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Informações:
Falhas:
ID
29552
Descrição
Study ID: 102932 Clinical Study ID: HZA102932 Study Title:An open-label, randomised, 3-way crossover single dose study to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) when administered as FF/VI inhalation powder from the novel dry powder inhaler in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01213849 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma Documentation part: Serious Adverse Event
Palavras-chave
Versões (4)
- 15/03/2018 15/03/2018 -
- 05/04/2018 05/04/2018 -
- 05/04/2018 05/04/2018 -
- 05/04/2018 05/04/2018 -
Titular dos direitos
GlaxoSmithKline
Transferido a
5 de abril de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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GSK Dose proportionality of fluticasone furoate and equivalence of vilanterol in healthy adults NCT01213849
Serious Adverse Event
- StudyEvent: ODM
Similar models
Serious Adverse Event
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
CL Item
Initial (1)
CL Item
Follow-Up (2)
Sequence Number
Item
Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
serious adverse event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Did SAE occur after initiation of study medication
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Start Date
Item
Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
C2697888 (UMLS CUI [1,2])
Start Time Serious Adverse Event
Item
Start Time Serious Adverse Event
time
C1519255 (UMLS CUI [1,1])
C2697889 (UMLS CUI [1,2])
C2697889 (UMLS CUI [1,2])
Serious Adverse Event End Date
Item
Serious Adverse Event End Date
date
C1519255 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
C2697886 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
Serious Adverse Event End Time
time
C1519255 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
C2826658 (UMLS CUI [1,2])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal, record Date of Death (5)
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Item
Intensity (maximum)
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Serious Adverse Event Maximum Grade
integer
C2985911 (UMLS CUI [1])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade4 (4)
CL Item
lnvestigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Relationship investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
integer
C1519255 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
C0946444 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
SAE Causation
Item
Was SAE caused by activities related to study participation (e.g.procedures)?
boolean
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Item
Seriousness, Specify the reason for considering this an SAE
integer
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify within general narrative comment (6)
CL Item
Is associated with liver injury and Impaired liver function defined as: ALT>= 3xULN, and either total bilirubin >=2xULN or JNR >1.5 (7)
General narrative comments
Item
General narrative comments
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
Relevant concomitant medication/treatment
C2347852 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Concomitant medication Sequence Number
Item
Concomitant medication Sequence Number
text
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1])
CL Item
Actuation ACTU (1)
CL Item
Ampoule AMP (2)
CL Item
Application AP (3)
CL Item
Bottle BT (4)
CL Item
Capsule CAP (5)
CL Item
Cubic centimeter cc (6)
CL Item
Drops 031 (7)
CL Item
Gram 002 (8)
CL Item
International units (9)
CL Item
International units per kilogram (10)
CL Item
Internatcional units per millilitre IUML (11)
CL Item
Litre (12)
CL Item
Litre per minute LM (13)
CL Item
Lozenge LOZ (14)
CL Item
Megaunits (million units) MEGU (15)
CL Item
Microgram (MCG) (16)
CL Item
Microgram (UG) (17)
CL Item
Microgram /kilogram (18)
CL Item
Microgram/kilogram per minute MCG/KG/MIN (19)
CL Item
Micrograms per minute MCG/MIN (20)
CL Item
Micro litre (21)
CL Item
Milliequivalent (22)
CL Item
Milliequivalent per 24 hours MEQ24 (23)
CL Item
Milligram (24)
CL Item
Milligrams percent MGPER (25)
CL Item
Milligram per hour MGH (26)
CL Item
Milligram/kilogram (27)
CL Item
Milligram/kilogram per hour MGKH (28)
CL Item
Milligram/kilogram per minute MGKM (29)
CL Item
Milligram/metre squared (30)
CL Item
Milligram/millilitre MGML (31)
CL Item
Millilitre (32)
CL Item
Millilitre per hour MLH (33)
CL Item
Millilitre per minute MLM (34)
CL Item
Millimole (35)
CL Item
Million international units (36)
CL Item
Minimum alveolar concentration MAC (37)
CL Item
Nebule NEB (38)
CL Item
Patch PAT (39)
CL Item
Percent (40)
CL Item
Puff PUFF (41)
CL Item
Sachet SAC (42)
CL Item
Spray SPR (43)
CL Item
Suppository SUP (44)
CL Item
Tablespoon TBS (45)
CL Item
Tablet TAB (46)
CL Item
Teaspoon TSP (47)
CL Item
Units UNT (48)
CL Item
Unknown u (49)
CL Item
Vial VIA (50)
CL Item
2 times per week 2W (1)
CL Item
3 times per week 3W (2)
CL Item
4times per week 4W (3)
CL Item
5 times per day 50 (4)
CL Item
5 times per week SW (5)
CL Item
AC AC (6)
CL Item
BID 2D (7)
CL Item
Continuous Infusion co (8)
CL Item
Every 2 weeks FO (9)
CL Item
Every 3 weeks Q3WK (10)
CL Item
Every 3 months Q3M (11)
CL Item
Every other day AD (12)
CL Item
At Bedtime IN (13)
CL Item
Once a month MO (14)
CL Item
Once a week WE (15)
CL Item
Once daily 1D (16)
CL Item
Once only 15 (17)
CL Item
PC PC (18)
CL Item
PRN PRN (19)
CL Item
Q2H 12D (20)
CL Item
Q3D Q3D (21)
CL Item
Q4D Q4D (22)
CL Item
Q4H 6D (23)
CL Item
Q6H 4D (24)
CL Item
Q8H 3D (25)
CL Item
Q12H 2D (26)
CL Item
QAM lM (27)
CL Item
QH 24D (28)
CL Item
QID 4D (29)
CL Item
QPM lN (30)
CL Item
TIO 3D (31)
CL Item
Unknown u (32)
CL Item
Both eyes 047 (1)
CL Item
Epidural 008 (2)
CL Item
Gastrostomy tube GT (3)
CL Item
Inhalation 055 (4)
CL Item
Injection INJ (5)
CL Item
Intra-arterial 013 (6)
CL Item
Intra-buru IBU (7)
CL Item
Intralesional 026 (8)
CL Item
IM Intramuscular 030 (9)
CL Item
Intranasal 045 (10)
CL Item
Intraocular 031 (11)
CL Item
Intraosteal 10S (12)
CL Item
Intraperitoneal 033 (13)
CL Item
lntrathecal 037 (14)
CL Item
Intrauterine 015 (15)
CL Item
IV Intravenous 042 (16)
CL Item
Nasal 045 (17)
CL Item
Oral 048 (18)
CL Item
Rectal 054 (19)
CL Item
Subcutaneous 058 (20)
CL Item
Sublingua1 060 (21)
CL Item
Topical 061 (22)
CL Item
Transdermal 062 (23)
CL Item
Unknown 065 (24)
CL Item
Vaginal 067 (25)
Primary Indication
Item
Primary Indication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C2347852 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
start date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing?
boolean
C2826666 (UMLS CUI [1])
End Date of medication
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
CL Item
Concomitant (1)
CL Item
Treatment (2)
CL Item
Cause of SAE (3)
Item Group
Relevant medical conditions/Risk factors
C0262926 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Specific Condition name
Item
Specific Condition name
text
C0012634 (UMLS CUI [1])
Date of onset
Item
Date of onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No, specify date of last occurrence (2)
CL Item
Unknown (3)
date of last occurrence
Item
No, specify date of last occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Relevant Medical History / Risk Factors
Item
Relevant Medical History / Risk Factors not noted above
text
C0262926 (UMLS CUI [1])
C0035648 (UMLS CUI [2])
C1519255 (UMLS CUI [3])
C0035648 (UMLS CUI [2])
C1519255 (UMLS CUI [3])
Item Group
Relevant Diagnostic Results
C0430022 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0456984 (UMLS CUI-2)
Lab Sequence Number
Item
Lab Sequence Number
text
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Test Name
Item
Test Name
text
C0022885 (UMLS CUI [1])
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
text
C0086715 (UMLS CUI [1])
Normal High Range
Item
Normal High Range
text
C0086715 (UMLS CUI [1])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0587081 (UMLS CUI [1])