ID

30874

Description

This ODM file contains documentation of Serious Adverse Events. To be checked for (and added if neccessary) at Sessions 1 and 2 (Day -1), Early Withdrawal and Follow-Up. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Link

https://clinicaltrials.gov/ct2/show/NCT01039454

Keywords

Versions (1)
  1. 6/29/18 6/29/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

June 29, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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    Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

    English

    Serious Adverse Events

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

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Serious Adverse Events - Section 1
    Description

    Serious Adverse Events - Section 1

    Alias
    UMLS CUI-1
    C1519255
    Did the subject experience a serious adverse event during the study?
    Description

    If Yes, record details below. A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death. b) is life-threatening: The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe. c) requires hospitalisation or prolongation of existing hospitalisation: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is ’serious’. When in doubt as to whether ’hospitalisation’ occurred or was necessary, the AE should be considered ’serious’. Hospitalisation for elective treatment of a pre-existing condition that did not worsen from baseline is not considered an AE. d) results in disability/incapacity: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e) is a congenital anomaly/birth defect. f) other. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse.

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519255
    Diagnosis only (if known, otherwise Sign/Symptom)
    Description

    Ensure that no medical or investigational procedures are captured on Non-Serious Adverse Events pages. Death should not be recorded as an SAE but should be recorded as the outcome of an SAE. The condition that resulted in the death should be recorded as the SAE. Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE. However, if multiple SAEs which are temporally or clinically related are apparent at the time of initial reporting then these may be reported on the same page. If this was recorded previously as a non-serious event but has progressed to serious, put a line through the Non-Serious AE record and transcribe the details onto the SAE form.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0011900
    Record the start date and time of the first occurrence of the event or signs/symptoms of the serious event, not the date and time the event became serious.
    Description

    Start dates must be provided for the reporting of adverse event data. If the exact date is not known, liaise with the investigator to ensure that a best estimate is provided.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2697888
    UMLS CUI [1,2]
    C1519255
    Start time
    Description

    Start Time Serious Adverse Event

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2697889
    UMLS CUI [1,2]
    C1519255
    Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases.
    Description

    Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficiently discomforting to interfere with everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = Those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C1519255
    Outcome
    Description

    All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was ’Recovered/Resolved’ or ’Recovered/Resolved with sequelae’. If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Also enter ’Not recovered/Not resolved’ if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1705586
    UMLS CUI [1,2]
    C1519255
    Action Taken with Investigational Prodcut(s) as a result of the Non-Serious AE
    Description

    Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1704758
    UMLS CUI [1,2]
    C1519255
    Record the end date; if fatal, record date of death.
    Description

    This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/ Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the SAE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2697886
    UMLS CUI [1,2]
    C1519255
    Did the subject withdraw from study as a result fo this AE?
    Description

    Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’. If the subject was withdrawn from the study due to an SAE, confirm that the following variables are consistent for the adverse event which resulted in withdrawal: If investigational product was permanently withdrawn due to an adverse event: ‘Primary Reason for Withdrawal’ on the Study Conclusion page is recorded as ‘Adverse Event’ If the subject was withdrawn from the study for an adverse event: ‘Withdrawal’ on the Serious Adverse Events page is recorded as ‘Yes’, ‘Action Taken with Investigational Product(s) as a Result of the SAE’ on the Non-Serious Adverse Events page is recorded as ‘Investigational Product Withdrawn’.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1710677
    UMLS CUI [1,2]
    C1519255
    Record the end time of the AE.
    Description

    End Time Serious Adverse Event

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2826658
    UMLS CUI [1,2]
    C1519255
    Is there a reasonable possibility that the SAE may have been caused by the investigational product?
    Description

    It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. ’A reasonable possibility’ is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C1519255
    Frequency
    Description

    Intermittent should be used if the subject experiences the same AE on multiple occasions over a period of time (e.g., dizziness). In these circumstances, the start date will be the start date of the first episode and the end date will be the date of resolution.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0439603
    If fatal, was a post-mortem/autopsy performed?
    Description

    If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0004398
    UMLS CUI [1,2]
    C1519255
    Serious Adverse Events - Section 2: Seriousness
    Description

    Serious Adverse Events - Section 2: Seriousness

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0439793
    A. reason(s) for considering this a SAE: results in Death
    Description

    Serious Adverse Event resulting in Death

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1705232
    B. reason(s) for considering this a SAE: is life- threatening
    Description

    Life-threatening Serious Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1517874
    UMLS CUI [1,2]
    C1519255
    C. reason(s) for considering this a SAE: requires hospitalisation or prolongation of existing hospitalisation
    Description

    Serious Adverse Event requiring hospitalisation (prolongation)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0019993
    D. reason(s) for considering this a SAE: results in disability/incapacity
    Description

    Serious adverse event resulting in disability

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0231170
    E. reason(s) for considering this a SAE: congenital anomaly/birth defect
    Description

    Serious Adverse Event: congenital anomaly/birth defect

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826727
    F. reason(s) for considering this a SAE: other
    Description

    Serious Adverse Event, other reason for seriousness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C3840932
    other reason for considering this a SAE, specify
    Description

    Serious Adverse Event, other reason for seriousness

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C3840932
    Serious Adverse Events - Section 3: Demography Data
    Description

    Serious Adverse Events - Section 3: Demography Data

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C0011298
    UMLS CUI-3
    C1519255
    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Description

    Gender

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Serious Adverse Events - Section 4: Recurrence
    Description

    Serious Adverse Events - Section 4: Recurrence

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0034897
    If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were administered?
    Description

    If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2945760
    UMLS CUI [1,2]
    C1519255
    Serious Adverse Events - Section 5: Possible Causes Of SAE Other Than Investigational Products
    Description

    Serious Adverse Events - Section 5: Possible Causes Of SAE Other Than Investigational Products

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0015127
    Possible Causes of SAE Other Than Investigational Product(s): Disease Under Study
    Description

    Cause of Serious Adverse Event: Disease under Study

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1547657
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C0008976
    UMLS CUI [1,4]
    C0012634
    Possible Causes of SAE Other Than Investigational Product(s): Medical Conditions
    Description

    Cause of Serious Adverse Event: Medical Condition

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1547657
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C0012634
    Possible Causes of SAE Other Than Investigational Product(s): Medical Conditions, specify
    Description

    Cause of Serious Adverse Event: Medical Condition

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1547657
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C0012634
    Possible Causes of SAE Other Than Investigational Product(s): Lack of Efficacy
    Description

    Cause of Serious Adverse Event: Lack of Efficacy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1547657
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C0235828
    Possible Causes of SAE Other Than Investigational Product(s): Withdrawal of investigational products
    Description

    Cause of Serious Adverse Event: Withdrawal of Investigational Products

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1547657
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C2349954
    UMLS CUI [1,4]
    C0013227
    Possible Causes of SAE Other Than Investigational Product(s): Concomitant Medication
    Description

    Cause of Serious Adverse Event: Concomitant Medications

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [1,3]
    C1547657
    Possible Causes of SAE Other Than Investigational Product(s): Concomitant Medication, Specify
    Description

    Cause of Serious Adverse Event: Concomitant Medications

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [1,3]
    C1547657
    Possible Causes of SAE Other Than Investigational Product(s): Activity related to study participation (e.g., procedures)
    Description

    Cause of Serious Adverse Event: Activity related to study participation (e.g., procedures)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1547657
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C2348568
    Other Possible Causes of SAE Other Than Investigational Product(s)
    Description

    Other Cause of Serious Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1547657
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C0205394
    Other Possible Causes of SAE Other Than Investigational Product(s), specify
    Description

    Other Cause of Serious Adverse Event

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1547657
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C0205394
    Serious Adverse Events - Section 6: Relevant medical conditions
    Description

    Serious Adverse Events - Section 6: Relevant medical conditions

    Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
    Description

    Serious Adverse Event: Medical Disorder, Allergy, Surgery

    Data type

    text

    Alias
    UMLS CUI [1]
    C0020517
    UMLS CUI [2]
    C0543467
    UMLS CUI [3]
    C0009488
    Date of Onset
    Description

    Date of Onset

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0574845
    UMLS CUI [1,2]
    C0009488
    UMLS CUI [2,1]
    C0574845
    UMLS CUI [2,2]
    C0020517
    UMLS CUI [3,1]
    C0574845
    UMLS CUI [3,2]
    C0543467
    Condition present at time of SAE?
    Description

    Present at Serious Adverse Event

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0348080
    UMLS CUI [1,3]
    C0150312
    If no, date of last occurence
    Description

    Date of last occurence

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C2745955
    Serious Adverse Events - Section 7: Other relevant risk factors
    Description

    Serious Adverse Events - Section 7: Other relevant risk factors

    Alias
    UMLS CUI-1
    C0035648
    UMLS CUI-2
    C1519255
    Other RELEVANT Risk Factors: provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
    Description

    other relvant risk factors: SAE

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0035648
    UMLS CUI [1,2]
    C1519255
    Serious Adverse Events - Section 8: Relevant concomitant medication
    Description

    Serious Adverse Events - Section 8: Relevant concomitant medication

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C2347852
    Drug name
    Description

    Include details of any concomitant medication(s) which may have contributed to the event. Trade name preferred.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2360065
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C1519255
    Dose
    Description

    Dose

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826767
    Unit
    Description

    Unit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826646
    Frequency
    Description

    Frequency

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826654
    Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826730
    UMLS CUI [1,2]
    C1519255
    Taken prior to study?
    Description

    Taken prior to study?

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826667
    UMLS CUI [1,2]
    C1519255
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2826734
    UMLS CUI [1,2]
    C1519255
    Stop Date
    Description

    Stop Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C2347852
    Ongoing medication?
    Description

    Ongoing medication?

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826666
    UMLS CUI [1,2]
    C1519255
    Reason for medication
    Description

    Reason for medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826696
    UMLS CUI [1,2]
    C1519255
    Serious Adverse Events - Section 9: Details of investigational Products
    Description

    Serious Adverse Events - Section 9: Details of investigational Products

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0304229
    Serious Adverse Event: Details of investigational Product
    Description

    Complete this section using the information in the Investigational Product page. Details of all investigational product(s) taken until the time of the SAE should be included. Provide specific details in Section 11 Narrative Remarks if the subject has taken an overdose of investigational product(s), including whether it was accidental or intentional.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1519255
    Was treatment blind broken at investigational site?
    Description

    Treatment blind broken

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C1519255
    SECTION 10: Details of RELEVANT Assessments
    Description

    SECTION 10: Details of RELEVANT Assessments

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0431080
    Details of Relevant Assessments
    Description

    Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0431080
    Serious Adverse Events - Section 11: Narrative Remarks
    Description

    Serious Adverse Events - Section 11: Narrative Remarks

    Alias
    UMLS CUI-1
    C0947611
    UMLS CUI-2
    C1519255
    Provide a brief narrative description of the SAE and details of treatment given
    Description

    Narrative Remarks

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C1519255
    Investigator's signature
    Description

    confirming that the data on the SAE pages are accurate and complete

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C1519255
    Date of Investigator signature
    Description

    Date of Investigator signature

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Investigator's Name (print)
    Description

    Investigator's Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
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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)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Serious Adverse Events - Section 1
    C1519255 (UMLS CUI-1)
    Item
    Did the subject experience a serious adverse event during the study?
    text
    C1519255 (UMLS CUI [1])
    Planned relative Time
    Code List
    Did the subject experience a serious adverse event during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Event
    Item
    Diagnosis only (if known, otherwise Sign/Symptom)
    text
    C1519255 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Start Date Serious Adverse Event
    Item
    Record the start date and time of the first occurrence of the event or signs/symptoms of the serious event, not the date and time the event became serious.
    date
    C2697888 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Start Time Serious Adverse Event
    Item
    Start time
    time
    C2697889 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases.
    text
    C0518690 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Maximum Intensity Non-Serious Adverse Event
    Code List
    Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases.
    CL Item
    Mild (1)
    (Comment:en)
    CL Item
    Moderate (2)
    (Comment:en)
    CL Item
    Severe (3)
    (Comment:en)
    CL Item
    Not applicable (X)
    (Comment:en)
    Item
    Outcome
    integer
    C1705586 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Taken Prior to Study
    Code List
    Outcome
    CL Item
    Recovered/Resolved (1)
    CL Item
    Recovering/Resolving (2)
    CL Item
    Not Recovered/Not resolved (3)
    CL Item
    Recovered/Resolved with Sequelae (4)
    CL Item
    Fatal (5)
    Item
    Action Taken with Investigational Prodcut(s) as a result of the Non-Serious AE
    text
    C1704758 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Action Taken with Investigational Prodcut(s) as a result of the Non-Serious Adverse Event
    Code List
    Action Taken with Investigational Prodcut(s) as a result of the Non-Serious 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)
    End Date serious Adverse Event
    Item
    Record the end date; if fatal, record date of death.
    date
    C2697886 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    Did the subject withdraw from study as a result fo this AE?
    text
    C1710677 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Planned relative Time
    Code List
    Did the subject withdraw from study as a result fo this AE?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    End Time Serious Adverse Event
    Item
    Record the end time of the AE.
    time
    C2826658 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    Is there a reasonable possibility that the SAE may have been caused by the investigational product?
    text
    C0304229 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Planned relative Time
    Code List
    Is there a reasonable possibility that the SAE may have been caused by the investigational product?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Frequency
    integer
    C1518404 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Frequency Non-Serious Adverse Event
    Code List
    Frequency
    CL Item
    Single Episode (1)
    CL Item
    Intermittent (2)
    Item
    If fatal, was a post-mortem/autopsy performed?
    text
    C0004398 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Planned relative Time
    Code List
    If fatal, was a post-mortem/autopsy performed?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Serious Adverse Events - Section 2: Seriousness
    C1519255 (UMLS CUI-1)
    C0439793 (UMLS CUI-2)
    Serious Adverse Event resulting in Death
    Item
    A. reason(s) for considering this a SAE: results in Death
    boolean
    C1519255 (UMLS CUI [1,1])
    C1705232 (UMLS CUI [1,2])
    Life-threatening Serious Adverse Event
    Item
    B. reason(s) for considering this a SAE: is life- threatening
    boolean
    C1517874 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Serious Adverse Event requiring hospitalisation (prolongation)
    Item
    C. reason(s) for considering this a SAE: requires hospitalisation or prolongation of existing hospitalisation
    boolean
    C1519255 (UMLS CUI [1,1])
    C0019993 (UMLS CUI [1,2])
    Serious adverse event resulting in disability
    Item
    D. reason(s) for considering this a SAE: results in disability/incapacity
    boolean
    C1519255 (UMLS CUI [1,1])
    C0231170 (UMLS CUI [1,2])
    Serious Adverse Event: congenital anomaly/birth defect
    Item
    E. reason(s) for considering this a SAE: congenital anomaly/birth defect
    boolean
    C2826727 (UMLS CUI [1])
    Serious Adverse Event, other reason for seriousness
    Item
    F. reason(s) for considering this a SAE: other
    boolean
    C1519255 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    Serious Adverse Event, other reason for seriousness
    Item
    other reason for considering this a SAE, specify
    text
    C1519255 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    Item Group
    Serious Adverse Events - Section 3: Demography Data
    C1828479 (UMLS CUI-1)
    C0011298 (UMLS CUI-2)
    C1519255 (UMLS CUI-3)
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Sex
    CL Item
    Male (Male)
    CL Item
    Female (Female)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Item Group
    Serious Adverse Events - Section 4: Recurrence
    C1519255 (UMLS CUI-1)
    C0034897 (UMLS CUI-2)
    Item
    If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were administered?
    text
    C2945760 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Recurrence of Serious Adverse Events after further Administration of Investigational Product
    Code List
    If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were administered?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Unknown at this time (Unknown at this time)
    CL Item
    Not applicable (Not applicable)
    Item Group
    Serious Adverse Events - Section 5: Possible Causes Of SAE Other Than Investigational Products
    C1519255 (UMLS CUI-1)
    C0015127 (UMLS CUI-2)
    Cause of Serious Adverse Event: Disease under Study
    Item
    Possible Causes of SAE Other Than Investigational Product(s): Disease Under Study
    boolean
    C1547657 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    C0012634 (UMLS CUI [1,4])
    Cause of Serious Adverse Event: Medical Condition
    Item
    Possible Causes of SAE Other Than Investigational Product(s): Medical Conditions
    boolean
    C1547657 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [1,3])
    Cause of Serious Adverse Event: Medical Condition
    Item
    Possible Causes of SAE Other Than Investigational Product(s): Medical Conditions, specify
    text
    C1547657 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [1,3])
    Cause of Serious Adverse Event: Lack of Efficacy
    Item
    Possible Causes of SAE Other Than Investigational Product(s): Lack of Efficacy
    boolean
    C1547657 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0235828 (UMLS CUI [1,3])
    Cause of Serious Adverse Event: Withdrawal of Investigational Products
    Item
    Possible Causes of SAE Other Than Investigational Product(s): Withdrawal of investigational products
    boolean
    C1547657 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [1,3])
    C0013227 (UMLS CUI [1,4])
    Cause of Serious Adverse Event: Concomitant Medications
    Item
    Possible Causes of SAE Other Than Investigational Product(s): Concomitant Medication
    boolean
    C2347852 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C1547657 (UMLS CUI [1,3])
    Cause of Serious Adverse Event: Concomitant Medications
    Item
    Possible Causes of SAE Other Than Investigational Product(s): Concomitant Medication, Specify
    text
    C2347852 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C1547657 (UMLS CUI [1,3])
    Cause of Serious Adverse Event: Activity related to study participation (e.g., procedures)
    Item
    Possible Causes of SAE Other Than Investigational Product(s): Activity related to study participation (e.g., procedures)
    boolean
    C1547657 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    Other Cause of Serious Adverse Event
    Item
    Other Possible Causes of SAE Other Than Investigational Product(s)
    boolean
    C1547657 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Other Cause of Serious Adverse Event
    Item
    Other Possible Causes of SAE Other Than Investigational Product(s), specify
    text
    C1547657 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Item Group
    Serious Adverse Events - Section 6: Relevant medical conditions
    Serious Adverse Event: Medical Disorder, Allergy, Surgery
    Item
    Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
    text
    C0020517 (UMLS CUI [1])
    C0543467 (UMLS CUI [2])
    C0009488 (UMLS CUI [3])
    Date of Onset
    Item
    Date of Onset
    date
    C0574845 (UMLS CUI [1,1])
    C0009488 (UMLS CUI [1,2])
    C0574845 (UMLS CUI [2,1])
    C0020517 (UMLS CUI [2,2])
    C0574845 (UMLS CUI [3,1])
    C0543467 (UMLS CUI [3,2])
    Item
    Condition present at time of SAE?
    text
    C1519255 (UMLS CUI [1,1])
    C0348080 (UMLS CUI [1,2])
    C0150312 (UMLS CUI [1,3])
    Planned relative Time
    Code List
    Condition present at time of SAE?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of last occurence
    Item
    If no, date of last occurence
    date
    C0012634 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C2745955 (UMLS CUI [1,3])
    Item Group
    Serious Adverse Events - Section 7: Other relevant risk factors
    C0035648 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    other relvant risk factors: SAE
    Item
    Other RELEVANT Risk Factors: provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
    text
    C0035648 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    Serious Adverse Events - Section 8: Relevant concomitant medication
    C1519255 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Drug name
    Item
    Drug name
    text
    C2360065 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Dose
    Item
    Dose
    float
    C1519255 (UMLS CUI [1,1])
    C2826767 (UMLS CUI [1,2])
    Unit
    Item
    Unit
    text
    C1519255 (UMLS CUI [1,1])
    C2826646 (UMLS CUI [1,2])
    Frequency
    Item
    Frequency
    text
    C1519255 (UMLS CUI [1,1])
    C2826654 (UMLS CUI [1,2])
    Route
    Item
    Route
    text
    C2826730 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    Taken prior to study?
    text
    C2826667 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Non-Serious Adverse Event
    Code List
    Taken prior to study?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Start Date
    Item
    Start Date
    date
    C2826734 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Item
    Ongoing medication?
    text
    C2826666 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Non-Serious Adverse Event
    Code List
    Ongoing medication?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Reason for medication
    Item
    Reason for medication
    text
    C2826696 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    Serious Adverse Events - Section 9: Details of investigational Products
    C1519255 (UMLS CUI-1)
    C0304229 (UMLS CUI-2)
    Item
    Serious Adverse Event: Details of investigational Product
    text
    C0304229 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Relative Time Period
    Code List
    Serious Adverse Event: Details of investigational Product
    Item
    Was treatment blind broken at investigational site?
    text
    C3897431 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Randomisation code broken
    Code List
    Was treatment blind broken at investigational site?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Not applicable (Not applicable)
    Item Group
    SECTION 10: Details of RELEVANT Assessments
    C1519255 (UMLS CUI-1)
    C0431080 (UMLS CUI-2)
    Relevant Assessments
    Item
    Details of Relevant Assessments
    text
    C1519255 (UMLS CUI [1,1])
    C0431080 (UMLS CUI [1,2])
    Item Group
    Serious Adverse Events - Section 11: Narrative Remarks
    C0947611 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Narrative Remarks
    Item
    Provide a brief narrative description of the SAE and details of treatment given
    text
    C0947611 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Investigator's signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Date of Investigator signature
    Item
    Date of Investigator signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator's Name
    Item
    Investigator's Name (print)
    text
    C2826892 (UMLS CUI [1])
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