ID
41666
Description
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive
Mots-clés
Versions (1)
- 07/12/2020 07/12/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
7 décembre 2020
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673
Logs and Repeats - Adverse Event/ Concomitant Medication/ Repeat Assessment Check Question; Non-Serious Adverse Events; Serious Adverse Events
Description
Adverse Event/ Concomitant Medication/ Repeat Assessment Check Questions
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0205341
- UMLS CUI-4
- C0220825
Description
Were any concomitant medications taken by the subject during the study?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0347984
Description
Did the subject experience any non-serious adverse events during the study?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0347984
Description
Did the subject experience any serious adverse event during the study?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0347984
Description
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Type de données
boolean
Alias
- UMLS CUI [1]
- C0522055
Description
Were any repeat haematology or clinical chemistry samples taken?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0018941
- UMLS CUI [2,2]
- C0200345
Description
Were any repeat ECGs performed?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Description
Were any repeat vital signs recorded?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Description
Were any repeat PK blood samples taken?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0205341
Description
Were any repeat Pulmonary Function Tests performed?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0205341
Description
Was any repeat Holter monitoring performed?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0205341
Description
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Description
Non-Serious Adverse Event Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Diagnosis Only (if known) Otherwise Sign/Symptom
Type de données
text
Alias
- UMLS CUI [1]
- C1518404
Description
Non-Serious Adverse Event - Modified term
Type de données
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2826798
Description
Non-Serious Adverse Event MedDRA synonym
Type de données
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1140263
Description
Non-Serious Adverse Event MedDRA lower level term code
Type de données
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C3898442
Description
Non-Serious Adverse Event - Failed coding
Type de données
text
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0805701
- UMLS CUI [2,2]
- C0231175
Description
Non-Serious Adverse Event - Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Description
Non-Serious Adverse Event - Start Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Description
Non-Serious Adverse Event Outcome
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Description
Non-Serious Adverse Event End Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Description
Non-Serious Adverse Event - End Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1522314
Description
Non-Serious Adverse Event Frequency
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Description
Non-Serious Adverse Event - Maximum Intensity
Type de données
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Description
Non-Serious Adverse Event - Maximum Grade
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Description
Non-Serious Adverse Event - Maximum Grade or Intensity
Type de données
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0518690
- UMLS CUI [1,4]
- C0806909
Description
Action Taken with Investigational Product(s) as a Result of the AE
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Description
Did the subject withdraw from study as a result of this AE?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Description
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
Duration of AE if < 24 hours
Type de données
integer
Unités de mesure
- h
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Description
Duration of AE if < 24 hours
Type de données
integer
Unités de mesure
- min
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Description
Serious Adverse Event - Type of Report
Alias
- UMLS CUI-1
- C3897642
- UMLS CUI-2
- C0332307
Description
Serious Adverse Event - Randomisation
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0034656
Description
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Description
SAE Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Diagnosis Only (if known) Otherwise Sign/Symptom
Type de données
text
Alias
- UMLS CUI [1]
- C1519255
Description
Serious Adverse Event - Modified Term
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826798
Description
Serious Adverse Event - MedDRA synonym
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Description
Serious Adverse Event - MedDRA lower level term code
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3898442
Description
Serious Adverse Event - Failed coding
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Description
Serious Adverse Event - Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Description
Serious Adverse Event - Start Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Description
Serious Adverse Event - Outcome
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
Serious Adverse Event - End Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Description
Serious Adverse Event - End Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Description
Serious Adverse Event - Maximum Intensity
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Description
Serious Adverse Event - Maximum Grade
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Description
Serious Adverse Event - Maximum Grade or Intensity
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0518690
- UMLS CUI [1,4]
- C0806909
Description
Action Taken with Investigational Product(s) as a Result of the SAE
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Description
Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Description
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
Duration of SAE if < 24 hours
Type de données
integer
Unités de mesure
- h
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Description
Duration of SAE if < 24 hours
Type de données
integer
Unités de mesure
- min
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Description
Was SAE caused by activities related to study participation (e.g. procedures)?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Description
Was the event serious?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Serious Adverse Event - Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Description
Serious Adverse Event - Relevant Concomitant/ Treatment Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C2347946
- UMLS CUI-4
- C0304229
Description
CM Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Description
Concomitant medication - Drug name
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2347852
Description
Concomitant medication dose
Type de données
float
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C2347852
Description
Concomitant medication unit
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519795
Description
Concomitant medication frequency
Type de données
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Description
Medication Route
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Description
Concomitant medication start date
Type de données
date
Alias
- UMLS CUI [1]
- C2826734
Description
Concomitant Medication continuing?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
If concomitant medication is not ongoing, specify end date.
Type de données
date
Alias
- UMLS CUI [1]
- C2826744
Description
Concomitant medication - Primary Indication
Type de données
text
Alias
- UMLS CUI [1]
- C2826696
Description
Concomitant medication - Drug type
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0457591
Description
Serious Adverse Events - Relevant Medical Conditions/ Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0035648
Description
MHx Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Description
Specific Condition Name
Type de données
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
Medical Condition - Date of onset
Type de données
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Description
Medical Condition - Continuing?
Type de données
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Description
Medical Condition - Date of last occurence
Type de données
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2745955
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1517741
Description
Relevant Medical History / Risk Factors not noted above
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035648
Description
Serious Adverse Event - Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Description
Lab Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Description
Test Name
Type de données
integer
Alias
- UMLS CUI [1]
- C0022885
Description
Test Date
Type de données
date
Alias
- UMLS CUI [1]
- C2826247
Description
Test Result
Type de données
text
Alias
- UMLS CUI [1]
- C0587081
Description
Test Units
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Description
Normal Low Range
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Description
Normal High Range
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205250
Description
Relevant diagnostic results not noted above
Type de données
text
Alias
- UMLS CUI [1]
- C0587081
Description
Serious Adverse Event - Investigational Product
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Description
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0457454
Description
General Narrative Comments
Alias
- UMLS CUI-1
- C0947611
Description
Serious Adverse Event - Non clinical
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0205210
Description
Send incomplete SAE data to GSK Safety
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Description
Receipt by GSK date
Type de données
datetime
Alias
- UMLS CUI [1]
- C2985846
Description
Was the event serious?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
SAE Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Version Number
Type de données
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
Description
Case ID
Type de données
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Description
Randomisation Number
Type de données
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Description
OCEANS Code
Type de données
text
Alias
- UMLS CUI [1]
- C0805701
Description
Email Flag
Type de données
text
Alias
- UMLS CUI [1]
- C0013849
Similar models
Logs and Repeats - Adverse Event/ Concomitant Medication/ Repeat Assessment Check Question; Non-Serious Adverse Events; Serious Adverse Events
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0200345 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0332307 (UMLS CUI-2)
C0034656 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C1710056 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0457591 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0262926 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C0035648 (UMLS CUI [1,2])
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C2348184 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,2])
C0304229 (UMLS CUI-2)
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
C0205210 (UMLS CUI-2)
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])