Argus Event Tab Screen - Katalyst HLS

ARGUS
EVENT SCREEN
01/29/17
Katalyst Healthcares & Life Sciences
1

 CODING
Standardisation of terminology by using a dictionary (MedDRA)
 GROUPING
Presentation of the available diagnostic information by
appropriately grouping the terms reported
FOR A PROPER MEDICAL ASSESSMENT AND
FOR MEANINGFUL SEARCHES WE REQUIRE
Coding & Grouping:
01/29/17Katalyst 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:
3

 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:
4

Situation 1a No diagnostic clue available
Example Breast cancer
Allergic reaction
Heart racing
Nose bleed
Rule Enter each term as separate event, do not
create any relationships.
Enter the most significant event first.
Coding & Grouping:
5

Situation 1b No diagnosis is given but terms share a
common pathophysiology
Example Vomiting
Nausea
Loss of appetite
Rule Enter each term as separate event, do not
create any relationships.
Enter the most significant event first.
Coding & Grouping:
6

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:
7

Situation 3 Diagnosis plus additional symptoms, not all
commonly associated with it
Example Pulmonary embolism
- Tachycardia
- Shortness of breath
- Thoracic pain
Arthralgia
Rule Enter pulmonary embolism as diagnosis and
tachycardia etc. as related symptoms
Enter arthralgia as separate event
Coding & Grouping:
8

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:
9

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:
10

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:
12

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:
13

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:
14

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:
15

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:
16

Coding of Differential diagnosis
 If there is one provisional diagnosis - code diagnosis and
symptoms.
 If more than one - code only the symptoms.
Coding:
17

 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:
18

 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:
19

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’
20

 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:
21

 Seriousness criteria is highlighted on event tabs
F = fatal
LT = Life-threatening
H = Hospitalization
S = all other serious criteria
no letter = non-serious
Seriousness Criteria:
22

 Click somewhere in the empty space, right
mouseclick to see
Re-arrange
Delete
Copy
Event Screen:
23

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
24

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
25

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
26

Event Assessment:
 The event assessment screen can be
filtered by selecting a value from the
drop down list eg BPI (datasheet)
27

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
28

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
29

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.
30

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. 01/29/17
31

Event Assessment:
Be aware
 The recalculate button should be pressed for every time a
case is updated with any information which requires re-
expediting
Why ?
 So that any newly configured licences will be updated to the
case and the case is distributed accordingly. This prevents
missed submissions
32

Thank YouThank You
&&
QuestionsQuestions
33
Contact:
Katalyst Healthcare’s & Life Sciences
South Plainfield, NJ, USA 07080.
E-Mail: info@KatalystHLS.com

Argus Event Tab Screen - Katalyst HLS

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