Trial Outcomes & Findings for A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease (NCT NCT04804540)

NCT ID: NCT04804540

Last Updated: 2025-02-12

Results Overview

AE was defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with the treatment. AE can therefore be any unfavourable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with use of a drug, whether or not it is considered related to the drug. A SAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in significant disability or incapacity, was a congenital anomaly/birth defect or was a medically important event. An AESI (serious or nonserious) was one of scientific and medical concern specific to the compound or program.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 150 participants
• Primary outcome timeframe: From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks)
• Results posted on: 2025-02-12

Participant Flow

Participants took part in the study at the 17 investigative sites in India from 08 December 2021 to 02 February 2024.

A total of 150 participants diagnosed with moderate to severe Ulcerative Colitis (UC) (102 participants) and Crohn's Disease (CD) (48 participants) were enrolled to receive vedolizumab treatment in this study.

Participant milestones

Measure	UC Participants: Vedolizumab 300 mg Participants received vedolizumab 300 milligrams (mg), intravenous (IV) infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Overall Study STARTED	102	48
Overall Study COMPLETED	76	35
Overall Study NOT COMPLETED	26	13

Reasons for withdrawal

Measure	UC Participants: Vedolizumab 300 mg Participants received vedolizumab 300 milligrams (mg), intravenous (IV) infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Overall Study Adverse Event	26	13

Baseline Characteristics

A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease

Baseline characteristics by cohort

Measure	UC Participants: Vedolizumab 300 mg n=102 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg n=48 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.	Total n=150 Participants Total of all reporting groups
Age, Continuous	38.55 years STANDARD_DEVIATION 11.190 • n=5 Participants	32.60 years STANDARD_DEVIATION 10.849 • n=7 Participants	36.65 years STANDARD_DEVIATION 11.391 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	16 Participants n=7 Participants	83 Participants n=5 Participants
Race/Ethnicity, Customized Race · Indian	102 Participants n=5 Participants	48 Participants n=7 Participants	150 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks)

Population: SAS included all enrolled participants who received at least 1 dose of study drug.

AE was defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with the treatment. AE can therefore be any unfavourable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with use of a drug, whether or not it is considered related to the drug. A SAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in significant disability or incapacity, was a congenital anomaly/birth defect or was a medically important event. An AESI (serious or nonserious) was one of scientific and medical concern specific to the compound or program.

Outcome measures

Measure	UC Participants: Vedolizumab 300 mg n=102 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg n=48 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) Participants with AEs	54 Participants	29 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) Participants with SAEs	6 Participants	2 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) Participants with AESIs	4 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks)

Population: SAS included all enrolled participants who received at least 1 dose of study drug.

An ADR was an AE for which there was at least a reasonable suspicion of a causal relationship between an AE and a suspected medicinal product. An unexpected ADR was an ADR with the nature, severity, or outcome which was not consistent with the product insert.

Outcome measures

Measure	UC Participants: Vedolizumab 300 mg n=102 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg n=48 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Number of Participants With Adverse Drug Reactions (ADRs) and Unexpected ADRs Participants with ADRs	5 Participants	0 Participants
Number of Participants With Adverse Drug Reactions (ADRs) and Unexpected ADRs Participants with Unexpected ADRs	2 Participants	0 Participants

SECONDARY outcome

Timeframe: At Weeks 14, 30 and 46

Population: SAS included all enrolled participants who received at least 1 dose of study drug.

Clinical response for UC participants was defined as decrease in Simple Clinical Colitis Activity Index (SCCAI) of greater than and equal to (>=) 3 from baseline or by physician assessment of clinical response. The SCCAI consists of five colitis activity symptom items (bowel frequency per day, bowel frequency per night, urgency of defecation, blood in stool, and general well-being) along with an assessment of extracolonic manifestations. Bowel frequency per night is scored on a 0-2 scale and General well-being is scored on a 0-4 scale. The other 3 symptom scores are scored on a 0-3 scale. 1 point each is added for the presence of any extracolonic manifestation (i.e., arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The total overall possible scoring range was 0-19 with increasing scores being indicative of more colitis activity.

Outcome measures

Measure	UC Participants: Vedolizumab 300 mg n=102 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Percentage of UC Participants With Clinical Response at Weeks 14, 30 and 46 At Week 14	54.9 percentage of participants Interval 44.7 to 64.8	—
Percentage of UC Participants With Clinical Response at Weeks 14, 30 and 46 At Week 30	62.7 percentage of participants Interval 52.6 to 72.1	—
Percentage of UC Participants With Clinical Response at Weeks 14, 30 and 46 At Week 46	73.5 percentage of participants Interval 63.9 to 81.8	—

SECONDARY outcome

Timeframe: At Weeks 14, 30 and 46

Population: SAS included all enrolled participants who received at least 1 dose of study drug.

Clinical response for CD participants was defined as decrease in Harvey Bradshaw Index (HBI) of >= 3 points from baseline. HBI was composed of five clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools/day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. The score < 5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and >16 severe disease. A higher score indicated a worse outcome.

Outcome measures

Measure	UC Participants: Vedolizumab 300 mg n=48 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Percentage of CD Participants With Clinical Response at Weeks 14, 30 and 46 At Week 30	70.8 percentage of participants Interval 55.9 to 83.0	—
Percentage of CD Participants With Clinical Response at Weeks 14, 30 and 46 At Week 46	68.8 percentage of participants Interval 53.7 to 81.3	—
Percentage of CD Participants With Clinical Response at Weeks 14, 30 and 46 At Week 14	72.9 percentage of participants Interval 58.2 to 84.7	—

SECONDARY outcome

Timeframe: At Weeks 14, 30 and 46

Population: SAS included all enrolled participants who received at least 1 dose of study drug.

Clinical remission for UC participants was defined as decrease in SCCAI of less than and equal to (<=) 2 with no individual score > 1. The SCCAI consists of five colitis activity symptom items (bowel frequency per day, bowel frequency per night, urgency of defecation, blood in stool, and general well-being) along with an assessment of extracolonic manifestations. Bowel frequency per night is scored on a 0-2 scale and General well-being is scored on a 0-4 scale. The other 3 symptom scores are scored on a 0-3 scale. 1 point each is added for the presence of any extracolonic manifestation (i.e., arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The total overall possible scoring range was 0-19 with increasing scores being indicative of more colitis activity.

Outcome measures

Measure	UC Participants: Vedolizumab 300 mg n=102 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Percentage of UC Participants With Clinical Remission at Weeks 14, 30 and 46 At Week 14	39.2 percentage of participants Interval 29.7 to 49.4	—
Percentage of UC Participants With Clinical Remission at Weeks 14, 30 and 46 At Week 30	43.1 percentage of participants Interval 33.4 to 53.3	—
Percentage of UC Participants With Clinical Remission at Weeks 14, 30 and 46 At Week 46	52.0 percentage of participants Interval 41.8 to 62.0	—

SECONDARY outcome

Timeframe: At Weeks 14, 30 and 46

Population: SAS included all enrolled participants who received at least 1 dose of study drug.

Clinical remission for CD participants was defined as HBI of <= 4. HBI was composed of five clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools/day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. The score < 5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and >16 severe disease. A higher score indicated a worse outcome.

Outcome measures

Measure	UC Participants: Vedolizumab 300 mg n=48 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Percentage of CD Participants With Clinical Remission at Weeks 14, 30 and 46 At Week 30	45.8 percentage of participants Interval 31.4 to 60.8	—
Percentage of CD Participants With Clinical Remission at Weeks 14, 30 and 46 At Week 14	47.9 percentage of participants Interval 33.3 to 62.8	—
Percentage of CD Participants With Clinical Remission at Weeks 14, 30 and 46 At Week 46	56.3 percentage of participants Interval 41.2 to 70.5	—

SECONDARY outcome

Timeframe: From first dose of study drug up to Week 46

Population: SAS included all enrolled participants who received at least 1 dose of study drug.

Vedolizumab discontinuation was defined as ceasing vedolizumab, or a treatment gap >= 90 days between consecutive doses.

Outcome measures

Measure	UC Participants: Vedolizumab 300 mg n=102 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg n=48 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Percentage of UC and CD Participants Who Discontinued Vedolizumab	25.5 percentage of participants Interval 17.4 to 35.1	27.1 percentage of participants Interval 15.3 to 41.8

SECONDARY outcome

Timeframe: At Week 46

Population: SAS included all enrolled participants who received at least 1 dose of study drug.

Mucosal healing was based on endoscopic evidence of no inflammation and healing of the mucosa as defined by a Mayo endoscopic sub-score of <=1 point. Full Mayo Score evaluated ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic sub-score) ranged from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 were considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe, with higher scores indicated more severe disease.

Outcome measures

Measure	UC Participants: Vedolizumab 300 mg n=102 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Percentage of UC Participants With Mucosal Healing at Week 46	22.5 percentage of participants Interval 14.9 to 31.9	—

SECONDARY outcome

Timeframe: At Week 46

Population: SAS included all enrolled participants who received at least 1 dose of study drug.

Mucosal healing was based on endoscopic evidence of no inflammation and healing of the mucosa as defined by a Simple Endoscopic Score for Crohn Disease (SES-CD) 0-2 or SES-CD <=4 and at least a 2-point reduction from baseline with no sub-score >1. SES-CD assessed the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables was scored from 0 to 3, with the sum of scores for each variable ranging from 0 to 15 yielding a total SES-CD score of 0-60, where higher scores indicated more severe disease.

Outcome measures

Measure	UC Participants: Vedolizumab 300 mg n=48 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Percentage of CD Participants With Mucosal Healing at Week 46	8.3 percentage of participants Interval 2.3 to 20.0	—

SECONDARY outcome

Timeframe: At Week 46

Population: SAS included all enrolled participants who received at least 1 dose of study drug.

Endoscopic response was defined as decrease in Mayo endoscopic sub-score of >=1 point in UC participants. Full Mayo Score evaluated ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic sub-score) ranges from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 are considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe, where higher scores indicated more severe disease.

Outcome measures

Measure	UC Participants: Vedolizumab 300 mg n=102 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Percentage of UC Participants With Endoscopic Response at Week 46	21.6 percentage of participants Interval 14.0 to 30.8	—

SECONDARY outcome

Timeframe: At Week 46

Population: SAS included all enrolled participants who received at least 1 dose of study drug.

Endoscopic response was defined as > 50% decrease in SES-CD in CD participants. SES-CD assessed the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables was scored from 0 to 3, with the sum of scores for each variable ranged from 0 to 15 yielding a total SES-CD score of 0-60, where higher scores indicated more severe disease.

Outcome measures

Measure	UC Participants: Vedolizumab 300 mg n=48 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Percentage of CD Participants With Endoscopic Response at Week 46	12.5 percentage of participants Interval 4.7 to 25.2	—

SECONDARY outcome

Timeframe: Baseline, Weeks 14, 30 and 46

Population: SAS included all enrolled participants who received at least 1 dose of study drug. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signified participants who were evaluable at specified timepoints.

The SIBDQ was a valid and reliable instrument used to assess quality of life in adult participants with Inflammatory Bowel Disease (IBD). It was a 10-item questionnaire that included questions on 4 domains of health-related quality of life (HRQoL): bowel systems, emotional function, social function, and systemic function and was scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). A total SIBDQ score was calculated by summing the scores from each domain; the total SIBDQ score ranged from 10 (poor HRQoL) to 70 (optimum HRQoL). Higher values of SIBDQ represented a better quality of life.

Outcome measures

Measure	UC Participants: Vedolizumab 300 mg n=91 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg n=45 Participants Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46 Change at Week 14	8.4 score on a scale Standard Deviation 12.91	8.3 score on a scale Standard Deviation 12.24
Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46 Change at Week 30	12.9 score on a scale Standard Deviation 13.16	8.4 score on a scale Standard Deviation 14.31
Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46 Change at Week 46	13.0 score on a scale Standard Deviation 12.84	10.6 score on a scale Standard Deviation 15.91

Adverse Events

UC Participants: Vedolizumab 300 mg

Serious events: 6 serious events

Other events: 25 other events

Deaths: 0 deaths

CD Participants: Vedolizumab 300 mg

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	UC Participants: Vedolizumab 300 mg n=102 participants at risk Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg n=48 participants at risk Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Hepatobiliary disorders Cholelithiasis	0.98% 1/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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% 0/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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	0.98% 1/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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% 0/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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 Intestinal obstruction	0.00% 0/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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% 1/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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 Pulmonary tuberculosis	0.98% 1/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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% 0/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.98% 1/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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% 0/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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 Small intestinal obstruction	0.98% 1/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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% 1/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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 Tuberculous pleurisy	0.98% 1/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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% 0/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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

Measure	UC Participants: Vedolizumab 300 mg n=102 participants at risk Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46.	CD Participants: Vedolizumab 300 mg n=48 participants at risk Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46.
Blood and lymphatic system disorders Anaemia	7.8% 8/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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.	12.5% 6/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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 Aphthous ulcer	0.00% 0/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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.	6.2% 3/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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	6.9% 7/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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% 0/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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 Dizziness	2.9% 3/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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.	6.2% 3/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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	4.9% 5/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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.	8.3% 4/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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	6.9% 7/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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.	12.5% 6/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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% 0/102 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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.	8.3% 4/48 • From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) 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: TrialDisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place