ID

17589

Beschreibung

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) Any untoward medical occurence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, wether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of effiacy), abuse or misuse. Examples of an AE includes: - Significant or unexpected worsening or exacerbation of the condition/ indication under study. - Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. - New condition(s) detected or diagnosed after investigational product administration even though it may have been present prior to the start of the study. - Signs, symptoms, or the clinical sequelae of a suspected interaction. - Signs, symptoms, or the clinical sequelae of a suspected overdose of either investigational product or a concomitant medication (overdose per se should not be reported as an AE/SAE). Examples of an AE does NOT include a/an: - Medical or surgical procedure (e.g. endescopy, appendectomy); the condition that leads to the procedure is an AE. -Situations where an untoward medical occurence did not occur (social and/or convenience admission to a hospital). - Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at the start of the study that do not worsen. -The disease/disorder being studied, or expected progression, signs, or symptoms of the diseae/disorder being studied, unless more severe than expected for the subject's condition. For GSK clinical studies, AEs may include pre- or post-treatment events that occur as a result of protocol-mandated procedures (i.e., invasive procedures, modification of subject's previous therapeutic regimen). See protocol for clarification. If this event meets the definition of serious, complete the Serious Adverse Event Section.

Stichworte

  1. 18.09.16 18.09.16 -
  2. 25.09.16 25.09.16 -
Hochgeladen am

25. September 2016

DOI

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REFLECT-1 Non-Serious Adverse Events NCT00428090

REFLECT-1 Non-Serious Adverse Events NCT00428090

Patient Information
Beschreibung

Patient Information

Alias
UMLS CUI-1
C1955348
Subject Identifier
Beschreibung

Patient Study ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events (AE)
Beschreibung

Non-Serious Adverse Events (AE)

Alias
UMLS CUI-1
C1518404
Event Diagnosis Only (if known) Otherwise Sign/Symptoms Enter only the diagnosis (if known); otherwise enter sign or symptom. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
Beschreibung

Non-Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1518404
Event Diagnosis Only (if known) Otherwise Sign/Symptoms Enter only the diagnosis (if known); otherwise enter sign or symptom. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
Beschreibung

Non-Serious Adverse Event Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2348235
Start Date Record the start date of the first occurence of the AE. (Day Month Year) Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
Beschreibung

Start Date

Datentyp

date

Maßeinheiten
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0808070
dd/MMM/yy
Outcome All AEs must be followed until the events are resolved, the conditin 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 AE 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 AE was ongoing at the time of death, but was not the cause of death. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
End Date Record the end date. This is the date the AE Recoverd/Resolved. If the event Recovered/Resolved with sequelae, enter the date the subject's medical condition resolved or stabilised. Leave blank if the AE is "Not recovered/Not resolved" or "Recovering/Resolving". Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
Beschreibung

End Date

Datentyp

date

Maßeinheiten
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0806020
dd/MMM/yy
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) Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE 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 occured. 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). Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
Beschreibung

Action Taken with Investigational Product

Datentyp

integer

Alias
UMLS CUI [1]
C1704758
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". Did the subject withdraw from study as a result of this AE? Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
Beschreibung

Withdrawal

Datentyp

boolean

Alias
UMLS CUI [1]
C2349954
Relationship to Investigational Product(s) it is a regulatory requirement for investigators to assess relationship to investigatinal product(s) based on information available. The asessment 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 of 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, a concurrent illness, or relevant medical history, should also be considered. Is there a reasonable possibility that the AE may have been caused by the investigational product? Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
Beschreibung

Relationship to Investigational Product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248

Ähnliche Modelle

REFLECT-1 Non-Serious Adverse Events NCT00428090

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Study ID
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events (AE)
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms Enter only the diagnosis (if known); otherwise enter sign or symptom. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
text
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event Specification
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms Enter only the diagnosis (if known); otherwise enter sign or symptom. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
text
C1518404 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Start Date
Item
Start Date Record the start date of the first occurence of the AE. (Day Month Year) Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
date
C0808070 (UMLS CUI [1])
Item
Outcome All AEs must be followed until the events are resolved, the conditin 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 AE 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 AE was ongoing at the time of death, but was not the cause of death. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
integer
C1705586 (UMLS CUI [1])
Code List
Outcome All AEs must be followed until the events are resolved, the conditin 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 AE 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 AE was ongoing at the time of death, but was not the cause of death. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End Date
Item
End Date Record the end date. This is the date the AE Recoverd/Resolved. If the event Recovered/Resolved with sequelae, enter the date the subject's medical condition resolved or stabilised. Leave blank if the AE is "Not recovered/Not resolved" or "Recovering/Resolving". Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
date
C0806020 (UMLS CUI [1])
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) Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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) Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE 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 occured. 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). Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
integer
C1704758 (UMLS CUI [1])
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE 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 occured. 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). Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
CL Item
Investigational product(s) (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 (6)
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". Did the subject withdraw from study as a result of this AE? Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
boolean
C2349954 (UMLS CUI [1])
Relationship to Investigational Product
Item
Relationship to Investigational Product(s) it is a regulatory requirement for investigators to assess relationship to investigatinal product(s) based on information available. The asessment 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 of 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, a concurrent illness, or relevant medical history, should also be considered. Is there a reasonable possibility that the AE may have been caused by the investigational product? Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])

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