ID

41526

Description

Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Serious Adverse Events) is to be filled out during the study. If you wish to record a new SAE please determine if the new SAE is clinically or temporally related to an SAE previously entered on this form. If yes, record it in the same instance of the form. If not clinically or temporally related, create a new SAE form for this subject.

Lien

https://clinicaltrials.gov/ct2/show/NCT00784550

Mots-clés

Versions (2)
  1. 29/10/2020 29/10/2020 -
  2. 01/11/2020 01/11/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

1 novembre 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 4.0
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Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

Anglais

Serious Adverse Events

1 Formulaires  
  1. StudyEvent: ODM
    1. Serious Adverse Events
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of assessment
Description

Date of assessment

Type de données

date

Alias
UMLS CUI [1]
C2985720
Subject identification number
Description

Subject identification number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Type of report, SAE
Description

Type of report, SAE

Alias
UMLS CUI-1
C0585733
UMLS CUI-2
C1519255
Initial report
Description

Initial report

Type de données

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0205265
Follow-up report
Description

Follow-up report

Type de données

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704685
Randomisation
Description

Randomisation

Alias
UMLS CUI-1
C0034656
Did SAE occur after initiation of study medication?
Description

SAE after experimental drug initiation

Type de données

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231290
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C1704686
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
SAE Sequence number
Description

[hidden]

Type de données

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Description

Include ONE event term only

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C3540840
Modified term
Description

[hidden]

Type de données

text

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

Hidden

Type de données

text

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

Hidden

Type de données

text

Alias
UMLS CUI [1,1]
C3898442
UMLS CUI [1,2]
C1519255
Failed coding
Description

[hidden]

Type de données

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C1519255
Start Date
Description

Condition item: Start time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.

Type de données

partialDatetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C1519255
Outcome
Description

SAE Outcome

Type de données

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Outcome: Recovered/Resolved, provide End Date and Time
Description

End Time is optional.

Type de données

partialDatetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1709863
UMLS CUI [1,3]
C0806020
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1709863
UMLS CUI [2,3]
C1522314
Outcome: Recovered/Resolved with sequelae, provide End Date and Time
Description

End Time is optional

Type de données

partialDatetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1709862
UMLS CUI [1,3]
C0806020
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1709862
UMLS CUI [2,3]
C1522314
Outcome: Fatal, record Date and Time of Death
Description

Outcome: Fatal, Date and Time of Death

Type de données

datetime

Alias
UMLS CUI [1,1]
C1705232
UMLS CUI [1,2]
C1519255
UMLS CUI [2]
C1148348
UMLS CUI [3]
C1301931
Record maximum intensity throughout duration of event
Description

Optional item: This item may be hidden if either the Maximum Grade or Maximum Grade or Intensity item has been used.

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Record intensity at the onset of the event.
Description

Conditional item: Conditional on the use of the Intensity Change section. If the section is not used then the item must be hidden. This item may be hidden if either the Grade/Grade or Intensity at onset of event item has been used. [hidden]

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0332162
Record maximum grade throughout duration of event.
Description

Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade or Intensity item has been used. Grade 5 is optional. [hidden]

Type de données

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Record grade at the onset of the event
Description

Conditional item: Conditional on using the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Intensity/Grade or Intensity at onset of event item has been used. Grade 5 is optional. [hidden]

Type de données

integer

Alias
UMLS CUI [1,1]
C0441800
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C1519255
Record maximum grade or intensity throughout duration of event
Description

Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade item has been used. Grade 5 is optional. [hidden]

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0518690
UMLS CUI [2,3]
C0806909
Record grade or intensity at the onset of the event
Description

Conditional item: Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Intensity or Grade at onset of event item has been used. Grade 5 is optional. [hidden]

Type de données

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C1519255
UMLS CUI [2,1]
C0441800
UMLS CUI [2,2]
C0332162
UMLS CUI [2,3]
C1519255
Action Taken with Investigational Product(s) as a Result of the AE
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]
C1519255
Did the subject withdraw from study as a result of the AE
Description

Subject withdrawal due to SAE

Type de données

text

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

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

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Duration of AE if < 24 hours
Description

If AE start and end time are used this item must be hidden. Record as xx Hr(s)(0<=n<=23) xx Min(s) (0<=n<=59) [hidden]

Type de données

durationDatetime

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
Time to onset since last dose
Description

This item is optional. Record as xx Hr(s) xx Min(s) (0<=n<=59) [hidden]

Type de données

durationDatetime

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C3174092
UMLS CUI [1,5]
C1517741
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc.)?
Description

SAE caused by study-related activities except investigational product

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0441655
UMLS CUI [1,4]
C2348568
UMLS CUI [1,5]
C0332300
UMLS CUI [1,6]
C0304229
Was the event serious?
Description

[hidden]

Type de données

text

Alias
UMLS CUI [1]
C1710056
Related Investigational Product
Description

[hidden]

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Intensity Changes
Description

Intensity Changes

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0518690
UMLS CUI-3
C0392747
SAE-Sequence-Number
Description

This item was not in the original document

Type de données

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C1519255
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Description

Include ONE event term only

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C3540840
Start Date and Time of event segment
Description

If the decision has been made to record every change in intensity, time must be collected to differentiate between, and to indicate the order of, changes that occur within a single day. Record as Hr:Min (00:00-23:59)

Type de données

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0808070
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0449719
UMLS CUI [2,3]
C1301880
Intensity of event segment
Description

Optional item: This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment item has been used and item not included in the section.

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0518690
Grade of event segment
Description

Optional item: This item may be hidden if either the Intensity of event segment or Grade or Intensity of event segment has been used and item not included in the section. Grade 5 is optional.

Type de données

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0441800
Grade or Intensity of event segment
Description

Optional item: This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment has been used and item not included in the section. Grade 5 is optional.

Type de données

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0518690
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0449719
UMLS CUI [2,3]
C0441800
Seriousness ?
Description

Seriousness ?

Alias
UMLS CUI-1
C1710056
[A] Results in death
Description

SAE results in death

Type de données

boolean

Alias
UMLS CUI [1,1]
C1705232
UMLS CUI [1,2]
C1519255
[B] Is life-threatening
Description

SAE is life-threatening

Type de données

boolean

Alias
UMLS CUI [1,1]
C1517874
UMLS CUI [1,2]
C1519255
[C] Requires hospitalisation or prolongation of existing hospitalisation
Description

SAE requires hospitalisation

Type de données

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826664
[D] Results in disability/incapacity
Description

SAE results in disability/incapacity

Type de données

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C3176592
[E] Congenital anomaly/birth defect
Description

SAE: Congenital anomaly/birth defect

Type de données

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1519255
Other, specify within general narrative comment
Description

SAE, other

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0205394
Relevant concomitant/treatment medications
Description

Relevant concomitant/treatment medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2347946
UMLS CUI-3
C0304229
CM Sequence Number
Description

[hidden]

Type de données

integer

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

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

Type de données

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Modified reported term
Description

[hidden]

Type de données

text

Alias
UMLS CUI [1]
C2826819
Dose
Description

Dose CM

Type de données

text

Alias
UMLS CUI [1]
C2826811
Unit
Description

Unit CM

Type de données

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519795
Frequency
Description

Frequency CM

Type de données

text

Alias
UMLS CUI [1]
C2826654
Route
Description

CM Route

Type de données

text

Alias
UMLS CUI [1]
C2826730
Start Date
Description

CM Start Date

Type de données

date

Alias
UMLS CUI [1]
C2826734
Ongoing?
Description

CM Ongoing?

Type de données

text

Alias
UMLS CUI [1]
C2826666
If not ongoing specify End Date
Description

CM End Date

Type de données

date

Alias
UMLS CUI [1]
C2826744
Primary Indication
Description

Enter a medical diagnosis not a description

Type de données

text

Alias
UMLS CUI [1]
C2826696
Modified reported term
Description

[hidden]

Type de données

text

Alias
UMLS CUI [1]
C2826819
Drug type
Description

Drug type CM

Type de données

text

Alias
UMLS CUI [1,1]
C0457591
UMLS CUI [1,2]
C2347852
Relevant medical conditions/risk factors
Description

Relevant medical conditions/risk factors

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C1519255
UMLS CUI-4
C0035648
UMLS CUI-5
C1519255
MHx Sequence Number
Description

[hidden]

Type de données

integer

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C2348184
Specific condition name
Description

Enter a medical diagnosis not description

Type de données

text

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

[hidden]

Type de données

text

Alias
UMLS CUI [1]
C2826923
Date of onset
Description

[hidden]

Type de données

date

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

Continuing?

Type de données

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
If not continuing please specify the date of the last occurrence
Description

Date of last occurrence if not continuous

Type de données

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0011008
Relevant Medical History /Risk Factors not noted above
Description

[hidden]

Type de données

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C2347946
UMLS CUI [2,3]
C0205394
Relevant Diagnostic Results
Description

Relevant Diagnostic Results

Alias
UMLS CUI-1
C2347946
UMLS CUI-2
C0430022
UMLS CUI-3
C0456984
Lab Sequence Number
Description

[hidden]

Type de données

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2348184
Test name
Description

Only allow site to choose from List of Values

Type de données

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C2826273
Test Date
Description

Test Date

Type de données

date

Alias
UMLS CUI [1]
C2826247
Test Result
Description

Test Result

Type de données

text

Alias
UMLS CUI [1]
C0456984
Test units
Description

Test Units

Type de données

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0022885
Normal low range
Description

Lower limit of normal

Type de données

text

Alias
UMLS CUI [1]
C1518030
Normal high range
Description

Upper limit of normal

Type de données

text

Alias
UMLS CUI [1]
C1519815
Relevant Diagnostic Results not listed above
Description

Other Relevant Diagnostic Results

Type de données

text

Alias
UMLS CUI [1,1]
C2347946
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0456984
UMLS CUI [1,4]
C0205394
Serious Adverse Events - Rechallenge
Description

Serious Adverse Events - Rechallenge

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347900
If Investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational product(s) were restarted?
Description

Recurrence of the reported SAE following new administration | administration of investigational agent interrupted earlier

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0231290
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C1533734
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0304229
UMLS CUI [2,3]
C1512900
Investigational product
Description

Investigational product

Alias
UMLS CUI-1
C0304229
Study Drug
Description

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate (this will apply to any multi phase study)

Type de données

text

Alias
UMLS CUI [1]
C0304229
Start Date
Description

Time is optional

Type de données

partialDatetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Stop Date
Description

Time is optional.

Type de données

partialDatetime

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

Optional item: This item may be hidden.

Type de données

text

Alias
UMLS CUI [1,1]
C0237125
UMLS CUI [1,2]
C0304229
Investigational product
Description

Investigational product

Alias
UMLS CUI-1
C0304229
Study Drug
Description

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate (this will apply to any multi phase study) [hidden]

Type de données

text

Alias
UMLS CUI [1]
C0304229
Start Date
Description

Time is optional. [hidden]

Type de données

partialDatetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Stop Date
Description

Time is optional. [hidden]

Type de données

partialDatetime

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

Optional item: This item may be hidden. [hidden]

Type de données

text

Alias
UMLS CUI [1,1]
C0237125
UMLS CUI [1,2]
C0304229
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Study Drug
Description

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate (this will apply to any multi phase study) [hidden]

Type de données

text

Alias
UMLS CUI [1]
C0304229
Start Date
Description

Time is optional. [hidden]

Type de données

partialDatetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Stop Date
Description

Time is optional. [hidden]

Type de données

partialDatetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Dose
Description

[hidden]

Type de données

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0678766
Cumulative Dose
Description

This item is conditional. [hidden]

Type de données

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2986497
Regimen
Description

Optional item: This item may be hidden. [hidden]

Type de données

text

Alias
UMLS CUI [1,1]
C0237125
UMLS CUI [1,2]
C0304229
General Narrative Comments
Description

General Narrative Comments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
General Narrative Comments
Description

General Narrative Comments

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Non Clinical
Description

Non Clinical

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0205210
UMLS CUI-3
C1298908
Send incomplete SAE data to GSK Safety
Description

This item is optional. [hidden]

Type de données

boolean

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0205257
Receipt by GSK date
Description

[hidden]

Type de données

datetime

Alias
UMLS CUI [1,1]
C2985846
UMLS CUI [1,2]
C2347796
Was the event serious?
Description

[hidden]

Type de données

text

Alias
UMLS CUI [1]
C1710056
SAE Sequence number
Description

[hidden]

Type de données

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Version number
Description

[hidden]

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0333052
UMLS CUI [1,3]
C0237753
Case ID
Description

[hidden]

Type de données

text

Alias
UMLS CUI [1,1]
C0868928
UMLS CUI [1,2]
C0600091
Randomisation number
Description

[hidden]

Type de données

text

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

[hidden]

Type de données

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C1516728
Email flag
Description

[hidden]

Type de données

text

Alias
UMLS CUI [1]
C0013849
Retour au début de la page

Similar models

Serious Adverse Events

1 Formulaires
  1. StudyEvent: ODM
    1. Serious Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Subject identification number
Item
Subject identification number
text
C2348585 (UMLS CUI [1])
Item Group
Type of report, SAE
C0585733 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Initial report
Item
Initial report
boolean
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
Follow-up report
Item
Follow-up report
boolean
C1519255 (UMLS CUI [1,1])
C1704685 (UMLS CUI [1,2])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
SAE after experimental drug initiation
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1704686 (UMLS CUI [1,4])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
SAE Sequence number
Item
SAE Sequence number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event Diagnosis or Sign/Symptom
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
Modified term SAE
Item
Modified term
text
C2826302 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
MedDRA synonym SAE
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
MedDRA lower level term code SAE
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Failed coding SAE
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
SAE Start Date/ Start Time
Item
Start Date
partialDatetime
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE Outcome
Code List
Outcome
CL Item
Recovered/Resolved, provide End Date and Time (Recovered/Resolved, provide End Date and Time)
CL Item
Recovering/Resolving (Recovering/Resolving)
CL Item
Not recovered/Not resolved (Not recovered/Not resolved)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (Recovered/Resolved with sequelae, provide End Date and Time)
CL Item
Fatal, record Date and Time of Death (Fatal, record Date and Time of Death)
Outcome: Recovered/Resolved, End Date and Time
Item
Outcome: Recovered/Resolved, provide End Date and Time
partialDatetime
C1519255 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C1709863 (UMLS CUI [2,2])
C1522314 (UMLS CUI [2,3])
Outcome: Recovered/Resolved with sequelae, End Date and Time
Item
Outcome: Recovered/Resolved with sequelae, provide End Date and Time
partialDatetime
C1519255 (UMLS CUI [1,1])
C1709862 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C1709862 (UMLS CUI [2,2])
C1522314 (UMLS CUI [2,3])
Outcome: Fatal, Date and Time of Death
Item
Outcome: Fatal, record Date and Time of Death
datetime
C1705232 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
C1301931 (UMLS CUI [3])
Item
Record maximum intensity throughout duration of event
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum intensity during SAE
Code List
Record maximum intensity throughout duration of event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Record intensity at the onset of the event.
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Maximum intensity during SAE
Code List
Record intensity at the onset of the event.
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Record maximum grade throughout duration of event.
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum Grade during SAE
Code List
Record maximum grade throughout duration 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
Record grade at the onset of the event
integer
C0441800 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Maximum Grade during SAE
Code List
Record grade at the onset of the 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
Record maximum grade or intensity throughout duration of event
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
Maximum Grade or Intensity
Code List
Record maximum grade or intensity throughout duration 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 (X)
Item
Record grade or intensity at the onset of the event
text
C0518690 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0441800 (UMLS CUI [2,1])
C0332162 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
Maximum Grade or Intensity
Code List
Record grade or intensity at the onset of the 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 (X)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the AE
Code List
Action Taken with Investigational Product(s) as a Result of the 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 (X)
Item
Did the subject withdraw from study as a result of the AE
text
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE after initiation of study medication
Code List
Did the subject withdraw from study as a result of the AE
CL Item
No (N)
CL Item
Yes (Y)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
SAE after initiation of study medication
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
No (N)
CL Item
Yes (Y)
Duration of SAE
Item
Duration of AE if < 24 hours
durationDatetime
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Time to onset of SAE since last dose
Item
Time to onset since last dose
durationDatetime
C1272706 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc.)?
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0332300 (UMLS CUI [1,5])
C0304229 (UMLS CUI [1,6])
SAE after initiation of study medication
Code List
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc.)?
CL Item
No (N)
CL Item
Yes (Y)
AE serious
Item
Was the event serious?
text
C1710056 (UMLS CUI [1])
Investigational Product related to SAE
Item
Related Investigational Product
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item Group
Intensity Changes
C1519255 (UMLS CUI-1)
C0518690 (UMLS CUI-2)
C0392747 (UMLS CUI-3)
SAE-Sequence-Number
Item
SAE-Sequence-Number
integer
C2348184 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event Diagnosis or Sign/Symptom
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
Start Date and Time of SAE segment
Item
Start Date and Time of event segment
datetime
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0449719 (UMLS CUI [2,2])
C1301880 (UMLS CUI [2,3])
Item
Intensity of event segment
text
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Intensity of event segment
Code List
Intensity of event segment
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Grade of event segment
integer
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Maximum Grade during SAE
Code List
Grade of event segment
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 or Intensity of event segment
integer
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0449719 (UMLS CUI [2,2])
C0441800 (UMLS CUI [2,3])
Grade or Intensity of event segment
Code List
Grade or Intensity of event segment
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Sever or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item Group
Seriousness ?
C1710056 (UMLS CUI-1)
SAE results in death
Item
[A] Results in death
boolean
C1705232 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE is life-threatening
Item
[B] Is life-threatening
boolean
C1517874 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE requires hospitalisation
Item
[C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
C1519255 (UMLS CUI [1,1])
C2826664 (UMLS CUI [1,2])
SAE results in disability/incapacity
Item
[D] Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C3176592 (UMLS CUI [2,2])
SAE: Congenital anomaly/birth defect
Item
[E] Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE, other
Item
Other, specify within general narrative comment
text
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Relevant concomitant/treatment medications
C2347852 (UMLS CUI-1)
C2347946 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
CM Sequence Number
Item
CM Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Drug name CM
Item
Drug name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Modified reported term CM
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Dose CM
Item
Dose
text
C2826811 (UMLS CUI [1])
Item
Unit
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Unit
Code List
Unit
CL Item
Actuation (ACTU)
CL Item
Ampoule (AMP)
CL Item
Application (AP)
CL Item
Bottle (BT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter (CC)
CL Item
Drops (031)
CL Item
Gram (002)
CL Item
International units (025)
CL Item
International units per kilogram (028)
CL Item
International units per millilitre (IUML)
CL Item
Litre (011)
CL Item
Litre per minute (LM)
CL Item
Lozenge (LOZ)
CL Item
Megaunits (million units) (MEGU)
CL Item
Microgram (UC) (004)
CL Item
Microgram (UC) (004)
CL Item
Microgram/kilogram (008)
CL Item
Microgram/kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Microlitre (013)
CL Item
Milliequivalent (029)
CL Item
Milliequivalent per 24 hours (MEQ24)
CL Item
Milligram (003)
CL Item
Milligrams percent (MGPER)
CL Item
Milligram per hour (MGH)
CL Item
Milligram/kilogram (007)
CL Item
Milligram/kilogram per hour (MGKH)
CL Item
Milligram/kilogram per minute (MGKM)
CL Item
Milligram/metre squared (009)
CL Item
Milligram/millilitre (MGML)
CL Item
Millilitre (012)
CL Item
Millilitre per hour (MLH)
CL Item
Millilitre per minute (MLM)
CL Item
Millimole (023)
CL Item
Million international units (027)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Nebel (NEB)
CL Item
Patch (PAT)
CL Item
Percent (030)
CL Item
Puff (PUFF)
CL Item
Sachet (SAC)
CL Item
Spray (SPR)
CL Item
Suppository (SUP)
CL Item
Tablespoon (TBS)
CL Item
Tablet (TAB)
CL Item
Teaspoon (TSP)
CL Item
Units (UNT)
CL Item
Unknown (U)
CL Item
Vial (VIA)
Item
Frequency
text
C2826654 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
2 times per week (2W)
CL Item
3 times per week (3W)
CL Item
4 times per week (4W)
CL Item
5 times per day (5D)
CL Item
5 times per week (5W)
CL Item
AC (AC)
CL Item
Q12H (2D)
CL Item
Continuous infection (CO)
CL Item
Every 2 weeks (FO)
CL Item
Every 3 weeks (Q3W)
CL Item
Every 3 months (Q3M)
CL Item
Every other day (AD)
CL Item
QPM (1N)
CL Item
Once a month (MO)
CL Item
Once a week (WE)
CL Item
Once daily (1D)
CL Item
Once only (1S)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q2H (12D)
CL Item
Q3D (Q3D)
CL Item
Q4D (Q4D)
CL Item
Q4H (6D)
CL Item
QID (4D)
CL Item
TID (3D)
CL Item
Q12H (2D)
CL Item
QAM (1M)
CL Item
QH (24D)
CL Item
QID (4D)
CL Item
QPM (1N)
CL Item
TID (3D)
CL Item
Unknown (U)
Item
Route
text
C2826730 (UMLS CUI [1])
Route
Code List
Route
CL Item
Both eyes (047)
CL Item
Epidural (008)
CL Item
Gastrostomy tube (GT)
CL Item
Inhalation (055)
CL Item
Injection (INJ)
CL Item
Intra-arterial (013)
CL Item
Intra-bursa (IBU)
CL Item
Intralesional (026)
CL Item
Intramuscular (030)
CL Item
Nasal (045)
CL Item
Intraocular (031)
CL Item
Intraosteal (IOS)
CL Item
Intraperitoneal (033)
CL Item
Intrathecal (037)
CL Item
Intrauterine (015)
CL Item
Intravenous (042)
CL Item
Nasal (045)
CL Item
Oral (048)
CL Item
rectal (054)
CL Item
Subcutaneous (058)
CL Item
Sublingual (060)
CL Item
Topical (061)
CL Item
Transdermal (062)
CL Item
Unknown (065)
CL Item
Vaginal (067)
CM Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
Item
Ongoing?
text
C2826666 (UMLS CUI [1])
Ongoing?
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No, specify end date (N)
CM End Date
Item
If not ongoing specify End Date
date
C2826744 (UMLS CUI [1])
Primary Indication for CM
Item
Primary Indication
text
C2826696 (UMLS CUI [1])
Modified reported term CM
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Item
Drug type
text
C0457591 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Drug type
Code List
Drug type
CL Item
Concomitant (2)
CL Item
Treatment (T)
CL Item
Cause of SAE (1)
Item Group
Relevant medical conditions/risk factors
C0262926 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0035648 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
MHx Sequence Number
Item
MHx Sequence Number
integer
C0262926 (UMLS CUI [1])
C2348184 (UMLS CUI [2])
Specific condition name
Item
Specific condition name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Modified reported term Medical History
Item
Modified reported term
text
C2826923 (UMLS CUI [1])
Date of onset of condition
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Item
Continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Continuing?
Code List
Continuing?
CL Item
Yes (Y)
CL Item
No, specify date of last occurrence (N)
CL Item
Unknown (U)
Date of last occurrence if not continuous
Item
If not continuing please specify the date of the last occurrence
date
C0012634 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Other Relevant Medical History /Risk Factors
Item
Relevant Medical History /Risk Factors not noted above
text
C0262926 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
Item Group
Relevant Diagnostic Results
C2347946 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Lab Sequence Number
Item
Lab Sequence Number
integer
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Test name
text
C0430022 (UMLS CUI [1,1])
C2826273 (UMLS CUI [1,2])
Test name
Code List
Test name
CL Item
Activated partial thromboplastin time (Activated partial thromboplastin time)
CL Item
Albumin (Albumin)
CL Item
Alkaline phosphatase (Alkaline phosphatase)
CL Item
Amylase (Amylase)
CL Item
Basophils (Basophils)
CL Item
Bicarbonate (Bicarbonate)
CL Item
Bilirubin (Bilirubin)
CL Item
Bilirubin direct (Bilirubin direct)
CL Item
Bilirubin total (Bilirubin total)
CL Item
Blood myoglobin (Blood myoglobin)
CL Item
Blood pH (Blood pH)
CL Item
Blood pressure (Blood pressure)
CL Item
Blood urea nitrogen (Blood urea nitrogen)
CL Item
Body temperature (Body temperature)
CL Item
Calcium (Calcium)
CL Item
CD4 lymphocytes (CD4 lymphocytes)
CL Item
CD8 lymphocytes (CD8 lymphocytes)
CL Item
Chloride (Chloride)
CL Item
Cholesterol total (Cholesterol total)
CL Item
C-reactive protein (C-reactive protein)
CL Item
Creatine (Creatine)
CL Item
Creatine phosphokinase (Creatine phosphokinase)
CL Item
Creatine phosphokinase MB (Creatine phosphokinase MB)
CL Item
Creatinin (Creatinin)
CL Item
Creatinin clearance (Creatinin clearance)
CL Item
Diastolic blood pressure (Diastolic blood pressure)
CL Item
Eosinophils (Eosinophils)
CL Item
Erythrocyte sedimentation rate (Erythrocyte sedimentation rate)
CL Item
Fasting blood glucose (Fasting blood glucose)
CL Item
FEV 1 (FEV 1)
CL Item
Gamma-glutamyltransferase (Gamma-glutamyltransferase)
CL Item
Glutamic-oxaloacetic transferase  (Glutamic-oxaloacetic transferase)
CL Item
Glutamic-pyruvate transaminase (Glutamic-pyruvate transaminase)
CL Item
HbA1c (HbA1c)
CL Item
HBV-DNA decreased (HBV-DNA decreased)
CL Item
HBV-DNA increased  (HBV-DNA increased)
CL Item
Heart rate (Heart rate)
CL Item
Hematocrit (Hematocrit)
CL Item
Hemoglobin (Hemoglobin)
CL Item
High density lipoprotein (High density lipoprotein)
CL Item
HIV viral load (HIV viral load)
CL Item
INR (INR)
CL Item
Lactic dehydrogenase (Lactic dehydrogenase)
CL Item
Lipase (Lipase)
CL Item
Low density lipoprotein (Low density lipoprotein)
CL Item
Lymphocytes (Lymphocytes)
CL Item
Magnesium (Magnesium)
CL Item
Neutrophils (Neutrophils)
CL Item
Oxygen saturation (Oxygen saturation)
CL Item
pCO2 (pCO2)
CL Item
pH (pH)
CL Item
Phosphate (Phosphate)
CL Item
Platelet count (Platelet count)
CL Item
pO2 (pO2)
CL Item
Potassium (Potassium)
CL Item
Protein total (Protein total)
CL Item
Prothrombin time (Prothrombin time)
CL Item
Red blood cell count (Red blood cell count)
CL Item
Respiratory rate (Respiratory rate)
CL Item
Reticulocyte count (Reticulocyte count)
CL Item
Serum glucose (Serum glucose)
CL Item
Serum uric acid (Serum uric acid)
CL Item
Sodium (Sodium)
CL Item
Systolic blood pressure (Systolic blood pressure)
CL Item
Thrombin time (Thrombin time)
CL Item
Total lung capacity (Total lung capacity)
CL Item
Triglycerides (Triglycerides)
CL Item
Troponin (Troponin)
CL Item
Troponin I (Troponin I)
CL Item
Troponin T (Troponin T)
CL Item
Urine myoglobin  (Urine myoglobin)
CL Item
Urine pH (Urine pH)
CL Item
Vital capacity (Vital capacity)
CL Item
White blood cell count (White blood cell count)
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0456984 (UMLS CUI [1])
Test Units
Item
Test units
text
C1519795 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Lower limit of normal
Item
Normal low range
text
C1518030 (UMLS CUI [1])
Upper limit of normal
Item
Normal high range
text
C1519815 (UMLS CUI [1])
Other Relevant Diagnostic Results
Item
Relevant Diagnostic Results not listed above
text
C2347946 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item Group
Serious Adverse Events - Rechallenge
C1519255 (UMLS CUI-1)
C2347900 (UMLS CUI-2)
Item
If Investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational product(s) were restarted?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0231290 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C1533734 (UMLS CUI [1,5])
C0231290 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C1512900 (UMLS CUI [2,3])
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Code List
If Investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational product(s) were restarted?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
Investigational product
C0304229 (UMLS CUI-1)
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Study Drug
Code List
Study Drug
CL Item
Actual study drug or blinded trial medication 1 (Actual study drug or blinded trial medication 1)
CL Item
Actual study drug or blinded trial medication 2 (Actual study drug or blinded trial medication 2)
CL Item
Actual study drug or blinded trial medication 3 (Actual study drug or blinded trial medication 3)
Investigational Product Start Date
Item
Start Date
partialDatetime
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Investigational Product Stop Date
Item
Stop Date
partialDatetime
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Investigational Product Regimen
Item
Regimen
text
C0237125 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Investigational product
C0304229 (UMLS CUI-1)
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Study Drug
Code List
Study Drug
CL Item
Dose level 1 (Dose level 1)
CL Item
Dose level 2 (Dose level 2)
CL Item
Dose level 3 (Dose level 3)
Investigational Product Start Date
Item
Start Date
partialDatetime
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Investigational Product Stop Date
Item
Stop Date
partialDatetime
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Investigational Product Regimen
Item
Regimen
text
C0237125 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Study Drug
Code List
Study Drug
CL Item
Course 1 (Course 1)
CL Item
Course 2 (Course 2)
CL Item
Course 3 (Course 3)
Investigational Product Start Date
Item
Start Date
partialDatetime
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Investigational Product Stop Date
Item
Stop Date
partialDatetime
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Investigational Product Dose
Item
Dose
text
C0304229 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
Investigational Product Cumulative Dose
Item
Cumulative Dose
text
C0304229 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Investigational Product Regimen
Item
Regimen
text
C0237125 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
General Narrative Comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
General Narrative Comments
Item
General Narrative Comments
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Non Clinical
C1519255 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
Incomplete SAE
Item
Send incomplete SAE data to GSK Safety
boolean
C1710056 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
Receipt by GSK date
Item
Receipt by GSK date
datetime
C2985846 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
Item
Was the event serious?
text
C1710056 (UMLS CUI [1])
SAE serious
Code List
Was the event serious?
CL Item
Yes (Y)
CL Item
No (N)
SAE Sequence number
Item
SAE Sequence number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version number
Item
Version number
text
C1519255 (UMLS CUI [1,1])
C0333052 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Case ID
Item
Case ID
text
C0868928 (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 [1,1])
C1516728 (UMLS CUI [1,2])
Email flag
Item
Email flag
text
C0013849 (UMLS CUI [1])
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