Adverse Event (AE) Medications

This form is required if, on the AE summary form, it is reported that relevant concomitant medications were administered to treat the adverse event.

Indicate any relevant concomitant medications

Indicate any relevant concomitant medications the subject received within one month prior to the onset of the adverse event or is currently still taking.

Document the following:

• Report the generic name of the medication (up to 100 characters).
• Indication: if “Other, specify,” in the space available (up to 200 characters).
• Start date and stop date: DD/MMM/YYYY format.
• Medication ongoing: If the subject is still receiving the medication at the time of form completion, select the checkbox to indicate “Ongoing.”
• Dose, route, and schedule of the medication (up to 100 characters).
  

Medication	Indication	Start Date	Stop Date	Ongoing	Dose, Route, Schedule
	• Discontinued due to AE • Treatment of adverse event • Other

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