OTIS Vedolizumab Pregnancy Exposure Registry

The drug being observed in this study is called Vedolizumab. Vedolizumab is approved for the
treatment of adult participants with moderately to severely active UC and CD who achieved an
inadequate response, had a loss of response, or were intolerant to conventional and/or
biologic treatments. This study will look at any possible association between vedolizumab and
pregnancy outcome, including the health of the mother, fetus, and infant in the female with
planned and unplanned pregnancies and who are at least 1 dose exposed at any time from last
menstrual period (LMP) during pregnancy to vedolizumab (Entyvio) or other biological agents
for UC or CD.

The study will enroll approximately 200 pregnant female participants drawn from 3 sources:
OTIS Network, pregnant women who spontaneously contact the study research center or the
sponsor or who are referred by their health care practitioners (HCP) in North America and
women in North America who become pregnant while participating in other Entyvio clinical
studies being undertaken by the sponsor. Participants will be assigned to one of the two
cohorts:

- No chronic disease prospective cohort

- UC/CD prospective cohort All participants will be observed throughout the study. All
participants will be asked to record all medications (including dose, frequency, and
route), any additional exposures or events as the pregnancy progresses in a pregnancy
diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this
study is 6 years. Cohort enrollment will be done before 20 weeks of gestation period and
intake interviews would be scheduled telephonically. Schedule of intake interviews of
participants will depends upon the duration of LMP prior to enrollment of participants in
study. Outcome interview would be conducted within 0 to 6 weeks after delivery,
dysmorphological examination of live infants would be conducted within 0 to 12 months after
delivery and pediatric medical record review and questionnaire would be held 1 year after
delivery.

Inclusion Criteria:

For the UC/CD Prospective Cohort:

1. Is a currently pregnant woman with UC or CD,

2. Has exposure to Entyvio or other biologic agents at any dose, and at any time from
first day of LMP,

3. Has enrolled no later than 19 completed weeks after LMP.

4. Agrees to the conditions and requirements of the study including the interview
schedule, release of medical records, and the physical examination of live born
infants.

For the 'no chronic disease' Prospective Cohort:

5. Is a currently pregnant woman with no chronic disease.

6. Has no exposure to any biological agent and at any time from first day of LMP,

7. Has enrolled no later than 19 completed weeks after LMP.

8. Agrees to the conditions and requirements of the study including the interview
schedule, release of medical records, and the physical examination of live born
infants.

Exclusion Criteria:

For the UC/CD Prospective Cohort:

1. Is greater than (>) 19 completed weeks gestation prior to enrollment,

2. Has first contact with OTIS after prenatal diagnosis of any major structural defect,

3. Has enrolled in this registry with a previous pregnancy,

4. Has had an exposure to the known or suspected human teratogens: Chlorambucil.
Cyclophosphamide, Mycophenylate mofetil.

For the 'no chronic disease' Prospective Cohort:

5. Is >19 completed weeks gestation prior to enrollment,

6. Has first contact with OTIS after prenatal diagnosis of any major structural defect,

7. Has enrolled in this registry with a previous pregnancy,

8. Has had an exposure to the known or suspected human teratogens: Chlorambucil,
Cyclophosphamide, Mycophenylate mofetil.

Note: women exposed to Entyvio during pregnancy but not meeting the above criteria can
enroll into the Entyvio pregnancy exposure case series component of this registry.