JOKER
Ziltivekimab
Lab tests
Adverse event
Medical history
100

How to code AE diagnosis: ‘Inferolateral ischaemia’

LLT/PT: “Ischaemia’

Since anatomic location is not specified (heart? cerebral?)

Query for clarification

100

How to code AE diagnosis: ‘Severe infection of the left foot with amputated fourth finger of the left feet’?

LLT: Foot infection
PT: Localised infection

100

Impaired liver function (ALT and/or AST elevated to twice normal concentration)

How to code and capture?

LLT/PT: ‘Liver function test’

Capture result: (ALT and/or AST elevated to twice normal concentration) as unstructured in lab note field

100

In SOUL following is reported:
‘Exacerbation of type 2 diabetes’

What to be coded?

LLT: ‘Diabetes mellitus exacerbated’
PT: ‘Diabetes mellitus’

Rationale: The trial indication is Type 2, then it is ok to leave it out in coding.

100

‘Exacerbated chronic congestive heart failure functional class III NYHA’

What is to be coded?

LLT: ‘Congestive cardiac failure aggravated’
PT: ‘Cardiac failure congestive’
and
consider to code LLT: ‘Heart failure NYHA class III’
PT: ‘Cardiac failure chronic’

200

Medical history is reported as:
‘Thickening of synovial membrane in left ankle joint’

How to code?

LLT/PT: ‘Synovial disorder’


200

How to code AE diagnosis:
 ‘Sepsis secondary to Bacteremia’?

LLT/PT: ‘Bacterial sepsis’

200

Several blood pressure measurements were reported for the same day on 01-APR-2024:
 
12:00-115/86,12:20-111/85,12:35-102/76. All without any units.

How to code and capture?

Code LLT: ‘Blood pressure’/PT: ‘Blood pressure measurement’
Date: 01-APR-2024
Capture result: (Lab notes):
12:00-115/86,12:20-111/85,12:35-102/76

Note: Capture and group BP measurements without units and for the same date; to facilitate smooth/lean case handling and to foresee limitation of characters in Relevant Test field after optimization.

200

How to code:

‘Paroxysmal second-degree AV block of Mobitz type I and 2:1’

LLT: ‘Mobitz type I’
PT: ‘Atrioventricular block second degree’

200

‘Ileocecal valve lipoma’

What is to be coded?

LLT: ‘Lipoma of intra-abdominal organs‘
PT: ‘Lipoma’

300

Medical history reported as:
‘Abdominal drainage surgery’

How to capture?

Code
LLT/ PT : ‘Drainage’
or
LLT/ PT : ‘Abdominal cavity drainage’

300

How to code AE diagnosis:
‘Right Leg Wound Infection (Venous Stasis Wound Right Lower Extremity)’?

LLT/PT: ‘Wound infection’

300

‘X-ray of shoulder, elbow and wrist was performed with
normal results’

 How to code and capture?

Code PT: ‘X-ray limb’
Capture results in lab notes

Rationale:
If all LLTs have same PT code to PT level.

Do not code: LLT: ‘X-ray shoulder’
and LLT: ‘X-ray of elbow & forearm’

300

‘Bladder tumor’


What is to be coded?

LLT/PT: ‘Bladder Neoplasm‘

Goes to different SOCs, primary SOC of Neoplasm and secondary SOC renal/urinary disorder

Query for exact location e.g. urinary bladder

Consult PTC document (Q179913):
When coding, be aware of the following in MedDRA:
The terms “cancer” and “carcinoma” are synonyms
The term “tumour” refers to a neoplasia
The terms “lump” and “mass” are not neoplasia

300

‘Gynecological disease’

What is to be coded?

LLT/PT: ‘Female reproductive tract disorder’

400

AE has been reported as ‘right groin partially thrombosed pseudoaneurysm’

How to code?

LLT/PT: ‘Vascular pseudoaneurysm thrombosis’

400

AE diagnosis reported as:
‘Acute exacerbation of chronic lung disease secondary to upper respiratory tract infection‘

What is to be coded?

LLT/PT:
‘Upper respiratory tract infection’

Ask for a split of terms and clarification of exact underlying disease e.g.

LLT/PT: ‘Infective exacerbation of chronic obstructive airways disease‘

400

In event description is stated: ‘The patient was hemodynamic stabile’

How do you code/capture?

We suggest not to code as lab data since unspecific. Only to be captured in narrative as reported.

400

‘Right comminuted displaced medial malleolus tibial fracture’

How to code?

LLT/PT:
‘Fracture displacement’
or
‘Comminuted fracture’
or
LLT: ‘Malleolar fracture’/PT: ‘Ankle fracture’

400

‘Stomach polyp’

What is to be coded?

LLT/PT: ‘Gastrointestinal polyp’

or

LLT/PT: ‘Gastric polyps’

500

Specific event form ‘Heart Failure’ in specific fields
”NYHA class at presentation”
and
“physical examination/findings on patient presentation”

How to capture in lab data section?

Code in laboratory data section:

LLT/PT: ‘NYHA classification’
and
LLT/PT: ‘Physical examination’

500

How to code AE:
‘Gangrene diabetic pedis sinistra’

LLT/PT: ‘Diabetic gangrene’

500

Renal profile showed;
Sodium 140mmol/L
Potassium 3.8
Creatinine 79
eGFR > 60

How to code and capture?

Code LLT/PT: ‘Renal function test’
Capture in lab note field (unstructured)
Potassium 3.8
Creatinine 79
eGFR > 60
+
Code LLT/PT: Blood sodium 140 mmol/L (structured)

500

‘Costal fracture’

LLT/PT : ‘Rib fracture’

or what about:
LLT/PT: ‘Costal cartilage fracture’

500

‘Basal cell carcinoma left chin frozen off’

How to code?

LLT: Basal cell carcinoma cryocautery

PT: Skin neoplasm excision

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