ID

22604

Description

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

Keywords

Versions (1)
  1. 6/8/17 6/8/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

June 8, 2017

DOI

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License

Creative Commons BY-NC 3.0
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VITAL SIGNS (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

English

VITAL SIGNS (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

1 forms  
Patient administration
Description

Patient administration

Subject Number
Description

PT

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

PTINIT

Data type

text

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

VDT

Data type

date

Alias
UMLS CUI [1,1]
C1302584
VITAL SIGNS (SCREENING)
Description

VITAL SIGNS (SCREENING)

Were any vital signs recorded at this visit?
Description

VITAL_SIGNS_RECORDS [VTLREC]

Data type

boolean

Alias
UMLS CUI [1,1]
C1740486
Vital Signs Date:
Description

VITAL_SIGNS_DT [VTLDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C2826644
DD/MMM/YY
Vital Signs Time:
Description

VITAL_SIGNS_TIME [VTLTM]

Data type

time

Measurement units
  • 24 hr clock
Alias
UMLS CUI [1]
C2827042
24 hr clock
Temp:
Description

TEMPERATURE [TEMP]

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Pulse:
Description

PULSE [PULSE]

Data type

integer

Measurement units
  • /min
Alias
UMLS CUI [1]
C0232117
/min
Resp:
Description

RESPIRATION [RESP]

Data type

integer

Measurement units
  • /min
Alias
UMLS CUI [1]
C0231832
/min
Blood Pressure sys:
Description

BLOOD_PRESSURE_SYS [BPS]

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure dys:
Description

BLOOD_PRESSURE_DIA [BPD]

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Height:
Description

HEIGHT [HT]

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight:
Description

WEIGHT [WT]

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
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Similar models

VITAL SIGNS (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
VITAL SIGNS (SCREENING)
VITAL_SIGNS_RECORDS [VTLREC]
Item
Were any vital signs recorded at this visit?
boolean
C1740486 (UMLS CUI [1,1])
VITAL_SIGNS_DT [VTLDT]
Item
Vital Signs Date:
date
C2826644 (UMLS CUI [1,1])
VITAL_SIGNS_TIME [VTLTM]
Item
Vital Signs Time:
time
C2827042 (UMLS CUI [1])
TEMPERATURE [TEMP]
Item
Temp:
float
C0005903 (UMLS CUI [1])
PULSE [PULSE]
Item
Pulse:
integer
C0232117 (UMLS CUI [1])
RESPIRATION [RESP]
Item
Resp:
integer
C0231832 (UMLS CUI [1])
BLOOD_PRESSURE_SYS [BPS]
Item
Blood Pressure sys:
integer
C0871470 (UMLS CUI [1])
BLOOD_PRESSURE_DIA [BPD]
Item
Blood Pressure dys:
integer
C0428883 (UMLS CUI [1])
HEIGHT [HT]
Item
Height:
float
C0005890 (UMLS CUI [1])
WEIGHT [WT]
Item
Weight:
float
C0005910 (UMLS CUI [1])
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