ID

29925

Beskrivning

Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Serious Adverse Events.

Nyckelord

Versioner (1)
  1. 2018-04-27 2018-04-27 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

27 april 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123

Engelsk

Serious Adverse Events

1 Formulär  
  1. StudyEvent: ODM
    1. Serious Adverse Events
Serious Adverse Events - Section 1
Beskrivning

Serious Adverse Events - Section 1

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

If Yes, record details in the other items of this form. The Investigator must inform GSK of serious adverse events by fax (preferred) or telephone within 24 hours of becoming aware of the event. 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.

Datatyp

text

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

No medical or investigational procedure. 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.

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Record the start date of the first occurrence of the SAE.
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2697888
UMLS CUI [1,2]
C1519255
Outcome
Beskrivning

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.

Datatyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Record the end date.
Beskrivning

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’.

Datatyp

date

Alias
UMLS CUI [1,1]
C2697886
UMLS CUI [1,2]
C1519255
Record the maximum intensity that occurred over the duration of the event.
Beskrivning

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 normal 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).

Datatyp

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the SAE
Beskrivning

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 stopped temporarily 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).

Datatyp

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this SAE?
Beskrivning

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 YES, complete Study Conclusion page and pick Adverse event as reason for withdrawal. If the subject was withdrawn from the study due to an SAE, confirm that the following variables are consistent for the SAE 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 SAE page is recorded as ’Yes’ and ’Action Taken with Investigational Product(s) as a Result of the SAE’ on the SAE page is recorded as ’Investigational Product Withdrawn’.

Datatyp

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beskrivning

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.

Datatyp

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?
Beskrivning

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

Datatyp

text

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

Serious Adverse Events - Section 2: Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0439793
Results in Death
Beskrivning

A

Datatyp

boolean

Alias
UMLS CUI [1]
C1705232
Is Life-Threatening
Beskrivning

B

Datatyp

boolean

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

C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0019993
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0745041
Results in disability/incapacity
Beskrivning

D

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3176592
UMLS CUI [1,2]
C1519255
Congenital anomaly/birth defect
Beskrivning

E

Datatyp

boolean

Alias
UMLS CUI [1]
C2826727
Other Reason
Beskrivning

F

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1710066
Other Reason, specify
Beskrivning

F

Datatyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1710066
UMLS CUI [1,3]
C1521902
Serious Adverse Events - Section 3: Demography Data
Beskrivning

Serious Adverse Events - Section 3: Demography Data

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C1519255
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date of Birth
Beskrivning

Date of Birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beskrivning

Gender

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Serious Adverse Events - Section 4: Recurrence
Beskrivning

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?
Beskrivning

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

Datatyp

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
Beskrivning

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

Alias
UMLS CUI-1
C0085978
UMLS CUI-2
C1519255
UMLS CUI-3
C0304229
UMLS CUI-4
C3845511
Disease under study
Beskrivning

Disease under study

Datatyp

boolean

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

Record in Section 6

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0009488
Lack of Efficacy
Beskrivning

Lack of Efficacy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0235828
Withdrawal of investigational product(s)
Beskrivning

Withdrawal of investigational product(s)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C2349954
Concomitant Medication
Beskrivning

Record in Section 8

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0015127
Activity related to study participation (e.g., procedures)
Beskrivning

Activity related to study participation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Other possible cause
Beskrivning

Other possible cause

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
If other possible cause, specify
Beskrivning

Other possible cause

Datatyp

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C1521902
Serious Adverse Events - Section 6: Relevant medical conditions
Beskrivning

Serious Adverse Events - Section 6: 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.
Beskrivning

Relevant medical conditions

Datatyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1519255
Date of onset
Beskrivning

Date of onset

Datatyp

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C1519255
Condition present at the time of the SAE?
Beskrivning

Condition present at time of SAE

Datatyp

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, give date of last occurence.
Beskrivning

Date of last Occurrence

Datatyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1519255
Serious Adverse Events - Section 7: Other relevant risk factors
Beskrivning

Serious Adverse Events - Section 7: Other relevant risk factors

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

Other Relevant Risk Factors

Datatyp

text

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

Serious Adverse Events - Section 8: Relevant concomitant medication

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

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

Datatyp

text

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

Dose

Datatyp

float

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

Unit

Datatyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2826646
Frequency
Beskrivning

Frequency

Datatyp

text

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

Route

Datatyp

text

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

Taken Prior to study

Datatyp

text

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

Start Date

Datatyp

date

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

Stop Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2826744
UMLS CUI [1,2]
C1519255
Ongoing Medication
Beskrivning

Ongoing Medication

Datatyp

text

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C1519255
Reason for Medication
Beskrivning

Reason for Medication

Datatyp

text

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

Serious Adverse Events - Section 9: Details of investigational Products

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
Relative Time Period
Beskrivning

Relative Time Period

Datatyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0304229
Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beskrivning

Stop Date

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Start Date of Interruption
Beskrivning

Only for investigational Product period of time.

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1512900
Stop Date of Interruption
Beskrivning

Only for Investigational Product period of time.

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1512900
Was randomisation code broken at investigational site?
Beskrivning

Randomisation code broken

Datatyp

text

Alias
UMLS CUI [1]
C3899531
Serious Adverse Events - Section 10: Details of relevant assessments
Beskrivning

Serious Adverse Events - Section 10: Details of relevant assessments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0431080
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.
Beskrivning

Details of Relevant Assessments

Datatyp

text

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

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
Beskrivning

Narrative Remarks

Datatyp

text

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

Investigator's signature

Alias
UMLS CUI-1
C2346576
Confirming that the data on the SAE pages are accurate and complete
Beskrivning

Investigator's Signature

Datatyp

text

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C1519255
Date of Investigator's Signature
Beskrivning

Date of Investigator's Signature

Datatyp

date

Alias
UMLS CUI [1]
C2346576
Investigator's Name
Beskrivning

Investigator's Name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Serious Adverse Events

1 Formulär
  1. StudyEvent: ODM
    1. Serious Adverse Events
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
Non-Serious Adverse Events
Code List
Did the subject experience a serious adverse event during the study?
CL Item
Yes (Y)
CL Item
No (N)
Event, Diagnosis
Item
Diagnosis only (if known), otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Start Date
Item
Record the start date of the first occurrence of the SAE.
date
C2697888 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
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
Record the end date.
date
C2697886 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Record the maximum intensity that occurred over the duration of the event.
text
C0518690 (UMLS CUI [1,1])
C1519255 (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
Action Taken with Investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
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 the subject withdraw from study as a result of this SAE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Non-Serious Adverse Events
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 AE may have been caused by the investigational product?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Non-Serious Adverse Events
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item
If fatal, was a post-mortem/autopsy performed?
text
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Non-Serious Adverse Events
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)
Death
Item
Results in Death
boolean
C1705232 (UMLS CUI [1])
Life-Threatening SAE
Item
Is Life-Threatening
boolean
C1517874 (UMLS CUI [1])
(Prolongation of) Hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C1519255 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C3176592 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C2826727 (UMLS CUI [1])
Other Reason
Item
Other Reason
boolean
C3840932 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Other Reason
Item
Other Reason, specify
text
C3840932 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Serious Adverse Events - Section 3: Demography Data
C0011298 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
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 after further Investigational Prodcut administration
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
C0085978 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C3845511 (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
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Lack of Efficacy
Item
Lack of Efficacy
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0235828 (UMLS CUI [1,3])
Withdrawal of investigational product(s)
Item
Withdrawal of investigational product(s)
boolean
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2349954 (UMLS CUI [1,4])
Concomitant Medication
Item
Concomitant Medication
boolean
C0877248 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
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])
Other possible cause
Item
Other possible cause
boolean
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other possible cause
Item
If other possible cause, specify
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Serious Adverse Events - Section 6: Relevant medical conditions
C0012634 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
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 [1,1])
C1519255 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item
Condition present at the 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 the time of the SAE?
CL Item
Yes (Y)
CL Item
No (N)
Date of last Occurrence
Item
If condition was not present at time of SAE, give date of last occurence.
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Item Group
Serious Adverse Events - Section 7: Other relevant risk factors
C0035648 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Other Relevant Risk Factors
Item
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
C2826767 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2826646 (UMLS CUI [1,2])
Frequency
Item
Frequency
text
C2826654 (UMLS CUI [1,1])
C1519255 (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 Events
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
C2826744 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Ongoing Medication
text
C2826666 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Non-Serious Adverse Events
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
Relative Time Period
text
C0439564 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Relative Time Period
Code List
Relative Time Period
CL Item
Screening Period (Screening Period)
CL Item
Investigational Product (Investigational Product)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Start Date of Interruption
Item
Start Date of Interruption
date
C0808070 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
Stop Date of Interruption
Item
Stop Date of Interruption
date
C0806020 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
Item
Was randomisation code broken at investigational site?
text
C3899531 (UMLS CUI [1])
Randomisation code broken
Code List
Was randomisation code broken at investigational site?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
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 any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range.
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])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
Confirming that the data on the SAE pages are accurate and complete
text
C2346576 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Date of Investigator's Signature
Item
Date of Investigator's Signature
date
C2346576 (UMLS CUI [1])
Investigator's Name
Item
Investigator's Name
text
C2826892 (UMLS CUI [1])
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