ID

29554

Beschreibung

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: 12-lead ECG Abnormalities

Stichworte

Versionen (4)
  1. 15.03.18 15.03.18 -
  2. 05.04.18 05.04.18 -
  3. 05.04.18 05.04.18 -
  4. 05.04.18 05.04.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. April 2018

DOI

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Creative Commons BY-NC 3.0
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GSK Dose proportionality of fluticasone furoate and equivalence of vilanterol in healthy adults NCT01213849

Englisch

Serious Adverse Event

1 Formulare  
  1. StudyEvent: ODM
    1. Serious Adverse Event
Serious Adverse Event
Beschreibung

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Date of visit/assessment
Beschreibung

Date of visit/assessment

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Type of report
Beschreibung

Type of report

Datentyp

integer

Alias
UMLS CUI [1,1]
C0585733
UMLS CUI [1,2]
C1519255
Sequence Number
Beschreibung

Sequence Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Modified term
Beschreibung

Modified term

Datentyp

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1519255
MedDRA synonym
Beschreibung

MedDRA synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C1140263
UMLS CUI [1,2]
C1519255
MedDRA lower level term code
Beschreibung

MedDRA lower level term code

Datentyp

text

Alias
UMLS CUI [1,1]
C3898442
UMLS CUI [1,2]
C1519255
Did the subject experience a serious adverse event during the study?
Beschreibung

serious adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Did SAE occur after initiation of study medication?
Beschreibung

Did SAE occur after initiation of study medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Beschreibung

Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event Start Date
Beschreibung

Serious Adverse Event Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697888
Start Time Serious Adverse Event
Beschreibung

Start Time Serious Adverse Event

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697889
Serious Adverse Event End Date
Beschreibung

Serious Adverse Event End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697886
Serious Adverse Event End Time
Beschreibung

Serious Adverse Event End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826658
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1624730
UMLS CUI [1,2]
C1519255
Date of Death
Beschreibung

Date of Death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Intensity (maximum)
Beschreibung

Intensity (maximum)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Serious Adverse Event Maximum Grade
Beschreibung

Serious Adverse Event Maximum Grade

Datentyp

integer

Alias
UMLS CUI [1]
C2985911
Action Taken with Respect to Investigational Drug
Beschreibung

Action Taken

Datentyp

integer

Alias
UMLS CUI [1]
C1547656
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship investigational product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Did the subject withdraw from study as a result of this AE?
Beschreibung

Did the subject withdraw from study as a result of this AE?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Duration of AE if < 24 hours
Beschreibung

Duration of AE if < 24 hours

Datentyp

integer

Maßeinheiten
  • Hr(s)
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
Hr(s)
Time to Onset Since Last Dose
Beschreibung

Time to Onset Since Last Dose

Datentyp

integer

Maßeinheiten
  • Min(s)
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0946444
UMLS CUI [1,3]
C0449244
Min(s)
Was SAE caused by activities related to study participation (e.g.procedures)?
Beschreibung

SAE Causation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3641099
UMLS CUI [1,2]
C1519255
Was the event serious?
Beschreibung

Serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Seriousness, Specify the reason for considering this an SAE
Beschreibung

Seriousness

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
General narrative comments
Beschreibung

General narrative comments

Datentyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1519255
Relevant concomitant medication/treatment
Beschreibung

Relevant concomitant medication/treatment

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0087111
UMLS CUI-3
C1519255
Concomitant medication Sequence Number
Beschreibung

Concomitant medication Sequence Number

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348184
Drug name
Beschreibung

Drug name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

float

Alias
UMLS CUI [1]
C2348070
Unit
Beschreibung

Unit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1519795
Frequency
Beschreibung

Frequency

Datentyp

integer

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

integer

Alias
UMLS CUI [1]
C0013153
Primary Indication
Beschreibung

Primary Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C0011900
Start Date
Beschreibung

start date of medication

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication Ongoing?
Beschreibung

Medication Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
End Date
Beschreibung

End Date of medication

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Drug Type
Beschreibung

Drug Type

Datentyp

integer

Alias
UMLS CUI [1]
C0457591
Relevant medical conditions/Risk factors
Beschreibung

Relevant medical conditions/Risk factors

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0035648
UMLS CUI-3
C1519255
Specific Condition name
Beschreibung

Specific Condition name

Datentyp

text

Alias
UMLS CUI [1]
C0012634
Date of onset
Beschreibung

Date of onset

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Continuing?
Beschreibung

Continuing?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
No, specify date of last occurrence
Beschreibung

date of last occurrence

Datentyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
Relevant Medical History / Risk Factors not noted above
Beschreibung

Relevant Medical History / Risk Factors

Datentyp

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0035648
UMLS CUI [3]
C1519255
Relevant Diagnostic Results
Beschreibung

Relevant Diagnostic Results

Alias
UMLS CUI-1
C0430022
UMLS CUI-2
C0456984
Lab Sequence Number
Beschreibung

Lab Sequence Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2348184
Test Name
Beschreibung

Test Name

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Test Date
Beschreibung

Test Date

Datentyp

date

Alias
UMLS CUI [1]
C2826247
Test Result
Beschreibung

Test Result

Datentyp

text

Alias
UMLS CUI [1]
C0587081
Test Units
Beschreibung

Test Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal Low Range
Beschreibung

Normal Low Range

Datentyp

text

Alias
UMLS CUI [1]
C0086715
Normal High Range
Beschreibung

Normal High Range

Datentyp

text

Alias
UMLS CUI [1]
C0086715
Relevant diagnostic results not noted above
Beschreibung

Relevant diagnostic results not noted above

Datentyp

text

Alias
UMLS CUI [1]
C0587081
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Ähnliche Modelle

Serious Adverse Event

1 Formulare
  1. StudyEvent: ODM
    1. Serious Adverse Event
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Item
Type of report
integer
C0585733 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Type of report
Code List
Type of report
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])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1,1])
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])
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])
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])
Start Time Serious Adverse Event
Item
Start Time Serious Adverse Event
time
C1519255 (UMLS CUI [1,1])
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])
Serious Adverse Event End Time
Item
Serious Adverse Event End Time
time
C1519255 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
Item
Outcome
integer
C1624730 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
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])
Intensity (maximum)
Code List
Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Serious Adverse Event Maximum Grade
integer
C2985911 (UMLS CUI [1])
Serious Adverse Event Maximum Grade
Code List
Serious Adverse Event Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade4 (4)
Item
Action Taken with Respect to Investigational Drug
integer
C1547656 (UMLS CUI [1])
Action Taken
Code List
Action Taken with Respect to Investigational Drug
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])
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])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C1519255 (UMLS CUI [1,1])
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])
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])
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])
Seriousness
Code List
Seriousness, Specify the reason for considering this an SAE
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])
Item Group
Relevant concomitant medication/treatment
C2347852 (UMLS CUI-1)
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])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1])
Item
Unit
integer
C0013227 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Unit
Code List
Unit
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)
Item
Frequency
integer
C3476109 (UMLS CUI [1])
Frequency
Code List
Frequency
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)
Item
Route
integer
C0013153 (UMLS CUI [1])
Route
Code List
Route
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])
start date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
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])
Item
Drug Type
integer
C0457591 (UMLS CUI [1])
Drug Type
Code List
Drug Type
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)
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])
Item
Continuing?
integer
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Continuing?
Code List
Continuing?
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])
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])
Item Group
Relevant Diagnostic Results
C0430022 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
Lab Sequence Number
Item
Lab Sequence Number
text
C0022885 (UMLS CUI [1,1])
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])
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])
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