Enter product details

Field or Control Name	Description
First Dose	The earliest regimen start date.
Last Dose	The latest regimen stop date.
Duration of Administration	Calculated automatically if full dates are available for the first and last doses.
Total Dosage	Calculated based on daily dose and duration.
Time Between First Dose/Primary Event	The time from the first dose to primary event onset.
Time between Last Dose/Primary Event	The time from the last dose to primary event onset.
Total Dose to Primary Event	The cumulative dose to the time of the event.
Action Taken	Select a term. If you select Dose Increased or No change, the dechallenge and rechallenge fields are disabled. Contact your administrator to adjust this list.
Dechallenge Results	Indicates the drug stopped for the purpose of determining if it was the drug that caused the adverse event.
Date	Enter the date the dechallenge was carried out.
Gestation Period at Exposure	Gestation Period at Exposure is automatically calculated for all Products in the case by using the formula: Date of First Dose of the respective Product – LMP Date. It is calculated only if full dates are available for both fields. If the First Dose occurs before the LMP Date, then this field is not populated with any data.
Taken Previously / Tolerated	Select a response from the list.
Rechallenge Results	Make a selection based on whether the drug was taken again. If Pos or Neg or UNK is selected for the Rechallenge field, the following fields are enabled: Rechallenge Start Date/Time Rechallenge Stop Date/Time Rechallenge Outcome
Start Date/Time	Enter the date and/or time when the rechallenge was started.
Stop Date/Time	Enter the date and/or time when the rechallenge was stopped.
Specialized Product Category	Select specialized FDA product categories such as combination products, compounded and repackaged products used in eVAERS reports.
Abuse Batch and lot tested and found within specifications Batch and lot tested and found not within specifications Counterfeit Drug taken beyond expiry date Drug taken by the father Medication error Misuse Occupational exposure Off label use Overdose Tampering FDA Additional Information on Drug	Select the corresponding check boxes to provide information on the drug populated as Additional Information on Drug [G.k.10.r] in the E2B(R3) reports. Select the FDA specific additional information on the drug.
Related Device Comments	Enter the details about the devices used with the drug that caused an adverse reaction. When entering data entries, only up to 2000 characters are allowed. Multi-language data entry is supported. This field is also displayed in the Japanese split-screen of the case form. A separate data entry field is applicable when using the Japanese language. Note: This field is visible only in the Drug and Vaccine tab, under the Product tab.