ID

25885

Description

A 24 week double-blind, randomised, placebo-controlled, parallel-group dose-ranging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer's disease.

Keywords

Versions (1)
  1. 9/25/17 9/25/17 -
Copyright Holder

Glaxo Smith Kline

Uploaded on

September 25, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK AVA100193 Rosiglitazone in Alzheimer´s Disease - Running Logs

English

Running Logs

1 forms  
  1. StudyEvent: ODM
    1. Running Logs
Running Logs
Description

Running Logs

Alias
UMLS CUI-1
C1708728
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Centre or investigator number
Description

Centre or investigator number

Data type

integer

Alias
UMLS CUI [1]
C2826689
- Check that either 'Yes' or 'No' box at the top of the page has been completed. - Ensure that the spelling of the Drug Name(s) is correct (use of Trade Names is preferred). - Ensure that combination drugs are recorded as shown in the investigator instructions. - Check that either medication start date is completed or 'Taken Prior to Study?' is 'Yes'. -It is acceptable for start date to be missing if 'Taken Prior to Study?' is 'Yes'. -It is acceptable if 'Taken Prior to Study?' is 'Yes' and a start date is present, as long as the start date is prior to the date of the subject's initial visit. - Check that either medication stop date is completed or 'Ongoing Medication?' is 'Yes'. -It is acceptable for stop date to be missing if 'ongoing Medication?' is 'Yes'. -It is acceptable if 'Ongoing medication?' is 'Yes' and an end date is present, as long as the stop date is after the date of the subject's final visit. - Ensure that the 'Reason for Medication' is recorded on one of the following pages using the same terms: -Current Medical Conditions -Non-Serious Adverse Events -Serious Adverse Events Form
Description

Monitor Data Validation Checks Concomitant Medication

Data type

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C2347852
Were any concomitant medications taken by the subject during the study?
Description

If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Drug name (Trade name preferred)
Description

Drug name

Data type

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose
Description

Total Daily Dose

Data type

float

Alias
UMLS CUI [1]
C2348070
Units
Description

Units

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0013227
Route
Description

Route of administration

Data type

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

i.e "Headache"

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Start date
Description

Day Month Year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Stop Date
Description

Day Month Year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Ongoing Medication?
Description

Ongoing Medication

Data type

text

Alias
UMLS CUI [1]
C2826666
Non-Serious Adverse Events Subject Identifier
Description

Non-Serious Adverse Events Subject Identifier

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2348585
Did the subject experience any non-serious adverse events during the study?
Description

If Yes, record details below.

Data type

text

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Event
Description

Any untoward medical occurrence in a patient or clinical investigation subject. temporally associated with the use of a medicinal product, whether 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 efficacy), abuse or misuse.

Data type

text

Alias
UMLS CUI [1]
C1518404
Event Diagnosis Only (if known) Otherwise Sign/Symptoms
Description

e.g. Headache Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.

Data type

text

Alias
UMLS CUI [1]
C1518404
Start Date
Description

Day Month Year

Data type

date

Alias
UMLS CUI [1]
C2697888
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
End Date
Description

Day Month Year

Data type

date

Alias
UMLS CUI [1]
C2697886
Maximum Intensity
Description

Maximum Intensity

Data type

text

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
Description

Action Taken with Investigational Product

Data type

text

Alias
UMLS CUI [1]
C1704758
Did the subject withdraw from study as a result of this AE?
Description

Complete Study Conclusion page and check Adverse event as reason for withdrawal.

Data type

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Relationship to Investigational Product(s)

Data type

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
A serious adverse event is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect. Other reasons for reporting SAE may be 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. 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.
Description

Serious Adverse Events

Data type

text

Alias
UMLS CUI [1]
C1519255
The Investigator must inform GSK of serious adverse events by Fax or Telephone (Fax preferred) within 24 hours of bekomming aware of the event. (The original pages must remain in the Case Report Form)
Description

Serious Adverse Events

Data type

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event Subject Identifier
Description

Serious Adverse Event Subject Identifier

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348585
Serious Adverse Event Centre or Investigator number
Description

Serious Adverse Event Centre or Investigator number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826689
Serious Adverse Events Randomisation Number
Description

Serious Adverse Events Randomisation Number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034656
Did the subject experience a serious adverse event during the study?
Description

Serious Adverse Events

Data type

text

Alias
UMLS CUI [1]
C1519255
Event Diagnose only (if known) otherwise Sign/Symptom
Description

e.g., Anaphylaxis

Data type

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event Start date
Description

Serious Adverse Event Start date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011008
Outcome
Description

Serious Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Serious Adverse Event End date
Description

Serious Adverse Event End date

Data type

date

Alias
UMLS CUI [1,1]
C2697886
UMLS CUI [1,2]
C1519255
Serious Adverse Event Maximum Intensity
Description

Serious Adverse Event Maximum Intensity

Data type

text

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

Action Taken with Investigational Product(s) as a Result of the Non-Serious SAE

Data type

text

Alias
UMLS CUI [1]
C1704758
Did subject withdraw from study as a result of this SAE?
Description

Complete Study Condusion page and check Adverse event as reason for withdrawal.

Data type

text

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

Relationship to Investigational Product

Data type

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
If fatal, was a post-mortem/autopsy performed?
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0206277
Seriousness
Description

specify reason(s) for considering this a SAE, check all that apply

Data type

text

Alias
UMLS CUI [1]
C1710056
Seriousness,please specify other serious event
Description

Serious Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3845569
If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s} Were Administered?
Description

Recurrence of Adverse Events

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0034897
Date of birth
Description

SAE Demography

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011298
UMLS CUI [1,3]
C0421451
Gender
Description

SAE Demography

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011298
UMLS CUI [1,3]
C0079399
Weight
Description

SAE Demography

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011298
UMLS CUI [1,3]
C0005910
kg
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
Description

SAE Recurrence

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
Possible Causes of SAE Other Than lnvestigational Product(s)
Description

Check all that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0015127
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Description

SAE Causes

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0009488
Date of Onset
Description

Day Month Year

Data type

date

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C1519255
Condition present at Time of the SAE?
Description

Condition present at Time of the SAE

Data type

text

Alias
UMLS CUI [1,1]
C3827351
UMLS CUI [1,2]
C1519255
If No, Date of Last Occurrence
Description

Day Month Year

Data type

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0011008
Other RELEVANT Risk Factors (provide any family or social history (e.g, smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Description

Risk Factors

Data type

text

Alias
UMLS CUI [1]
C0035648
RELEVANT Concomitant Medications
Description

(include details of any concomitant medication(s) which may have contributed to the event)

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0015127
Drug name (Trade name preferred)
Description

e.g Zantac

Data type

text

Alias
UMLS CUI [1]
C0013227
Dose
Description

Medication Dose

Data type

float

Alias
UMLS CUI [1]
C3174092
Unit
Description

Unit

Data type

text

Relevant Concomitant Medications: Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Route
Description

Application route

Data type

text

Alias
UMLS CUI [1]
C0013153
Taken prior to study
Description

Concomitant medication

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1514463
Relevant Concomitant Medications: Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Relevant Concomitant Medications: Stop date
Description

Stop date

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Ongoing Medication?
Description

Ongoing Medication

Data type

text

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

(e.g. Gastric Ulcer)

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Details of lnvestigational Product(s)
Description

Complete this section using the information in the lnvestigational 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 whether it was accidental or intentional.

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1522508
Was randomisation code broken at investigational site?
Description

Randomisation code broken

Data type

text

Alias
UMLS CUI [1]
C3899531
Details of RELEVANT Assessments
Description

(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)

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C1522508
Narrative remarks
Description

(provide a brief narrative description of the SAE and details of treatment given)

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Investigators signature (confirming that the above data are accurate and complete)
Description

Investigators signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigators name
Description

Print

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Date of completion

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0850287
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Similar models

Running Logs

1 forms
  1. StudyEvent: ODM
    1. Running Logs
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Running Logs
C1708728 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Centre or investigator number
Item
Centre or investigator number
integer
C2826689 (UMLS CUI [1])
Monitor Data Validation Checks Concomitant Medication
Item
- Check that either 'Yes' or 'No' box at the top of the page has been completed. - Ensure that the spelling of the Drug Name(s) is correct (use of Trade Names is preferred). - Ensure that combination drugs are recorded as shown in the investigator instructions. - Check that either medication start date is completed or 'Taken Prior to Study?' is 'Yes'. -It is acceptable for start date to be missing if 'Taken Prior to Study?' is 'Yes'. -It is acceptable if 'Taken Prior to Study?' is 'Yes' and a start date is present, as long as the start date is prior to the date of the subject's initial visit. - Check that either medication stop date is completed or 'Ongoing Medication?' is 'Yes'. -It is acceptable for stop date to be missing if 'ongoing Medication?' is 'Yes'. -It is acceptable if 'Ongoing medication?' is 'Yes' and an end date is present, as long as the stop date is after the date of the subject's final visit. - Ensure that the 'Reason for Medication' is recorded on one of the following pages using the same terms: -Current Medical Conditions -Non-Serious Adverse Events -Serious Adverse Events Form
text
C1519941 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medication
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Drug name
Item
Drug name (Trade name preferred)
text
C0013227 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1])
Item
Units
text
C1519795 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Units
Code List
Units
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Route
text
C0013153 (UMLS CUI [1])
Route of administration
Code List
Route
CL Item
lntramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Medical indication for pharmaceutical agent
Item
Reason for Medication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start date of medication
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
stop date of medication
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
Ongoing Medication
Code List
Ongoing Medication?
CL Item
No (N)
CL Item
Yes (Y)
Non-Serious Adverse Events Subject Identifier
Item
Non-Serious Adverse Events Subject Identifier
integer
C1518404 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
non-serious adverse events
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
No (N)
CL Item
Yes (Y)
Non-Serious Adverse Event
Item
Non-Serious Adverse Event
text
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms
text
C1518404 (UMLS CUI [1])
ae start date
Item
Start Date
date
C2697888 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (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 with sequelae / Resolved with sequelae (4)
AE End Date
Item
End Date
date
C2697886 (UMLS CUI [1])
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
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 Non-Serious AE
text
C1704758 (UMLS CUI [1])
Action Taken with Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
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 AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
No (N)
CL Item
Yes (Y)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Relationship to Investigational Product(s)
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
No (N)
CL Item
Yes (Y)
Serious Adverse Events
Item
A serious adverse event is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect. Other reasons for reporting SAE may be 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. 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.
text
C1519255 (UMLS CUI [1])
Serious Adverse Events
Item
The Investigator must inform GSK of serious adverse events by Fax or Telephone (Fax preferred) within 24 hours of bekomming aware of the event. (The original pages must remain in the Case Report Form)
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Subject Identifier
Item
Serious Adverse Event Subject Identifier
integer
C1519255 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Serious Adverse Event Centre or Investigator number
Item
Serious Adverse Event Centre or Investigator number
integer
C1519255 (UMLS CUI [1,1])
C2826689 (UMLS CUI [1,2])
Serious Adverse Events Randomisation Number
Item
Serious Adverse Events Randomisation Number
integer
C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Item
Did the subject experience a serious adverse event during the study?
text
C1519255 (UMLS CUI [1])
Ongoing Medication
Code List
Did the subject experience a serious adverse event during the study?
CL Item
No (N)
CL Item
Yes (Y)
Serious Adverse Events
Item
Event Diagnose only (if known) otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Start date
Item
Serious Adverse Event Start date
date
C1519255 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event 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)
Serious Adverse Event End date
Item
Serious Adverse Event End date
date
C2697886 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Serious Adverse Event Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Maximum Intensity
Code List
Serious Adverse Event Maximum Intensity
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 Non-Serious SAE
text
C1704758 (UMLS CUI [1])
Action Taken with Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious 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 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 subject withdraw from study as a result of this SAE?
CL Item
No (N)
CL Item
Yes (Y)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Ongoing Medication
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
CL Item
No (N)
CL Item
Yes (Y)
Item
If fatal, was a post-mortem/autopsy performed?
text
C1519255 (UMLS CUI [1,1])
C0206277 (UMLS CUI [1,2])
Ongoing Medication
Code List
If fatal, was a post-mortem/autopsy performed?
CL Item
No (N)
CL Item
Yes (Y)
Item
Seriousness
text
C1710056 (UMLS CUI [1])
Serious Adverse Event
Code List
Seriousness
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,please specify (F)
Serious Adverse Event
Item
Seriousness,please specify other serious event
text
C1519255 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Recurrence of Adverse Events
Item
If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s} Were Administered?
text
C0877248 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
SAE Demography
Item
Date of birth
date
C1519255 (UMLS CUI [1,1])
C0011298 (UMLS CUI [1,2])
C0421451 (UMLS CUI [1,3])
Item
Gender
text
C1519255 (UMLS CUI [1,1])
C0011298 (UMLS CUI [1,2])
C0079399 (UMLS CUI [1,3])
SAE Demography
Code List
Gender
CL Item
Male (Male)
CL Item
Female (Female)
SAE Demography
Item
Weight
float
C1519255 (UMLS CUI [1,1])
C0011298 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
Item
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
integer
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
SAE Recurrence
Code List
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
CL Item
Unknown at this time (4)
Item
Possible Causes of SAE Other Than lnvestigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
SAE causes
Code List
Possible Causes of SAE Other Than lnvestigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) (record in Section 6) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication (record in Section 8) (5)
CL Item
Activity related to study participation (e.g. , procedures) (6)
CL Item
Other, specify (7)
SAE Causes
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Adverse Event Onset Date
Item
Date of Onset
date
C2985916 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Condition present at Time of the SAE?
text
C3827351 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Ongoing Medication
Code List
Condition present at Time of the SAE?
CL Item
No (N)
CL Item
Yes (Y)
Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
SAE Causes-Concomitant Medication
Item
RELEVANT Concomitant Medications
text
C2347852 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
Drug name
Item
Drug name (Trade name preferred)
text
C0013227 (UMLS CUI [1])
Medication Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Item
Unit
text
Units
Code List
Unit
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Frequency
Item
Relevant Concomitant Medications: Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item
Route
text
C0013153 (UMLS CUI [1])
Route of administration
Code List
Route
CL Item
lntramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Item
Taken prior to study
text
C2347852 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Ongoing Medication
Code List
Taken prior to study
CL Item
No (N)
CL Item
Yes (Y)
Start Date
Item
Relevant Concomitant Medications: Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Stop date
Item
Relevant Concomitant Medications: Stop date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Ongoing Medication
Code List
Ongoing Medication?
CL Item
No (N)
CL Item
Yes (Y)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
lnvestigational Product
Item
Details of lnvestigational Product(s)
text
C0304229 (UMLS CUI [1,1])
C1522508 (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 (1)
CL Item
No (2)
CL Item
Not applicable (3)
Details of RELEVANT Assessments
Item
Details of RELEVANT Assessments
text
C1519255 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Narrative remarks
Item
Narrative remarks
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Investigators signature
Item
Investigators signature (confirming that the above data are accurate and complete)
text
C2346576 (UMLS CUI [1])
Investigators name
Item
Investigators name
text
C2826892 (UMLS CUI [1])
Date of completion
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
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