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Oracle Argus 7.0.

4
Case Form: Events Tab

Foresight Training Course 120-0576

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CASE FORM: EVENTS TAB

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Module Contents
 Events Tab
o Event Sub-Tab
• Event Information
• Event Coding
• Seriousness Criteria
• Event Death Details
o Event Assessment Sub-Tab
o Product-Event Details Sub-Tab

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Events Tab
 The Events tab captures information related to the adverse
events and event-level assessments in three sub-tabs:
o Event
o Event Assessment
o Product-Event Details

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Events Tab: Event Sub-Tab
Event
Information

Event Coding

Seriousness
Criteria

Event Death
Details

Details

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Events Tab: Event Assessment Sub-Tab
Seriousness / Severity
License
/ Duration

Product Causality / Diagnosis / Data Sheet As Determined


Event Symptom Listedness

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Events Tab: Product-Event Details Sub-Tab
Most Important Latency
Diagnosis Information

Product Causality / Event Occurred


Event as a
Consequence of

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Argus Safety – Events Tab

Event Sub-Tab

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Event Sub-Tab
 The Event sub-tab consists of four main sections. A fifth section is
enabled in certain cases:
o Event Information – enter information about the event including verbatim
term, onset/outcome dates, outcome of event, and severity
o Event Coding – displays the MedDRA hierarchy of the coded event term
o Seriousness Criteria – select one or more serious criteria per event
o Event Death Details – this section is enabled only if ‘Death’ is selected in
the Seriousness Criteria section; enter information about the death
including Death Date, Cause of Death, and Autopsy Results
• If this information is entered here and not on the Patient tab, the fields in
this section will automatically populate in the Event Death Details section
under the Patient tab when the case is saved.
o Details – enter information about the event that has not been entered in
any other fields under the Event sub-tab; if a Reported Causality was
entered when the case was booked in, it will be automatically populated
in this field but it can be manually overwritten

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Argus Safety – Events Tab

Event Information

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Event Sub-Tab: Event Information
 Grouping of Adverse Events/ SAEs
o The order of the events is very important as the event on
the left-most tab will be printed first on regulatory forms
and will determine the organ system under which the case
appears in line listings and in the PSUR
o The most serious event or diagnosis should appear on the
left-most tab. If there are more than one serious events or
diagnoses, any suspected term should be on the left-most
tab (instead of not suspected terms).
o If there are more than one serious suspected leading events
or Diagnoses, any Unlisted/Unexpected term should be on
the left-most tab.

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Event Sub-Tab: Event Information
 A syndrome represents a common association of signs and
symptoms that occur together.
 A diagnosis is a means of categorizing and medically grouping
the patient‘s signs and symptoms.
 The use of appropriate categorization and grouping allows the
preservation of diagnostic content and will also provide more
meaningful analysis in summary statistics.
 Diagnosis vs. Symptoms radio button
o Tick the Diagnosis radio button to indicate that the Primary Event
is a diagnosis. The Diagnosis radio button will be toggled as the
default option.
o Tick the Symptoms radio button to indicated that an event is a
Symptom or secondary event

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Event Sub-Tab: Event Information
 Event Relationships
o Click the Relationships button to enable the Event
Relationships dialog.
• The User can associate events reported as Symptoms with a
reported diagnosis. The Event Relationships dialog should be
utilized if, and only if, the Reporter clearly stated that an event is a
Symptom of the Diagnosis or Primary Event.
• The Event Relationships dialog should not be used if the reporter
has not clearly indicated that an event is a Symptom of the
Diagnosis or Primary Event.

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Event Sub-Tab: Event Information
 Associating events reported as
Symptoms with a reported Diagnosis:
o Click the Relationships button and the
Event Relationships dialog will be
displayed.
o All events toggled as a Diagnosis will be
listed first, and all secondary events will
be listed under Unassociated Symptoms.
Under Unassociated Symptoms, highlight
the event to be associated with the
applicable event.
o Click the Up button to move the event up
to be associated with the Primary Event.
o Click the Down button to move the event
down to the Unassociated Symptoms
section.

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Event Sub-Tab: Event Information
 Diagnosis vs. Symptoms:
 Example:
o Pneumonia is the Diagnosis and Cough and Pyrexia are Symptoms.

o To group them, click on the


Relationships button
• Select the Symptom and
click on the Up button or
drag and drop the Symptom
under the Diagnosis.

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Events Sub-Tab – Event Information
Training Point – Diagnosis vs. Symptoms Printing on
Regulatory Reports
Example: An Initial case report describes a patient suffering from "Somnolence," "Sore
Throat," and "Fever”. These events would appear on a CIOMS-I form as:
1. Somnolence [SEDATION]
2. Sore Throat [SORE THROAT NOS]
3. Fever [PYREXIA]
FU is then received that the patient also had neutropenia, and had been diagnosed as
suffering from agranulocytosis (the cause of the sore throat and fever). The somnolence was
considered to be co-incidental, and unrelated to any other adverse events
 Neutropenia and agranulocytosis would be entered into the system, and a diagnosis-
event relationship would be established as follows:
These events would appear on a CIOMS I form as:
1. AGRANULOCYTOSIS
2. [AGRANULOCYTOSIS] ([SORE THROAT], [PYREXIA
NOS], [NEUTROPENIA])
3. Somnolence [SEDATION]
This immediately gives a clear clinical picture of the
case.

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Event Sub-Tab: Event Information
 Onset Date/Time, Stop Date/Time and Duration
o If full dates are entered in the Onset Date/Time and Stop Date/Time
fields, the Duration will be automatically calculated.
o If full dates are entered in the Event Onset and Product Start Date
fields, the Time Between First Dose/Primary Event in the Product
Details section under the Products tab will be automatically
calculated.
 The following fields should be entered in accordance with company
conventions: Note: If a future date is entered in the
o Term Highlighted by Reporter Onset Date/Time field, an error
o Lack of Efficacy message will display when the case is
saved and a red dot will appear,
o Progression of Disease indicating that an error has occurred.
o Adverse Drug Withdrawal Reaction
o Infection
o Nature of Event

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Event Sub-Tab: Event Information

 The causality and labeling must be consistent between


Diagnosis and linked Symptoms; however, the outcome of the
Symptoms should reflect the outcome that was reported.
 Do not leave the Outcome of Event field blank.
o ‘UNK’ should be entered when the outcome is reported as unknown.
o ’Not Reported’ should be entered when the outcome is not reported.

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Event Sub-Tab: Event Information
 Associated with Rechallenge?: This field appears only if ‘Pos’ is selected in the
Rechallenge Results field under the Products tab.

 Toggle the Yes or No radio button for each event.


o Yes: this event was associated with the positive rechallenge
o No: this event was not associated with the positive rechallenge
 If Yes is toggled, click the Add button:

 After clicking Add, the Products Associated with Rechallenge dialog containing
a list of the products in the case will appear. Select the product associated with
the positive Rechallenge and the Product Name will be populated in the
Associated with Rechallenge? field.

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Argus Safety – Events Tab

Event Coding

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Event Sub-Tab: Event Coding

 All reported adverse events occurring after the start of


company drug therapy must be entered and coded for
unsolicited reports.
 Confirm that the ‘Low level Term’ and ‘Preferred Term’ point to
the correct ‘High level Group Term’ and ‘Body System’. There
are options in the MedDRA Dictionary and the first LLT
highlighted by the coding tool may not point through the right
hierarchy to the appropriate System Organ Class.
 The ‘Preferred Term’ (PT) and the ‘Verbatim Term’ are the
terms that will print on regulatory forms.

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Event Sub-Tab: Event Coding
 Auto-encoding:
o Enter the Description as Reported and [tab] out of the field.
o The Description to be Coded field will auto-populate but it can be
manually overwritten.
o The system will attempt to code the term to the MedDRA Dictionary.
• If an exact match is found, the Event Coding section will be auto-populated
and a green check mark will be displayed.
• If an exact match is not found, the Event Coding section will NOT be
populated and a red ‘X’ will be displayed.
 Manual coding:
o If the system is unable to auto-encode a term, the User will need to
manually code the term using the MedDRA Browser.
o Click on the Encode button to display the MedDRA Dictionary and
encode a term.

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Argus Safety – Events Tab

Seriousness Criteria

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Event Sub-Tab: Seriousness Criteria
 Seriousness Criteria
o Select all applicable criteria for each event. The available options are:
• Death, Medically Significant, Hospitalized, Life-Threatening, Disability, Intervention
Required, Other and Congenital Anomaly
o If ‘Other’ is selected, the corresponding free-text field will be enabled.
o If ‘Hospitalized’ is selected, the Hospitalization Details dialog box will be displayed. The
User can enter additional hospitalization details such as Hospitalization Start Date,
Hospitalization End Date, and Duration of Hospitalization.
o If ‘Death’ is selected, the Event Death Details section will be displayed.
• When booking in a case, either a Seriousness Criteria, “Case is non-serious”, or “Unable to
Determine” must be checked. However, for events added after Bookin, if no Seriousness
Criteria are selected, the event is considered Non-Serious.
o The system will flag each serious event based upon the Seriousness Criteria selected
for the event. In the individual event sub-tabs, the following will be displayed:
• “S” is displayed in a yellow triangle to indicate that at least one Seriousness Criterion was
selected for the event:
• F (yellow) = Death
• LT (green) = Life-threatening
• H (blue) = Hospitalized
• A combination of all flags will be displayed if multiple Seriousness Criteria are selected for
an individual event:

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Argus Safety – Events Tab

Event Death Details

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Event Sub-Tab: Event Death Details

 The Event Death Details section will appear in the Events tab only
when ‘Death’ is selected as a Seriousness Criterion for a serious
event (i.e., the Event Death Details section on the Events tab will
not be available for entry if a reported AE is not fatal).
 If a reported AE has a Seriousness Criteria of ‘Death’, any values
entered in the Event Death Details section in the Patient tab will be
copied into the Event Death Details section in the Events tab and
vice versa.

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Event Sub-Tab: Event Death Details
 The Event Death Details section contains the following fields:
o Death Date – Enter the date of death
o Autopsy Done? – Select whether an autopsy was performed
o Autopsy Results Available? – This field is enabled only if the Autopsy
Done? field is set to Yes. Select whether autopsy results were
provided.
o Term Type:
• The Term Type field will be disabled if the Autopsy Results Available?
field is set to No; however, the User can always enter a Cause of Death.
• ‘Autopsy Results’ can be selected only if the Autopsy Results Available?
field is set to Yes.
o Verbatim/Description as Reported – Enter the verbatim Cause of
Death or Autopsy Results and [tab] out of the field.

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Argus Safety – Events Tab

Event Assessment
Sub-Tab

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Event Assessment Sub-Tab

 This tab allows the User to assess the causality and listedness
of each event in the case for each company suspect product.
o Uncoded products and events will not be displayed.
 The User can filter on specific Products, Events, or Data Sheets
using the drop-down menus.

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Event Assessment Sub-Tab

 Causality
o As Partner Causality – select causality as per Partner
o As Reported Causality – select causality as per Reporter
o As Determined Causality – select causality as per Company
 D/S – Displays the Diagnosis/Symptom details as D or S for each event.
 Data Sheet – displays the company datasheets configured in the system
(e.g., US IB, PI, etc.)
 License – displays a list of licenses configured in the system for the suspect
product
 As Determined Listedness – automatically calculated based on the
configured datasheets/licenses but this value can be manually overwritten

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Event Assessment Sub-Tab
Training Point – As Determined Listedness
The As Determined Listedness value can be manually
overwritten.
• Select the new value from the drop-down
menu:

• The Listedness Justification dialog will be


displayed, prompting the User to select/
enter the reason for the change.
• Enter/Select the reason for the change and
click OK.
• The new value will be populated in red text.
• Click the green dot to open the Listedness
Justification dialog.

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Event Assessment Sub-Tab

 The Recalculate button enables the User to restore the system-calculated


As Determined Listedness value.
o Select Recalculate in the drop-down menu in the As Determined Listedness
field(s) of the datasheet(s) or license(s) to be recalculated.
o Click the Recalculate button and the system will
Recalculate the listedness value.

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Event Assessment Sub-Tab
Training Point – Recalculate Button

 Clicking on the Recalculate button creates records for


event assessment only if the following conditions are met:
o At least one company suspected drug (coded) exists
o At least one event is encoded
 Save the case and click the Recalculate button again if no
event assessment records are generated despite meeting
both of the pre-requisites listed above.

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Argus Safety – Events Tab

Product-Event Details
Sub-Tab

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Product-Event Details Sub-Tab

 All Suspect Company Product / Event combinations will


appear in this screen, but only Suspect Company Drugs (no
Vaccines or Devices) will be automatically calculated for Time
to Onset (TTO). Differences between this tab and the Events
and Products tabs are:

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Product-Event Details Sub-Tab
 On the Product-Event Details tab:
o Onset from First Dose is calculated based on the earliest dosage regimen Start Date for
that individual product.
o Onset from Last Dose is calculated based on the latest dosage regimen Stop Date for
that individual product.
o Total Dosage is calculated based on the Daily Dosage and Duration for that individual
product.
o Action Taken, Dechallenge Result, and Rechallenge Result are selected for each
product/event combination.
 On the Events tab:
o Onset from First Dose is calculated based on the earliest Start Date of all suspect drugs.
o Onset from Last Dose is calculated based on the latest Stop Date of all suspect drugs.
 On the Products tab:
o Total Dosage field is calculated based on each individual product.
o Action Taken, Dechallenge Result, and Rechallenge Result are calculated for each
individual product.

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Product-Event Details Sub-Tab

 The Event Occurred as Consequence of and Term fields enable the User to
enter information about the circumstances that triggered the adverse
event.
o Event Occurred as a Consequence of: If a value is selected in this field, the
Term field cannot be left blank.
• For each Event Occurred as a Consequence of selected, at least one Term must be
selected.
o Term: This field is enabled only if a value is selected in the Event Occurred as
a Consequence of field.
• Multiples Terms can be selected for each Consequence.

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Questions

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