Events Tab

In the Events tab the details of only one event can be specified at a time.

Table 3-14 describes the fields in the Events tab. The field values you specify are used as the query criteria to retrieve matching cases.

Table 3-14 QUERY BY EXAMPLE Page > Events Tab — Field Description

Section	Field or Check Box	Description
Event Information	Diagnosis	Select the Yes, No, or Ignore option, as appropriate, to indicate whether the query looks for cases where event diagnosis flag is set.
Event Information	Description as Reported	Enter the reported event description that the query looks for in cases.
Event Information	Description to be Coded	Tab out of this field to use the MedDRA Browser to specify an event term as query criteria. See "Use the MedDRA Browser" for more information. The MedDRA event terms for the selected term are displayed in the Seriousness Criteria section. The query is restricted to the terms displayed.
Event Information	Onset Date/Time	Enter the event onset date that the query looks for in cases.
Event Information	Duration	Enter the event duration that the query looks for in cases.
Event Information	Onset From Last Dose	Enter the event onset duration from last dose as the query criteria.
Event Information	Onset Latency	Enter the event onset latency duration that the query looks for in cases.
Event Information	Time to Onset from First Dose	Enter the duration from first dose to the event onset as the query criteria. Alternatively, click the associated Calculate button to view the Duration Calculator dialog box and make your selection.
Event Information	Receipt Date	Enter the event receipt date that the query looks for in cases.
Event Information	Term Highlighted by Reporter	Select the Yes, No, or Ignore option, as appropriate, to indicate whether the query looks for cases where case seriousness status is specified.
Event Information	Patient Has Prior History?	Select the Yes, No, Unknown, or Ignore option, as appropriate, to indicate whether the query looks for cases where event past history is specified.
Event Information	Treatment Received?	Select the Yes, No, Unknown, or Ignore option, as appropriate, to indicate whether the query looks for cases where patient received treatment for the event.
Event Information	Time to Onset from Last Dose	Enter the duration from last dose to the event onset as the query criteria. Alternatively, click the associated Calculate button to view the Duration Calculator dialog box and make your selection.
Event Information	Progression of Disease	Select this check box to retrieve cases where Event Progression of Disease is selected.
Event Information	Adverse Drug Withdrawal Reaction	Select this check box to retrieve cases where Event Withdrawal Reaction is selected.
Event Information	Stop Date/Time	Enter the event stop date that the query looks for in cases.
Event Information	Intensity	Select the event intensity option that the query looks for in cases.
Event Information	Frequency	Select the event frequency option that the query looks for in cases.
Event Information	Lack of Efficacy	Select Yes from the drop-down list to retrieve cases where Event Lack of Efficacy is selected, else select No.
Event Information	Related to Study Conduct? (As Reported)	Select the Yes, No, Unknown, or N/A from the drop-down list, to indicate whether the query looks for cases where the event is related to a study.
Event Information	Outcome of Event	Enter the event outcome that the query looks for in cases.
Event Information	Nature of Event	Enter the nature of the event that the query looks for in cases.
Event Coding	System Organ Class (SOC) High Level Group Term High Level Term Preferred Term Lower Level Term	Click the associated Encode button to use the MedDRA Browser to specify event terms as query criteria. See Use the MedDRA Browser for details.
Seriousness Criteria	Seriousness Criteria check boxes	Select one or more check boxes to specify the seriousness criteria that the query looks for in cases. The available values are: Death Medically Significant Hospitalized Life-threatening Disability Intervention Required Congenital Anomaly Other