Analysis Tab

The Analysis tab has two views: Case Analysis and AFSSaPS.

Analysis information about Regulatory Information (notification log), MedWatch Information, BfArM Information, and EU devices is not available. For more sophisticated queries, use filters or advanced conditions.

The tables below describe all the fields in the Case Analysis view. The field values you specify are used as the query criteria to retrieve matching cases.

Table 3-15 QUERY BY EXAMPLE Page > Analysis Tab > Case Analysis View -- Narrative section

Field or Check Box Description

Narrative

Enter the case narrative that the query looks for in cases.

Case Comment

Enter the case comment that the query looks for in cases.

Local Evaluator Comment

Enter the local evaluator' comment that the query looks for in cases.

Company Comment

Enter the company's comment that the query looks for in cases.

Abbreviated Narrative

Enter the abbreviated case narrative that the query looks for in cases.

Evaluation in light of similar events in the past

Enter the evaluation comment that takes in to consideration similar events that have occurred in the past. The query will look for the specified text in cases.

Table 3-16 QUERY BY EXAMPLE Page > Analysis Tab > Case Analysis View -- Other Information section

Field or Check Box Description

Case Serious

Select the Yes, No, or Ignore option, as appropriate, to indicate whether the query looks for cases where case seriousness status is specified.

Notes

Enter the case seriousness notes that the query looks for in cases.

Company Agent Causal

Select the Yes, No, Unknown, or Ignore option, as appropriate, to indicate whether the query looks for cases where the company agent causality status is specified.

Notes

Enter the company agent causality notes that the query looks for in cases.

Listedness Determination

Select the case listedness status that the query looks for in cases.

Notes

Enter the case assessment listedness notes that the query looks for in cases.

Case Outcome

Select the case outcome that the query looks for in cases.

Company Diagnosis/Syndrome

Click the associated Encode button to use the MedDRA Browser to specify the company diagnosis as query criteria. See "Use the MedDRA Browser" for more information.

Notes

Enter the company diagnosis/syndrome notes that the query looks for in cases.

Table 3-17 describes all the fields in the AFSSaPS view. The field values you specify are used as the query criteria to retrieve matching cases.

Table 3-17 QUERY BY EXAMPLE Page > Analysis Tab > AFSSaPS View — Case Event Imputability Details section

Field Description

Preferred Term

Click the associated Select button to use the MedDRA Browser to specify the Event Preferred Term as query criteria.

See Use the MedDRA Browser for more information.

Agent

Click the associated Select button to choose the suspect product that the query looks for in cases.

Chronology

Select the imputability chronology code that the query looks for in cases.

Semiology

Select the imputability semiology code that the query looks for in cases.

Bibliography

Select the imputability bibliography code that the query looks for in cases.

Imputability

Select the imputability score that the query looks for in cases.