12-month adverse events

Is this an original or revised submission?

Original

Revised

Name of the Person Entering Data into this CRF

First Name

Last Name

Adverse Event

This form is being used for adverse events occurring between the 6-month and 12-month post-procedure visits. If "no," then this CRF can be considered complete.

Yes

No

Date of AE Onset

MM

DD

YYYY

Was a hospital admission required?

Yes

No

If "yes" for hospital admission, specify the hospital admission date

MM

DD

YYYY

If "yes" for hospital admission, specify the hospital discharge date

MM

DD

YYYY

Were additional medications required?

Yes

No

Was surgery required?

Yes

No

If "yes" for surgery, specify the date of surgery.

MM

DD

YYYY

Was there permanent adverse sequelae associated with this adverse event?

Yes

No

Serious Adverse Event

If "yes," please complete a serious adverse event (SAE) form.

Yes

No

SIR Classification for Adverse Events

A - No therapy, no consequences

B - Nominal therapy, no consequences; includes overnight admission for observation only

C - Requires therapy, minor hospitalization (<48 hours)

D - Requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours)

E - Have permanent adverse sequelae

F - Death

Attestation *

I approve the data entered into this CRF and attest to its accuracy.

Date of Completion

MM

DD

YYYY