Argus Event Tab Screen - Katalyst HLS

ARGUSEVENT SCREEN

05/02/23Katalyst Healthcares & Life

Sciences

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CODINGStandardisation of terminology by using a dictionary (MedDRA)

GROUPINGPresentation of the available diagnostic information by appropriately grouping the terms reported

FOR A PROPER MEDICAL ASSESSMENT ANDFOR MEANINGFUL SEARCHES WE REQUIRE

Coding & Grouping:

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Katalyst Healthcares & Life Sciences

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GROUPING permits COMMON ASSESSMENT of DIAGNOSES mentioned in the REPORT RECEIVED

USE ONLY DIAGNOSES MADE BY REPORTER ONE COMMON ASSESSMENT FOR ALL SYMPTOMS RELATED TO A GIVEN DIAGNOSIS

Grouping:

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Grouping of symptoms belonging to a given diagnosis provides better structured reports

Assessment of clinical entities reported and not of each single symptom

Permits better searches Facilitates reconciliation with clinical database (all symptoms

coded)

Coding & Grouping:

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Situation 1a No diagnostic clue availableExample Breast cancer

Allergic reactionHeart racing Nose bleed

Rule Enter each term as separate event, do not create any relationships. Enter the most significant event first.

Coding & Grouping:

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Situation 1b No diagnosis is given but terms share a common pathophysiology

Example VomitingNauseaLoss of appetite

Rule Enter each term as separate event, do not create any relationships. Enter the most significant event first.

Coding & Grouping:

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Situation 2 Diagnosis plus additional symptoms commonly associated with it

Example Agranulocytosis- Fever- Sore throat- Malaise

Rule Enter agranulocytosis as diagnosis and fever, sore throat and malaise as related symptoms

Coding & Grouping:

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Situation 3 Diagnosis plus additional symptoms, not all commonly associated with it

Example Pulmonary embolism- Tachycardia- Shortness of breath- Thoracic painArthralgia

Rule Enter pulmonary embolism as diagnosis and tachycardia etc. as related symptomsEnter arthralgia as separate event

Coding & Grouping:

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Situation 4 A labelled diagnosis/symptom is reported plus symptoms rendering it unlabelled

Example Intraventricular haemorrhage Thrombocytopenia- Petechiae

Rule Enter intraventricular haemorrhage as diagnosis Enter thrombocytopenia as second diagnosis and petechiae as related symptom.

Coding & Grouping:

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Situation 5 A verbatim symptom term point to certain diagnosis.

Enter reported verbatim but encode the diagnosis

Example White blood cell count reduced (<0.5 x 109/L)

-fever

-weakness

Rule Enter verbatim term white blood cell count reduced as diagnosis

Enter description to be coded as Leukopenia

(provided by PVL/BSL)

Handle other symptoms according to previous rules.

Coding & Grouping:

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Situation 6 A leading event has consequences as well as symptoms. Example Hypotension

-Nausea

-lightheadedness

Fall (consequence; lead event)

Head injury (consequence; lead event)

Rule Consequence should be entered as separate leading events as they are not part of the expected symptom profile of the primary event.

Coding & Grouping:

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Be aware To always check MedDRA selection because of MedDRA

mapping problems to SOC level If two or more reported symptoms code to the same

MedDRA preferred term the information should be:• either merged into one verbatim term, therefore requiring only one

MedDRA code selection• or MedDRA should be thoroughly searched to

find an alternative suitable preferred term

• Example:

Coding:


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Handling surgery as an adverse event term

If surgery is reported as secondary to a clinical diagnosis the surgery will be coded as a subordinate symptom of the diagnosis

If surgery is the only mentioned clinical term then the surgery is coded as the leading symptom. No interpretation will be made as to the diagnosis leading to the surgery.

Coding:

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Temporally unassociated death

Always code unassociated fatal outcome

When arranging leading symptom order a temporally unassociated death does not have priority over reported event term as the left most symptom

For such cases check the case level outcome to ensure fatal outcome is reflected (see Analysis chapter)

Coding:

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Entering consequences (AE) of a leading adverse event as opposed to symptoms of a diagnosis

Example: A patient experiences nausea and lightheadedness due to hypotension and then falls and sustains a head injury.

Code the hypotension as a leading diagnosis and link the symptoms (nausea and lightheadedness) to the diagnosis.

The fall and head injury are not symptoms of the event but consequences.

Consequently they should be entered as separate leading symptoms as they are not part of the expected symptom profile of the primary event.

Coding:

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Entering consequences (AE) of a leading adverse event as opposed to symptoms of a diagnosis:

For clinical trials: If the causality assessment is automatically assumed to be that of

the primary event, this may lead to inappropriate INs. Unless the investigator has specifically provided a causality

assessment for the consequence of the event, the event should be regarded as a missing causality.

The MSE will provide a provisional causality assessment pending further information from the site.

Coding:

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Coding of Differential diagnosis

If there is one provisional diagnosis - code diagnosis and symptoms.

If more than one - code only the symptoms.

Coding:

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Reported Serious drop down list should be selected as appropriate for each coded term.

Where the reporter is a HCP and has reported the event as serious, select Yes.

Where the HCP has indicated that the event is non serious, select No. Where no indication has been made or the reporter is a consumer, select

unk.

Reported Serious:

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All cancers must be assigned a ‘medically significant’ seriousness criterion unless another, more appropriate criterion is valid, e.g. ‘hospitalisation’, ‘life-threatening’.

The seriousness criterion “Intervention Required” is not used by Novartis

If there is more than one serious leading symptom any unlisted/unexpected term should be the left most symptom.

For PMS: If there is more than one serious leading symptom any suspected term should be the left most symptom (has priority over not suspected).

Seriousness:

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Event Outcome:

Whilst causality and labelling must be consistent, the outcome can be different for the symptoms associated with a diagnosis.

E.g. Pneumonia (improving)Cough (improving)Wheezing (recovered)Rales (recovered)

For SRs: If no information on the outcome of the event is provided by the reporter select ‘not reported’ if the outcome of the event is reported as unknown to the reporter select ‘unknown’

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Coding events is not automatic the moment you click into another field.

Click into the description to be coded and then tab to onset for auto-encoding to run.

Caution

Soundex is not working correctly on MedDRA searching DO NOT check the Complete Search (Like, Soundex box) Use wild card searching with the % sign before (not required after a

word)

Coding Events:

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Seriousness criteria is highlighted on event tabs

F = fatalLT = Life-threateningH = HospitalizationS = all other serious criteriano letter =non-serious

Seriousness Criteria:


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Click somewhere in the empty space, right mouseclick to see

Re-arrange Delete Copy

Event Screen:


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Event Arrangement:

To rearrange highlight the term to move and click on the Up button or the Down or

Drag and drop the term you want to move


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Event Relationship:

To relate events click on the relationship button Click on Up or Down to relate events and position in the

preferred order or Drag and drop the term


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Event Assessment

Click on Assessment button. Assessment screen opens

Event verbatim is displayed in brackets

Diagnosis or symptoms are displayes with D or S

The seriousness is now also displayed

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Event Assessment:

The event assessment screen can be filtered by selecting a value from the drop down list eg BPI (datasheet)


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Event Assessment – Labeling:

SRs, Literature and PMS Reports:

To view any justification comment right mouse click on the green button

For SRs where no CDS exists no labelling assessment should be added and no Novartis comment is entered, unless a particular national data sheet has been identified as equivalent to CDS

Causality and labelling must be consistent between Diagnoses and linked symptoms

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Event Assessment – Causality:

For PMS report (report type Clinical Trial) The investigator causality is entered in ‘as reported’ Ensure that each event has a causality and if

suspected, the labelling is entered Causality and labelling must be consistent between

Diagnoses and linked symptoms

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Causality:

These fields are critical for all cases with report type ‘Clinical Trial’ since the causality assessment drives the selection for the case for expediting to the CPOs.

For Spontaneous Reports the causality is entered as reported, if it not reported this field is left blank.

The ‘As Determined’ causality field should not be populated for Spontaneous Reports. If it is populated the entered information is not retained on saving the case.

For Clinical Trial cases the investigator causality is entered in ‘As reported’. An ‘As Determined’ causality assessment is not required unless the causality is upgraded by the PVL or the case is missing investigator's causality. The ‘As Determined’ causality is not retained on saving the case unless it differs from the ‘As reported’ causality.

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Causality cont.

For Clinical Trials cases and PMS/registry cases provided without reporter causality the PVL must make an assessment of causality. ‘Unknown’ should be entered in the ‘As Reported’ causality field until the reporter causality is determined by follow-up. If the (previously missing) reporter’s causality has been received in a follow-up report, the ‘As Determined’ causality assessment must be removed.

If the ‘As Determined’ causality assessment is in any way different from that provided by the reporter the selection of a different term autogenerates the ‘Action Justification’ screen where a reason justifying the different assessment has to be provided.

For clinical trial cases where the patient has not yet received study medication, the case should be assessed as not suspected unless the investigator has specifically indicated that the event is due to the study conduct. 05/02/23


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Event Assessment:

Be aware The recalculate button should be pressed for every time a

case is updated with any information which requires re-expeditingWhy ?

So that any newly configured licences will be updated to the case and the case is distributed accordingly. This prevents missed submissions

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Thank YouThank You&&

QuestionsQuestions

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Contact:Katalyst Healthcare’s & Life SciencesSouth Plainfield, NJ, USA 07080.E-Mail: [email protected]

05/02/23


mailto:[email protected]

Argus Event Tab Screen - Katalyst HLS

Health & Medicine

Transcript of Argus Event Tab Screen - Katalyst HLS