Inglese

CDASH Exposure

1 moduli  
  1. StudyEvent: SE
    1. CDASH Exposure
Exposure
Descrizione

Exposure

Alias
UMLS CUI-1
C0332157
Start Date and Time
Descrizione

Start date and time of treatment.

Tipo di dati

datetime

Alias
CDASH
EXSTDTC
UMLS CUI-1
C2826878
End Date and Time
Descrizione

End date and time of treatment.

Tipo di dati

datetime

Alias
CDASH
EXENDTC
UMLS CUI-1
C2826872
Dose
Descrizione

Dose per administration.

Tipo di dati

float

Unità di misura
  • mg
Alias
CDASH
EXDSTXT
UMLS CUI-1
C0178602
mg
Lot Number
Descrizione

EXLOT = Lot Number of the EXTRT product.

Tipo di dati

text

Alias
CDASH
EXLOT
CDASH/SDTM
EXLOT
UMLS CUI-1
C2826710
Treatment Name
Descrizione

Name of the study treatment or intervention given per single administration or during the “constant dosing interval” for the observation.

Tipo di dati

text

Alias
CDASH
EXTRT
CDASH/SDTM
EXTRT
UMLS CUI-1
C2826702
Adjusted
Descrizione

Confirmation of dose adjustment. {NY} (See Section 2.2.)

Tipo di dati

text

Alias
CDASH
EXDOSADJ
UMLS CUI-1
C2826673
Reason adjusted
Descrizione

Describes reason or explanation of why a dose is adjusted – used only when an adjustment is represented in EXPOSURE dataset. May be used for variations from protocol-specified doses, or changes from expected doses.

Tipo di dati

text

Alias
CDASH
EXADJ
CDASH/SDTM
EXADJ
UMLS CUI-1
C2826652
Frequency
Descrizione

Number of doses given per a specific interval. {FREQ} (See Section 2.2.)

Tipo di dati

text

Alias
CDASH
EXDOSFRQ
CDASH/SDTM
EXDOSFRQ
UMLS CUI-1
C2826655
Route
Descrizione

Route of administration for EXTRT. {ROUTE} (See Section 2.2.)

Tipo di dati

text

Alias
CDASH
EXROUTE
CDASH/SDTM
EXROUTE
UMLS CUI-1
C2826731
Interruption Duration
Descrizione

Duration of the treatment interruption.

Tipo di dati

durationDatetime

Alias
CDASH
EXINTRP
UMLS CUI-1
C2826657
Anatomical Location
Descrizione

Specifies anatomical location of administration. {LOC} (See Section 2.2.)

Tipo di dati

text

Alias
CDASH
EXLOC
CDASH/SDTM
EXLOC
UMLS CUI-1
C2826698
Total Amount
Descrizione

Total amount of study treatment (drug + vehicle) administered or given to the subject.

Tipo di dati

float

Unità di misura
  • mg
Alias
CDASH
EXVAMT
UMLS CUI-1
C2981467
mg
Infusion Rate
Descrizione

Rate of infusion.

Tipo di dati

float

Unità di misura
  • mg
Alias
CDASH
EXFLRT
UMLS CUI-1
C2826682
mg
Completed treatment
Descrizione

Study Treatment Course Completion Occurrence Subject did not/did complete the intended regimen {NY} (See Section 2.2.)

Tipo di dati

text

Alias
CDASH
EXMEDCMP
UMLS CUI-1
C2826674
Planned Dose
Descrizione

Planned dose per administration.

Tipo di dati

float

Unità di misura
  • mg
Alias
CDASH
EXPDOSE
UMLS CUI-1
C2826722
mg
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Similar models

CDASH Exposure

1 moduli
  1. StudyEvent: SE
    1. CDASH Exposure
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Exposure
C0332157 (UMLS CUI-1)
Exposure Start Date Time
Item
Start Date and Time
datetime
EXSTDTC (CDASH)
C2826878 (UMLS CUI-1)
Exposure End Date Time
Item
End Date and Time
datetime
EXENDTC (CDASH)
C2826872 (UMLS CUI-1)
Dose
Item
Dose
float
EXDSTXT (CDASH)
C0178602 (UMLS CUI-1)
Exposure Lot Number
Item
Lot Number
text
EXLOT (CDASH)
EXLOT (CDASH/SDTM)
C2826710 (UMLS CUI-1)
Exposure Reported Name of Treatment
Item
Treatment Name
text
EXTRT (CDASH)
EXTRT (CDASH/SDTM)
C2826702 (UMLS CUI-1)
Item
Adjusted
text
EXDOSADJ (CDASH)
C2826673 (UMLS CUI-1)
No Yes Response
Code List
Adjusted
CL Item
NO (N)
CL Item
YES (Y)
Exposure Dose Adjustment Reason
Item
Reason adjusted
text
EXADJ (CDASH)
EXADJ (CDASH/SDTM)
C2826652 (UMLS CUI-1)
Item
Frequency
text
EXDOSFRQ (CDASH)
EXDOSFRQ (CDASH/SDTM)
C2826655 (UMLS CUI-1)
Frequency
Code List
Frequency
CL Item
QID (QID)
CL Item
TID (TID)
CL Item
BID (BID)
CL Item
QOD (QOD)
CL Item
QM (QM)
CL Item
PRN (PRN)
Item
Route
text
EXROUTE (CDASH)
EXROUTE (CDASH/SDTM)
C2826731 (UMLS CUI-1)
Route of Administration
Code List
Route
CL Item
ORAL (ORAL)
CL Item
TOPICAL (TOPICAL)
CL Item
SUBCUTANEOUS (SUBCUTANEOUS)
CL Item
TRANSDERMAL (TRANSDERMAL)
CL Item
INTRAOCULAR (INTRAOCULAR)
CL Item
INTRAMUSCULAR (INTRAMUSCULAR)
Exposure Interruption Duration
Item
Interruption Duration
durationDatetime
EXINTRP (CDASH)
C2826657 (UMLS CUI-1)
Item
Anatomical Location
text
EXLOC (CDASH)
EXLOC (CDASH/SDTM)
C2826698 (UMLS CUI-1)
Anatomical Location
Code List
Anatomical Location
CL Item
ARM (ARM)
CL Item
SHOULDER (SHOULDER)
CL Item
LEG (LEG)
CL Item
HIP (HIP)
Exposure Treatment Amount
Item
Total Amount
float
EXVAMT (CDASH)
C2981467 (UMLS CUI-1)
Exposure Flow Rate (Infusion)
Item
Infusion Rate
float
EXFLRT (CDASH)
C2826682 (UMLS CUI-1)
Item
Completed treatment
text
EXMEDCMP (CDASH)
C2826674 (UMLS CUI-1)
No Yes Response
Code List
Completed treatment
CL Item
NO (N)
CL Item
YES (Y)
Exposure Planned Dose
Item
Planned Dose
float
EXPDOSE (CDASH)
C2826722 (UMLS CUI-1)
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