ID

23136

Beskrivning

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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Versioner (2)
  1. 2017-06-25 2017-06-25 -
  2. 2017-06-25 2017-06-25 -
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25 juni 2017

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NON-SERIOUS ADVERSE EVENT REPORTING (MONTH 13 - MONTH 24) CRFs Roche FVF4168G Macular Edema NCT00473330

Engelsk

NON-SERIOUS ADVERSE EVENT REPORTING (MONTH 13 - MONTH 24) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulär  
Patient administration
Beskrivning

Patient administration

Subject Number
Beskrivning

PT

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beskrivning

PTINIT

Datatyp

text

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

VDT

Datatyp

date

Alias
UMLS CUI [1,1]
C1302584
NON-SERIOUS ADVERSE EVENT REPORTING
Beskrivning

NON-SERIOUS ADVERSE EVENT REPORTING

Were there any events / illnesses?
Beskrivning

If Yes, record below.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0877248
Adverse Event
Beskrivning

Adverse Event

PRIMARY ADVERSE EVENT (AE)
Beskrivning

AE_RAW_TERM [AERAW]

Datatyp

text

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

AE_LOCATION [AELOC]

Datatyp

integer

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

AE_ONSET_DT [AEODT]

Datatyp

date

Måttenheter
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2985916
DD/MMM/YY
RESOLUTION
Beskrivning

AE_RESOLVE_DT [AERDT]

Datatyp

date

Måttenheter
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2985918
DD/MMM/YY
AE SEVERITY
Beskrivning

AE_INTENSITY [AEINT]

Datatyp

integer

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

AE_CAUSE_STUDY_DRUG [AETX]

Datatyp

boolean

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

AE_CAUSE_CONCUR_DX [AECDX1]

Datatyp

boolean

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

AE_CAUSE_CONCUR_DX [AECDX2]

Datatyp

boolean

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

AE_CAUSE_CONCUR_DX [AECDX3]

Datatyp

boolean

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

AE_CAUSE_CONCUR_DX [AECDX4]

Datatyp

boolean

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

AE_CAUSE_CONCUR_DX [AECDX5]

Datatyp

boolean

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

AE_CAUSE_CONCUR_DX [AECDX6]

Datatyp

boolean

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

AE_CAUSE_CONCUR_DX [AECDX7]

Datatyp

boolean

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

AE_CAUSE_CONCUR_DX [AECDX8]

Datatyp

boolean

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

AE_ACTION_STUDY_DRUG [AEACTX]

Datatyp

integer

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

AE_TX_MEDICATIONS [AETXMD1]

Datatyp

boolean

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

AE_TX_MEDICATIONS [AETXMD2]

Datatyp

boolean

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

AE_TX_MEDICATIONS [AETXMD3]

Datatyp

boolean

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

AE_TX_MEDICATIONS [AETXMD4]

Datatyp

boolean

Alias
UMLS CUI [1]
C2981656
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Similar models

NON-SERIOUS ADVERSE EVENT REPORTING (MONTH 13 - MONTH 24) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
NON-SERIOUS ADVERSE EVENT REPORTING
AE_RECORDS [AEREC]
Item
Were there any events / illnesses?
boolean
C0262926 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
Adverse Event
AE_RAW_TERM [AERAW]
Item
PRIMARY ADVERSE EVENT (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
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])
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])
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