STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

ID

23263

Descrizione

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 #: FVF4170g 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

Keywords

Clinical Trial

Clinical Trial, Phase III

E08-E13

Makulaödem

Ophthalmologie

01/07/17 01/07/17 -

Titolare del copyright

Genentech, Inc.

Caricato su

1 luglio 2017

DOI

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Licenza

Creative Commons BY-NC 3.0

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1 moduli

StudyEvent: ODM
1. STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Patient administration

Item Group

Patient administration

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])

STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)

Item Group

STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)

DISC_COMPLETED_STUDY [DCCMP]

Item

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

integer

C2826674 (UMLS CUI [1])

TX_DRUG_DISC [TXDISC]

Code List

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

CL Item

Subject Completed Study (1)

CL Item

Subject Discontinued Early (2)

DISC_COMP_DT [DCCDT]

Item

Date Subject Completed or Discontinued Early from Study:

date

C2983670 (UMLS CUI [1])

DISC_PRIMARY_REASON [DCRS]

Item

Check the PRIMARY reason the subject discontinued early from the study (check one only):

integer

C2348571 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])

TX_DRUG_DISC_REASON [TXREAS]

Code List

Check the PRIMARY reason the subject discontinued early from the study (check one only):

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 withdraw (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)

DISC_PRIMARY_REAS_SP [DCRSP]

Item

Please specify intervention:

text

C2348571 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])

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Keywords

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STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382