ID

29761

Beschreibung

https://clinicaltrials.gov/show/NCT00197028 Concomitant vaccination and medication Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria

Link

https://clinicaltrials.gov/show/NCT00197028

Stichworte

Versionen (1)
  1. 18.04.18 18.04.18 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

18. April 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028

Englisch

Concomitant vaccination and medication

1 Formulare  
Concomitan vaccination
Beschreibung

Concomitan vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered before Clinic Visit 10 (Interim Analysis)?
Beschreibung

Concomitan vaccination

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Trade / (Generic) Name
Beschreibung

Vaccine name

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0042210
Route
Beschreibung

Vaccination route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration date
Beschreibung

Vaccine administration date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Medication
Beschreibung

Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C2347852
Have any medications/treatments been administered before Clinic Visit 10 (Interim Analysis)?
Beschreibung

Medication

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2347852
Trade / Generic Name
Beschreibung

Trade / Generic Name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Medical Indication: Prophylactic
Beschreibung

Medical Indication

Datentyp

boolean

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

Medical Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Total daily Dose
Beschreibung

Total daily Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0013227
Start and end date
Beschreibung

Start and end date

Datentyp

date

Alias
UMLS CUI [1]
C3844769
Tick box if continuing at end of study
Beschreibung

Tick box if continuing at end of study

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
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Ähnliche Modelle

Concomitant vaccination and medication

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Concomitan vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Has any vaccine other than the study vaccine(s) been administered before Clinic Visit 10 (Interim Analysis)?
integer
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitan vaccination
Code List
Has any vaccine other than the study vaccine(s) been administered before Clinic Visit 10 (Interim Analysis)?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date. (2)
Vaccine name
Item
Trade / (Generic) Name
text
C2360065 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccination route
Code List
Route
CL Item
Intradermal  (ID)
CL Item
Parenteral (PE)
CL Item
Inhalation  (IH)
CL Item
Oral (PO)
CL Item
Intramuscular (IM)
CL Item
Subcutaneous (SC)
CL Item
Intravenous  (IV)
CL Item
Sublingual (SL)
CL Item
Intranasal  (NA)
CL Item
Transdermal (TD)
CL Item
Other  (OTH)
CL Item
Unknown (UNK)
Vaccine administration date
Item
Administration date
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item Group
Medication
C0013227 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Have any medications/treatments been administered before Clinic Visit 10 (Interim Analysis)?
integer
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medication
Code List
Have any medications/treatments been administered before Clinic Visit 10 (Interim Analysis)?
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Trade / Generic Name
Item
Trade / Generic Name
text
C2360065 (UMLS CUI [1])
Medical Indication
Item
Medical Indication: Prophylactic
boolean
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Indication
Item
Medical Indication:
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Total daily Dose
Item
Total daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
EXT External (EXT External)
CL Item
ID Intradermal (ID Intradermal)
CL Item
IH Inhalation (IH Inhalation)
CL Item
IM Intramuscular (IM Intramuscular)
CL Item
IR Intraarticular (IR Intraarticular)
CL Item
IT Intrathecal (IT Intrathecal)
CL Item
IV Intravenous (IV Intravenous)
CL Item
NA Intranasal (NA Intranasal)
CL Item
OTH Other (OTH Other)
CL Item
PE Parenteral (PE Parenteral)
CL Item
PO Oral (PO Oral)
CL Item
PR Rectal (PR Rectal)
CL Item
SC Subcutaneous (SC Subcutaneous)
CL Item
SL Sublingual (SL Sublingual)
CL Item
TD Transdermal (TD Transdermal)
CL Item
TO Topical (TO Topical)
CL Item
UNK Unknown (UNK Unknown)
Start and end date
Item
Start and end date
date
C3844769 (UMLS CUI [1])
Tick box if continuing at end of study
Item
Tick box if continuing at end of study
boolean
C2826666 (UMLS CUI [1])
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