ID
41259
Description
Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)
Mots-clés
Versions (1)
- 29/07/2020 29/07/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
29 juillet 2020
DOI
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Licence
Creative Commons BY 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)
Non-serious Adverse Events (AE); Serious Adverse Events (SAE)
- StudyEvent: ODM
Description
Non-serious Adverse Events (AE)
Alias
- UMLS CUI-1
- C1518404
Description
Non-serious Adverse Events (AE)
Alias
- UMLS CUI-1
- C1518404
Description
Diagnosis only (if known), otherwise sign/ symptom
Type de données
text
Alias
- UMLS CUI [1]
- C1518404
Description
Non-serious Adverse Events (AE) - Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Description
Non-serious Adverse Events (AE) - Start Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Description
Non-serious Adverse Events (AE) - Outcome
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Description
Non-serious Adverse Events (AE) - End Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Description
Non-serious Adverse Events (AE) - End Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1522314
Description
Non-serious Adverse Events (AE) - Frequency
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Description
Action taken with investigational product(s) as a result of the non-serious 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 investigationhal product?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
Serious Adverse Event (SAE)
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event (SAE) - Section 1
Alias
- UMLS CUI-1
- C1519255
Description
Diagnosis only (if known), otherwise sign/ symptom
Type de données
text
Alias
- UMLS CUI [1]
- C1519255
Description
Serious Adverse Event (SAE) - Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Description
Serious Adverse Event (SAE) - Start Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Description
Serious Adverse Event (SAE) - Outcome
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
Serious Adverse Event (SAE) - End Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Description
Serious Adverse Event (SAE) - End Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Description
Serious Adverse Event (SAE) - Maximum Intensity
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- 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
Did the subject withdraw from study as a result of this SAE?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Description
Is there a reasonable possibility 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
If yes, summarise findings in Section 11 Narrative Remarks of this SAE form
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1519255
Description
Serious Adverse Event (SAE) - Section 2 Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Description
Check all that apply
Type de données
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
Description
If other reason(s) for considering this a SAE ,specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Description
Serious Adverse Event (SAE) - Section 3 Demography Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0011298
Description
Serious Adverse Event (SAE) - Section 4
Alias
- UMLS CUI-1
- C1519255
Description
If investigational product(s) was 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 [2,1]
- C0304229
- UMLS CUI [2,2]
- C0457454
Description
Serious Adverse Event (SAE) - Section 5
Alias
- UMLS CUI-1
- C1519255
Description
Check all that apply
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0205394
Description
Specify medical condition(s)
Type de données
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
Specify concomitant medication(s)
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348235
Description
Specify other cause of SAE
Type de données
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C2348235
Description
Serious Adverse Event (SAE) - Section 6 Relevant Medical Conditions
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
Description
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Type de données
text
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0020517
- UMLS CUI [3]
- C0543467
- UMLS CUI [4]
- C1519255
Description
Date of onset of medical condition
Type de données
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Description
Condition present at time of the SAE?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Description
If condition not present at time of the SAE, enter date of last occurence
Type de données
date
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C1519255
- UMLS CUI [3,1]
- C2745955
- UMLS CUI [3,2]
- C1517741
- UMLS CUI [3,3]
- C0011008
Description
Serious Adverse Event (SAE) - Section 7 Other relevant risk factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
Description
Provide any family or social history (e.g. smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
Type de données
text
Alias
- UMLS CUI [1]
- C0241889
- UMLS CUI [2]
- C3714536
- UMLS CUI [3]
- C1519384
- UMLS CUI [4]
- C0001948
- UMLS CUI [5]
- C0012155
- UMLS CUI [6]
- C0013146
- UMLS CUI [7]
- C0337074
- UMLS CUI [8]
- C1519255
Description
Serious Adverse Event (SAE) - Section 8 Concomitant medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Description
Trade name preferred
Type de données
text
Alias
- UMLS CUI [1]
- C0013227
Description
Medication dose
Type de données
float
Alias
- UMLS CUI [1]
- C3174092
Description
Medication unit
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519795
Description
Medication Frequency
Type de données
text
Alias
- UMLS CUI [1]
- C3476109
Description
Medication Route
Type de données
text
Alias
- UMLS CUI [1]
- C0013153
Description
Medication taken prior to study?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826667
Description
Medication start date
Type de données
date
Alias
- UMLS CUI [1]
- C2826734
Description
Medication stop date
Type de données
date
Alias
- UMLS CUI [1]
- C2826744
Description
Ongoing medication?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for medication?
Type de données
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
Serious Adverse Event (SAE) - Section 9 Details of investigational product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
- UMLS CUI-3
- C1522508
Description
Visit
Type de données
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Date of dose
Type de données
date
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0011008
Description
Was treatment blind broken at investigational site?
Type de données
text
Alias
- UMLS CUI [1]
- C3897431
Description
Serious Adverse Event (SAE) - Section 10
Alias
- UMLS CUI-1
- C1519255
Description
Provide details of any other tests/ procedures which were carried out to diagnose or confirm the SAE e.g. laboratory data with units and normal range
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0431080
- UMLS CUI [2]
- C0022885
- UMLS CUI [3]
- C1519795
- UMLS CUI [4]
- C0086715
Description
Serious Adverse Event (SAE) - Section 11 Narrative remarks
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Description
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Description
Confirming that the data on the SAE pages are accurate and complete
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's name (print)
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator's signature date
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Non-serious Adverse Events (AE); Serious Adverse Events (SAE)
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
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])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (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])
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])
C1710056 (UMLS CUI-2)
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0011298 (UMLS CUI-2)
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0457454 (UMLS CUI [2,2])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0012634 (UMLS CUI-2)
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C1519255 (UMLS CUI [4])
C0574845 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
C2745955 (UMLS CUI [3,1])
C1517741 (UMLS CUI [3,2])
C0011008 (UMLS CUI [3,3])
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C3714536 (UMLS CUI [2])
C1519384 (UMLS CUI [3])
C0001948 (UMLS CUI [4])
C0012155 (UMLS CUI [5])
C0013146 (UMLS CUI [6])
C0337074 (UMLS CUI [7])
C1519255 (UMLS CUI [8])
C2347852 (UMLS CUI-2)
C1519795 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0431080 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2])
C1519795 (UMLS CUI [3])
C0086715 (UMLS CUI [4])
C0947611 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1522508 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])