Adverse Event (AE) Summary

Adverse event description:
Provide a short description of the adverse event (up to 1000 characters). Include signs, symptoms, diagnosis, and any action taken.

!Note: If any of the following questions are answered “Yes,” an additional form will come due to capture additional details:
• Was the subject taking any relevant concomitant medications
• Were relevant laboratory tests performed
• Were relevant diagnostic tests or procedures performed
• Does the subject have any relevant past medical history, including pre-existing conditions

Was the subject taking any relevant concomitant medications?
Select “Yes” or “No” to indicate if the subject was taking any relevant concomitant medications within one month prior to the onset of the adverse event and/or any relevant medication used to treat the adverse event. If “Yes,” the AE medication form will be generated in the AE folder.

Were relevant laboratory tests performed?
Select “Yes” or “No” to indicate if any relevant laboratory tests were performed to assess the adverse event. If “Yes,” the AE Laboratory values form will be generated in the AE folder.

Were relevant diagnostic tests or procedures performed?
Select “Yes” or “No” to indicate if any relevant diagnostic tests or procedures were performed to assess the adverse event. For example, radiographic assessment, cardiac assessment (BAL), etc. If “Yes,” the AE Tests form will be generated in the AE folder.

Does the subject have any relevant past medical history, including pre-existing conditions?
Select “Yes” or “No” to indicate if the subject had any relevant past medical history, including pre-existing conditions. If “Yes,” continue with the following questions: condition, date of onset, and any comments.

Indicate any relevant past medical history, including pre-existing conditions

Indicate any relevant past medical history, including pre-existing conditions, the date of onset, and any comments (up to 100 characters). If the subject had more than one relevant past or pre-existing medical condition, add a new log line in the Rave application to capture each condition, date of onset, and additional comments.

CCG v.4.0 | CRF v.3.0

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