Products Tab

In the Products tab, you can:

• Enter information only about one product.
• Specify details of only one dosage regimen.
• Scroll the page to view all the fields available.

Table 3-11 QUERY BY EXAMPLE Page > Products Tab -- Product Information

Field or Check Box	Description
Product Name	Click the associated Select button to use the Product Browser to specify product information for your query criteria. Selecting the product name populates the Product Name, Generic Name, Company Drug Code, Formulation, Concentration, and Units fields with the details of the product you selected. See Use the Product Browser for details. Alternatively, click the associated Encode button to use the Drug Coding Browser to specify the WHO drug name as the query criteria. See Use the WHO Drug Browser for details.
Drug Type	Select the Suspect, Concomitant, Treatment, or Ignore option, as appropriate, to indicate whether the query looks for cases where drug type is specified.
Generic Name	Click the Select button associated with the Product Name field to select a generic name that the query looks for in cases. See Use the Product Browser for details.
Product Indication PT	Click the associated Encode button to use the MedDRA Browser to specify the drug primary indication event term as the query criteria. See Use the MedDRA Browser for details.
Company Product	Click the associated Select button to select the company product that the query looks for in cases.
Study Drug	Click the associated Select button to use the Study Drug Lookup dialog box to specify the study drug name as the query criteria. Use this field to retrieve clinical trial cases with the selected study drug. See Use the Study Drug Lookup for details.
Company Drug Code	Click the Select button associated with the Product Name field to select the company drug code that the query looks for in cases. See Use the Product Browser for details.
Drug Code	Enter the drug code that the query looks for in cases.
Manufacturer	Enter the product manufacturer that the query looks for in cases.
Formulation	Click the Select button associated with the Product Name field to select a drug formulation that the query looks for in cases. See Use the Product Browser for details.
WHO DRUG ATC CODE	Enter the Anatomical, Therapeutic, Chemical (ATC) classification code that the query looks for in cases.
WHO DRUG ATC DESCRIPTION	Enter the Anatomical, Therapeutic, Chemical (ATC) classification description that the query looks for in cases.
Concentration	Click the Select button associated with the Product Name field to select a drug concentration that the query looks for in cases. See Use the Product Browser for details.
Units	Click the Select button associated with the Product Name field to select the units that the query looks for in cases. See Use the Product Browser for details.
Interaction?	Select the Yes, No, Unknown, or Ignore option, as appropriate, to indicate whether the query looks for cases where drug interaction status is specified.
Contraindicated?	Select the Yes, No, or Ignore option, as appropriate, to indicate whether the query looks for cases where drug contraindication status is specified.

Table 3-12 QUERY BY EXAMPLE Page > Products Tab -- Dosage Regimens

Fields or Check Box	Description
Ongoing	Select this check box to retrieve cases where the dosage regimen is ongoing.
Outside Therapeutic Range	Select this check box to retrieve cases where the dosage regimen is outside therapeutic range. This means that the drug has not been used in accordance with the label or has been used for outside the Therapeutic Range. Consult with your administrator for further company-specific information about the use of this field.
Start Date/Time	Enter the dosage regimen start date that the query looks for in cases.
Stop Date/Time	Enter the dosage regimen start date that the query looks for in cases.
Duration of Regimen	Enter the dosage regimen duration (specified in minutes) as the query criteria. You can click Calculate to view the Duration Calculator dialog box. You can enter the time in hours, days, weeks, months, or years, and then convert the time to minutes. Alternatively, you can select a duration band and value if available. A system administrator must define the bands.
Dose Number	Enter the drug dose number as the query criteria.
Dose	Enter the drug dose received by the patient as the query criteria.
Units	Specify the units for the value you specified in the Dose field.
Dose Description	Enter the dose description based on the values you specified in Dose, Dose Units, and Frequency fields.
Daily Dosage	Enter the daily dose based on the values you specified in Dose and Frequency fields.
Regimen Daily Dosage Unit	Select the same option you selected in the Dose Units field.
Regimen Dosage	Daily dose, duration, and frequency.
Regimen Dosage Unit	Select the total dose regimen unit based on the values you specified in Dose, Dosage Regimen Duration, and Frequency fields.
Patient Route of Administration	Select the route of dosage administration as the query criteria.
Frequency	Specify the dosage frequency as the query criteria.
Expiration Date	Enter the product expiration date as the query criteria.
Accidental Exposure	Select the area of accidental exposure as the query criteria.
Package ID	Enter the package ID as the query criteria.
Pack Units	Enter the package units.
Batch/Lot #	Enter the batch/lot number as the query criteria. Alternatively, click the associated Select button to view the Batch/Lot #s dialog box, enter search criteria to find the batch/ lot number you need, and make your selection.
Parent Route of Administration	Select the route of dosage administration of the parent as the query criteria.

Table 3-13 QUERY BY EXAMPLE Page > Product Tab – Product Details section

Field or Check Box	Description
First Dose	Enter the earliest dosage regimen start date as the query criteria.
Last Dose	Enter the latest regimen stop date as the query criteria.
Duration of Administration	Enter the duration of drug administration as the query criteria. This duration is the difference between the first and last dose for all dosage regimens. You can click Calculate to view the Duration Calculator dialog box. You can enter the time in hours, days, weeks, months, or years, and then convert the time to minutes. Alternatively, you can select a duration band and value if available. A system administrator must define the bands.
Date	Enter the date on which the drug dechallenge was carried out. Note that this date is the same as the Drug Dechallenge Date.
Other Information	Select the Abuse, Overdose, and Tampering check boxes.
Time between First Dose / Primary Event	Enter the time between the event onset and the first dose.
Time between Last Dose / Primary Event	Enter the time between the event onset and the last dose.
Total Dose to Primary Event	Enter the total dose for the drug.
Action Taken	Select the action taken to mitigate the adverse event.
Dechallenge Results	Select the Yes, No, Unknown, N/A, or Ignore option, as appropriate, to indicate whether the query looks for cases where drug dechallenge status is specified.
Drug Dechallenge Date	Enter the date on which the drug dechallenge was carried out.
Total Dosage	Enter the total drug usage duration as the query criteria.
Units	Enter the total dosage unit as the query criteria. This is based on the daily dose, duration and frequency.
Start Date/Time	Enter the rechallenge start date as the query criteria.
Stop Date/Time	Enter the rechallenge stop date as the query criteria.
Taken Previously/Tolerated	Select the Yes, No, Unknown, or Ignore option, as appropriate, to indicate whether the query looks for cases where drug was taken previously.
Rechallenge Results	Select the Yes, No, Unknown, N/A or Ignore option, as appropriate, to indicate whether the query looks for cases where drug rechallenge status is specified.

For more information, see:

• Use the Product Browser
  
• Use the WHO Drug Browser
  
• Use the Study Drug Lookup