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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  1. 25.06.17 25.06.17 -
  2. 20.09.21 20.09.21 -
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20. September 2021

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SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4168G Macular Edema NCT00473330

Englisch

SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulare  
Patient administration
Beschreibung

Patient administration

Subject Number
Beschreibung

PT

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beschreibung

PTINIT

Datentyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Report Date:
Beschreibung

VDT

Datentyp

date

Alias
UMLS CUI [1,1]
C1302584
SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36)
Beschreibung

SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36)

AE_SERIOUS [AESER]
Beschreibung

AE_SERIOUS [AESER]

Datentyp

integer

Alias
UMLS CUI [1]
C1519255
Adverse Event
Beschreibung

Adverse Event

PRIMARY SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT (SAE/AE)
Beschreibung

AE_RAW_TERM [AERAW]

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Ocular AEs only indicate eye affected:
Beschreibung

AE_LOCATION [AELOC]

Datentyp

integer

Alias
UMLS CUI [1,1]
C2826797
UMLS CUI [1,2]
C0015392
ONSET
Beschreibung

AE_ONSET_DT [AEODT]

Datentyp

date

Maßeinheiten
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2985916
DD/MMM/YY
RESOLUTION
Beschreibung

AE_RESOLVE_DT [AERDT]

Datentyp

date

Maßeinheiten
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2985918
DD/MMM/YY
AE SEVERITY
Beschreibung

AE_INTENSITY [AEINT]

Datentyp

integer

Alias
UMLS CUI [1]
C2985921
SAE/AE SUSPECTED TO BE CAUSED BY STUDY DRUG? (Investigator’s
Beschreibung

AE_CAUSE_STUDY_DRUG [AETX]

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1706742
UMLS CUI [1,2]
C0304229
OTHER SUSPECTED CAUSES OF AE None
Beschreibung

AE_CAUSE_CONCUR_DX [AECDX1]

Datentyp

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Disease Under Study
Beschreibung

AE_CAUSE_CONCUR_DX [AECDX2]

Datentyp

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Withdrawal of Study Drug
Beschreibung

AE_CAUSE_CONCUR_DX [AECDX3]

Datentyp

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Concurrent Illness
Beschreibung

AE_CAUSE_CONCUR_DX [AECDX4]

Datentyp

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Concomitant Medication
Beschreibung

AE_CAUSE_CONCUR_DX [AECDX5]

Datentyp

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Non-Drug Intervention (procedure)
Beschreibung

AE_CAUSE_CONCUR_DX [AECDX6]

Datentyp

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Study Drug Injection / Sham Procedure
Beschreibung

AE_CAUSE_CONCUR_DX [AECDX7]

Datentyp

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Laser Photocoagulation
Beschreibung

AE_CAUSE_CONCUR_DX [AECDX8]

Datentyp

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Medication Error
Beschreibung

AE_CAUSE_CONCUR_DX [AECDX9]

Datentyp

boolean

Alias
UMLS CUI [1]
C1706742
ACTION TAKEN WITH STUDY DRUG DUE TO AE
Beschreibung

AE_ACTION_STUDY_DRUG [AEACTX]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1608430
TREATMENT FOR AE 1. None
Beschreibung

AE_TX_MEDICATIONS [AETXMD1]

Datentyp

boolean

Alias
UMLS CUI [1]
C2981656
TREATMENT FOR AE 2. Medications (record on meds CRF)
Beschreibung

AE_TX_MEDICATIONS [AETXMD2]

Datentyp

boolean

Alias
UMLS CUI [1]
C2981656
TREATMENT FOR AE 3. Procedure / Surgery (record on protocol specific Concurrent Ocular Procedures CRF)
Beschreibung

AE_TX_MEDICATIONS [AETXMD3]

Datentyp

boolean

Alias
UMLS CUI [1]
C2981656
TREATMENT FOR AE 4. Subject Discontinued from Study
Beschreibung

AE_TX_MEDICATIONS [AETXMD4]

Datentyp

boolean

Alias
UMLS CUI [1]
C2981656
Serious AE
Beschreibung

Serious AE

1 It resulted in death:
Beschreibung

Death

Datentyp

boolean

Alias
UMLS CUI [1]
C1306577
2 Date of death
Beschreibung

Date of Death

Datentyp

date

Maßeinheiten
  • DD/MMM/YY
Alias
UMLS CUI [1]
C1148348
DD/MMM/YY
3 Autopsy performed?
Beschreibung

Autopsy

Datentyp

integer

Alias
UMLS CUI [1]
C4274690
4 It was life-threatening (i.e., the recorded SAE placed subject at immediate risk of death)
Beschreibung

Life-threatening

Datentyp

boolean

Alias
UMLS CUI [1]
C2826244
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)
Beschreibung

hospitalization

Datentyp

boolean

Alias
UMLS CUI [1]
C0745041
6 Admission Date
Beschreibung

Admission date

Datentyp

date

Alias
UMLS CUI [1]
C1302393
It was disabling (i.e., the recorded SAE resulted in substantial disruption of the subject’s ability to carry out normal life functions)
Beschreibung

Disability

Datentyp

boolean

Alias
UMLS CUI [1]
C0231170
8 It is a congenital anomaly/birth defect in offspring of study subject
Beschreibung

congenital anomaly

Datentyp

boolean

Alias
UMLS CUI [1]
C2826727
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.
Beschreibung

subject in danger

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C2164151
Relevant Diagnostic Tests Performed
Beschreibung

Relevant Diagnostic Tests Performed

Relevant Diagnostic Tests performed?
Beschreibung

tests performed

Datentyp

boolean

Alias
UMLS CUI [1]
C3259360
If Yes, please indicate:
Beschreibung

diagnostic test

Datentyp

text

Alias
UMLS CUI [1]
C3259360
Tests
Beschreibung

Tests

Relevant Diagnostic Test
Beschreibung

Diagnostic Test

Datentyp

text

Alias
UMLS CUI [1]
C0430022
Date Performed
Beschreibung

Date

Datentyp

date

Maßeinheiten
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Relevant Diagnostic Test Result
Beschreibung

test result

Datentyp

text

Alias
UMLS CUI [1]
C0456984
Result Pending
Beschreibung

test result pending

Datentyp

boolean

Alias
UMLS CUI [1]
C2711509
Additional Case Details:
Beschreibung

Additional Case Details:

Additional Case Details:
Beschreibung

- Associated signs and symptoms, if applicable - Clinical course (e.g. sequence of events) - Any specific treatment for the SAE - Elaborate on suspected causes of SAE

Datentyp

text

Alias
UMLS CUI [1]
C0868928
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Ähnliche Modelle

SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Patient administration
PT
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
PTINIT
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
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)
Item
integer
C1519255 (UMLS CUI [1])
AE_SERIOUS [AESER]
Code List
AE_SERIOUS [AESER]
CL Item
Serious (1)
CL Item
Non-Serious Expedited (2)
Item Group
Adverse Event
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])
LIGHT_PERCEPTION [LIPEC]
Code List
Ocular AEs only indicate eye affected:
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])
Item
AE SEVERITY
integer
C2985921 (UMLS CUI [1])
AE_INTENSITY [AEINT]
Code List
AE SEVERITY
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])
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])
AE_ACTION_STUDY_DRUG [AEACTX]
Code List
ACTION TAKEN WITH STUDY DRUG DUE TO AE
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])
Item Group
Serious AE
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])
Item
3 Autopsy performed?
integer
C4274690 (UMLS CUI [1])
Autopsy
Code List
3 Autopsy performed?
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])
Item Group
Relevant Diagnostic Tests Performed
tests performed
Item
Relevant Diagnostic Tests performed?
boolean
C3259360 (UMLS CUI [1])
diagnostic test
Item
If Yes, please indicate:
text
C3259360 (UMLS CUI [1])
Item Group
Tests
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])
test result
Item
Relevant Diagnostic Test Result
text
C0456984 (UMLS CUI [1])
test result pending
Item
Result Pending
boolean
C2711509 (UMLS CUI [1])
Item Group
Additional Case Details:
case details
Item
Additional Case Details:
text
C0868928 (UMLS CUI [1])
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