ID

34513

Descrição

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder The purpose of this form is to document any serious adverse events. A serious adverse event is defined as follows: A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death. b) is life-threatening. Note: 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. Note: 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 preexisting condition that did not worsen from baseline is not considered an AE. d) results in disability/incapacity, or Note: 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. SECTION 4: If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s)Were Administered? If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur? SECTION 9: Details of Investigational Product 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. SECTION 12: SAE Additional/Follow-up Information On receipt of follow-up information, the appropriate section(s) on the SAE form must be amended/updated with any changes (i.e., diagnosis, end date or death, change in intensity, or causality). These changes must be initialled and dated with confirmation by the investigator with his/her re-signing the form and forwarded to GSK within 24 hours. The investigator and others responsible for subject care should institute any supplementary investigations of SAEs based on their clinical judgement of the likely causative factors. This may include seeking a further opinion from a specialist in the field of the AE. GSK may also request extra tests or extra follow-up information. If a subject dies, any post-mortem/autopsy findings, including histopathology, must be provided to GSK.

Palavras-chave

Versões (2)
  1. 16/01/2019 16/01/2019 -
  2. 18/01/2019 18/01/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

18 de janeiro de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Inglês

Serious Adverse Event Notification Form

1 Formulários  
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Descrição

Centre Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Randomisation Number
Descrição

Randomisation Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
SECTION 1: Serious Adverse Event
Descrição

SECTION 1: Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Did the subject experience any serious adverse events during the study?
Descrição

If YES, record details below

Tipo de dados

text

Alias
UMLS CUI [1]
C1519255
SECTION 1: Serious Adverse Events Record
Descrição

SECTION 1: Serious Adverse Events Record

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C1828479
Serious adverse events: Diagnosis only (if known) or signs / symptoms
Descrição

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.

Tipo de dados

text

Alias
UMLS CUI [1]
C1519255
Start Date
Descrição

Day Month Year 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.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Start Time
Descrição

Hr : Min 00:00-23:59 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.

Tipo de dados

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C1519255
Outcome
Descrição

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.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
End Date
Descrição

If fatal, record date of death Record the end date. 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’. Record the end time of the SAE.

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
UMLS CUI [2]
C1148348
End Time
Descrição

Hr : Min 00:00-23:59 Record the end date. 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’. Record the end time of the SAE.

Tipo de dados

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
Maximum Intensity
Descrição

Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. 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).

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Action taken with investigational product(s) as a result of the non-serious AE
Descrição

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).

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did subject withdraw from study as a result of this serious AE?
Descrição

If yes, complete Study Conclusion page and tick Adverse event as reason for withdrawal. Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
Descrição

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.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
If fatal, was a post-mortem/autopsy performed?
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1]
C0004398
UMLS CUI [2]
C1519255
SECTION 2: Seriousness
Descrição

SECTION 2: Seriousness

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C1710056
Results in Death
Descrição

Results in Death

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011065
Is Life Threatening
Descrição

Is Life Threatening

Tipo de dados

text

Alias
UMLS CUI [1]
C1517874
Requires hospitalisation or prolongation of existing hospitalisation
Descrição

Requires hospitalisation or prolongation of existing hospitalisation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019993
UMLS CUI [2]
C0745041
Results in disability/incapacity
Descrição

Results in disability/incapacity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0231170
UMLS CUI [2]
C3176592
Congenital anomaly/birth defect
Descrição

Congenital anomaly/birth defect

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0000768
Other
Descrição

Other

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0205394
Seriousness, if other please specify
Descrição

Seriousness Specification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C2348235
SECTION 3: Demography Data
Descrição

SECTION 3: Demography Data

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C1828479
Date of birth
Descrição

Date of birth

Tipo de dados

date

Alias
UMLS CUI [1]
C0421451
Sex
Descrição

Sex

Tipo de dados

text

Alias
UMLS CUI [1]
C0079399
Weight
Descrição

Weight

Tipo de dados

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
SECTION 4: Serious Adverse Event Recurrence
Descrição

SECTION 4: Serious Adverse Event Recurrence

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0034897
UMLS CUI-3
C1828479
If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) Were Administered?
Descrição

SAE Recurrence

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
SECTION 5: Causes of SAE
Descrição

SECTION 5: Causes of SAE

Alias
UMLS CUI-1
C3828190
UMLS CUI-2
C1519255
UMLS CUI-4
C1828479
Disease under Study
Descrição

Disease under Study

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Medical Condition(s)
Descrição

Medical Condition(s)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0012634
Medical Condition(s), specify
Descrição

Medical Condition(s) Specification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Lack of Efficacy
Descrição

Lack of Efficacy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0235828
Withdrawal of investigational product(s)
Descrição

Withdrawal of investigational product(s)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
Concomitant medication(s)
Descrição

Concomitant medication(s)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant medication(s), specify
Descrição

Concomitant medication(s) Specification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348235
Activity related to study participation (e.g., procedures)
Descrição

Activity Related to Study Participation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
UMLS CUI [2]
C0199171
Other
Descrição

Other

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0205394
Other, specify
Descrição

Other Specification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
SECTION 6: Relevant Medical Conditions
Descrição

SECTION 6: Relevant Medical Conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0262926
UMLS CUI-3
C1519255
UMLS CUI-4
C1828479
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
Descrição

Relevant Medical Conditions

Tipo de dados

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C1519255
UMLS CUI [3]
C0020517
UMLS CUI [4]
C0543467
Date of onset
Descrição

Day Month Year

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1519255
Condition present at time of the SAE?
Descrição

Condition present at time of the SAE

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3827351
UMLS CUI [1,2]
C1519255
If NO, date of last occurrence
Descrição

Day Month Year

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
UMLS CUI [2]
C1519255
SECTION 7: Other Relevant Risk Factors
Descrição

SECTION 7: Other Relevant Risk Factors

Alias
UMLS CUI-1
C0035648
UMLS CUI-2
C1519255
UMLS CUI-3
C0205394
UMLS CUI-4
C1828479
Other Relevant Risk Factors
Descrição

provide any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.

Tipo de dados

text

Alias
UMLS CUI [1]
C0035648
UMLS CUI [2]
C1519255
SECTION 8: Relevant Concomitant Medications
Descrição

SECTION 8: Relevant Concomitant Medications

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C2347852
Drug, Trade name preferred
Descrição

Include any concomitant medications that may contribute to the occurrence of the SAE Trade name preferred

Tipo de dados

text

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

Dose

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Unit
Descrição

Unit

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Frequency
Descrição

Frequency

Tipo de dados

text

Alias
UMLS CUI [1]
C1519255
Route
Descrição

Route

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Taken Prior to Study?
Descrição

Taken Prior to Study

Tipo de dados

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C1519255
Start Date
Descrição

Day Month Year

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Stop date
Descrição

Day Month Year

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Ongoing Medication?
Descrição

Ongoing Medication

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3494713
UMLS CUI [2]
C1519255
Reason for Medication
Descrição

Indication

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
SECTION 9: Details of Investigational Product(s)
Descrição

SECTION 9: Details of Investigational Product(s)

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0013230
UMLS CUI-3
C1522508
Details of Investigational Product
Descrição

Details of Investigational Product

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1522508
Was treatment blind broken at investigational site?
Descrição

Treatment Blind Broken

Tipo de dados

text

Alias
UMLS CUI [1]
C3897431
SECTION 10: Details of Relevant Assessments
Descrição

SECTION 10: Details of Relevant Assessments

Alias
UMLS CUI-1
C1261322
UMLS CUI-2
C1519255
Details of Relevant Assessments
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
SECTION 11: Narrative Remarks
Descrição

SECTION 11: Narrative Remarks

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0947611
Narrative Remarks
Descrição

provide a brief narrative description of the SAE and details of treatment given

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Conclusion
Descrição

Conclusion

Alias
UMLS CUI-1
C1707478
Investigator's Signature
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Investigator's name
Descrição

print

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
Date
Descrição

Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0011008
SECTION 12: Additional/Follow-Up Information
Descrição

SECTION 12: Additional/Follow-Up Information

Alias
UMLS CUI-1
C1524062
UMLS CUI-2
C1533716
UMLS CUI-3
C1519255
UMLS CUI-4
C1522577
SAE Additional/Follow-up Information
Descrição

use this page to provide any additional details on the SAE not already captured on the previous pages

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1524062
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C1522577
Investigator's Signature
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Investigator's name
Descrição

print

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
Date
Descrição

Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Serious Adverse Event Notification Form

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
SECTION 1: Serious Adverse Event
C1519255 (UMLS CUI-1)
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
serious adverse events
Code List
Did the subject experience any serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
SECTION 1: Serious Adverse Events Record
C1519255 (UMLS CUI-1)
C1828479 (UMLS CUI-3)
Serious adverse event
Item
Serious adverse events: Diagnosis only (if known) or signs / symptoms
text
C1519255 (UMLS CUI [1])
Start Date
Item
Start Date
text
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Sex
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)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Seriousness
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action taken with investigational product(s) as a result of the non-serious AE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal
Code List
Action taken with investigational product(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)
Item
Did subject withdraw from study as a result of this serious AE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Seriousness
Code List
Did subject withdraw from study as a result of this serious AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Cause of SAE
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
Item
If fatal, was a post-mortem/autopsy performed?
text
C0004398 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Withdrawal
Code List
If fatal, was a post-mortem/autopsy performed?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
SECTION 2: Seriousness
C1828479 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Results in Death
Item
Results in Death
boolean
C0011065 (UMLS CUI [1])
Is Life Threatening
Item
Is Life Threatening
text
C1517874 (UMLS CUI [1])
Requires hospitalisation or prolongation of existing hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
C0745041 (UMLS CUI [2])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C0231170 (UMLS CUI [1])
C3176592 (UMLS CUI [2])
Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1])
Seriousness Specification
Item
Seriousness, if other please specify
text
C1710056 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
SECTION 3: Demography Data
C0011298 (UMLS CUI-1)
C1828479 (UMLS CUI-2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Seriousness
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
SECTION 4: Serious Adverse Event Recurrence
C1519255 (UMLS CUI-1)
C0034897 (UMLS CUI-2)
C1828479 (UMLS CUI-3)
Item
If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) Were Administered?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Cause of SAE
Code List
If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational 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
SECTION 5: Causes of SAE
C3828190 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1828479 (UMLS CUI-4)
Disease under Study
Item
Disease under Study
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Medical Condition(s)
Item
Medical Condition(s)
boolean
C0012634 (UMLS CUI [1])
Medical Condition(s) Specification
Item
Medical Condition(s), specify
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Lack of Efficacy
Item
Lack of Efficacy
boolean
C0235828 (UMLS CUI [1])
Withdrawal of investigational product(s)
Item
Withdrawal of investigational product(s)
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant medication(s)
Item
Concomitant medication(s)
boolean
C2347852 (UMLS CUI [1])
Concomitant medication(s) Specification
Item
Concomitant medication(s), specify
text
C2347852 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Activity Related to Study Participation
Item
Activity related to study participation (e.g., procedures)
boolean
C2348568 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0199171 (UMLS CUI [2])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1])
Other Specification
Item
Other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
SECTION 6: Relevant Medical Conditions
C0012634 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1828479 (UMLS CUI-4)
Relevant Medical Conditions
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0262926 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C0020517 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
Date of onset
Item
Date of onset
text
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Condition present at time of the SAE?
text
C3827351 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Seriousness
Code List
Condition present at time of the SAE?
CL Item
Yes (Y)
CL Item
No (N)
Date of Last Occurrence
Item
If NO, date of last occurrence
text
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
Item Group
SECTION 7: Other Relevant Risk Factors
C0035648 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C1828479 (UMLS CUI-4)
Other relevant risk factors
Item
Other Relevant Risk Factors
text
C0035648 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Item Group
SECTION 8: Relevant Concomitant Medications
C1828479 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug
Item
Drug, Trade name preferred
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Frequency
Item
Frequency
text
C1519255 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Taken Prior to Study?
text
C2347852 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Seriousness
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Ongoing Medication?
text
C2347852 (UMLS CUI [1,1])
C3494713 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Sex
Code List
Ongoing Medication?
CL Item
Male (M)
CL Item
Female (F)
Indication
Item
Reason for Medication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item Group
SECTION 9: Details of Investigational Product(s)
C1828479 (UMLS CUI-1)
C0013230 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Details of Investigational Product
Item
Details of Investigational Product
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item
Was treatment blind broken at investigational site?
text
C3897431 (UMLS CUI [1])
Treatment Blind 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
C1261322 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Details of Relevant Assessments
Item
Details of Relevant Assessments
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SECTION 11: Narrative Remarks
C1828479 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Narrative Remarks
Item
Narrative Remarks
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
SECTION 12: Additional/Follow-Up Information
C1524062 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
SAE Additional/Follow-up Information
Item
SAE Additional/Follow-up Information
text
C1524062 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,4])
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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