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.

Link

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

Keywords

Versions (2)
  1. 10/29/20 10/29/20 -
  2. 11/1/20 11/1/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 1, 2020

DOI

To request one please log in.

License

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

    English

    Serious Adverse Events

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

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Date of assessment
    Description

    Date of assessment

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720
    Subject identification number
    Description

    Subject identification number

    Data type

    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

    Data type

    boolean

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

    Follow-up report

    Data type

    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

    Data type

    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]

    Data type

    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

    Data type

    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]

    Data type

    text

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

    Hidden

    Data type

    text

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

    Hidden

    Data type

    text

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

    [hidden]

    Data type

    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.

    Data type

    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

    Data type

    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.

    Data type

    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

    Data type

    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

    Data type

    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.

    Data type

    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]

    Data type

    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]

    Data type

    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]

    Data type

    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]

    Data type

    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]

    Data type

    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

    Data type

    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

    Data type

    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.

    Data type

    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]

    Data type

    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]

    Data type

    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

    Data type

    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]

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710056
    Related Investigational Product
    Description

    [hidden]

    Data type

    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

    Data type

    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

    Data type

    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)

    Data type

    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.

    Data type

    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.

    Data type

    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.

    Data type

    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

    Data type

    boolean

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

    SAE is life-threatening

    Data type

    boolean

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

    SAE requires hospitalisation

    Data type

    boolean

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

    SAE results in disability/incapacity

    Data type

    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

    Data type

    boolean

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

    SAE, other

    Data type

    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]

    Data type

    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)

    Data type

    text

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

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826819
    Dose
    Description

    Dose CM

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826811
    Unit
    Description

    Unit CM

    Data type

    text

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

    Frequency CM

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826654
    Route
    Description

    CM Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826730
    Start Date
    Description

    CM Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826734
    Ongoing?
    Description

    CM Ongoing?

    Data type

    text

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

    CM End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744
    Primary Indication
    Description

    Enter a medical diagnosis not a description

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826696
    Modified reported term
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826819
    Drug type
    Description

    Drug type CM

    Data type

    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]

    Data type

    integer

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

    Enter a medical diagnosis not description

    Data type

    text

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

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826923
    Date of onset
    Description

    [hidden]

    Data type

    date

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

    Continuing?

    Data type

    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

    Data type

    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]

    Data type

    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]

    Data type

    integer

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

    Only allow site to choose from List of Values

    Data type

    text

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

    Test Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826247
    Test Result
    Description

    Test Result

    Data type

    text

    Alias
    UMLS CUI [1]
    C0456984
    Test units
    Description

    Test Units

    Data type

    text

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

    Lower limit of normal

    Data type

    text

    Alias
    UMLS CUI [1]
    C1518030
    Normal high range
    Description

    Upper limit of normal

    Data type

    text

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

    Other Relevant Diagnostic Results

    Data type

    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

    Data type

    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)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0304229
    Start Date
    Description

    Time is optional

    Data type

    partialDatetime

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

    Time is optional.

    Data type

    partialDatetime

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

    Optional item: This item may be hidden.

    Data type

    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]

    Data type

    text

    Alias
    UMLS CUI [1]
    C0304229
    Start Date
    Description

    Time is optional. [hidden]

    Data type

    partialDatetime

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

    Time is optional. [hidden]

    Data type

    partialDatetime

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

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

    Data type

    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]

    Data type

    text

    Alias
    UMLS CUI [1]
    C0304229
    Start Date
    Description

    Time is optional. [hidden]

    Data type

    partialDatetime

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

    Time is optional. [hidden]

    Data type

    partialDatetime

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

    [hidden]

    Data type

    text

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

    This item is conditional. [hidden]

    Data type

    text

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

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

    Data type

    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

    Data type

    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]

    Data type

    boolean

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

    [hidden]

    Data type

    datetime

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

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710056
    SAE Sequence number
    Description

    [hidden]

    Data type

    integer

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

    [hidden]

    Data type

    text

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

    [hidden]

    Data type

    text

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

    [hidden]

    Data type

    text

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

    [hidden]

    Data type

    text

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

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013849
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    Similar models

    Serious Adverse Events

    1 forms
    1. StudyEvent: ODM
      1. Serious Adverse Events
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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