Entyvio (Vedolizumab) Long Term Safety Study

The drug being tested in this prospective, observational study is called vedolizumab.
Vedolizumab is being used to treat people who have UC or CD. This study will look at the
long-term safety of vedolizumab versus other biologic agents in participants with UC or CD.
The study will enroll approximately 5000 participants. All participants enrolled in this will
belong to one of the two treatment group:

- Vedolizumab

- Other Biologic Agents -adalimumab, certolizumab pegol.

Golimumab and infliximab. Study drugs will be prescribed by the physician according to local
prescribing information in the participating countries. This multi-centre trial will be
conducted worldwide. The overall time to participate in this study is 7 years. Participants
will make visits at every 6 months to their treating physician.

Inclusion Criteria:

1. Signed informed consent, by the participant or a legally acceptable representative.

2. Aged at least 18 years.

3. Initiating vedolizumab or another biologic agent for UC or CD.

4. Signed release form, by the participant or a legally acceptable representative,
permitting abstraction of the participant's medical records at Baseline and during
participation in the study.

Exclusion Criteria:

1. The participant is enrolled in a clinical trial in which treatment for CD or UC is
managed through a protocol.

2. Prior treatment with vedolizumab.

3. Any other reason that, in the Investigator's opinion, makes the participant unsuitable
to participate in this study.