Adverse Event Details

In Link to Study, choose the study related to the Adverse Event or choose N/A for an Adverse Event not associated with a study.
iKnowMed sets CTCAE Version to the version specified in the Clinical Trial Detail for you. To change the CTCAE Version, choose a different version.
In Common Toxicities Quick Select, find and select a common toxicity. The values in this list depend on the selected CTCAE Version. iKnowMed fills in the Category and Type for you.
In Grade, select the reaction experienced.
Enter the Onset Date and, if known, the Resolution Date.

Choose an Outcome of Adverse Event.
To indicate this event is a Severe Adverse Event, check SAE.
To indicate a baseline symptom, check Baseline.
To indicate an event is intermittent, check Intermittent.
Set Requires Review by to the signing Physician or APP who will review the Adverse Event. Choose an Attending or search for and select another Physician or APP.

Causality

Choose the Most Likely Cause of Event, if known.
To designate which medication may have caused or contributed to the Adverse Event, find and select a Medication and choose the Relationship to Study/Cancer Treatment. To add another medication, click the Add (plus) icon. Up to 6 medications can be associated with an Adverse Event under Causality. To remove a medication, click the Remove (minus) icon (not shown).

Protocol Specific AE Classification

Check the Yes box for each Protocol Specific AE Classification that applies to this Adverse Event. These include Adverse Event of Special Interest, Immune Related AE (IRAE), Dose Limiting Toxicity, and Infusion-Related Reaction (IRR).

Impact on Treatment

Choose an answer to the question, Did this Adverse Event result in a change to study treatment?

Concomitant Medications Used to Treat Adverse Event

To list the Concomitant Medications Used to Treat Adverse Event, check the Yes box and then find and select a Concomitant medication. To add another medication, click the Add (plus) icon. Up to 6 Concomitant medications can be associated with an Adverse Event. To remove a medication, click the Remove (minus) icon (not shown).
To add an External Medication, click Add an external medication.

Comments

Save the Adverse Event

To save the entries without sending the Adverse Event to be reviewed, click SAVE.
To save the entries and send the Adverse Event to the Unified Sign Queue for review by a signing Physician or APP, click SEND & SAVE.
To save the entries and sign the Adverse Event as reviewed, a signing Physician or APP clicks SIGN & SAVE.

Access Adverse Events