Englisch

Concomitant Medication

1 Formulare  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Beschreibung

Cohort

Datentyp

integer

Alias
UMLS CUI [1]
C0599755
Visit Type
Beschreibung

Visit Type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Have any medications/treatments been administered during the time frame as specified in the Protocol?
Beschreibung

If yes, fill in the itemgroup below for each medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1948053
UMLS CUI [1,4]
C2348563
Concomitant Medication Details
Beschreibung

Concomitant Medication Details

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2348235
Concomitant Medication Name
Beschreibung

Generic names; trade names are allowed for combination drugs only

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Medical Indication
Beschreibung

Medical Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Prophylactic Indication
Beschreibung

A prophylactic medication is a medication administered in the absence of ANY symptom and in anticipation of a reaction to the vaccination (e.g. an anti-pyretic is considered to be prophylactic when it is given in the absence of fever [rectal temperature < 38.0°C or oral/axillary/ tympanic temperature <37.5 °C] and any other symptom, to prevent fever from oc curring). Any concomitant medication administered prophylactically in anticipation of reaction to the vaccination must be recorded in the eCRF with generic name of the medication (trade names are allowed for combination drugs only), total daily dose, route of administration, start and end dates of treatment and coded as ‘Prophylactic’. It has been noted that prophylactic administration of antipyretics before or immediately after vaccine administration can reduce the incidence and intensity of post-vaccination febrile reactions. Data however suggest that the use of prophylactic paracetamol might reduce the immune response to pneumococcal vaccines. The clinical relevance of this observation remains unknown.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0199176
Total daily dose
Beschreibung

Total daily dose

Datentyp

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Administration Route
Beschreibung

Administration Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Medication Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Medication End Date
Beschreibung

Medication End Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
continuing at end of study
Beschreibung

continuing at end of study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C2983670
Sponsor Comment
Beschreibung

(for GSK)

Datentyp

text

Alias
UMLS CUI [1,1]
C2347796
UMLS CUI [1,2]
C0947611
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Ähnliche Modelle

Concomitant Medication

1 Formulare
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
HIV-pos. (1)
CL Item
HIV-neg. exposed (2)
CL Item
HIV-neg. unexposed, 3+1 schedule (3)
CL Item
HIV-neg. unexposed, 3+0 schedule (4)
CL Item
HIV-neg. unexposed, 2+1 schedule (5)
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Interim Analysis at/after Visit 6 (1)
CL Item
End of Study Analysis at/after Visit 10 (2)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant agents during protocol-specified period?
Item
Have any medications/treatments been administered during the time frame as specified in the Protocol?
boolean
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
Item Group
Concomitant Medication Details
C2347852 (UMLS CUI-1)
C2348235 (UMLS CUI-2)
Concomitant Medication Name
Item
Concomitant Medication Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Indication
Code List
Medical Indication
Prophylactic Indication
Item
Prophylactic Indication
boolean
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0199176 (UMLS CUI [1,3])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Item
Administration Route
text
C0013153 (UMLS CUI [1])
Administration Route
Code List
Administration Route
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (IN)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication End Date
Item
Medication End Date
date
C2826744 (UMLS CUI [1])
continuing at end of study
Item
continuing at end of study
boolean
C1553904 (UMLS CUI [1,1])
C2983670 (UMLS CUI [1,2])
Sponsor Comment
Item
Sponsor Comment
text
C2347796 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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