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:
|
Parent topic: Query By Example Page—Input Fields