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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002784-14 | EudraCT Number | ||
| NMRR-08-1040-2195 | Registry Identifier | NMRR | |
| CTRI/2009/091/000138 | Registry Identifier | CTRI | |
| 10/H1102/12 | Registry Identifier | NRES | |
| NL25209.096.08 | Registry Identifier | CCMO |
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The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis or Crohn's disease. This study will determine the safety profile of long-term vedolizumab treatment.
The study enrolled 2243 patients. Participants who received either placebo or vedolizumab 300 mg IV infusion every 4 or 8 weeks in previous vedolizumab studies received:
• Vedolizumab 300 mg
All participants received vedolizumab intravenous infusion every 4 weeks for approximately up to 510 weeks.
This multicenter trial is being conducted worldwide. The overall time to participate in this study was up to October 2017 until vedolizumab was available in the country in which the participant resided, or until participant withdrawal, whichever came first. Participants made multiple visits to the clinic up to 16 weeks after receiving their last dose of vedolizumab and were being followed up for 2-years during which a safety questionnaire was administered by telephone for follow-up assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vedolizumab 300 mg | Experimental | Vedolizumab 300 mg, 30-minute intravenous (IV) infusion every 4 weeks, starting at Week 0 for approximately up to 510 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab | Drug | Vedolizumab intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. | From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years) |
| Number of Participants With Markedly Abnormal Safety Laboratory Findings | A laboratory value was considered a marked abnormality if it met the predefined criteria or parameters and the on-treatment value was more extreme than the Baseline value for the following parameters: hemoglobin <= 70 g/L, absolute lymphocyte count <0.5 X 10^9/L, leukocytes <2.0 X 10^9/L (absolute value), platelets <75.0 X 10^9/L, absolute neutrophil Count <1.0 X 10^9/L, prothrombin time >1.25 x upper limit of normal (ULN), alanine aminotransferase (ALT) >3.0 x ULN, aspartate aminotransferase (AST) >3.0 x ULN, bilirubin >2.0 x ULN, amylase >2.0 x ULN, lipase >2.0 x ULN. | From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years) |
| Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements | Vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure, and temperature) measurements were collected throughout the study. Any clinically significant mean change in vital signs over time as assessed by the investigator was reported as a TEAE. |
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Inclusion Criteria:
Exclusion Criteria:
1. Development of any new, unstable, or uncontrolled disease
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35934286 | Derived | Dulai PS, Feagan BG, Sands BE, Chen J, Lasch K, Lirio RA. Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):456-466.e7. doi: 10.1016/j.cgh.2022.07.027. Epub 2022 Aug 4. | |
| 33908636 | Derived | Wyant T, Yang L, Lirio RA, Rosario M. Vedolizumab Immunogenicity With Long-Term or Interrupted Treatment of Patients With Inflammatory Bowel Disease. J Clin Pharmacol. 2021 Sep;61(9):1174-1181. doi: 10.1002/jcph.1877. Epub 2021 Jul 14. |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a diagnosis of ulcerative colitis and Crohn's disease who participated in previous studies: C13004 (NCT00619489), C13006 (NCT00783718), C13007 (NCT00783692) and C13011 (NCT01224171) and DeNovo participants were enrolled into 1 treatment group, vedolizumab 300 mg, 30-minute intravenous (IV) infusion, every 4 weeks (Q4W).
Participants took part in study at 298 sites in North America, Western/Northern Europe, Central Europe, Eastern Europe, Asia, Australia and Africa from 22 May 2009 to 31 October 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vedolizumab 300 mg (C13006) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab every 8 weeks (Q8W), IV infusion up to Week 52. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 22, 2016 | Oct 31, 2018 |
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| From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years) |
| Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings | A standard 12-lead ECG was performed. Any ECGs assessed by the investigator to be clinically significant were reported as TEAEs. | From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years) |
| Time to Major Inflammatory Bowel Disease (IBD) - Related Events | IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis and Crohn's disease. | Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years) |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 |
| Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 |
| Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 |
| San Diego |
| California |
| 92114 |
| United States |
| San Francisco | California | 94115 | United States |
| Lafayette | Colorado | 80026 | United States |
| Littleton | Colorado | 80120 | United States |
| Thornton | Colorado | 80229 | United States |
| Hamden | Connecticut | 06518 | United States |
| Jacksonville | Florida | 32256 | United States |
| Miami | Florida | 33172 | United States |
| Winter Park | Florida | 32789 | United States |
| Atlanta | Georgia | 30024 | United States |
| Decatur | Georgia | 30033 | United States |
| Macon | Georgia | 31201 | United States |
| Topeka | Kansas | 66606 | United States |
| Louisville | Kentucky | 40202 | United States |
| Baton Rouge | Louisiana | 70809 | United States |
| Chevy Chase | Maryland | 20815 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Troy | Michigan | 48098 | United States |
| Rochester | Minnesota | 55904 | United States |
| Cheektowaga | New York | 10029 | United States |
| New York | New York | 10029 | United States |
| Charlotte | North Carolina | 28207 | United States |
| Elkin | North Carolina | 28621 | United States |
| Portland | Oregon | 97225 | United States |
| Germantown | Tennessee | 38138 | United States |
| San Antonio | Texas | 78229 | United States |
| Tyler | Texas | 75701 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Richmond | Virginia | 23249 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Adelaide | South Australia | 5000 | Australia |
| Leuven | 3000 | Belgium |
| Edmonton | Alberta | T6G2X8 | Canada |
| Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Prague | 170 04 | Czechia |
| Halle | Saint | 6097 | Germany |
| Szekszárd | 7100 | Hungary |
| Tel Aviv | 64239 | Israel |
| Kuala Lumpur | 59100 | Malaysia |
| Seoul | 130-702 | South Korea |
| 32876349 | Derived | Loftus EV Jr, Feagan BG, Panaccione R, Colombel JF, Sandborn WJ, Sands BE, Danese S, D'Haens G, Rubin DT, Shafran I, Parfionovas A, Rogers R, Lirio RA, Vermeire S. Long-term safety of vedolizumab for inflammatory bowel disease. Aliment Pharmacol Ther. 2020 Oct;52(8):1353-1365. doi: 10.1111/apt.16060. Epub 2020 Sep 2. |
| 30365009 | Derived | Feagan BG, Schreiber S, Wolf DC, Axler JL, Kaviya A, James A, Curtis RI, Geransar P, Stallmach A, Ehehalt R, Bokemeyer B, Khalid JM, O'Byrne S. Sustained Clinical Remission With Vedolizumab in Patients With Moderate-to-Severe Ulcerative Colitis. Inflamm Bowel Dis. 2019 May 4;25(6):1028-1035. doi: 10.1093/ibd/izy323. |
| 27802155 | Derived | Arijs I, De Hertogh G, Lemmens B, Van Lommel L, de Bruyn M, Vanhove W, Cleynen I, Machiels K, Ferrante M, Schuit F, Van Assche G, Rutgeerts P, Vermeire S. Effect of vedolizumab (anti-alpha4beta7-integrin) therapy on histological healing and mucosal gene expression in patients with UC. Gut. 2018 Jan;67(1):43-52. doi: 10.1136/gutjnl-2016-312293. Epub 2016 Oct 7. |
| 26893500 | Derived | Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18. |
| FG001 |
| Vedolizumab 300 mg (C13007) |
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52. |
| FG002 | Vedolizumab 300 mg (C13011) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| FG003 | Vedolizumab 300 mg (C13004) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78. |
| FG004 | Vedolizumab 300 mg (C13008 De Novo Participants) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn's disease (CD) or ulcerative colitis (UC) not treated in a previous study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population was defined as all participants who received any amount of vedolizumab in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vedolizumab 300 mg (C13006) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab Q8W, IV infusion up to Week 52. |
| BG001 | Vedolizumab 300 mg (C13007) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52. |
| BG002 | Vedolizumab 300 mg (C13011) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| BG003 | Vedolizumab 300 mg (C13004) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78. |
| BG004 | Vedolizumab 300 mg (C13008 De Novo Participants) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn's disease (CD) or ulcerative colitis (UC) not treated in a previous study. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||
| Body Weight | Mean | Standard Deviation | kg |
| ||||||||||
| BMI | Body Mass Index = weight (kg)/[height (m)^2]. BMI was not calculated for de novo participants as height was not collected for these participants. BMI data was available for only 1822 participants. | BMI was not calculated for de novo participants due to no collection of height information. | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. | The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population. | Posted | Number | percentage of participants | From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years) |
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| Primary | Number of Participants With Markedly Abnormal Safety Laboratory Findings | A laboratory value was considered a marked abnormality if it met the predefined criteria or parameters and the on-treatment value was more extreme than the Baseline value for the following parameters: hemoglobin <= 70 g/L, absolute lymphocyte count <0.5 X 10^9/L, leukocytes <2.0 X 10^9/L (absolute value), platelets <75.0 X 10^9/L, absolute neutrophil Count <1.0 X 10^9/L, prothrombin time >1.25 x upper limit of normal (ULN), alanine aminotransferase (ALT) >3.0 x ULN, aspartate aminotransferase (AST) >3.0 x ULN, bilirubin >2.0 x ULN, amylase >2.0 x ULN, lipase >2.0 x ULN. | The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population. | Posted | Number | participants | From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years) |
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| Primary | Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements | Vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure, and temperature) measurements were collected throughout the study. Any clinically significant mean change in vital signs over time as assessed by the investigator was reported as a TEAE. | The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population. | Posted | Number | percentage of participants | From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years) |
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| Primary | Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings | A standard 12-lead ECG was performed. Any ECGs assessed by the investigator to be clinically significant were reported as TEAEs. | The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population. | Posted | Number | participants | From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years) |
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| Primary | Time to Major Inflammatory Bowel Disease (IBD) - Related Events | IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis and Crohn's disease. | Efficacy population included participants who received at least one dose of vedolizumab and had at least one postbaseline disease activity measurement. | Posted | Median | 95% Confidence Interval | weeks | Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years) |
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| Primary | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | Intent to treat (ITT) population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 |
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| Primary | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 |
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| Primary | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 |
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| Primary | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 |
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| Primary | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 |
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| Primary | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 |
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| Primary | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 |
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| Primary | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 |
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| Primary | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 |
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| Primary | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable (NA) for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 |
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| Primary | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. | ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 |
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| Primary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. | ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 |
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| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. | ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. | ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 |
|
From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vedolizumab 300 mg | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13006, C13007 and C13011. | 10 | 2,243 | 825 | 2,243 | 1,820 | 2,243 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Epiploic appendagitis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pouchitis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Small intestinal stenosis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Intestinal stenosis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Enterocolonic fistula | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Colonic stenosis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Colon dysplasia | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Anal stenosis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Rectal stenosis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Periproctitis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with vedolizumab 300 mg and is not related. |
|
| Lobar pneumonia | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vaginal cellulitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was not related. |
|
| Septic shock | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Blister infected | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abscess jaw | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Campylobacter intestinal infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cryptosporidiosis infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| West Nile viral infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was related. |
|
| Giardiasis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cholangitis suppurative | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Infusion site infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Intestinal anastomosis complication | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dislocation of vertebra | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Accidental poisoning | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was not related. |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Urethral injury | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Carcinoid tumour of the appendix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was related. |
|
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with vedolizumab 300 mg and is not related. |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Spinal meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Neurilemmoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Fistula discharge | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Muscle disorder | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cholangitis sclerosing | Hepatobiliary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hernia obstructive | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pseudopolyp | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| No therapeutic response | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was not related. |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was not related. |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was not related. |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Bladder hypertrophy | Renal and urinary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Bladder prolapse | Renal and urinary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Urethral prolapse | Renal and urinary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Uterine cervical erosion | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Ovarian adhesion | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Ovarian mass | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Breast haematoma | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Myopericarditis | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Homicidal ideation | Psychiatric disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA, Version 14.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was not related. |
|
| Deep vein thrombosis | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus rash | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Scar | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vitello-intestinal duct remnant | Congenital, familial and genetic disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Spinal cord neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Arteriospasm coronary | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Serum sickness | Immune system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Bladder papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Rectourethral fistula | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Inguinal hernia strangulated | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Anal inflammation | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vulval cellulitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Enterocolitis viral | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Incision site infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Peridiverticular abscess | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Herpes zoster ophthalmic | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA, Version 14.0 | Systematic Assessment |
|
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 7, 2013 | Oct 31, 2018 | SAP_000.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C543529 | vedolizumab |
Not provided
Not provided
Not provided
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| India |
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| Malaysia |
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| New Zealand |
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| Singapore |
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| South Africa |
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| Korea, Republic Of |
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| Taiwan, Province Of China |
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| Czech Republic |
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| Greece |
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| Hungary |
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| Poland |
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| Romania |
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| Serbia |
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| Israel |
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| Russia |
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| Turkey |
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| Ukraine |
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| Canada |
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| United States |
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| Belgium |
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| Denmark |
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| France |
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| Germany |
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| Iceland |
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| Ireland |
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| Italy |
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| Netherlands |
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| Spain |
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| Sweden |
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| Switzerland |
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| United Kingdom |
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| Units | Counts |
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| Participants |
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| Counts |
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| Participants |
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|
| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q8W) |
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q8W) |
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q8W) |
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
|
|
| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
| OG008 | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study. |
| OG009 | Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
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| OG001 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q8W) |
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
| OG006 | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6. |
| OG007 | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
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| OG001 | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50. |
| OG002 | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50. |
| OG003 | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52. |
| OG004 | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52. |
| OG005 | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52. |
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