ID
23006
Beschreibung
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive
Stichworte
Versionen (2)
- 18.06.17 18.06.17 -
- 19.06.17 19.06.17 -
Hochgeladen am
19. Juni 2017
DOI
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Creative Commons BY-NC 3.0
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Serious Adverse Event (SAE) - GSK Milveterol COPD 100527
Serious Adverse Event (SAE) - GSK Milveterol COPD 100527
- StudyEvent: ODM
Beschreibung
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Beschreibung
serious adverse events
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Diagnosis or serious signs/symptoms of SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0037088
- UMLS CUI [1,3]
- C1519255
Beschreibung
Date of onset SAE
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beschreibung
Time of onset SAE
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Beschreibung
Maximum Intensity SAE
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Beschreibung
Outcome SAE
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
Date of resolution or death
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2985918
- UMLS CUI [2]
- C1148348
Beschreibung
Time of resolution or death
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2]
- C1301931
Beschreibung
Investigational drug, change of dose
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1608430
Beschreibung
Withdrawal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beschreibung
Relationship to investigational product
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0013230
Beschreibung
Definition of Seriousness
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704788
- UMLS CUI [1,2]
- C1710056
Beschreibung
possible causes of SAE
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0085978
Beschreibung
Seriousness
Datentyp
integer
Alias
- UMLS CUI [1]
- C1710056
Beschreibung
SAE fatal, autopsy
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0004398
Beschreibung
Narrative / Comments
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1519255
Beschreibung
Details of Relevant Assessments
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0431080
Beschreibung
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0243087
Beschreibung
Relevant Medical Conditions
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
Beschreibung
Date of onset
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Beschreibung
Condition present at time of the SAE
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Beschreibung
Date of last occurrence
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [2]
- C1519255
Beschreibung
Other relevant risk factors
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0035648
- UMLS CUI [1,2]
- C1519255
Beschreibung
Details of lnvestigational Product(s)
Alias
- UMLS CUI-1
- C0013230
Beschreibung
Treatment period
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3161471
- UMLS CUI [1,2]
- C1948053
Beschreibung
Date of dose
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beschreibung
Start time of dose
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0178602
Beschreibung
event during washout period
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348792
- UMLS CUI [1,3]
- C1710661
Beschreibung
event during screening
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348792
- UMLS CUI [1,3]
- C1710477
Beschreibung
event during follow-up
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348792
- UMLS CUI [1,3]
- C1522577
Beschreibung
Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1704627
Beschreibung
Drug Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Dose
Datentyp
float
Alias
- UMLS CUI [1]
- C2826638
Beschreibung
Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C2826646
Beschreibung
Frequency
Datentyp
text
Alias
- UMLS CUI [1]
- C2826654
Beschreibung
Route
Datentyp
text
Alias
- UMLS CUI [1]
- C2826730
Beschreibung
Start Date
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
Started pre-study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2981448
Beschreibung
Stop Date
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826744
Beschreibung
Ongoing Medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Reason for Medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826696
Beschreibung
Reporting lnvestigator
Alias
- UMLS CUI-1
- C2826892
Beschreibung
Reporting lnvestigator
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Reporting lnvestigator: Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1442065
Beschreibung
Reporting lnvestigator: Signature
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1519316
Beschreibung
Date of report
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C1302584
Beschreibung
Additional or follow-up information
Alias
- UMLS CUI-1
- C1533716
- UMLS CUI-2
- C1519255
Beschreibung
Additional or follow-up information
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2,1]
- C1522577
- UMLS CUI [2,2]
- C1533716
- UMLS CUI [2,3]
- C1519255
Ähnliche Modelle
Serious Adverse Event (SAE) - GSK Milveterol COPD 100527
- StudyEvent: ODM
C0037088 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
C2699488 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1301931 (UMLS CUI [2])
C1608430 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C1710056 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0004398 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0431080 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C2348792 (UMLS CUI [1,2])
C1710661 (UMLS CUI [1,3])
C2348792 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
C2348792 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C1442065 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2,1])
C1533716 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])