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Fehler:
ID
13273
Beschreibung
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.
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- 28.01.16 28.01.16 -
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28. Januar 2016
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Creative Commons BY-NC 3.0
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Serious adverse events_LAIS grass tablets by allergic rhinoconjunctivitis EudraCT-Nr. 2012-004916-79
Documentation serious adverse events
- StudyEvent: ODM
Ähnliche Modelle
Documentation serious adverse events
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)