baseline history

Is this an original or revised submission

Original

Revised

Name of the Person Entering Data into this CRF

First Name

Last Name

Premenopausal

Yes

No

Patient has no active plans for pregnancy for a minimum of 1 year after UFE

Yes

No

Abnormal Menstrual Bleeding

Yes

No

Unknown

Pelvic Pain/Discomfort

Yes

No

Unknown

Abdominal Distension

Yes

No

Unknown

Increased Urinary Frequency

Yes

No

Unknown

Urinary Hesitancy

Yes

No

Unknown

Constipation

Yes

No

Unknown

Dyspareunia

Yes

No

Unknown

History of Pelvic Malignancy

Yes

No

Unknown

Currently Pregnant

Yes

No

History of an abnormal PAP smear (anything other than normal or atypical squamous cells of unknown significance) within 12 months of the UFE procedure

Yes

No

Unknown

History of Endometriosis

Yes

No

Unknown

History of Endometrial Hyperplasia

Yes

No

Unknown

History of Recurrent Pelvic Inflammatory Disease

Yes

No

Unknown

History of Current or Recent Uterine Infection

Yes

No

Unknown

History of Uncontrolled Diabetes Mellitus

Yes

No

Unknown

History of Current or Recent Cancer

Yes

No

Unknown

History of Current or Recent Pulmonary Conditions (COPD)

Yes

No

Unknown

History of Current or Recent Cardiac Conditions (CHF, MI))

Yes

No

Unknown

History of Allergy to Iodine-Based Contrast

Yes

No

Unknown

History of Renal Insufficiency

Yes

No

Unknown

Previous Fibroid Treatment

Yes

No

Unknown

Attestation *

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

Date of Completion

MM

DD

YYYY