Informatie:
Fout:
ID
13273
Beschrijving
Study part: Documentation serious adverse events. Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.
Trefwoorden
Versies (1)
- 28-01-16 28-01-16 -
Geüploaded op
28 januari 2016
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Serious adverse events_LAIS grass tablets by allergic rhinoconjunctivitis EudraCT-Nr. 2012-004916-79
Documentation serious adverse events
- StudyEvent: ODM
Similar models
Documentation serious adverse events
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Patient id
Item
Patient ID
integer
C2348585 (UMLS CUI [1])
date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Visit number
Item
Visit number
integer
C1549755 (UMLS CUI [1])
CL Item
male (1)
CL Item
female (2)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
date
Item
Date of serious adverse event appearance
date
C0011008 (UMLS CUI [1])
symptom serious adverse event
Item
Symptoms of serious adverse event
text
C1457887 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
laboratory test
Item
Laboratory test
text
C0022885 (UMLS CUI [1])
Medical history
Item
Medical history
text
C0262926 (UMLS CUI [1])
Comorbidity
Item
Comorbidity
text
C0009488 (UMLS CUI [1])
drug
Item
Medication name
text
C0013227 (UMLS CUI [1])
dose
Item
Medication dose
text
C3174092 (UMLS CUI [1])
Drug administration route
Item
Drug administration route
text
C0013153 (UMLS CUI [1])
date
Item
Drug intake begin
date
C0011008 (UMLS CUI [1])
date
Item
Drug intake ended
date
C0011008 (UMLS CUI [1])
Item
Relation between study drug and serious adverse event
text
C0013227 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [2])
CL Item
no relation (1)
CL Item
implausible (2)
CL Item
possible (3)
CL Item
plausible (4)
CL Item
certain (5)
CL Item
undecidable, insufficient data (6)