ID

29795

Beschreibung

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Serious Adverse Events.

Link

https://clinicaltrials.gov/ct2/show/NCT00086593

Stichworte

Versionen (1)
  1. 19.04.18 19.04.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

19. April 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

Englisch

Serious Adverse Events

1 Formulare  
  1. StudyEvent: ODM
    1. Serious Adverse Events
Serious Adverse Events
Beschreibung

Serious Adverse Events

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

If YES, fill out the other itemgroups of this form. Use a separate set of SAE pages for each SAE, except if they are temporally and/or clinically related (can be reported on the same page). Inform GSK within 24 hours via telephone or fax. On receipt of follow-up information (e.g., diagnosis, dates of resolution, changes in intensity or causality) the appropriate SAE pages must be amended/updated. These changes must be initialed and dated by the investigator. A copy of the full set of SAE pages must always be faxed or mailed to GlaxoSmithKline within 24 hours of the investigator becoming aware of the new information. A serious adverse event is any untoward medical occurrence that, at any dose:1 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 hospitalization or prolongation of existing hospitalization: In general, hospitalization 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 outpatient setting. Complications that occur during hospitalization are AEs. If a complication prolongs hospitalization or fulfills any other serious criteria, the event is serious. When in doubt as to whether “hospitalization” occurred or was necessary, the AE should be considered serious. Hospitalization 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, diarrhea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e) 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 hospitalization but may jeopardize 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 hospitalization, or development of drug dependency or drug abuse.

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Events - Section 1: Demography
Beschreibung

Serious Adverse Events - Section 1: Demography

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C1519255
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

text

Alias
UMLS CUI [1]
C0034510
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Serious Adverse Events - Section 2
Beschreibung

Serious Adverse Events - Section 2

Alias
UMLS CUI-1
C1519255
Diagnosis only (if known) or signs/symptoms (list one per line).
Beschreibung

Enter only the diagnosis (if known); otherwise each sign and symptom should be entered on a separate line. If a diagnosis subsequently becomes available, then this should be entered and the signs and symptoms crossed out.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1457887
Record the date of onset of the first occurrence of the SAE.
Beschreibung

Date of onset

Datentyp

date

Alias
UMLS CUI [1]
C2985916
Record the maximum intensity that occurred over the duration of the event.
Beschreibung

Amend the intensity if it increases.

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Outcome
Beschreibung

All SAEs must be followed until the events are resolved, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was "Resolved", "Resolved with sequelae", or was "Fatal". 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 resolved". Also enter "Not resolved" if the SAE was ongoing at the time of death, but was not the cause of death.

Datentyp

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Record the date of resolution or the date of death.
Beschreibung

If the event resolved with sequelae, enter the date the subject’s medical condition stabilized. Leave blank if the AE is "Not resolved".

Datentyp

date

Alias
UMLS CUI [1]
C2985918
UMLS CUI [2]
C1148348
Action Taken with Investigational Product(s) as a result of the Serious Adverse Event
Beschreibung

Indicate only for the specific event(s) that were directly responsible for the action taken with investigational product(s): None = Investigational product(s) continue(s) even though an adverse event has occurred. Dose adjusted = Dose is increased or decreased for one or more investigational product(s). Temporarily interrupted = Administration of one or more investigational product(s) was stopped temporarily but then restarted. Permanently discontinued = Administration of one or more investigational product(s) was stopped permanently and not restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre- or postdosing).

Datentyp

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this SAE?
Beschreibung

Indicate only the event(s) directly responsible for the subject’s withdrawal as indicated on the End of Study Record form.

Datentyp

text

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

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/arguments that may support "A reasonable possibility" include, for example, a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concomitant illness, or relevant medical history, should also be considered.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Does the AE meet the definition of serious?
Beschreibung

If NO, fill out the non-serious adverse event form instead.

Datentyp

text

Alias
UMLS CUI [1]
C1710056
Serious Adverse Events - Section 3: Possible Causes of SAE other than Investigational Product(s)
Beschreibung

Serious Adverse Events - Section 3: Possible Causes of SAE other than Investigational Product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0015127
Disease under study
Beschreibung

Disease under study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Treatment failure
Beschreibung

Treatment failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0162643
Withdrawal of investigational product(s)
Beschreibung

Withdrawal of investigational product(s)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
Concomitant disorder
Beschreibung

Concomitant disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
Concomitant disorder, specify
Beschreibung

Concomitant disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1521902
Concomitant Medication
Beschreibung

Concomitant Medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant Medication, specify:
Beschreibung

Concomitant Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1521902
Activity related to study participation (e.g. procedures)
Beschreibung

Activity related to study participation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0199171
Activity related to study participation (e.g. procedures), specify:
Beschreibung

Activity related to study participation

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0199171
UMLS CUI [1,3]
C1521902
Other possible cause
Beschreibung

Other possible cause

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1519255
Other possible cause, specify:
Beschreibung

Other possible cause

Datentyp

text

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C1521902
Serious Adverse Events - Section 4: Seriousness
Beschreibung

Serious Adverse Events - Section 4: Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0439793
Death
Beschreibung

a

Datentyp

boolean

Alias
UMLS CUI [1]
C1705232
If fatal, was an autopsy done/to be performed?
Beschreibung

If yes, send autopsy report when available.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705232
UMLS CUI [1,2]
C0004398
Life threatening
Beschreibung

b

Datentyp

boolean

Alias
UMLS CUI [1]
C1517874
Hospitalization required or prolonged
Beschreibung

c

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348993
UMLS CUI [1,2]
C1519255
Disabling or incapacitating
Beschreibung

d

Datentyp

boolean

Alias
UMLS CUI [1]
C3830477
Congenital anomaly
Beschreibung

e

Datentyp

boolean

Alias
UMLS CUI [1]
C2826727
Other
Beschreibung

f See definition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1710056
Other, specify
Beschreibung

Other

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1710056
UMLS CUI [1,3]
C1521902
Serious Adverse Events - Section 5: Relevant Medical Conditions
Beschreibung

Serious Adverse Events - Section 5: Relevant Medical Conditions

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

Medical Conditions explaining SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1519255
Date of Onset
Beschreibung

Date of Onset

Datentyp

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0009488
Condition present at time of the SAE
Beschreibung

Condition present at time of the SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C1519255
If condition was not present at time of SAE, date of last occurence:
Beschreibung

Date of last occurence

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C0009488
Serious Adverse Events - Section 6: Other Relevant Risk Factors
Beschreibung

Serious Adverse Events - Section 6: Other Relevant Risk Factors

Alias
UMLS CUI-1
C0035648
UMLS CUI-2
C1519255
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
Beschreibung

Risk factors for SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
Serious Adverse Events - Section 7: Details of investigational Products
Beschreibung

Serious Adverse Events - Section 7: Details of investigational Products

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
Attach a copy of the INVESTIGATIONAL PRODUCT case report form when submitting this report to GSK.
Beschreibung

Investigational Product CRF

Datentyp

text

Serious Adverse Events - Section 8: Relevant concomitant medication
Beschreibung

Serious Adverse Events - Section 8: Relevant concomitant medication

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
Drug Name
Beschreibung

Trade name preferred.

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Dose
Beschreibung

Dose

Datentyp

float

Alias
UMLS CUI [1]
C2826811
Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1]
C2826646
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C2826654
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C2826730
Date Started
Beschreibung

Date Started

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Pre-Study Start
Beschreibung

Pre-Study Start

Datentyp

boolean

Alias
UMLS CUI [1]
C2981448
Date stopped
Beschreibung

Date stopped

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Ongoing post-SAE
Beschreibung

Ongoing post-SAE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C1519255
Conditions treated
Beschreibung

Conditions treated

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Serious Adverse Events - Section 9: Narrative/Comments
Beschreibung

Serious Adverse Events - Section 9: Narrative/Comments

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C1519255
Provide a textual description of the serious adverse event (including treatment of the event).
Beschreibung

Provide a textual description of the SAE. This should include but not be limited to the following: Any previous occurrences of this type of event Any relevant non-serious adverse events that occurred prior to the SAE The full clinical presentation and sequelae/evolution of the SAE Any associated signs and symptoms of the SAE Explain any possible causes of the SAE Treatment for the SAE (including any specific medications administered or non-drug treatment) Any other action taken for the management of the SAE or the subject Duration and outcome of the SAE If the SAE is associated with an overdose of investigational product(s), details of the amount of overdose and whether it was intentional or accidental.

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Serious Adverse Events - Section 10: Details of relevant assessments
Beschreibung

Serious Adverse Events - Section 10: Details of relevant assessments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0431080
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.
Beschreibung

Provide details of any other assessments or supplementary investigations/examinations that were conducted as part of the subject’s care and/or based on clinical judgment of the likely causative factors of the SAE. This may include, but not be limited to: Laboratory data. Always provide the reference range and baseline values (fax or mail pages if extensive supporting data) Findings of ECGs, X-rays, etc. Results of other diagnostic tests or assays Key findings from hospital discharge or pathology reports

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0431080
Serious Adverse Events - Section 11: Reporting Investigator
Beschreibung

Serious Adverse Events - Section 11: Reporting Investigator

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0008961
UMLS CUI-3
C1533716
Name (print)
Beschreibung

Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Address
Beschreibung

Address

Datentyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0008961
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Beschreibung

The reporting investigator (not the study nurse or study monitor) must sign and date the SAE page.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Serious Adverse Events: Additional or follow-up Information
Beschreibung

Serious Adverse Events: Additional or follow-up Information

Alias
UMLS CUI-1
C1524062
UMLS CUI-2
C1533716
UMLS CUI-3
C1519255
UMLS CUI-4
C1522577
Use this page to provide any additional details on the serious adverse event not already captured on the previous pages. The appropriate section(s) (1-11) of SAE CRF must be amended/updated with any changes and re-faxed/mailed.
Beschreibung

Use this page to provide any additional details or follow-up information on the SAE not already recorded on the previous pages. On receipt of follow-up information, the appropriate section(s) [1 to 11] must be amended/updated with any changes (i.e., diagnosis, date of resolution of death, change in intensity, or causality). These changes must be initialed and dated with confirmation by the investigator with his/her resigning the forms and forwarding to GCSP within 24 hours. The investigator and others responsible for subject care should institute any supplementary investigations of SAEs based on their clinical judgment of the likely causative factors. This may include seeking a further opinion from a specialist in the field of the adverse event. GlaxoSmithKline may also request extra tests or extra follow-up information. If a subject dies, any postmortem findings, including histopathology, must be provided to GlaxoSmithKline.

Datentyp

text

Alias
UMLS CUI [1,1]
C1524062
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C1519255
UMLS CUI [2,1]
C1522577
UMLS CUI [2,2]
C1519255
Reporting Investigator Name
Beschreibung

Reporting Investigator Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Reporting Investigator Address
Beschreibung

Reporting Investigator Address

Datentyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0008961
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Beschreibung

The reporting investigator (not the study nurse or study monitor) must sign and date any additional or follow-up information relating to the SAE.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of Signature
Beschreibung

Date of Signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Serious Adverse Events

1 Formulare
  1. StudyEvent: ODM
    1. Serious Adverse Events
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
Non-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
Serious Adverse Events - Section 1: Demography
C0011298 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (White)
CL Item
Asian (Asian)
CL Item
Black (Black)
CL Item
American Hispanic (American Hispanic)
CL Item
Other (Other)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Item Group
Serious Adverse Events - Section 2
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Diagnosis only (if known) or signs/symptoms (list one per line).
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
Date of onset
Item
Record the date of onset of the first occurrence of the SAE.
date
C2985916 (UMLS CUI [1])
Item
Record the maximum intensity that occurred over the duration of the event.
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Maximum Intensity
Code List
Record the maximum intensity that occurred over the duration of the event.
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Resolved (R)
CL Item
Resolved with Sequelae (S)
CL Item
Not Resolved (N)
CL Item
Fatal (F)
Date of Resolution or death
Item
Record the date of resolution or the date of death.
date
C2985918 (UMLS CUI [1])
C1148348 (UMLS CUI [2])
Item
Action Taken with Investigational Product(s) as a result of the Serious Adverse Event
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a result of the Non-Serious Adverse Event
Code List
Action Taken with Investigational Product(s) as a result of the Serious Adverse Event
CL Item
None (0)
CL Item
Dose adjusted (1)
CL Item
Temporarily interrupted (2)
CL Item
Permantently discontinued (3)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this SAE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal
Code List
Did the subject withdraw from study as a result of this SAE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
text
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Non-Serious Adverse Events
Code List
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the AE meet the definition of serious?
text
C1710056 (UMLS CUI [1])
Non-Serious Adverse Events
Code List
Does the AE meet the definition of serious?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Serious Adverse Events - Section 3: Possible Causes of SAE other than Investigational Product(s)
C1519255 (UMLS CUI-1)
C0015127 (UMLS CUI-2)
Disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Treatment failure
Item
Treatment failure
boolean
C0162643 (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 disorder
Item
Concomitant disorder
boolean
C0009488 (UMLS CUI [1])
Concomitant disorder
Item
Concomitant disorder, specify
text
C0009488 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Concomitant Medication
Item
Concomitant Medication
boolean
C2347852 (UMLS CUI [1])
Concomitant Medication
Item
Concomitant Medication, specify:
text
C2347852 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Activity related to study participation
Item
Activity related to study participation (e.g. procedures)
boolean
C2348568 (UMLS CUI [1,1])
C0199171 (UMLS CUI [1,2])
Activity related to study participation
Item
Activity related to study participation (e.g. procedures), specify:
text
C2348568 (UMLS CUI [1,1])
C0199171 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Other possible cause
Item
Other possible cause
boolean
C0015127 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other possible cause
Item
Other possible cause, specify:
text
C0015127 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Serious Adverse Events - Section 4: Seriousness
C1519255 (UMLS CUI-1)
C0439793 (UMLS CUI-2)
Death
Item
Death
boolean
C1705232 (UMLS CUI [1])
Autopsy
Item
If fatal, was an autopsy done/to be performed?
boolean
C1705232 (UMLS CUI [1,1])
C0004398 (UMLS CUI [1,2])
Life threatening
Item
Life threatening
boolean
C1517874 (UMLS CUI [1])
Hospitalization required or prolonged
Item
Hospitalization required or prolonged
boolean
C2348993 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Disabling or incapacitating
Item
Disabling or incapacitating
boolean
C3830477 (UMLS CUI [1])
Congenital anomaly
Item
Congenital anomaly
boolean
C2826727 (UMLS CUI [1])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Other
Item
Other, specify
text
C0205394 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Serious Adverse Events - Section 5: Relevant Medical Conditions
C0012634 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Medical Conditions explaining SAE
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Item
Condition present at time of the SAE
text
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Non-Serious Adverse Events
Code List
Condition present at time of the SAE
CL Item
Yes (Y)
CL Item
No (N)
Date of last occurence
Item
If condition was not present at time of SAE, date of last occurence:
date
C0011008 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Item Group
Serious Adverse Events - Section 6: Other Relevant Risk Factors
C0035648 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Risk factors for SAE
Item
Specify any family history or any 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 7: Details of investigational Products
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Investigational Product CRF
Item
Attach a copy of the INVESTIGATIONAL PRODUCT case report form when submitting this report to GSK.
text
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])
Dose
Item
Dose
float
C2826811 (UMLS CUI [1])
Unit
Item
Unit
text
C2826646 (UMLS CUI [1])
Frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Route
Item
Route
text
C2826730 (UMLS CUI [1])
Date Started
Item
Date Started
date
C2826734 (UMLS CUI [1])
Pre-Study Start
Item
Pre-Study Start
boolean
C2981448 (UMLS CUI [1])
Date stopped
Item
Date stopped
date
C2826744 (UMLS CUI [1])
Ongoing post-SAE
Item
Ongoing post-SAE
boolean
C2826666 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Conditions treated
Item
Conditions treated
text
C2826696 (UMLS CUI [1])
Item Group
Serious Adverse Events - Section 9: Narrative/Comments
C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Description of the Serious Adverse Event
Item
Provide a textual description of the serious adverse event (including treatment of the event).
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious Adverse Events - Section 10: Details of relevant assessments
C1519255 (UMLS CUI-1)
C0431080 (UMLS CUI-2)
Details of relevant assessments
Item
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.
text
C1519255 (UMLS CUI [1,1])
C0431080 (UMLS CUI [1,2])
Item Group
Serious Adverse Events - Section 11: Reporting Investigator
C1519255 (UMLS CUI-1)
C0008961 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
Name
Item
Name (print)
text
C2826892 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Signature
Item
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Serious Adverse Events: Additional or follow-up Information
C1524062 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
Additional or follow-up information
Item
Use this page to provide any additional details on the serious adverse event not already captured on the previous pages. The appropriate section(s) (1-11) of SAE CRF must be amended/updated with any changes and re-faxed/mailed.
text
C1524062 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Reporting Investigator Name
Item
Reporting Investigator Name
text
C2826892 (UMLS CUI [1])
Reporting Investigator Address
Item
Reporting Investigator Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Reporting Investigator Signature
Item
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
text
C2346576 (UMLS CUI [1])
Date of Signature
Item
Date of Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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