ID

36223

Description

NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1) A serious adverse event is any untoward medical occurence taht, 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 dies 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 stay9 at the hospital or emergency ward fro observation and/or treatment that would not have been appropriate in the physicican's office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hopsialisation or fulfills any other serious criteria, the event is "serious". When in doubt as to whether "hospitalisation" occured or was necessary, the AE should be considered "serious". Hospitalisation for elective treatment of pre-existing condition that did not worsen from baseline is not considered an AE. d) results in disability/incapacity, or Note: the term disability means a sbustantial 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 consitute a substantial disruption. e) is a congenital anomaly/birht defect. f) other. Medical or scientific judgement should be exercised in deiding whether reporting is appropriate in other situations, such as important medical events that may not be immedaitely life-threatening or result in death or hospitalisation but may jeopardise the subejct 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 convusions that do not result in hospitalisation, or development of drug dependency or drug abuse.

Keywords

Versions (3)
  1. 9/27/17 9/27/17 -
  2. 9/27/17 9/27/17 -
  3. 4/23/19 4/23/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 23, 2019

DOI

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License

Creative Commons BY-NC-ND 3.0
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REFLECT-1 Serious Adverse Events NCT00428090

English

REFLECT-1 Serious Adverse Events NCT00428090

1 forms  
Serious Adverse Events (SAE) - Section 1
Description

Serious Adverse Events (SAE) - Section 1

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

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Event Diagnosis Only (if known) Otherwise Sign/Symptoms (e.g., Anaphylaxis) Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator. A seperate 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.
Description

Serious Adverse Event Specification

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348235
Outcome 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.
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
Maximum Intensity Record the maximum intensity that occured 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 everday activities. Moderate= An event that is sufficiently discomforting to interfere with normal everday 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)
Description

Maximum Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
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". If "Yes", complete Study Conclusion page and tick Adverse Event as reason for withdrawal. Did the subject withdraw from study as a result of this AE?
Description

Withdrawal

Data type

boolean

Alias
UMLS CUI [1]
C2349954
IF fatal, was a post-mortem/autopsy perfomed? (If "Yes", summarise findings in Section 11 Narrative Remarks on this SAE form.)
Description

Autopsy

Data type

boolean

Alias
UMLS CUI [1]
C0004398
Serious Adverse Event: Seriousness - Section 2
Description

Serious Adverse Event: Seriousness - Section 2

Alias
UMLS CUI-1
C1710056
Specify reason(s) for considering this a SAE, tick all that apply: If "Other", specify (see definition of SAE):
Description

Serious Adverse Event: Seriousness Specification

Data type

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C2348235
Serious Adverse Event: Ongoing Event - Section 4
Description

Serious Adverse Event: Ongoing Event - Section 4

Alias
UMLS CUI-1
C0580798
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 occured, did the reported adverse event recur?
Description

Ongoing event

Data type

text

Alias
UMLS CUI [1]
C0580798
Serious Adverse Event: Relevant Medical Condition - Section 6
Description

Serious Adverse Event: Relevant Medical Condition - Section 6

Alias
UMLS CUI-1
C0012634
Date of onset
Description

Date of Onset

Data type

date

Measurement units
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0574845
dd/MMM/yy
If "No", Date of Last Occurrence
Description

Date of Last Occurrence

Data type

date

Measurement units
  • dd/MMM/yy
Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0011008
dd/MMM/yy
Serious Adverse Event: RELEVANT Concomitant Medication (include details of any concomitant medication(s) which may have contributed to the event) - Section 8
Description

Serious Adverse Event: RELEVANT Concomitant Medication (include details of any concomitant medication(s) which may have contributed to the event) - Section 8

Alias
UMLS CUI-1
C2347852
Drug Name (Trade Name preferred) (e.g. Zantac)
Description

Drug Name

Data type

text

Alias
UMLS CUI [1]
C2360065
Unit (e.g. mg)
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Route (e.g. PO)
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Start Date
Description

Start Date

Data type

date

Measurement units
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0808070
dd/MMM/yy
Ongoing Medication?
Description

Ongoing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Serious Adverse Event: Assessment - Section 10
Description

Serious Adverse Event: Assessment - Section 10

Alias
UMLS CUI-1
C1516048
Details of RELEVANT Assessments (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)
Description

Assessment

Data type

text

Alias
UMLS CUI [1]
C1516048
Identification and Signature
Description

Identification and Signature

Alias
UMLS CUI-1
C0205396
UMLS CUI-2
C1519316
Date of report
Description

Date of report

Data type

date

Measurement units
  • dd/MMM/yy
Alias
UMLS CUI [1]
C1302584
dd/MMM/yy
Investigator's signature (confirming that the data on the SAE pages are accurate and complete)
Description

Investigator's Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

REFLECT-1 Serious Adverse Events NCT00428090

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Serious Adverse Events (SAE) - Section 1
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event Specification
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms (e.g., Anaphylaxis) Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator. A seperate 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.
text
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Outcome 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.
integer
C1705586 (UMLS CUI [1])
Serious Adverse Event: Seriousness
Code List
Outcome 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.
CL Item
Results in death (Results in death)
CL Item
Is life-threatening (Is life-threatening)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (Requires hospitalisation or prolongation of existing hospitalisation)
CL Item
Results in disability/incapacity (Results in disability/incapacity)
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
CL Item
Other (Other)
Item
Maximum Intensity Record the maximum intensity that occured 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 everday activities. Moderate= An event that is sufficiently discomforting to interfere with normal everday 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)
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Serious Adverse Event: Seriousness
Code List
Maximum Intensity Record the maximum intensity that occured 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 everday activities. Moderate= An event that is sufficiently discomforting to interfere with normal everday 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)
CL Item
Results in death (Results in death)
CL Item
Is life-threatening (Is life-threatening)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (Requires hospitalisation or prolongation of existing hospitalisation)
CL Item
Resutls in disablity/incapacity (Resutls in disablity/incapacity)
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
CL Item
Other (Other)
Withdrawal
Item
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". If "Yes", complete Study Conclusion page and tick Adverse Event as reason for withdrawal. Did the subject withdraw from study as a result of this AE?
boolean
C2349954 (UMLS CUI [1])
Autopsy
Item
IF fatal, was a post-mortem/autopsy perfomed? (If "Yes", summarise findings in Section 11 Narrative Remarks on this SAE form.)
boolean
C0004398 (UMLS CUI [1])
Item Group
Serious Adverse Event: Seriousness - Section 2
C1710056 (UMLS CUI-1)
Serious Adverse Event: Seriousness Specification
Item
Specify reason(s) for considering this a SAE, tick all that apply: If "Other", specify (see definition of SAE):
text
C1710056 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Serious Adverse Event: Ongoing Event - Section 4
C0580798 (UMLS CUI-1)
Item
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 occured, did the reported adverse event recur?
text
C0580798 (UMLS CUI [1])
Ongoing event
Code List
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 occured, did the reported adverse event recur?
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 Event: Relevant Medical Condition - Section 6
C0012634 (UMLS CUI-1)
Date of Onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Date of Last Occurrence
Item
If "No", Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Serious Adverse Event: RELEVANT Concomitant Medication (include details of any concomitant medication(s) which may have contributed to the event) - Section 8
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name (Trade Name preferred) (e.g. Zantac)
text
C2360065 (UMLS CUI [1])
Unit
Item
Unit (e.g. mg)
text
C1519795 (UMLS CUI [1])
Route
Item
Route (e.g. PO)
text
C0013153 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Ongoing Medication
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Item Group
Serious Adverse Event: Assessment - Section 10
C1516048 (UMLS CUI-1)
Assessment
Item
Details of RELEVANT Assessments (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
C1516048 (UMLS CUI [1])
Item Group
Identification and Signature
C0205396 (UMLS CUI-1)
C1519316 (UMLS CUI-2)
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Investigator's Signature
Item
Investigator's signature (confirming that the data on the SAE pages are accurate and complete)
text
C2346576 (UMLS CUI [1])
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