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ID
24290
Beschrijving
Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Serious Adverse Event (SAE)
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- 28-07-17 28-07-17 -
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GlaxoSmithKline
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28 juli 2017
DOI
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Creative Commons BY-NC-ND 3.0
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Serious Adverse Event (SAE) GSK Rosiglitazone Alzheimer's disease 100468
Serious Adverse Event (SAE) GSK Rosiglitazone Alzheimer's disease 100468
Similar models
Serious Adverse Event (SAE) GSK Rosiglitazone Alzheimer's disease 100468
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
Code List
Did the subject experience any serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Serious Adverse Events Diagnosis
Item
Event (e.g. Headache) Diagnosis Only (if known) otherwise Sign/Symptom. Record one SAE diagnosis perline, 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, initiated 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
Start Date
Item
Start Date (e.g. 25 Jan 02) Record the start date of the first occurence of the SAE.
date
Item
Outcome (e.g. 1) 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.
integer
Code List
Outcome (e.g. 1) 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.
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
End Date (e.g. 27 Jan 02) 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'. Leave blank if the SAE is 'Not Recovered/Not resolved' or 'Recovering/Resolving'.
date
Item
Maximum Intesity (e.g. 1) Record the maximum intesity that occured over the duration of the event. Amend the intesity 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 everday activities. Not applicable = those event(s) where intensity is meaningless or impossible to determine (i.e. blindness and coma)
text
Code List
Maximum Intesity (e.g. 1) Record the maximum intesity that occured over the duration of the event. Amend the intesity 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 everday activities. Not applicable = those event(s) where intensity is meaningless or impossible to determine (i.e. blindness and coma)
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 (e.g. 4) 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 occured (e.g. pre- or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).
text
Code List
Action Taken with Investigational Product(s) as a Result of the SAE (e.g. 4) 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 occured (e.g. pre- or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).
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
Withdrawal (e.g. Y) Did the subject withdrawal from study as a result of this SAE? Indicate 'YES' if the event(s) were directly responsible for the subject's withdrawal as a indicated on the Study Conclusion page, otherwise indicate 'NO'.
text
Code List
Withdrawal (e.g. Y) Did the subject withdrawal from study as a result of this SAE? Indicate 'YES' if the event(s) were directly responsible for the subject's withdrawal as a indicated on the Study Conclusion page, otherwise indicate 'NO'.
CL Item
Yes* (Y)
CL Item
No (N)
Item
Relationship to Investigational Product(s) (e.g. Y) Is there a reasonable possibility that the SAE may have been caused by the investigational product? 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.
text
Code List
Relationship to Investigational Product(s) (e.g. Y) Is there a reasonable possibility that the SAE may have been caused by the investigational product? 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.
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Yes* (Y)
CL Item
No (N)
Item
Specify reason(s) for considerint this a SAE, tick all that apply:
text
C1710056 (UMLS CUI [1])
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other (F)
Seriousness Specification
Item
Specify reason(s) for considerint this a SAE, tick all that apply: If Other, specify:
text
C1710056 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Patient Date of Birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (Male)
CL Item
Female (Female)
Body Weight
Item
Weight
float
Item Group
Investigational Product Readministration - Section 4
C0304229 (UMLS CUI-1)
C0376495 (UMLS CUI-2)
C0376495 (UMLS CUI-2)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered? If deliberate or inadvertant administration of further dose(s) of investigational product(s) to the subject occured, did the reported adverse event recur?
text
C0304229 (UMLS CUI [1,1])
C0376495 (UMLS CUI [1,2])
C0376495 (UMLS CUI [1,2])
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered? If deliberate or inadvertant 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
Cause of Serious Adverse Event - Section 5
C1519255 (UMLS CUI-1)
C0015127 (UMLS CUI-2)
C0015127 (UMLS CUI-2)
Item
Possible Cuases of SAE Other Than Investigational Product(s). Tick all that apply:
text
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
Code List
Possible Cuases of SAE Other Than Investigational Product(s). Tick all that apply:
CL Item
Diesease under study (Diesease under study)
CL Item
Medical condition(s) (record in Section 6) (Medical condition(s) (record in Section 6))
CL Item
Lack of efficacy (Lack of efficacy)
CL Item
Withdrawal of investigational product(s) (Withdrawal of investigational product(s))
CL Item
Concomitant medication (record in Section 8) (Concomitant medication (record in Section 8))
CL Item
Activity related to study participation (e.g. procedures) (Activity related to study participation (e.g. procedures))
CL Item
Other (Other)
Cause of Serious Adverse Event Specification
Item
Possible Cuases of SAE Other Than Investigational Product(s). Tick all that apply: If Other, specify:
text
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Medical Conditions
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0012634 (UMLS CUI [1])
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
Item
Condition Present at Time of the SAE?
text
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Risk Factors
Item
Other RELEVANT Risk Factors (provide any family or social history (e.g, smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
text
C0035648 (UMLS CUI [1])
Item Group
RELEVANT Concomitant Medications - Section 8 (include details of any concomitant medication(s) which may have contributed to the event)
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name (Trade Name preferred) (e.g., Zantac)
text
Dose
Item
Dose (e.g., 150)
float
Unit
Item
Unit (e.g., mg)
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency (e.g., BID)
text
C3476109 (UMLS CUI [1])
Administration Route
Item
Route (e.g., PO)
text
C0013153 (UMLS CUI [1])
CL Item
Yes (Y)
CL Item
No (N)
Concomitant Medications: Start Date
Item
Start Date (e.g., 25 Jan 02)
date
C2347852 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Concomitant Medications: Stop Date
Item
Stop Date (e.g., 27 Jan 02)
date
C2347852 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
Reason for Medication
Item
Reason for Medication (e.g., Gastric Ulcer)
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Item Group
Details of Investigational Product(s) - Section 9
C0304229 (UMLS CUI-1)
Investigational Product
Item
Details of Investigational Product(s) 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 wehter it was accidental or intentional.
text
C0304229 (UMLS CUI [1])
Item
Was randomisation code broken at investigational site?
text
C0034656 (UMLS CUI [1])
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
Assessments
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
Comment
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
text
C0947611 (UMLS CUI [1])
Date of Report
Item
Date of Report
date
C1302584 (UMLS CUI [1])
Investigator's name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])