Observational Registry Study of Quality of Life When Treating BTcP With Abstral

This is a post-marketing, single arm, open label multicenter trial to assess Abstral
(fentanyl) Sublingual Tablets for breakthrough cancer pain (BTcP) in opioid-tolerant cancer
patients.

- Prior to study enrollment, patient enrollment in the TIRF REMS Access program must be
confirmed.

- Eligible patients will sign written informed consent. Patients or their proxy with a
witness must be able to sign written informed consent to participate in the study; and
the patient may use a proxy caregiver to assist in the completion of the study
questionnaires.

- Day 0, study site must enroll patient by completing a patient demographic profile
(de-identified).

- Day 0, patient will be instructed how to use the questionnaires.

- Day 0, patient will complete the baseline questionnaire before leaving the physician
office.

- On study Days 14, 21, and 28 (±3 days) patient questionnaire will be completed by
patient (or caregiver proxy) via secure online data entry portal.

- For patients completing paper questionnaires, within 1 month of day 28, patient will
return completed questionnaires via mail, fax or hand carried to the study site
coordinator for processing.

- Patient will be considered to have completed the study successfully once all completed
questionnaires have been received by the CRO within appropriate time limits.

Inclusion Criteria:

- All patients 18 years of age and older with breakthrough cancer pain who are
registered in the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and
Mitigation Strategy (REMS) Access program and receiving Abstral® under the direction
of a TIRF REMS Access program-registered physician are eligible for the study.

Patients or their proxy with a witness must be able to sign written informed consent to
participate in the study; and the patient may also use a proxy caregiver to assist in the
completion of the study questionnaires.

Exclusion Criteria:

- No patient can be enrolled who has not been prescribed Abstral for BTcP in compliance
with Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation
Strategy (REMS) Access program guidelines.

No patient may be enrolled who has a contraindication to receiving Abstral or who is
pregnant.