderate (2 )
CL Item
Severe (3 )
AE_CAUSE_STUDY_DRUG [AETX]
Item
SAE/AE SUSPECTED TO BE CAUSED BY STUDY DRUG? (Investigator’s
boolean
C1706742 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
AE_CAUSE_CONCUR_DX [AECDX1]
Item
OTHER SUSPECTED CAUSES OF AE None
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX2]
Item
OTHER SUSPECTED CAUSES OF AE Disease Under Study
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX3]
Item
OTHER SUSPECTED CAUSES OF AE Withdrawal of Study Drug
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX4]
Item
OTHER SUSPECTED CAUSES OF AE Concurrent Illness
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX5]
Item
OTHER SUSPECTED CAUSES OF AE Concomitant Medication
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX6]
Item
OTHER SUSPECTED CAUSES OF AE Non-Drug Intervention (procedure)
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX7]
Item
OTHER SUSPECTED CAUSES OF AE Study Drug Injection / Sham Procedure
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX8]
Item
OTHER SUSPECTED CAUSES OF AE Laser Photocoagulation
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX9]
Item
OTHER SUSPECTED CAUSES OF AE Medication Error
boolean
C1706742 (UMLS CUI [1])
Item
ACTION TAKEN WITH STUDY DRUG DUE TO AE
integer
C0304229 (UMLS CUI [1,1])
C1608430 (UMLS CUI [1,2])
C1608430 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Drug Permanently (2)
CL Item
Dose Held Discontinued (3)
CL Item
Not Applicable (4)
AE_TX_MEDICATIONS [AETXMD1]
Item
TREATMENT FOR AE 1. None
boolean
C2981656 (UMLS CUI [1])
AE_TX_MEDICATIONS [AETXMD2]
Item
TREATMENT FOR AE 2. Medications (record on meds CRF)
boolean
C2981656 (UMLS CUI [1])
AE_TX_MEDICATIONS [AETXMD3]
Item
TREATMENT FOR AE 3. Procedure / Surgery (record on protocol specific Concurrent Ocular Procedures CRF)
boolean
C2981656 (UMLS CUI [1])
AE_TX_MEDICATIONS [AETXMD4]
Item
TREATMENT FOR AE 4. Subject Discontinued from Study
boolean
C2981656 (UMLS CUI [1])
Death
Item
1 It resulted in death:
boolean
C1306577 (UMLS CUI [1])
Date of Death
Item
2 Date of death
date
C1148348 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Life-threatening
Item
4 It was life-threatening (i.e., the recorded SAE placed subject at immediate risk of death)
boolean
C2826244 (UMLS CUI [1])
hospitalization
Item
5 It required or prolonged inpatient hospitalization (i.e., the recorded SAE caused the subject to be hospitalized or prolonged hospitalization beyond the expected length of stay)
boolean
C0745041 (UMLS CUI [1])
Admission date
Item
6 Admission Date
date
C1302393 (UMLS CUI [1])
Disability
Item
It was disabling (i.e., the recorded SAE resulted in substantial disruption of the subject’s ability to carry out normal life functions)
boolean
C0231170 (UMLS CUI [1])
congenital anomaly
Item
8 It is a congenital anomaly/birth defect in offspring of study subject
boolean
C2826727 (UMLS CUI [1])
subject in danger
Item
It does not meet any of the above serious criteria, but may jeopardize the subject, and may require medical or surgical intervention to prevent one of the outcomes listed above.
boolean
C0681850 (UMLS CUI [1,1])
C2164151 (UMLS CUI [1,2])
C2164151 (UMLS CUI [1,2])
tests performed
Item
Relevant Diagnostic Tests performed?
boolean
C3259360 (UMLS CUI [1])
diagnostic test
Item
If Yes, please indicate:
text
C3259360 (UMLS CUI [1])
Diagnostic Test
Item
Relevant Diagnostic Test
text
C0430022 (UMLS CUI [1])
Date
Item
Date Performed
date
C0430022 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
test result
Item
Relevant Diagnostic Test Result
text
C0456984 (UMLS CUI [1])
test result pending
Item
Result Pending
boolean
C2711509 (UMLS CUI [1])
case details
Item
Additional Case Details:
text
C0868928 (UMLS CUI [1])