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

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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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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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