ID

23259

Descrição

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

Palavras-chave

Versões (2)
  1. 28/6/17 28/6/17 -
  2. 1/7/17 1/7/17 -
Titular dos direitos

Genentech, Inc.

Transferido a

1 de julio de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)CRFs Roche FVF4168G Macular Edema NCT00473330

Inglês

STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulários  
Patient administration
Descrição

Patient administration

Subject Number
Descrição

PT

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Descrição

PTINIT

Tipo de dados

text

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

VDT

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1302584
STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)
Descrição

STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)

Indicate if the subject completed the study drug treatment or discontinued early (check one only):
Descrição

TX_DRUG_DISC [TXDISC]

Tipo de dados

integer

Alias
UMLS CUI [1]
C2826674
Date Subject Discontinued Study Drug Treatment Early:
Descrição

TX_DISCONTINUED_DT [TXDCDT]

Tipo de dados

date

Unidades de medida
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0558681
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Check the PRIMARY reason the subject discontinued study drug treatment early
Descrição

TX_DRUG_DISC_REASON [TXREAS]

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0558681
UMLS CUI [1,2]
C0566251
Please specify intervention:
Descrição

TX_DISC_REASON_SP [TXDCRS]

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0558681
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0184661
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Similar models

STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)
Item
Indicate if the subject completed the study drug treatment or discontinued early (check one only):
integer
C2826674 (UMLS CUI [1])
TX_DRUG_DISC [TXDISC]
Code List
Indicate if the subject completed the study drug treatment or discontinued early (check one only):
CL Item
Subject Completed Study Drug Treatment (1)
CL Item
Subject Discontinued Study Drug Treatment Early (2)
TX_DISCONTINUED_DT [TXDCDT]
Item
Date Subject Discontinued Study Drug Treatment Early:
date
C0558681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Check the PRIMARY reason the subject discontinued study drug treatment early
integer
C0558681 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
TX_DRUG_DISC_REASON [TXREAS]
Code List
Check the PRIMARY reason the subject discontinued study drug treatment early
CL Item
Adverse Event (complete appropriate Adverse Event CRF) (1)
CL Item
Death (complete Study Completion / Early Discontinuation CRF) (2)
CL Item
Lost to follow-up (3)
CL Item
Physician’s decision to discontinue treatment (for reasons other than AE) (4)
CL Item
Subject’s decision to discontinue treatment (for reasons other than AE) (5)
CL Item
Sponsor’s decision to terminate study (6)
CL Item
Pregnancy (complete Pregnancy CRF) (7)
CL Item
Subject non-compliance (8)
CL Item
Subject’s condition mandated other therapeutic intervention (9)
Item
Please specify intervention:
text
C0558681 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
TX_DRUG_DISC_REASON [TXREAS]
Code List
Please specify intervention:
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