Trial Outcomes & Findings for A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC) (NCT NCT04779307)

Last Updated: 2026-04-30

Results Overview

Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy). Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

121 participants

Primary outcome timeframe

At Week 54

Results posted on

2026-04-30

Participant Flow

The study was conducted across 43 investigative sites in the United States, Asia/Australia, Europe, and Israel from 19 October 2021 to 1 July 2025.

A total of 121 participants with ulcerative colitis (UC) were enrolled. Study has two periods: a 14-week induction phase and a 40-week maintenance phase. Participants who achieved a clinical response at Week 14 were stratified by previous exposure/failure to tumor necrosis factor -alpha (TNF-α) or naive TNF-α antagonist therapy and by weight group (greater than or equal to \[\>=\]30kg; less than \[\>\]15 kg to \<30 kg; 10 kg to 15 kg) were randomized to receive vedolizumab in maintenance period.

Participant milestones

Participant milestones
Measure	Participants 10 to 15 kg: Vedolizumab 150 mg Participants with UC who had a baseline weight of 10 to 15 kilograms (kg) received a dose of vedolizumab 150 milligrams (mg), as an intravenous (IV) infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously every 8 weeks (Q8W) from Week 14 through Week 46.	Participants >15 to <30 kg: Vedolizumab 200 mg Participants with UC who had a baseline weight of greater than (\>)15 to less than (\<) 30 kg received a dose of vedolizumab 200 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of greater than or equal to (\>=) 30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Period 1: Induction (up to 14 Weeks) STARTED	3	27	91	0	0
Period 1: Induction (up to 14 Weeks) Switched Weight Group From 10-15kg to >15kg to <30kg Weight	1	0	0	0	0
Period 1: Induction (up to 14 Weeks) Switched Weight Group From >15 to <30kg to >=30kg Weight Group	0	4	0	0	0
Period 1: Induction (up to 14 Weeks) Treated	3	27	90	0	0
Period 1: Induction (up to 14 Weeks) COMPLETED	2	21	70	0	0
Period 1: Induction (up to 14 Weeks) NOT COMPLETED	1	6	21	0	0
Period 2: Maintenance (up to 40 Weeks) STARTED	0	0	0	47	46
Period 2: Maintenance (up to 40 Weeks) COMPLETED	0	0	0	43	31
Period 2: Maintenance (up to 40 Weeks) NOT COMPLETED	0	0	0	4	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants 10 to 15 kg: Vedolizumab 150 mg Participants with UC who had a baseline weight of 10 to 15 kilograms (kg) received a dose of vedolizumab 150 milligrams (mg), as an intravenous (IV) infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously every 8 weeks (Q8W) from Week 14 through Week 46.	Participants >15 to <30 kg: Vedolizumab 200 mg Participants with UC who had a baseline weight of greater than (\>)15 to less than (\<) 30 kg received a dose of vedolizumab 200 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of greater than or equal to (\>=) 30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Period 1: Induction (up to 14 Weeks) Adverse Event	0	2	2	0	0
Period 1: Induction (up to 14 Weeks) Failure to meet continuation criteria	0	0	1	0	0
Period 1: Induction (up to 14 Weeks) Lack of Efficacy	0	4	15	0	0
Period 1: Induction (up to 14 Weeks) Withdrawal by parent/guardian	0	0	2	0	0
Period 1: Induction (up to 14 Weeks) Other	1	0	1	0	0
Period 2: Maintenance (up to 40 Weeks) Adverse Event	0	0	0	1	0
Period 2: Maintenance (up to 40 Weeks) Lack of Efficacy	0	0	0	1	4
Period 2: Maintenance (up to 40 Weeks) Withdrawal by Subject	0	0	0	2	6
Period 2: Maintenance (up to 40 Weeks) Withdrawal by Parent/Guardian	0	0	0	0	1
Period 2: Maintenance (up to 40 Weeks) Failure to Meet Continuation Criteria	0	0	0	0	1
Period 2: Maintenance (up to 40 Weeks) Protocol Deviation	0	0	0	0	2
Period 2: Maintenance (up to 40 Weeks) Other	0	0	0	0	1

Baseline Characteristics

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants 10 to 15 kg: Vedolizumab 150 mg n=3 Participants Participants with UC who had a baseline weight of 10 to 15 kg received a dose of vedolizumab 150 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants >15 to <30 kg: Vedolizumab 200 mg n=27 Participants Participants with UC who had a baseline weight of \>15 to \<30 kg received a dose of vedolizumab 200 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg n=91 Participants Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Total n=121 Participants Total of all reporting groups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	0 Participants n=34 Participants	0 Participants n=69 Participants	0 Participants n=140 Participants
Race (NIH/OMB) Black or African American	0 Participants n=14 Participants	2 Participants n=34 Participants	0 Participants n=69 Participants	2 Participants n=140 Participants
Race (NIH/OMB) White	3 Participants n=14 Participants	13 Participants n=34 Participants	64 Participants n=69 Participants	80 Participants n=140 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=34 Participants	0 Participants n=69 Participants	0 Participants n=140 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=34 Participants	1 Participants n=69 Participants	1 Participants n=140 Participants
Age, Continuous	2.7 years STANDARD_DEVIATION 0.58 • n=14 Participants	6.2 years STANDARD_DEVIATION 2.78 • n=34 Participants	13.8 years STANDARD_DEVIATION 2.24 • n=69 Participants	11.9 years STANDARD_DEVIATION 4.2 • n=140 Participants
Sex: Female, Male Female	2 Participants n=14 Participants	14 Participants n=34 Participants	47 Participants n=69 Participants	63 Participants n=140 Participants
Sex: Female, Male Male	1 Participants n=14 Participants	13 Participants n=34 Participants	44 Participants n=69 Participants	58 Participants n=140 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=14 Participants	1 Participants n=34 Participants	2 Participants n=69 Participants	3 Participants n=140 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=14 Participants	26 Participants n=34 Participants	89 Participants n=69 Participants	118 Participants n=140 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=34 Participants	0 Participants n=69 Participants	0 Participants n=140 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants	0 Participants n=34 Participants	0 Participants n=69 Participants	0 Participants n=140 Participants
Race (NIH/OMB) Asian	0 Participants n=14 Participants	12 Participants n=34 Participants	26 Participants n=69 Participants	38 Participants n=140 Participants

PRIMARY outcome

Timeframe: At Week 54

Population: The intent to treat-maintenance (ITT-M) analysis set included all participants who were randomized into the maintenance period. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=47 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With Clinical Remission at Week 54 Based on Modified Mayo Score	51.1 percentage of participants Interval 36.1 to 65.9	43.5 percentage of participants Interval 28.9 to 58.9	—	—	—

SECONDARY outcome

Timeframe: At Week 14

Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=3 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=27 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg n=91 Participants Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With Clinical Remission at Week 14 Based on Modified Mayo Score	33.3 percentage of participants Interval 0.8 to 90.6	44.4 percentage of participants Interval 25.5 to 64.7	31.9 percentage of participants Interval 22.5 to 42.5	—	—

SECONDARY outcome

Timeframe: At Week 54

Population: The ITT-M analysis set included all participants who were randomized into the maintenance period. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan.

Participants who had clinical remission at Week 14 were analyzed for sustained clinical remission at Week 54. Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=47 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With Sustained Clinical Remission at Week 54 Based on Modified Mayo Score	29.8 percentage of participants Interval 17.3 to 44.9	28.3 percentage of participants Interval 16.0 to 43.5	—	—	—

SECONDARY outcome

Timeframe: At Week 54

Participants who had endoscopic remission at Week 14 were analyzed for sustained endoscopic remission at Week 54. Mayo endoscopic sub score (MES) was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=47 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With Sustained Endoscopic Remission at Week 54	36.2 percentage of participants Interval 22.7 to 51.5	30.4 percentage of participants Interval 17.7 to 45.8	—	—	—

SECONDARY outcome

Timeframe: At Week 14

Population: The ITT analysis set included all enrolled participants for the induction period, defined by when the informed consent form was obtained, and the participant was not a screen failure.

Endoscopic response was defined as a decrease from baseline in the MES \>=1 point. MES was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=3 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=27 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg n=91 Participants Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With Endoscopic Response at Week 14	66.7 percentage of participants Interval 9.4 to 99.2	48.1 percentage of participants Interval 28.7 to 68.1	49.5 percentage of participants Interval 38.8 to 60.1	—	—

SECONDARY outcome

Timeframe: At Week 54

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=47 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With Endoscopic Response at Week 54	59.6 percentage of participants Interval 44.3 to 73.6	47.8 percentage of participants Interval 32.9 to 63.1	—	—	—

SECONDARY outcome

Timeframe: At Week 54

Corticosteroid-free clinical remission based on the modified Mayo score was defined as when a participant meets the definition described in the primary endpoint and was off corticosteroids at least 12 weeks prior to and at Week 54 and without presence of any intercurrent event. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=23 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=18 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With Corticosteroid-free Clinical Remission at Week 54	56.5 percentage of participants Interval 34.5 to 76.8	27.8 percentage of participants Interval 9.7 to 53.5	—	—	—

SECONDARY outcome

Timeframe: At Week 54

Clinical remission based on complete Mayo score was a score (inclusive of physician global assessment \[PGA\]) of \<=2 points with no individual sub score \>1 and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Complete Mayo score was a composite index of 4 disease activity variables (stool frequency, rectal bleeding, endoscopy \[modified so that a score of 1 does not include friability\], and PGA sub scores) ranging from 0-12. Higher score indicated more severe disease.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=47 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With Clinical Remission at Week 54 Based on Complete Mayo Score	53.2 percentage of participants Interval 38.1 to 67.9	43.5 percentage of participants Interval 28.9 to 58.9	—	—	—

SECONDARY outcome

Timeframe: Predose at Week 14 and post dose at Week 54

Population: PKAS-M: All participants who received at least 1 dose with measurable drug concentration in blood. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. Here "overall number of participants" are participants evaluable for this Outcome and "number analyzed" signifies participants at the specific categories.

Serum trough concentration of vedolizumab was reported.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=43 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Serum Trough Concentrations of Vedolizumab Over Time At Week 14	16.92 microgram/ml (mcg/ml) Standard Deviation 10.275	13.26 microgram/ml (mcg/ml) Standard Deviation 9.522	—	—	—
Serum Trough Concentrations of Vedolizumab Over Time At Week 54	5.97 microgram/ml (mcg/ml) Standard Deviation 4.120	12.60 microgram/ml (mcg/ml) Standard Deviation 7.413	—	—	—

SECONDARY outcome

Timeframe: Up to Week 54

Population: The Safety analysis set maintenance (SAF-M) included all participants who received at least 1 maintenance dose of study vedolizumab. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

AVA positive was defined as a confirmed AVA positive result.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=43 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With Positive Anti-vedolizumab Antibodies (AVA)	2.3 percentage of participants	6.5 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to Week 54

Population: The SAF-M included all participants who received at least 1 maintenance dose of study vedolizumab. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Positive Neutralizing AVA was defined as a positive result in the neutralizing AVA assay at any visit.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=43 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With Positive Neutralizing AVA	0 percentage of participants	2.2 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: At Week 54

Participants who had clinical response at Week 14 were analyzed for sustained clinical response at Week 54. Sustained refers to meeting the specific endpoint criteria at both Week 14 and Week 54. Sustained clinical response is defined as meeting the following criteria at both Week 14 and Week 54: reduction in complete Mayo score of \>=3 points and \>=30% from baseline with an accompanying decrease in rectal bleeding sub score of \>=1 point or absolute rectal bleeding sub score of \<=1 point. Mayo score was an instrument designed to measure disease activity of UC. Complete Mayo score was a composite index of 4 disease activity variables (stool frequency, rectal bleeding, endoscopy \[modified so that a score of 1 does not include friability\], and PGA sub scores) ranging from 0-12. Higher score indicated more severe disease.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=47 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With Sustained Clinical Response at Week 54 Based on Complete Mayo Score	66.0 percentage of participants Interval 50.7 to 79.1	63.0 percentage of participants Interval 47.5 to 76.8	—	—	—

SECONDARY outcome

Timeframe: At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54

Population: The ITT analysis set included all enrolled participants for the induction period, defined by when the informed consent form was obtained, and the participant was determined not to be a screen failure. Participants continued to be evaluated according to their originally assigned induction treatment arms within the ITT framework, hence, analyses for this outcome measure are presented for the ITT population, regardless of subsequent randomization.

Clinical response was where a participant achieved clinical response if they had a reduction of \>=2 points and \>=25% from the baseline partial Mayo score, including a \>=1 point decrease in the Mayo stool frequency sub score and a \>=1 point reduction in the rectal bleeding sub score or absolute rectal bleeding sub score of \<=1 point. Mayo score was an instrument designed to measure disease activity of UC. A partial Mayo score was defined as composite index of 3 disease activity variables (stool frequency, rectal bleeding, and PGA sub scores) that ranged from 0-9 and excluded the endoscopy sub score. Higher score indicates more severe disease.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=3 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=27 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg n=91 Participants Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With Clinical Response up to Week 54 Based on Partial Mayo Score At Week 10	66.7 percentage of participants Interval 9.4 to 99.2	77.8 percentage of participants Interval 57.7 to 91.4	64.8 percentage of participants Interval 54.1 to 74.6	—	—
Percentage of Participants With Clinical Response up to Week 54 Based on Partial Mayo Score At Week 14	100 percentage of participants Interval 29.2 to 100.0	77.8 percentage of participants Interval 57.7 to 91.4	72.5 percentage of participants Interval 62.2 to 81.4	—	—
Percentage of Participants With Clinical Response up to Week 54 Based on Partial Mayo Score At Week 30	0.0 percentage of participants Interval 0.0 to 70.8	74.1 percentage of participants Interval 53.7 to 88.9	59.3 percentage of participants Interval 48.5 to 69.5	—	—
Percentage of Participants With Clinical Response up to Week 54 Based on Partial Mayo Score At Week 38	33.3 percentage of participants Interval 0.8 to 90.6	63.0 percentage of participants Interval 42.4 to 80.6	58.2 percentage of participants Interval 47.4 to 68.5	—	—
Percentage of Participants With Clinical Response up to Week 54 Based on Partial Mayo Score At Week 2	66.7 percentage of participants Interval 9.4 to 99.2	37.0 percentage of participants Interval 19.4 to 57.6	39.6 percentage of participants Interval 29.5 to 50.4	—	—
Percentage of Participants With Clinical Response up to Week 54 Based on Partial Mayo Score At Week 6	66.7 percentage of participants Interval 9.4 to 99.2	70.4 percentage of participants Interval 49.8 to 86.2	61.5 percentage of participants Interval 50.8 to 71.6	—	—
Percentage of Participants With Clinical Response up to Week 54 Based on Partial Mayo Score At Week 22	33.3 percentage of participants Interval 0.8 to 90.6	59.3 percentage of participants Interval 38.8 to 77.6	60.4 percentage of participants Interval 49.6 to 70.5	—	—
Percentage of Participants With Clinical Response up to Week 54 Based on Partial Mayo Score At Week 46	33.3 percentage of participants Interval 0.8 to 90.6	70.4 percentage of participants Interval 49.8 to 86.2	56.0 percentage of participants Interval 45.2 to 66.4	—	—
Percentage of Participants With Clinical Response up to Week 54 Based on Partial Mayo Score At Week 54	33.3 percentage of participants Interval 0.8 to 90.6	70.4 percentage of participants Interval 49.8 to 86.2	57.1 percentage of participants Interval 46.3 to 67.5	—	—

SECONDARY outcome

Timeframe: At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54

Clinical remission based on partial Mayo score was defined as a partial Mayo score of \<=2 points and no individual sub score \>1 point. Mayo score was an instrument designed to measure disease activity of UC. A partial Mayo score was defined as composite index of 3 disease activity variables (stool frequency, rectal bleeding, and PGA sub scores) that ranged from 0-9 and excluded the endoscopy sub score. Higher score indicates more severe disease.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=3 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=27 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg n=91 Participants Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With Clinical Remission up to Week 54 Based on Partial Mayo Score At Week 22	33.3 percentage of participants Interval 0.8 to 90.6	59.3 percentage of participants Interval 38.8 to 77.6	58.2 percentage of participants Interval 47.4 to 68.5	—	—
Percentage of Participants With Clinical Remission up to Week 54 Based on Partial Mayo Score At Week 30	0.0 percentage of participants Interval 0.0 to 70.8	70.4 percentage of participants Interval 49.8 to 86.2	61.5 percentage of participants Interval 50.8 to 71.6	—	—
Percentage of Participants With Clinical Remission up to Week 54 Based on Partial Mayo Score At Week 38	33.3 percentage of participants Interval 0.8 to 90.6	70.4 percentage of participants Interval 49.8 to 86.2	60.4 percentage of participants Interval 49.6 to 70.5	—	—
Percentage of Participants With Clinical Remission up to Week 54 Based on Partial Mayo Score At Week 46	33.3 percentage of participants Interval 0.8 to 90.6	74.1 percentage of participants Interval 53.7 to 88.9	58.2 percentage of participants Interval 47.4 to 68.5	—	—
Percentage of Participants With Clinical Remission up to Week 54 Based on Partial Mayo Score At Week 54	33.3 percentage of participants Interval 0.8 to 90.6	66.7 percentage of participants Interval 46.0 to 83.5	53.8 percentage of participants Interval 43.1 to 64.4	—	—
Percentage of Participants With Clinical Remission up to Week 54 Based on Partial Mayo Score At Week 14	66.7 percentage of participants Interval 9.4 to 99.2	77.8 percentage of participants Interval 57.7 to 91.4	65.9 percentage of participants Interval 55.3 to 75.5	—	—
Percentage of Participants With Clinical Remission up to Week 54 Based on Partial Mayo Score At Week 2	33.3 percentage of participants Interval 0.8 to 90.6	29.6 percentage of participants Interval 13.8 to 50.2	23.1 percentage of participants Interval 14.9 to 33.1	—	—
Percentage of Participants With Clinical Remission up to Week 54 Based on Partial Mayo Score At Week 6	66.7 percentage of participants Interval 9.4 to 99.2	59.3 percentage of participants Interval 38.8 to 77.6	48.4 percentage of participants Interval 37.7 to 59.1	—	—
Percentage of Participants With Clinical Remission up to Week 54 Based on Partial Mayo Score At Week 10	66.7 percentage of participants Interval 9.4 to 99.2	55.6 percentage of participants Interval 35.3 to 74.5	59.3 percentage of participants Interval 48.5 to 69.5	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to end of follow up (up to 3.7 years)

Population: The SAF included all participants who received at least 1 dose of study vedolizumab.

A TEAE was defined as an AE whose date of onset occurred on or after the first dose of study drug through Week 54 for participants entering the extension study or the final safety visit 18 weeks after their last dose of study drug for those who do not enter the extension study or those who early terminate. A TESAE was defined as an undesirable event that was not present prior to medical treatment or an already present event that worsened either in intensity or frequency following the first dose of study drug, that occurred from the first dose of study drug to the day of last dose of study drug + 126 days. AESI was defined as an AE (serious or nonserious) of medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was appropriate. AESIs include infusion-related reactions and hypersensitivity, serious infection, malignancy, or other (liver injury and progressive multifocal leukoencephalopathy \[PML\]).

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=3 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=27 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg n=90 Participants Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=47 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (TESAE), and Adverse Event of Special Interest (AESI) Participants with at Least One TEAE	100 percentage of participants	77.8 percentage of participants	66.7 percentage of participants	72.3 percentage of participants	63.0 percentage of participants
Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (TESAE), and Adverse Event of Special Interest (AESI) Participants with TESAE	0 percentage of participants	14.8 percentage of participants	10.0 percentage of participants	6.4 percentage of participants	10.9 percentage of participants
Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (TESAE), and Adverse Event of Special Interest (AESI) Participants with AESI	0 percentage of participants	25.9 percentage of participants	12.2 percentage of participants	10.6 percentage of participants	19.6 percentage of participants

SECONDARY outcome

Timeframe: At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54

Population: ITT-M analysis set. As ITT-M is defined based on maintenance eligibility, and does not exclude induction-period assessments, data for these participants were also presented within the analysis. Participants who shifted weight categories between both phases were dosed according to their weight at randomization; therefore their weight group was summarized as predefined in analysis plan. Here "number analyzed" signifies participants who were evaluable for specific categories in the outcome measure.

Change from baseline in weight was reported.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=47 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Change From Baseline in Weight Change at Week 2	0.50 kilograms (kg) Standard Deviation 1.287	0.74 kilograms (kg) Standard Deviation 1.037	—	—	—
Change From Baseline in Weight Change at Week 6	1.04 kilograms (kg) Standard Deviation 2.050	1.38 kilograms (kg) Standard Deviation 1.960	—	—	—
Change From Baseline in Weight Change at Week 10	1.56 kilograms (kg) Standard Deviation 2.458	1.66 kilograms (kg) Standard Deviation 2.155	—	—	—
Change From Baseline in Weight Change at Week 14	1.93 kilograms (kg) Standard Deviation 2.762	1.88 kilograms (kg) Standard Deviation 2.806	—	—	—
Change From Baseline in Weight Change at Week 22	2.40 kilograms (kg) Standard Deviation 3.051	2.79 kilograms (kg) Standard Deviation 3.540	—	—	—
Change From Baseline in Weight Change at Week 30	2.97 kilograms (kg) Standard Deviation 3.379	3.22 kilograms (kg) Standard Deviation 4.338	—	—	—
Change From Baseline in Weight Change at Week 38	3.93 kilograms (kg) Standard Deviation 3.698	3.70 kilograms (kg) Standard Deviation 4.900	—	—	—
Change From Baseline in Weight Change at Week 46	4.40 kilograms (kg) Standard Deviation 4.551	4.51 kilograms (kg) Standard Deviation 4.578	—	—	—
Change From Baseline in Weight Change at Week 54	4.56 kilograms (kg) Standard Deviation 4.833	4.85 kilograms (kg) Standard Deviation 5.033	—	—	—

SECONDARY outcome

Timeframe: At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54

Change from baseline in weight Z-score was reported. Weight z-score expresses how an individual's measured weight compares to the expected weight of a reference population of the same age and sex, standardized using population growth charts. It represents the number of standard deviations (SDs) an individual's weight is above or below the mean of the reference population. Z-score was calculated as: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score indicates that the observed value is below (lower than) the reference mean, while a positive Z-score indicates that the observed value is above (higher than) the reference mean.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=47 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Change From Baseline in Weight Z-score Change at Week 38	0.519 Z-score Standard Deviation 0.4425	0.462 Z-score Standard Deviation 0.5510	—	—	—
Change From Baseline in Weight Z-score Change at Week 2	0.080 Z-score Standard Deviation 0.1407	0.084 Z-score Standard Deviation 0.1489	—	—	—
Change From Baseline in Weight Z-score Change at Week 6	0.161 Z-score Standard Deviation 0.2532	0.164 Z-score Standard Deviation 0.2490	—	—	—
Change From Baseline in Weight Z-score Change at Week 10	0.227 Z-score Standard Deviation 0.2955	0.210 Z-score Standard Deviation 0.2799	—	—	—
Change From Baseline in Weight Z-score Change at Week 14	0.269 Z-score Standard Deviation 0.3479	0.237 Z-score Standard Deviation 0.3312	—	—	—
Change From Baseline in Weight Z-score Change at Week 22	0.325 Z-score Standard Deviation 0.3708	0.347 Z-score Standard Deviation 0.3861	—	—	—
Change From Baseline in Weight Z-score Change at Week 30	0.410 Z-score Standard Deviation 0.4268	0.394 Z-score Standard Deviation 0.4892	—	—	—
Change From Baseline in Weight Z-score Change at Week 46	0.585 Z-score Standard Deviation 0.5224	0.570 Z-score Standard Deviation 0.5000	—	—	—
Change From Baseline in Weight Z-score Change at Week 54	0.609 Z-score Standard Deviation 0.5462	0.622 Z-score Standard Deviation 0.5570	—	—	—

SECONDARY outcome

Timeframe: At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54

Change from baseline in height was reported.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=47 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Change From Baseline in Height Change at Week 2	0.20 centimeters (cm) Standard Deviation 0.448	0.27 centimeters (cm) Standard Deviation 0.699	—	—	—
Change From Baseline in Height Change at Week 6	0.45 centimeters (cm) Standard Deviation 0.645	0.39 centimeters (cm) Standard Deviation 1.051	—	—	—
Change From Baseline in Height Change at Week 10	0.65 centimeters (cm) Standard Deviation 0.866	0.85 centimeters (cm) Standard Deviation 1.317	—	—	—
Change From Baseline in Height Change at Week 14	1.08 centimeters (cm) Standard Deviation 1.087	1.14 centimeters (cm) Standard Deviation 1.492	—	—	—
Change From Baseline in Height Change at Week 22	1.80 centimeters (cm) Standard Deviation 1.617	1.82 centimeters (cm) Standard Deviation 2.007	—	—	—
Change From Baseline in Height Change at Week 30	2.45 centimeters (cm) Standard Deviation 1.996	2.59 centimeters (cm) Standard Deviation 2.064	—	—	—
Change From Baseline in Height Change at Week 38	3.30 centimeters (cm) Standard Deviation 2.359	3.07 centimeters (cm) Standard Deviation 2.433	—	—	—
Change From Baseline in Height Change at Week 46	3.93 centimeters (cm) Standard Deviation 2.893	3.76 centimeters (cm) Standard Deviation 2.748	—	—	—
Change From Baseline in Height Change at Week 54	4.64 centimeters (cm) Standard Deviation 3.274	3.99 centimeters (cm) Standard Deviation 3.227	—	—	—

SECONDARY outcome

Timeframe: At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54

Change from baseline in linear growth Z-score were reported. Linear growth Z-score is a standardized measure that describes how far a measured height deviates from the median height of a reference population of the same age and sex based on established growth charts. It is expressed in units of standard deviations (SD). Z-score was calculated as: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score indicates that the observed value is below (lower than) the reference mean, while a positive Z-score indicates that the observed value is above (higher than) the reference mean.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=47 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Change From Baseline in Linear Growth Z-score Change at Week 14	0.175 Z-score Standard Deviation 0.1883	0.186 Z-score Standard Deviation 0.2631	—	—	—
Change From Baseline in Linear Growth Z-score Change at Week 30	0.389 Z-score Standard Deviation 0.3575	0.407 Z-score Standard Deviation 0.3755	—	—	—
Change From Baseline in Linear Growth Z-score Change at Week 38	0.537 Z-score Standard Deviation 0.4534	0.490 Z-score Standard Deviation 0.4553	—	—	—
Change From Baseline in Linear Growth Z-score Change at Week 2	0.033 Z-score Standard Deviation 0.0711	0.040 Z-score Standard Deviation 0.1032	—	—	—
Change From Baseline in Linear Growth Z-score Change at Week 6	0.072 Z-score Standard Deviation 0.1026	0.057 Z-score Standard Deviation 0.1457	—	—	—
Change From Baseline in Linear Growth Z-score Change at Week 10	0.106 Z-score Standard Deviation 0.1532	0.134 Z-score Standard Deviation 0.2267	—	—	—
Change From Baseline in Linear Growth Z-score Change at Week 22	0.290 Z-score Standard Deviation 0.2893	0.297 Z-score Standard Deviation 0.3682	—	—	—
Change From Baseline in Linear Growth Z-score Change at Week 46	0.629 Z-score Standard Deviation 0.5383	0.602 Z-score Standard Deviation 0.5154	—	—	—
Change From Baseline in Linear Growth Z-score Change at Week 54	0.754 Z-score Standard Deviation 0.6341	0.616 Z-score Standard Deviation 0.5673	—	—	—

SECONDARY outcome

Timeframe: At Week 54

Population: ITT-M analysis set. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. Here "Overall Number of Participants Analyzed" signifies participants with both Male and Female pubertal development stages and "number analyzed" signifies participants who were evaluable for the specific categories in the outcome measure.

Tanner stages are used to evaluate growth parameters. They are standardized for age, sex, and pubertal development, with Stage 1 representing the prepubertal stage and Stage 5 representing the fully mature adult stage. It measures Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). The data reported shows shifts in participants' Tanner stages from baseline to Week 54.

Outcome measures

Outcome measures
Measure	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=43 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=35 Participants Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 2 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 2 (Baseline) - Tanner Stage 2 (Week 54)	1 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 2 (Baseline) - Tanner Stage 3 (Week 54)	2 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 2 (Baseline) - Tanner Stage 4 (Week 54)	1 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 5 (Baseline) - Tanner Stage 3 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 5 (Baseline) - Tanner Stage 5 (Week 54)	3 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 1 (Baseline) - Tanner Stage 1 (Week 54)	5 Participants	5 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 1 (Baseline) - Tanner Stage 3 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 1 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 2 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 2 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 2 (Baseline) - Tanner Stage 3 (Week 54)	2 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 2 (Baseline) - Tanner Stage 4 (Week 54)	1 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 2 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 3 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 3 (Baseline) - Tanner Stage 2 (Week 54)	1 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 3 (Baseline) - Tanner Stage 3 (Week 54)	0 Participants	2 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 3 (Baseline) - Tanner Stage 4 (Week 54)	2 Participants	2 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 3 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 4 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 5 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 5 (Baseline) - Tanner Stage 3 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 1 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	2 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 3 (Baseline) - Tanner Stage 3 (Week 54)	2 Participants	4 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 3 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 5 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 5 (Baseline) - Tanner Stage 3 (Week 54)	1 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 1 (Baseline) - Tanner Stage 3 (Week 54)	1 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 2 (Baseline) - Tanner Stage 3 (Week 54)	3 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 2 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 2 (Baseline) - Tanner Stage 5 (Week 54)	1 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 4 (Baseline) - Tanner Stage 4 (Week 54)	1 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 4 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	2 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 5 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 1 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 3 (Baseline) - Tanner Stage 3 (Week 54)	4 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 3 (Baseline) - Tanner Stage 4 (Week 54)	2 Participants	3 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 4 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 5 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 5 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 1 (Baseline) - Tanner Stage 1 (Week 54)	8 Participants	6 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 1 (Baseline) - Tanner Stage 2 (Week 54)	2 Participants	2 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 1 (Baseline) - Tanner Stage 3 (Week 54)	2 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 1 (Baseline) - Tanner Stage 5 (Week 54)	1 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 2 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 3 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 3 (Baseline) - Tanner Stage 4 (Week 54)	1 Participants	2 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 1 (Baseline) - Tanner Stage 1 (Week 54)	4 Participants	4 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 1 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 1 (Baseline) - Tanner Stage 3 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 1 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 1 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 2 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 3 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 3 (Baseline) - Tanner Stage 2 (Week 54)	1 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 3 (Baseline) - Tanner Stage 3 (Week 54)	0 Participants	2 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 3 (Baseline) - Tanner Stage 4 (Week 54)	2 Participants	2 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 3 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 4 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 4 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 4 (Baseline) - Tanner Stage 3 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 4 (Baseline) - Tanner Stage 4 (Week 54)	1 Participants	3 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 4 (Baseline) - Tanner Stage 5 (Week 54)	6 Participants	4 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 5 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 5 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Genitals · Tanner Stage 5 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 1 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 1 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 4 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 4 (Baseline) - Tanner Stage 3 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 4 (Baseline) - Tanner Stage 4 (Week 54)	1 Participants	3 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 4 (Baseline) - Tanner Stage 5 (Week 54)	5 Participants	4 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 5 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 5 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Pubic Hair · Tanner Stage 5 (Baseline) - Tanner Stage 5 (Week 54)	4 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 1 (Baseline) - Tanner Stage 1 (Week 54)	4 Participants	5 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 1 (Baseline) - Tanner Stage 3 (Week 54)	1 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 1 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 1 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 2 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 2 (Baseline) - Tanner Stage 2 (Week 54)	2 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 2 (Baseline) - Tanner Stage 3 (Week 54)	2 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 2 (Baseline) - Tanner Stage 4 (Week 54)	1 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 2 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 3 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 3 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 3 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 4 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 4 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 4 (Baseline) - Tanner Stage 3 (Week 54)	1 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 4 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 4 (Baseline) - Tanner Stage 5 (Week 54)	3 Participants	2 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 5 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 5 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Male: Growth · Tanner Stage 5 (Baseline) - Tanner Stage 5 (Week 54)	4 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 1 (Baseline) - Tanner Stage 1 (Week 54)	5 Participants	3 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 1 (Baseline) - Tanner Stage 2 (Week 54)	1 Participants	3 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 1 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 1 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 2 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 2 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 3 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 3 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 3 (Baseline) - Tanner Stage 3 (Week 54)	4 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 3 (Baseline) - Tanner Stage 4 (Week 54)	3 Participants	3 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 3 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 4 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 4 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 4 (Baseline) - Tanner Stage 3 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 5 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 5 (Baseline) - Tanner Stage 3 (Week 54)	0 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 5 (Baseline) - Tanner Stage 4 (Week 54)	1 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Breast Development · Tanner Stage 5 (Baseline) - Tanner Stage 5 (Week 54)	2 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 1 (Baseline) - Tanner Stage 1 (Week 54)	5 Participants	5 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 1 (Baseline) - Tanner Stage 2 (Week 54)	1 Participants	2 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 1 (Baseline) - Tanner Stage 3 (Week 54)	1 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 1 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 2 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 2 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 2 (Baseline) - Tanner Stage 3 (Week 54)	5 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 2 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 2 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 3 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 3 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 3 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 4 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 4 (Baseline) - Tanner Stage 3 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 4 (Baseline) - Tanner Stage 4 (Week 54)	1 Participants	2 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 4 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	2 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 5 (Baseline) - Tanner Stage 3 (Week 54)	1 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 5 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Pubic Hair · Tanner Stage 5 (Baseline) - Tanner Stage 5 (Week 54)	2 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 1 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 2 (Baseline) - Tanner Stage 1 (Week 54)	2 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 2 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 2 (Baseline) - Tanner Stage 3 (Week 54)	1 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 2 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 3 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 3 (Baseline) - Tanner Stage 3 (Week 54)	3 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 3 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 4 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 4 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 4 (Baseline) - Tanner Stage 3 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 4 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 4 (Baseline) - Tanner Stage 5 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 5 (Baseline) - Tanner Stage 1 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 5 (Baseline) - Tanner Stage 2 (Week 54)	0 Participants	1 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 5 (Baseline) - Tanner Stage 3 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 5 (Baseline) - Tanner Stage 4 (Week 54)	0 Participants	0 Participants	—	—	—
Number of Participants With Change From Baseline in Tanner Stage at Week 54 Female: Growth · Tanner Stage 5 (Baseline) - Tanner Stage 5 (Week 54)	2 Participants	2 Participants	—	—	—

Adverse Events

Participants 10 to 15 kg: Vedolizumab 150 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Participants >15 to <30 kg: Vedolizumab 200 mg

Serious events: 4 serious events

Other events: 16 other events

Deaths: 0 deaths

Participants >=30 kg: Vedolizumab 300 mg

Serious events: 9 serious events

Other events: 34 other events

Deaths: 0 deaths

Participants With All Weight Groups Combined: Vedolizumab Low Dose

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Participants With All Weight Groups Combined: Vedolizumab High Dose

Serious events: 5 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants 10 to 15 kg: Vedolizumab 150 mg n=3 participants at risk Participants with UC who had a baseline weight of 10 to 15 kg received a dose of vedolizumab 150 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants >15 to <30 kg: Vedolizumab 200 mg n=27 participants at risk Participants with UC who had a baseline weight of \>15 to \<30 kg received a dose of vedolizumab 200 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg n=90 participants at risk Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=47 participants at risk Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 participants at risk Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Infections and infestations Adenovirus infection	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 1/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Appendicitis	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.1% 1/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.7% 1/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Cellulitis	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.4% 2/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 5/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 2/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Cytomegalovirus infection	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 1/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.1% 1/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.7% 1/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Idiopathic intracranial hypertension	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 1/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Liver injury	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Peripheral swelling	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.7% 1/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Peritonitis	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.1% 1/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.4% 2/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.1% 1/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Other adverse events
Measure	Participants 10 to 15 kg: Vedolizumab 150 mg n=3 participants at risk Participants with UC who had a baseline weight of 10 to 15 kg received a dose of vedolizumab 150 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants >15 to <30 kg: Vedolizumab 200 mg n=27 participants at risk Participants with UC who had a baseline weight of \>15 to \<30 kg received a dose of vedolizumab 200 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants >=30 kg: Vedolizumab 300 mg n=90 participants at risk Participants with UC who had a baseline weight of \>=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab Low Dose n=47 participants at risk Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of \>10 to \<15 kg and \>=15 to \<30 kg, and 150 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.	Participants With All Weight Groups Combined: Vedolizumab High Dose n=46 participants at risk Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of \>10 to \<15 kg, 200 mg for \>=15 to \<30 kg, and 300 mg for \>=30 kg as an IV infusion Q8W from Week 14 through Week 46.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 3/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.4% 3/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 2/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.4% 3/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.4% 4/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.1% 1/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.7% 4/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.7% 1/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.4% 4/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.4% 3/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 1/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Clostridium difficile infection	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.4% 2/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 1/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.7% 1/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.4% 4/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.5% 4/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	13.0% 6/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.7% 4/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Gastroenteritis viral	33.3% 1/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.4% 2/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.4% 4/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.5% 3/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Influenza	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 3/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.5% 4/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 1/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Nasopharyngitis	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.7% 1/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 2/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.5% 3/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.4% 2/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.1% 1/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 2/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Oral herpes	33.3% 1/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 1/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 3/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.5% 4/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 1/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Proctalgia	33.3% 1/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 3/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 5/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.5% 4/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.7% 4/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Rectal prolapse	33.3% 1/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 1/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Thrombocytosis	33.3% 1/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.4% 2/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.1% 1/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	29.6% 8/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.6% 14/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	27.7% 13/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	17.4% 8/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.4% 2/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 2/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.4% 2/27 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 3/90 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/47 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.5% 3/46 • From first dose of study drug up to end of follow up (up to 3.7 years) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place