ID
34366
Description
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.
Keywords
Versions (2)
- 1/16/19 1/16/19 -
- 1/18/19 1/18/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 16, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434
Serious Adverse Event Notification Form
- StudyEvent: ODM
Description
SECTION 1: Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Description
SECTION 1: Serious Adverse Events Record
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C1828479
Description
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]
- C1519255
Description
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Description
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.
Data type
time
Alias
- UMLS CUI [1]
- C1301880
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
Description
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.
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2]
- C1148348
Description
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.
Data type
time
Alias
- UMLS CUI [1]
- C1522314
Description
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).
Data type
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
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
Description
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’.
Data type
text
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
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
Description
SECTION 2: Seriousness
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C1710056
Description
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form
Data type
text
Alias
- UMLS CUI [1]
- C0004398
- UMLS CUI [2]
- C1519255
Description
Seriousness
Data type
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
Description
Seriousness Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C2348235
Description
SECTION 3: Demography Data
Alias
- UMLS CUI-1
- C0011298
- UMLS CUI-2
- C1828479
Description
SECTION 4: Serious Adverse Event Recurrence
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0034897
- UMLS CUI-3
- C1828479
Description
SECTION 5: Causes of SAE
Alias
- UMLS CUI-1
- C3828190
- UMLS CUI-2
- C1519255
- UMLS CUI-4
- C1828479
Description
Disease under Study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Description
Medical Condition(s)
Data type
boolean
Alias
- UMLS CUI [1]
- C0012634
Description
Medical Condition(s) Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
Lack of Efficacy
Data type
boolean
Alias
- UMLS CUI [1]
- C0235828
Description
Withdrawal of investigational product(s)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Description
Concomitant medication(s)
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Concomitant medication(s) Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348235
Description
Activity Related to Study Participation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2]
- C0199171
Description
Other
Data type
boolean
Alias
- UMLS CUI [1]
- C0205394
Description
Other Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Description
SECTION 6: Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C1519255
- UMLS CUI-5
- C1828479
Description
Relevant Medical Conditions
Data type
text
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2]
- C1519255
- UMLS CUI [3]
- C0020517
- UMLS CUI [4]
- C0543467
Description
Day Month Year
Data type
text
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Description
Condition present at time of the SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C1519255
Description
Day Month Year
Data type
text
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [2]
- C1519255
Description
SECTION 7: Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C0205394
- UMLS CUI-4
- C1828479
Description
SECTION 8: Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C2347852
Description
Include any concomitant medications that may contribute to the occurrence of the SAE Trade name preferred
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [2]
- C1519255
Description
Dose
Data type
text
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C1519255
Description
Unit
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C1519255
Description
Frequency
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
Route
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C1519255
Description
Taken Prior to Study
Data type
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C1519255
Description
Day Month Year
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C1519255
Description
Day Month Year
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C1519255
Description
Ongoing Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3494713
- UMLS CUI [2]
- C1519255
Description
Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C1519255
Description
SECTION 9: Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0013230
- UMLS CUI-3
- C1522508
Description
Details of Investigational Product
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1522508
Description
Treatment Blind Broken
Data type
text
Alias
- UMLS CUI [1]
- C3897431
Description
SECTION 10: Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1261322
- UMLS CUI-2
- C1519255
Description
SECTION 11: Narrative Remarks
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0947611
Description
Conclusion
Alias
- UMLS CUI-1
- C1707478
Description
SECTION 12: Additional/Follow-Up Information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Description
use this page to provide any additional details on the SAE not already captured on the previous pages
Data type
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1522577
Description
confirming that the data on the SAE pages are accurate and complete
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
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- StudyEvent: ODM
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C2360065 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
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C1519255 (UMLS CUI [2])
C3494713 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C0013230 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0304229 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C1519255 (UMLS CUI-2)
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C1519255 (UMLS CUI [1,2])
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