ID

33172

Beschreibung

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Stichworte

Versionen (2)
  1. 02.11.18 02.11.18 -
  2. 30.11.18 30.11.18 -
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GSK group of companies

Hochgeladen am

30. November 2018

DOI

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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

Englisch

Initial Serious Adverse Event Form

1 Formulare  
Randomisation
Beschreibung

Randomisation

Alias
UMLS CUI-1
C0034656
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
UMLS CUI [1,3]
C1704686
SAE Sequence Number
Beschreibung

SAE Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event Entry
Beschreibung

Serious Adverse Event Entry

Alias
UMLS CUI-1
C1519255
Serious Adverse Event Start Date
Beschreibung

Start Date

Datentyp

date

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

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Serious Adverse Event End Date
Beschreibung

if FATAL, Date of Death

Datentyp

date

Alias
UMLS CUI [1,1]
C2697886
UMLS CUI [1,2]
C1519255
Maximum Intensity of Serious Adverse Event
Beschreibung

Maximum Intensity of Serious Adverse Event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Intensity at onset of event
Beschreibung

Intensity at onset of event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0332162
Maximum Grade of Serious Adverse Event
Beschreibung

Maximum Grade

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C0441800
Grade at onset of event
Beschreibung

Grade at onset of event

Datentyp

integer

Alias
UMLS CUI [1,1]
C0806909
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0332162
Maximum Grade of Intensity of Serious Adverse Event
Beschreibung

Record maximum grade or intensity throughout duration of event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0441800
UMLS CUI [1,4]
C0806909
Grade of Intensity at onset of event
Beschreibung

Record grade of intensity at the onset of the event

Datentyp

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0332162
Action taken with Investigational Product(s) as a result of AE?
Beschreibung

Action taken with Investigational Product(s) as a result of AE?

Datentyp

integer

Alias
UMLS CUI [1]
C2826626
Did the subject withdraw from the study as a result of AE?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0422727
UMLS CUI [2]
C1519255
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Use best judgement at initial entry. May be amended when additional information becomes available.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Duration of AE if < 24 hours
Beschreibung

HH:MM

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
Time to Onset since last Dose
Beschreibung

Time to Onset since last Dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C1517741
Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?
Beschreibung

Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [2,1]
C2603343
UMLS CUI [2,2]
C0679823
UMLS CUI [3]
C0304229
UMLS CUI [4]
C2700391
UMLS CUI [5]
C0005834
UMLS CUI [6]
C1710661
Was the event serious?
Beschreibung

Was the event serious?

Datentyp

boolean

Alias
UMLS CUI [1]
C1710056
Related Investigational Product
Beschreibung

Related Investigational Product

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Seriousness
Beschreibung

Seriousness

Alias
UMLS CUI-1
C1710056
Level of seriousness of the event
Beschreibung

Level of seriousness of the event

Datentyp

integer

Alias
UMLS CUI [1]
C1710056
Relevant Concomitant/Treatment Medication
Beschreibung

Relevant Concomitant/Treatment Medication

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0013227
CM Sequence Number
Beschreibung

Iclude any details of any medication that may help explain the SAE, may have caused the SAE or was used to treat the SAE.

Datentyp

text

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

Enter drug name, not description (Generic name preferred. If combination product, enter Trade Name).

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Modified reported term
Beschreibung

Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826819
Medication Dose
Beschreibung

Dose

Datentyp

float

Alias
UMLS CUI [1]
C3174092
Medication Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1]
C2826646
Medication Frequency
Beschreibung

Frequency

Datentyp

integer

Alias
UMLS CUI [1]
C3476109
Medication Route
Beschreibung

Medication Route

Datentyp

integer

Alias
UMLS CUI [1]
C0013153
Medication Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Is medication ongoing?
Beschreibung

Is medication ongoing?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
If NO, specify End Date
Beschreibung

If NO, specify End Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Primary Indication for medication
Beschreibung

Enter a medical diagnosis not description

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Modified reported term
Beschreibung

Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826819
Drug Type
Beschreibung

Drug Type

Datentyp

text

Alias
UMLS CUI [1]
C0457591
Relevant Medical Conditions/Risk Factors
Beschreibung

Relevant Medical Conditions/Risk Factors

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0035648
MHx Sequence Number
Beschreibung

MHx Sequence Number

Datentyp

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0262926
Specific Condition Name
Beschreibung

Enter a medical diagnosis not description.

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Modified reported term
Beschreibung

Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826923
Date of onset
Beschreibung

Date of onset

Datentyp

date

Alias
UMLS CUI [1]
C0574845
Is medical condition continuing?
Beschreibung

Continuing?

Datentyp

integer

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

If NO, specify date of last occurrence

Datentyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0011008
Relevant Diagnosis Results
Beschreibung

Relevant Diagnosis Results

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

Provide details of any tests or procedures carried out to diagnose the SAE.

Datentyp

text

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

Test Name

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0027365
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

integer

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205251
Normal High Range
Beschreibung

Normal High Range

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205251
UMLS CUI [1,2]
C0205250
Relevant diagnostic results not noted above
Beschreibung

Relevant diagnostic results not noted above

Datentyp

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0205394
Rechallenge
Beschreibung

Rechallenge

Alias
UMLS CUI-1
C2347900
If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Beschreibung

If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C2745955
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
Study Drug
Beschreibung

Study Drug

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Study Drug Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Study Drug Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Regimen
Beschreibung

Regimen

Datentyp

text

Alias
UMLS CUI [1]
C1276413
General narrative comments
Beschreibung

General narrative comments

Alias
UMLS CUI-1
C0947611
A brief narrative description of SAE
Beschreibung

possible other causes of the event (e.g., lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of treatment.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
Non Clinical
Beschreibung

Non Clinical

Alias
UMLS CUI-1
C0205210
UMLS CUI-2
C1298908
Send incomplete SAE data to GSK Safety
Beschreibung

Send incomplete SAE data to GSK Safety

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1511726
UMLS CUI [1,3]
C0205257
Receipt by GSK date
Beschreibung

Receipt by GSK date

Datentyp

date

Alias
UMLS CUI [1]
C2985846
Was the event serious?
Beschreibung

Was the event serious?

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
SAE Sequence number
Beschreibung

SAE Sequence number

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Version Number
Beschreibung

Version Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0333052
UMLS CUI [1,2]
C0237753
Case ID
Beschreibung

Case ID

Datentyp

text

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
Randomisation Number
Beschreibung

Randomisation Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
OCEANS Code
Beschreibung

OCEANS Code

Datentyp

text

Alias
UMLS CUI [1]
C0805701
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Ähnliche Modelle

Initial Serious Adverse Event Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Randomisation
C0034656 (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])
C1704686 (UMLS CUI [1,3])
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item Group
Serious Adverse Event Entry
C1519255 (UMLS CUI-1)
Start Date
Item
Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
Item
Serious Adverse Event Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Serious Adverse Event 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 (5)
End Date
Item
Serious Adverse Event End Date
date
C2697886 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity of Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum Intensity
Code List
Maximum Intensity of Serious Adverse Event
CL Item
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
CL Item
[x] Not applicable (4)
Item
Intensity at onset of event
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Intensity at onset of event
Code List
Intensity at onset of event
CL Item
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
CL Item
[x] Not applicable (4)
Item
Maximum Grade of Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Maximum Grade
Code List
Maximum Grade of Serious Adverse Event
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Grade at onset of event
integer
C0806909 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Grade at onset of event
Code List
Grade at onset of event
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Maximum Grade of Intensity of Serious Adverse Event
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
Maximum Grade of Intensity
Code List
Maximum Grade of Intensity of Serious Adverse Event
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Grade of Intensity at onset of event
text
C0518690 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Grade of Intensity at onset of event
Code List
Grade of Intensity at onset of event
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Action taken with Investigational Product(s) as a result of AE?
integer
C2826626 (UMLS CUI [1])
Action taken with Investigational Product(s) as a result of AE?
Code List
Action taken with Investigational Product(s) as a result of AE?
CL Item
Investigational 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)
Did the subject withdraw from the study as a result of AE?
Item
Did the subject withdraw from the study as a result of AE?
boolean
C0422727 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Is there a reasonable possibility that the AE may have been caused by the 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])
C1518404 (UMLS CUI [1,3])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
text
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset since last Dose
Item
Time to Onset since last Dose
time
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C2603343 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3])
C2700391 (UMLS CUI [4])
C0005834 (UMLS CUI [5])
C1710661 (UMLS CUI [6])
Was the event serious?
Item
Was the event serious?
boolean
C1710056 (UMLS CUI [1])
Related Investigational Product
Item
Related Investigational Product
text
C0304229 (UMLS CUI [1])
Item Group
Seriousness
C1710056 (UMLS CUI-1)
Item
Level of seriousness of the event
integer
C1710056 (UMLS CUI [1])
Level of seriousness of the event
Code List
Level of seriousness of the event
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)
Item Group
Relevant Concomitant/Treatment Medication
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
CM Sequence Number
Item
CM Sequence Number
text
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Dose
Item
Medication Dose
float
C3174092 (UMLS CUI [1])
Item
Medication Unit
text
C2826646 (UMLS CUI [1])
Unit
Code List
Medication Unit
CL Item
Actuation (1)
CL Item
Ampuole (2)
CL Item
Application (3)
CL Item
Bottle (4)
CL Item
Capsule (5)
CL Item
Cubic centimeter (6)
CL Item
Drops (7)
CL Item
Gram (8)
CL Item
International units (9)
CL Item
International units per kilogram (10)
CL Item
International units per mililire (11)
CL Item
Litre (12)
CL Item
Litre per minute (13)
CL Item
Lozenge (14)
CL Item
Megaunits (million units) (15)
CL Item
Microgram (MCG) (16)
CL Item
Microgram (UG) (17)
CL Item
Microgram/ kilogram (18)
CL Item
Microgram/ kilogram per minute (19)
CL Item
Micrograms per minute (20)
CL Item
Microlitre (21)
CL Item
Milliequivalent (22)
CL Item
Milliequivalent per 24 hours (23)
CL Item
Milligram (24)
CL Item
Milligrams percent (25)
CL Item
Milligrams per hour (26)
CL Item
Milligram per hour (27)
CL Item
Milligram/ kilogram (28)
CL Item
Milligram/ kilogram per hour (29)
CL Item
Milligram/ kilogram per minute (30)
CL Item
Milligram per metre squared (31)
CL Item
Milligram/ millilitre (32)
CL Item
Millilitre (33)
CL Item
Millilitre per hour (34)
CL Item
Millilitre per minute (35)
CL Item
Millimole (36)
CL Item
Million International Units (37)
CL Item
Minimum alveolar concentration (38)
CL Item
Nebule (39)
CL Item
Patch (40)
CL Item
Percent (41)
CL Item
Puff (42)
CL Item
Sachet (43)
CL Item
Spray (44)
CL Item
Suppository (45)
CL Item
Tablespoon (46)
CL Item
Tablet (47)
CL Item
Teaspoon (48)
CL Item
Units (49)
CL Item
Unknown (50)
CL Item
Vial (51)
Item
Medication Frequency
integer
C3476109 (UMLS CUI [1])
Frequency
Code List
Medication Frequency
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
AC (6)
CL Item
BID (7)
CL Item
Continuous infusion (8)
CL Item
Every 2 weeks (9)
CL Item
Every 3 weeks (10)
CL Item
Every 3 months (11)
CL Item
Every other day (12)
CL Item
At Bedtime (13)
CL Item
Once a month (14)
CL Item
Once a week (15)
CL Item
Once daily (16)
CL Item
Once only (17)
CL Item
PC (18)
CL Item
PRN (19)
CL Item
Q2H (20)
CL Item
Q3D (21)
CL Item
Q4D (22)
CL Item
Q4H (23)
CL Item
Q6H (24)
CL Item
Q8H (25)
CL Item
Q12H (26)
CL Item
QAM (27)
CL Item
QH (28)
CL Item
QID (29)
CL Item
QPM (30)
CL Item
TID (31)
CL Item
Unknown (32)
Item
Medication Route
integer
C0013153 (UMLS CUI [1])
Medication Route
Code List
Medication Route
CL Item
Both eyes (1)
CL Item
Epidural (2)
CL Item
Gastrostomy tube (3)
CL Item
Inhalation (4)
CL Item
Injection (5)
CL Item
Intra- arterial (6)
CL Item
Intra- bursa (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Intraocular (11)
CL Item
Intraosteal (12)
CL Item
Intraperitoneal (13)
CL Item
Intrathecal (14)
CL Item
Intrauterine (15)
CL Item
Intravenous (16)
CL Item
Nasal (17)
CL Item
Oral (18)
CL Item
Rectal (19)
CL Item
Subcutaneous (20)
CL Item
Sublingual (21)
CL Item
Topical (22)
CL Item
Transdermal (23)
CL Item
Unknown (24)
CL Item
Vaginal (25)
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Is medication ongoing?
Item
Is medication ongoing?
boolean
C2826666 (UMLS CUI [1])
If NO, specify End Date
Item
If NO, specify End Date
date
C2826744 (UMLS CUI [1])
Primary Indication
Item
Primary Indication for medication
text
C2826696 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Drug Type
Item
Drug Type
text
C0457591 (UMLS CUI [1])
Item Group
Relevant Medical Conditions/Risk Factors
C0012634 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
MHx Sequence Number
Item
MHx Sequence Number
text
C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Modified reported term
Item
Modified reported term
text
C2826923 (UMLS CUI [1])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Is medical condition continuing?
integer
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Continuing?
Code List
Is medical condition continuing?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
If NO, specify date of last occurrence
Item
If NO, specify date of last occurrence
date
C2745955 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Relevant Diagnosis 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])
Item
Test Name
integer
C0022885 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Test Name
Code List
Test Name
CL Item
Activated partial thromboplastin time (1)
CL Item
Albumin (2)
CL Item
Alkaline phosphatase (3)
CL Item
Amylase (4)
CL Item
Basophils (5)
CL Item
Bicarbonate (6)
CL Item
Bilirubin (7)
CL Item
Bilirubin direct (8)
CL Item
Bilirubin total (9)
CL Item
Blood myoglobin (10)
CL Item
Blood pH (11)
CL Item
Blood pressure (12)
CL Item
Blood urea nitrogen (13)
CL Item
Body temperature (14)
CL Item
Calcium (15)
CL Item
CD4 lymphocytes (16)
CL Item
CD8 lymphocytes (17)
CL Item
Chloride (18)
CL Item
Cholesterol total (19)
CL Item
C- reactive protein (20)
CL Item
Creatine (21)
CL Item
Creatine phosphokinase (22)
CL Item
Creatine phoshokinase MB (23)
CL Item
Creatinine (24)
CL Item
Creatinine clearance (25)
CL Item
Diastolic blood pressure (26)
CL Item
Eosinophils (27)
CL Item
Erythrocyte sedimentation rate (28)
CL Item
Fasting blood glucose (29)
CL Item
FEV1 (30)
CL Item
Gamma- glutamyltransferase (31)
CL Item
Glutamic- oxaloacetic transferase (32)
CL Item
Glutamic- pyruvate transaminase (33)
CL Item
HbA1c (34)
CL Item
HBV- DNA decreased (35)
CL Item
HBV- DNA increased (36)
CL Item
Heart rate (37)
CL Item
Hematocrit (38)
CL Item
Hemoglobin (39)
CL Item
High density lipoprotein (40)
CL Item
HIV viral load (41)
CL Item
INR (42)
CL Item
Lactic dehydrogenase (43)
CL Item
Lipase (44)
CL Item
Low density lipoprotein (45)
CL Item
Lymphocytes (46)
CL Item
Magnesium (47)
CL Item
Mean cell hemoglobin concentration (48)
CL Item
Mean corpuscular hemoglobin (49)
CL Item
Mean corpuscular volume (50)
CL Item
Monocytes (51)
CL Item
Neutrophils (52)
CL Item
Oxygen saturation (53)
CL Item
pCO2 (54)
CL Item
PH (55)
CL Item
Phosphate (56)
CL Item
Platelet count (57)
CL Item
pO2 (58)
CL Item
Potassium (59)
CL Item
Protein total (60)
CL Item
Prothrombin time (61)
CL Item
Red blood cell count (62)
CL Item
Respiratory rate (63)
CL Item
Reticulocyte count (64)
CL Item
Serum glucose (65)
CL Item
Serum uric acid (66)
CL Item
Sodium (67)
CL Item
Systolic blood pressure (68)
CL Item
Thrombin time (69)
CL Item
Total lung capacity  (70)
CL Item
Triglycerides (71)
CL Item
Troponin (72)
CL Item
Troponin I (73)
CL Item
Troponin T (74)
CL Item
Urine myoglobin (75)
CL Item
Urine pH (76)
CL Item
Vital capacity (77)
CL Item
White blood cell count (78)
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
integer
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Normal High Range
Item
Normal High Range
integer
C0205251 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0587081 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Rechallenge
C2347900 (UMLS CUI-1)
Item
If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
integer
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Code List
If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Study Drug
Code List
Study Drug
CL Item
Novel dry powder inhaler (1)
Start Date
Item
Study Drug Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop Date
Item
Study Drug Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Regimen
Item
Regimen
text
C1276413 (UMLS CUI [1])
Item Group
General narrative comments
C0947611 (UMLS CUI-1)
A brief narrative description of SAE
Item
A brief narrative description of SAE
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
Non Clinical
C0205210 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
Send incomplete SAE data to GSK Safety
Item
Send incomplete SAE data to GSK Safety
text
C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
Receipt by GSK date
Item
Receipt by GSK date
date
C2985846 (UMLS CUI [1])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
SAE Sequence number
Item
SAE Sequence number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number
text
C0333052 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Case ID
Item
Case ID
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code
text
C0805701 (UMLS CUI [1])
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