ID

15670

Beschreibung

Nerventra Study (Eudra CT 2007-003226-19) Study MS-LAQ-301: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS)

Stichworte

Versionen (1)
  1. 08.06.16 08.06.16 -
Hochgeladen am

8. Juni 2016

DOI

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Nerventra Study Visit 1

Englisch

Nerventra Study Visit 1

1 Formulare  
Demographic Information Visit 1
Beschreibung

Demographic Information Visit 1

Protocol Number
Beschreibung

Protocol Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0008971
UMLS CUI [1,2]
C0600091
Visit Type
Beschreibung

i.e "Screening"

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Date of visit
Beschreibung

Visit date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Study site number
Beschreibung

Study site

Datentyp

integer

Alias
UMLS CUI [1]
C2825164
Subject number:
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C1709561
Section blank?
Beschreibung

Blank

Datentyp

boolean

Alias
UMLS CUI [1]
C0750479
Safety measurements Visit 1
Beschreibung

Safety measurements Visit 1

Temperature
Beschreibung

Temperature

Datentyp

float

Alias
UMLS CUI [1]
C0005903
Temperature type of measurement
Beschreibung

Temperature

Datentyp

integer

Alias
UMLS CUI [1]
C0005903
Units used for measurement
Beschreibung

Units used for measurement

Datentyp

integer

Alias
UMLS CUI [1]
C1519795
Measurement not done
Beschreibung

not done

Datentyp

boolean

Alias
UMLS CUI [1]
C1272696
Blood pressure measurement
Beschreibung

Blood pressure

Datentyp

text

Maßeinheiten
  • mm/Hg
Alias
UMLS CUI [1]
C0005823
mm/Hg
Measurement not done
Beschreibung

not done

Datentyp

boolean

Alias
UMLS CUI [1]
C1272696
Pulse
Beschreibung

Pulse Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Measurement not done
Beschreibung

not done

Datentyp

boolean

Alias
UMLS CUI [1]
C1272696
Investigators ECG interpretation
Beschreibung

ECG

Datentyp

text

Alias
UMLS CUI [1]
C1623258
ECG interpretation not done
Beschreibung

ECG not done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0420795
Where all required laboratory samples obtained?
Beschreibung

Laboratory specimen

Datentyp

boolean

Alias
UMLS CUI [1]
C0200345
Menstruation
Beschreibung

Menstruation

Datentyp

boolean

Alias
UMLS CUI [1]
C0025344
Population Pharmacokinetics Visit 1
Beschreibung

Population Pharmacokinetics Visit 1

Was Population Pharmacokinetics performed?
Beschreibung

Population Pharmacokinetics

Datentyp

boolean

Alias
UMLS CUI [1]
C0031328
Please specify why population pharmacokinetics was not done
Beschreibung

Population Pharmacokinetics not done

Datentyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C1272696
If Population Pharmacokinetics was performed, did the subject eat this morning?
Beschreibung

Population Pharmacokinetics

Datentyp

boolean

Alias
UMLS CUI [1]
C0031328
Meal time
Beschreibung

24h clock

Datentyp

time

Alias
UMLS CUI [1]
C0578574
Did the subject take the study drug regularly during the past week?
Beschreibung

Compliance behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
If the study drug was not taken regularly, please specify
Beschreibung

Compliance behavior

Datentyp

text

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
Date of last study drug dose prior to blood sample
Beschreibung

Last dose

Datentyp

date

Alias
UMLS CUI [1,1]
C3173975
UMLS CUI [1,2]
C3854006
Time of last study drug dose prior to blood sample
Beschreibung

24h clock

Datentyp

time

Alias
UMLS CUI [1,1]
C3173975
UMLS CUI [1,2]
C3854006
Date of PPK Blood sample
Beschreibung

PPK Blood sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0190979
UMLS CUI [1,2]
C0031328
Time of PPK Blood sample
Beschreibung

PPK Blood sample

Datentyp

time

Alias
UMLS CUI [1,1]
C0190979
UMLS CUI [1,2]
C0031328
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Ähnliche Modelle

Nerventra Study Visit 1

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Demographic Information Visit 1
Protocol Number
Item
Protocol Number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Visit
Item
Visit Type
text
C0545082 (UMLS CUI [1])
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Study site
Item
Study site number
integer
C2825164 (UMLS CUI [1])
Subject number
Item
Subject number:
integer
C1709561 (UMLS CUI [1])
Blank
Item
Section blank?
boolean
C0750479 (UMLS CUI [1])
Item Group
Safety measurements Visit 1
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature type of measurement
integer
C0005903 (UMLS CUI [1])
Temperature
Code List
Temperature type of measurement
CL Item
oral (1)
CL Item
axillary (2)
CL Item
aural (3)
CL Item
temporal (4)
Item
Units used for measurement
integer
C1519795 (UMLS CUI [1])
Units used for measurement
Code List
Units used for measurement
CL Item
F (1)
CL Item
C (2)
not done
Item
Measurement not done
boolean
C1272696 (UMLS CUI [1])
Blood pressure
Item
Blood pressure measurement
text
C0005823 (UMLS CUI [1])
not done
Item
Measurement not done
boolean
C1272696 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
not done
Item
Measurement not done
boolean
C1272696 (UMLS CUI [1])
ECG
Item
Investigators ECG interpretation
text
C1623258 (UMLS CUI [1])
ECG not done
Item
ECG interpretation not done
boolean
C1623258 (UMLS CUI [1,1])
C0420795 (UMLS CUI [1,2])
Laboratory specimen
Item
Where all required laboratory samples obtained?
boolean
C0200345 (UMLS CUI [1])
Menstruation
Item
Menstruation
boolean
C0025344 (UMLS CUI [1])
Item Group
Population Pharmacokinetics Visit 1
Population Pharmacokinetics
Item
Was Population Pharmacokinetics performed?
boolean
C0031328 (UMLS CUI [1])
Population Pharmacokinetics not done
Item
Please specify why population pharmacokinetics was not done
text
C0031328 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Population Pharmacokinetics
Item
If Population Pharmacokinetics was performed, did the subject eat this morning?
boolean
C0031328 (UMLS CUI [1])
Time of last food intake
Item
Meal time
time
C0578574 (UMLS CUI [1])
Compliance behavior
Item
Did the subject take the study drug regularly during the past week?
boolean
C1321605 (UMLS CUI [1])
Compliance behavior
Item
If the study drug was not taken regularly, please specify
text
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Last dose
Item
Date of last study drug dose prior to blood sample
date
C3173975 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Last dose
Item
Time of last study drug dose prior to blood sample
time
C3173975 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
PPK Blood sample
Item
Date of PPK Blood sample
date
C0190979 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
PPK Blood sample
Item
Time of PPK Blood sample
time
C0190979 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
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