A Phase 3 interventional study of Vedolizumab in Ulcerative Colitis and Crohn's Disease, sponsored by Takeda. Completed at 41 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-24.
Sponsored by Takeda · Phase 3, Interventional, and Other
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:
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.
1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.
This study's enrollment of 2,243 is above the median of 70 across 1,069 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Takeda is the lead sponsor of 1,025 studies on the registry; 92 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Development of any new, unstable, or uncontrolled disease
Vedolizumab 300 mg, 30-minute intravenous (IV) infusion every 4 weeks, starting at Week 0 for approximately up to 510 weeks.
Drug: Vedolizumab
Vedolizumab intravenous infusion
Also known as: MLN0002
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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.
| Milestone | Vedolizumab 300 mg (C13006) | Vedolizumab 300 mg (C13007) | Vedolizumab 300 mg (C13011) | Vedolizumab 300 mg (C13004) | Vedolizumab 300 mg (C13008 De Novo Participants) |
|---|---|---|---|---|---|
| Started | 675 | 726 | 384 | 37 | 421 |
| Completed | 237 | 246 | 115 | 23 | 145 |
| Not completed | 438 | 480 | 269 | 14 | 276 |
| Withdrew: Adverse event | 94 | 119 | 65 | 5 | 69 |
| Withdrew: Protocol violation(s) | 8 | 18 | 7 | 0 | 12 |
| Withdrew: Lack of efficacy | 192 | 176 | 130 | 1 | 121 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 123 | 120 | 52 | 6 | 50 |
| Withdrew: Lost to follow-up | 13 | 31 | 10 | 1 | 15 |
| Withdrew: Reason not specified | 8 | 16 | 4 | 1 | 9 |
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.
| percentage of participants | Vedolizumab 300 mg (UC) | Vedolizumab 300 mg (CD) |
|---|---|---|
| TEAEs | 93 | 96 |
| SAEs | 31 | 41 |
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.
| participants | Vedolizumab 300 mg (UC) | Vedolizumab 300 mg (CD) |
|---|---|---|
| Hemoglobin <= 70 g/L | 16 | 11 |
| Absolute Lymphocyte Count <0.5 X 10^9/L | 28 | 56 |
| Leukocytes <2.0 X 10^9/L (Absolute Value) | 1 | 3 |
| Platelets <75.0 X 10^9/L | 2 | 5 |
| Absolute Neutrophil Count <1.0 X 10^9/L | 9 | 9 |
| Prothrombin Time >1.25 x ULN | 42 | 37 |
| ALT >3.0 x ULN | 30 | 47 |
| AST >3.0 x ULN | 35 | 34 |
| Bilirubin >2.0 x ULN | 12 | 14 |
| Amylase >2.0 x ULN | 16 | 36 |
| Lipase >2.0 x ULN | 27 | 41 |
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.
| percentage of participants | Vedolizumab 300 mg (UC) | Vedolizumab 300 mg (CD) |
|---|---|---|
| Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements | 0 | 0 |
A standard 12-lead ECG was performed. Any ECGs assessed by the investigator to be clinically significant were reported as TEAEs.
| participants | Vedolizumab 300 mg (UC) | Vedolizumab 300 mg (CD) |
|---|---|---|
| Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings | 7 | 7 |
IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis and Crohn's disease.
| weeks | Vedolizumab 300 mg |
|---|---|
| IBD-related events, UC | NA (NA to NA) |
| IBD-related events, CD | NA (NA to NA) |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 125.34 ± 34.895 | 129.12 ± 34.289 | 124.37 ± 31.632 | 122.33 ± 31.114 | 127.56 ± 33.718 | 127.11 ± 30.537 | 123.88 ± 31.620 | 124.35 ± 33.310 | 131.44 ± 27.715 | 132.14 ± 32.245 |
| Change at Week 28 | 60.00 ± 41.165 | 62.71 ± 34.600 | 62.53 ± 35.072 | 57.17 ± 38.851 | 57.52 ± 42.561 | 51.48 ± 34.576 | 41.71 ± 36.508 | 40.49 ± 39.733 | 42.90 ± 32.581 | 30.84 ± 34.614 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 123.53 ± 36.160 | 131.17 ± 33.675 | 125.03 ± 32.560 | 120.29 ± 30.894 | 129.46 ± 34.799 | 128.69 ± 30.461 | 125.30 ± 30.075 | 125.31 ± 34.140 | 130.63 ± 28.446 | 132.71 ± 33.108 |
| Change at Week 52 | 66.84 ± 41.733 | 59.89 ± 33.170 | 61.06 ± 37.386 | 59.31 ± 34.837 | 58.87 ± 40.707 | 52.30 ± 29.385 | 44.31 ± 37.923 | 47.38 ± 37.687 | 47.07 ± 30.463 | 37.33 ± 40.232 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 123.66 ± 36.115 | 131.31 ± 33.726 | 123.87 ± 31.752 | 120.00 ± 29.667 | 128.47 ± 34.724 | 129.06 ± 31.694 | 124.89 ± 31.629 | 125.89 ± 34.478 | 130.75 ± 28.587 | 132.46 ± 33.245 |
| Change at Week 76 | 65.53 ± 40.584 | 59.88 ± 35.290 | 64.27 ± 32.443 | 59.91 ± 34.449 | 55.05 ± 47.181 | 52.85 ± 36.486 | 47.43 ± 35.811 | 46.32 ± 36.397 | 50.59 ± 30.794 | 40.14 ± 39.305 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 124.70 ± 37.614 | 130.90 ± 34.361 | 124.52 ± 30.033 | 120.89 ± 29.745 | 129.53 ± 35.261 | 128.25 ± 32.333 | 123.50 ± 29.662 | 128.35 ± 33.793 | 132.41 ± 28.538 | 132.48 ± 32.305 |
| Change at Week 100 | 61.83 ± 41.505 | 62.46 ± 32.502 | 62.83 ± 34.475 | 57.04 ± 38.448 | 58.53 ± 45.644 | 53.40 ± 32.651 | 49.89 ± 36.806 | 46.95 ± 34.691 | 52.50 ± 32.267 | 38.52 ± 36.982 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 127.33 ± 36.470 | 130.83 ± 34.399 | 123.65 ± 30.180 | 119.77 ± 29.963 | 132.36 ± 34.573 | 130.01 ± 33.454 | 122.91 ± 29.869 | 129.08 ± 33.576 | 132.75 ± 28.131 | 131.56 ± 31.567 |
| Change at Week 124 | 63.94 ± 44.480 | 60.94 ± 37.769 | 63.71 ± 34.542 | 61.91 ± 36.288 | 53.91 ± 44.023 | 53.74 ± 34.514 | 46.62 ± 38.435 | 47.60 ± 40.634 | 54.47 ± 29.636 | 40.35 ± 41.543 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 127.33 ± 36.470 | 131.95 ± 34.649 | 123.02 ± 29.685 | 119.07 ± 30.344 | 132.23 ± 35.877 | 130.25 ± 34.108 | 122.01 ± 28.967 | 128.66 ± 34.624 | 133.36 ± 28.616 | 132.38 ± 32.172 |
| Change at Week 148 | 60.66 ± 41.786 | 62.72 ± 33.786 | 65.81 ± 33.232 | 60.41 ± 36.074 | 54.53 ± 48.036 | 56.08 ± 32.954 | 52.30 ± 39.123 | 49.40 ± 36.880 | 54.50 ± 32.874 | 42.13 ± 40.030 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 130.25 ± 36.650 | 132.93 ± 34.216 | 123.47 ± 30.141 | 120.49 ± 30.221 | 131.60 ± 36.013 | 132.31 ± 33.860 | 120.70 ± 27.535 | 127.42 ± 34.779 | 133.34 ± 28.981 | 131.69 ± 32.229 |
| Change at Week 172 | 58.67 ± 42.513 | 62.20 ± 33.187 | 62.16 ± 33.969 | 65.43 ± 35.350 | 54.91 ± 40.758 | 53.92 ± 33.132 | 51.55 ± 40.714 | 47.97 ± 35.121 | 56.02 ± 33.863 | 41.18 ± 40.805 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 127.33 ± 36.470 | 135.33 ± 33.596 | 122.00 ± 30.129 | 119.35 ± 31.651 | 130.39 ± 36.410 | 132.16 ± 34.217 | 121.15 ± 28.703 | 126.44 ± 34.826 | 136.55 ± 27.551 | 137.27 ± 30.844 |
| Change at Week 196 | 63.19 ± 38.061 | 59.13 ± 33.318 | 68.89 ± 34.578 | 64.81 ± 36.563 | 58.90 ± 46.107 | 55.67 ± 32.453 | 52.22 ± 42.363 | 49.41 ± 35.662 | 49.05 ± 30.390 | 36.35 ± 41.424 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 116.05 ± 31.747 | 133.61 ± 32.538 | 120.28 ± 30.875 | 116.63 ± 32.888 | 131.81 ± 35.906 | 129.37 ± 31.455 | 122.00 ± 27.231 | 125.93 ± 35.080 | 127.00 ± 63.930 | 128.00 ± 35.749 |
| Change at Week 248 | 76.21 ± 38.693 | 57.52 ± 31.841 | 69.56 ± 38.680 | 65.72 ± 34.776 | 54.97 ± 41.658 | 58.76 ± 35.250 | 51.39 ± 45.950 | 53.04 ± 38.830 | 73.00 ± 48.446 | 72.00 ± 32.156 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) |
|---|---|---|---|---|---|---|---|---|
| Baseline | 100.71 ± 21.831 | 137.50 ± 30.478 | 120.38 ± 24.401 | 119.67 ± 33.463 | 134.88 ± 36.957 | 121.38 ± 30.133 | 120.25 ± 19.085 | 162.50 ± 47.376 |
| Change at Week 300 | 94.29 ± 38.612 | 55.43 ± 41.694 | 67.54 ± 27.823 | 69.00 ± 41.192 | 53.00 ± 41.542 | 72.00 ± 35.219 | 73.50 ± 12.342 | 2.00 ± 5.657 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) |
|---|---|---|---|---|---|---|
| Baseline | 89.00 ± NA | 120.00 ± NA | 118.00 ± 32.047 | 70.00 ± NA | 137.00 ± 28.284 | 126.00 ± NA |
| Change at Week 352 | 123.00 ± NA | 86.00 ± NA | 66.00 ± 33.181 | 131.00 ± NA | 37.50 ± 28.991 | 84.00 ± NA |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 39.57 ± 8.599 | 41.15 ± 8.313 | 40.05 ± 7.634 | 37.05 ± 7.522 | 37.87 ± 8.113 | 39.09 ± 7.771 | 37.92 ± 8.355 | 36.81 ± 8.274 | 40.06 ± 8.631 | 39.20 ± 7.306 |
| Change at Week 28 | 10.20 ± 8.792 | 8.22 ± 9.015 | 8.89 ± 7.110 | 9.85 ± 8.789 | 12.46 ± 8.900 | 9.60 ± 7.620 | 6.48 ± 8.514 | 7.74 ± 9.310 | 7.07 ± 8.752 | 5.67 ± 7.695 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 39.98 ± 11.349 | 40.70 ± 11.226 | 38.28 ± 11.039 | 35.49 ± 11.139 | 38.53 ± 10.631 | 37.70 ± 12.423 | 36.60 ± 11.545 | 38.04 ± 12.567 | 40.87 ± 11.385 | 39.29 ± 11.535 |
| Change at Week 28 | 8.36 ± 13.096 | 11.10 ± 11.098 | 11.52 ± 12.464 | 13.35 ± 11.857 | 10.88 ± 12.396 | 10.94 ± 12.386 | 7.48 ± 12.061 | 6.34 ± 13.161 | 6.48 ± 10.809 | 3.72 ± 12.377 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 39.94 ± 8.930 | 41.72 ± 8.314 | 40.12 ± 7.694 | 36.75 ± 7.510 | 37.82 ± 8.301 | 39.23 ± 7.807 | 37.87 ± 7.992 | 37.40 ± 8.171 | 40.51 ± 8.454 | 39.27 ± 7.469 |
| Change at Week 52 | 9.55 ± 10.155 | 8.57 ± 7.889 | 9.77 ± 6.766 | 9.43 ± 9.088 | 12.97 ± 9.147 | 9.98 ± 7.824 | 7.48 ± 8.800 | 8.97 ± 8.743 | 8.37 ± 8.401 | 6.72 ± 7.842 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 39.33 ± 11.878 | 41.18 ± 11.150 | 38.29 ± 11.062 | 35.43 ± 11.445 | 39.45 ± 9.910 | 38.98 ± 11.963 | 36.80 ± 11.052 | 38.54 ± 12.379 | 40.32 ± 11.333 | 39.16 ± 11.518 |
| Change at Week 52 | 10.27 ± 12.895 | 10.40 ± 10.777 | 12.18 ± 11.506 | 12.68 ± 11.843 | 10.54 ± 11.719 | 8.40 ± 11.598 | 8.27 ± 11.770 | 7.86 ± 13.129 | 6.71 ± 10.363 | 6.23 ± 12.306 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 39.79 ± 8.801 | 41.33 ± 8.517 | 40.07 ± 7.625 | 37.03 ± 7.675 | 37.92 ± 8.353 | 39.59 ± 7.809 | 37.53 ± 8.286 | 37.47 ± 8.147 | 40.73 ± 8.552 | 39.25 ± 7.667 |
| Change at Week 76 | 9.69 ± 9.714 | 8.97 ± 8.891 | 10.54 ± 6.416 | 10.48 ± 7.797 | 11.98 ± 9.496 | 10.28 ± 7.651 | 7.77 ± 8.397 | 8.82 ± 8.501 | 9.73 ± 8.461 | 7.31 ± 8.436 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 39.41 ± 11.201 | 41.30 ± 10.710 | 38.26 ± 10.974 | 35.50 ± 11.582 | 38.86 ± 10.046 | 38.52 ± 12.244 | 36.68 ± 11.947 | 39.03 ± 12.679 | 40.32 ± 11.673 | 39.16 ± 11.712 |
| Change at Week 76 | 9.64 ± 14.272 | 8.52 ± 11.462 | 10.51 ± 12.334 | 12.92 ± 13.174 | 8.02 ± 14.020 | 9.13 ± 13.719 | 8.27 ± 12.720 | 8.26 ± 12.809 | 7.77 ± 10.989 | 7.16 ± 13.144 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 41.26 ± 8.825 | 41.03 ± 8.260 | 40.29 ± 7.480 | 36.97 ± 7.677 | 38.11 ± 8.169 | 39.59 ± 7.989 | 37.26 ± 7.974 | 37.90 ± 8.297 | 41.13 ± 8.579 | 39.28 ± 7.458 |
| Change at Week 100 | 10.28 ± 8.418 | 9.41 ± 7.934 | 9.42 ± 7.556 | 11.18 ± 8.322 | 12.97 ± 9.396 | 10.78 ± 8.926 | 8.47 ± 8.096 | 9.45 ± 8.747 | 9.70 ± 8.869 | 7.40 ± 8.473 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 39.56 ± 11.833 | 41.10 ± 11.140 | 38.21 ± 10.885 | 35.61 ± 11.568 | 38.76 ± 10.215 | 37.41 ± 11.857 | 36.61 ± 11.894 | 39.43 ± 12.474 | 40.39 ± 11.559 | 39.04 ± 11.604 |
| Change at Week 100 | 8.80 ± 14.395 | 9.87 ± 10.552 | 10.82 ± 12.303 | 10.64 ± 13.629 | 8.94 ± 13.798 | 9.98 ± 11.450 | 8.25 ± 12.562 | 7.93 ± 11.053 | 7.66 ± 10.685 | 6.94 ± 13.189 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 41.75 ± 7.947 | 41.08 ± 8.219 | 39.88 ± 7.332 | 37.00 ± 7.854 | 38.58 ± 8.078 | 39.31 ± 8.279 | 37.09 ± 8.044 | 38.36 ± 8.240 | 41.10 ± 8.747 | 39.01 ± 7.363 |
| Change at Week 124 | 10.12 ± 9.685 | 7.91 ± 9.483 | 10.15 ± 8.551 | 11.79 ± 8.053 | 12.87 ± 8.803 | 11.01 ± 8.319 | 8.36 ± 7.495 | 7.77 ± 9.228 | 10.56 ± 8.804 | 9.27 ± 8.274 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 40.34 ± 12.065 | 40.81 ± 11.132 | 37.85 ± 11.106 | 35.29 ± 11.668 | 38.59 ± 9.956 | 38.33 ± 12.409 | 39.04 ± 12.421 | 36.64 ± 11.938 | 40.87 ± 11.156 | 38.90 ± 11.427 |
| Change at Week 124 | 9.53 ± 16.289 | 10.02 ± 10.734 | 9.70 ± 12.781 | 11.35 ± 12.681 | 9.20 ± 12.521 | 10.38 ± 13.230 | 8.50 ± 12.808 | 8.78 ± 13.283 | 7.73 ± 11.048 | 6.26 ± 13.274 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 41.75 ± 7.947 | 41.33 ± 8.438 | 39.86 ± 7.312 | 36.68 ± 8.055 | 39.22 ± 7.511 | 39.21 ± 8.303 | 36.94 ± 8.087 | 37.99 ± 8.430 | 43.32 ± 10.405 | 38.77 ± 7.024 |
| Change at Week 148 | 9.08 ± 9.090 | 9.35 ± 8.228 | 10.34 ± 6.524 | 12.15 ± 9.941 | 12.54 ± 9.695 | 11.26 ± 7.231 | 9.37 ± 8.223 | 8.94 ± 8.442 | 9.81 ± 8.727 | 10.39 ± 6.824 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 40.34 ± 12.065 | 41.20 ± 11.115 | 37.48 ± 11.101 | 35.05 ± 11.782 | 38.56 ± 10.221 | 39.21 ± 12.368 | 36.71 ± 12.021 | 39.36 ± 12.612 | 42.40 ± 8.427 | 41.67 ± 10.953 |
| Change at Week 148 | 6.89 ± 14.522 | 9.79 ± 11.176 | 11.09 ± 12.299 | 10.47 ± 12.517 | 9.27 ± 11.720 | 9.81 ± 12.524 | 8.91 ± 12.680 | 8.26 ± 12.835 | 6.44 ± 12.279 | 6.85 ± 12.118 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 42.23 ± 8.073 | 41.52 ± 8.401 | 40.23 ± 6.713 | 37.29 ± 8.057 | 38.82 ± 8.231 | 39.16 ± 8.177 | 36.92 ± 8.023 | 37.85 ± 8.538 | 41.12 ± 9.029 | 39.30 ± 7.264 |
| Change at Week 172 | 10.08 ± 8.996 | 9.20 ± 8.324 | 9.68 ± 6.804 | 11.83 ± 8.042 | 13.21 ± 9.194 | 10.88 ± 7.837 | 9.61 ± 8.461 | 9.07 ± 7.519 | 10.47 ± 8.921 | 8.55 ± 8.546 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 40.79 ± 12.254 | 41.49 ± 11.015 | 37.00 ± 10.963 | 35.47 ± 11.757 | 38.77 ± 10.268 | 39.83 ± 12.249 | 36.64 ± 11.938 | 39.01 ± 12.258 | 40.98 ± 11.479 | 38.85 ± 11.972 |
| Change at Week 172 | 7.43 ± 12.227 | 10.37 ± 10.420 | 9.57 ± 12.850 | 12.84 ± 12.281 | 9.12 ± 14.244 | 8.45 ± 13.317 | 8.78 ± 13.283 | 7.52 ± 12.609 | 8.66 ± 10.767 | 7.48 ± 12.329 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) |
|---|---|---|---|---|---|---|---|---|
| Baseline | 40.72 ± 7.823 | 40.83 ± 8.135 | 40.52 ± 7.242 | 35.64 ± 7.862 | 36.65 ± 9.250 | 39.33 ± 8.136 | 39.53 ± 7.830 | 38.40 ± 9.680 |
| Change at Week 196 | 11.82 ± 9.370 | 9.98 ± 7.569 | 9.31 ± 5.771 | 12.35 ± 8.867 | 14.10 ± 10.616 | 11.75 ± 8.261 | 6.94 ± 8.667 | 9.83 ± 8.111 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) |
|---|---|---|---|---|---|---|---|---|
| Baseline | 39.46 ± 13.424 | 42.74 ± 10.517 | 40.40 ± 9.771 | 36.17 ± 12.536 | 39.07 ± 10.804 | 37.63 ± 12.199 | 40.11 ± 10.932 | 40.05 ± 13.807 |
| Change at Week 196 | 9.37 ± 12.087 | 9.43 ± 9.349 | 9.79 ± 11.516 | 12.62 ± 14.386 | 10.05 ± 15.471 | 9.26 ± 12.732 | 8.59 ± 14.645 | 9.75 ± 14.824 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 39.99 ± 7.219 | 40.71 ± 7.605 | 39.33 ± 6.820 | 37.54 ± 8.054 | 38.32 ± 8.047 | 40.28 ± 8.878 | 37.95 ± 8.232 | 37.77 ± 8.654 | 39.17 ± 13.987 | 38.79 ± 7.735 |
| Change at Week 248 | 11.22 ± 10.562 | 9.95 ± 8.355 | 11.43 ± 8.047 | 11.70 ± 6.541 | 13.88 ± 8.511 | 9.98 ± 9.027 | 9.32 ± 9.261 | 10.50 ± 8.803 | 15.98 ± 7.868 | 9.88 ± 6.977 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 38.00 ± 12.537 | 41.76 ± 10.579 | 38.01 ± 10.876 | 34.26 ± 12.252 | 38.06 ± 10.300 | 38.04 ± 11.320 | 36.41 ± 13.568 | 36.77 ± 12.333 | 38.65 ± 18.372 | 31.20 ± 4.603 |
| Change at Week 248 | 11.99 ± 13.421 | 6.13 ± 9.986 | 10.41 ± 13.081 | 12.70 ± 12.140 | 9.84 ± 11.433 | 10.61 ± 11.204 | 7.37 ± 16.473 | 10.61 ± 12.188 | 7.64 ± 18.599 | 15.98 ± 13.355 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) |
|---|---|---|---|---|---|---|---|---|
| Baseline | 36.89 ± 5.913 | 38.84 ± 7.720 | 39.22 ± 5.469 | 36.56 ± 8.514 | 34.80 ± 8.431 | 39.97 ± 6.626 | 41.04 ± 12.016 | 34.80 ± 10.515 |
| Change at Week 300 | 12.03 ± 10.338 | 10.58 ± 8.335 | 11.15 ± 6.497 | 15.47 ± 9.920 | 14.42 ± 6.749 | 10.69 ± 6.448 | 9.10 ± 9.330 | 6.41 ± 9.023 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) |
|---|---|---|---|---|---|---|---|---|
| Baseline | 34.53 ± 12.530 | 43.55 ± 9.074 | 35.77 ± 8.585 | 33.38 ± 11.168 | 39.40 ± 11.144 | 35.79 ± 12.157 | 31.35 ± 13.760 | 46.99 ± 7.729 |
| Change at Week 300 | 21.86 ± 13.935 | 4.82 ± 10.738 | 9.82 ± 11.463 | 13.46 ± 15.324 | 6.31 ± 11.916 | 14.79 ± 15.281 | 19.87 ± 6.588 | -3.67 ± 20.577 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) |
|---|---|---|---|---|---|---|
| Baseline | 35.68 ± NA | 38.32 ± NA | 44.36 ± 0.920 | 31.07 ± NA | 37.14 ± 3.711 | 33.67 ± NA |
| Change at Week 352 | 17.97 ± NA | 17.87 ± NA | 5.06 ± 5.188 | 24.06 ± NA | 11.18 ± 2.116 | 18.02 ± NA |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) |
|---|---|---|---|---|---|---|
| Baseline | 42.19 ± NA | 35.34 ± NA | 32.72 ± 7.252 | 22.18 ± NA | 39.80 ± 14.563 | 42.98 ± NA |
| Change at Week 352 | 17.40 ± NA | 19.87 ± NA | 14.14 ± 10.114 | 25.04 ± NA | 8.65 ± 7.463 | 13.08 ± NA |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 7.42 ± 1.328 | 7.21 ± 1.354 | 7.54 ± 1.399 | 8.00 ± 1.559 | 7.77 ± 1.442 | 7.73 ± 1.434 | 7.67 ± 1.475 | 7.85 ± 1.525 | 7.30 ± 1.360 | 7.48 ± 1.420 |
| Change at Week 28 | -1.29 ± 1.873 | -1.03 ± 1.705 | -1.44 ± 1.568 | -1.65 ± 1.867 | -1.82 ± 1.675 | -1.46 ± 1.510 | -0.75 ± 1.648 | -0.90 ± 1.634 | -0.96 ± 1.380 | -0.69 ± 1.493 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 58.4 ± 20.96 | 62.1 ± 16.54 | 53.5 ± 17.30 | 51.5 ± 17.57 | 52.2 ± 18.72 | 52.3 ± 18.39 | 53.2 ± 18.02 | 51.3 ± 19.09 | 56.4 ± 19.64 | 55.6 ± 16.72 |
| Change at Week 28 | 22.7 ± 24.11 | 20.0 ± 18.75 | 25.1 ± 22.09 | 23.8 ± 23.79 | 27.6 ± 22.58 | 23.7 ± 22.51 | 16.8 ± 22.55 | 19.9 ± 22.44 | 17.1 ± 21.75 | 13.4 ± 19.48 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 7.50 ± 1.368 | 7.17 ± 1.318 | 7.54 ± 1.390 | 8.08 ± 1.499 | 7.75 ± 1.468 | 7.65 ± 1.358 | 7.62 ± 1.398 | 7.74 ± 1.538 | 7.33 ± 1.386 | 7.49 ± 1.429 |
| Change at Week 52 | -1.59 ± 1.775 | -1.00 ± 1.571 | -1.43 ± 1.556 | -1.60 ± 1.673 | -1.77 ± 1.640 | -1.46 ± 1.457 | -0.87 ± 1.666 | -1.15 ± 1.703 | -0.95 ± 1.551 | -0.85 ± 1.637 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 57.5 ± 21.39 | 61.9 ± 16.18 | 52.3 ± 18.09 | 50.8 ± 17.82 | 52.6 ± 19.43 | 52.7 ± 18.38 | 53.3 ± 17.21 | 52.2 ± 18.94 | 55.9 ± 20.51 | 56.3 ± 16.21 |
| Change at Week 52 | 22.9 ± 27.46 | 18.5 ± 20.31 | 27.0 ± 21.87 | 27.9 ± 20.70 | 30.8 ± 21.59 | 25.0 ± 18.85 | 19.9 ± 22.83 | 23.5 ± 23.03 | 20.8 ± 21.93 | 17.6 ± 22.69 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 7.48 ± 1.379 | 7.18 ± 1.337 | 7.56 ± 1.267 | 8.11 ± 1.434 | 7.72 ± 1.420 | 7.64 ± 1.385 | 7.69 ± 1.489 | 7.74 ± 1.545 | 7.28 ± 1.348 | 7.52 ± 1.464 |
| Change at Week 76 | -1.38 ± 1.498 | -1.05 ± 1.583 | -1.33 ± 1.513 | -1.67 ± 1.430 | -1.50 ± 1.724 | -1.52 ± 1.466 | -1.11 ± 1.518 | -1.14 ± 1.496 | -1.26 ± 1.481 | -1.05 ± 1.546 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 58.8 ± 21.93 | 62.3 ± 17.01 | 52.0 ± 18.47 | 50.7 ± 16.81 | 52.0 ± 19.38 | 52.4 ± 18.88 | 52.5 ± 17.18 | 51.4 ± 18.99 | 56.1 ± 20.36 | 55.8 ± 16.19 |
| Change at Week 76 | 20.9 ± 25.66 | 18.7 ± 20.65 | 25.1 ± 19.62 | 27.3 ± 18.87 | 30.3 ± 23.68 | 27.0 ± 21.49 | 22.2 ± 20.82 | 23.3 ± 21.40 | 19.2 ± 25.10 | 17.8 ± 22.04 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 7.48 ± 1.451 | 7.22 ± 1.325 | 7.55 ± 1.391 | 8.04 ± 1.507 | 7.69 ± 1.446 | 7.67 ± 1.375 | 7.71 ± 1.428 | 7.71 ± 1.507 | 7.28 ± 1.360 | 7.53 ± 1.401 |
| Change at Week 100 | -1.48 ± 1.602 | -1.26 ± 1.528 | -1.43 ± 1.452 | -1.64 ± 1.773 | -1.73 ± 1.741 | -1.62 ± 1.394 | -1.04 ± 1.609 | -1.16 ± 1.538 | -1.37 ± 1.477 | -0.98 ± 1.473 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 59.2 ± 22.81 | 61.3 ± 16.80 | 52.9 ± 16.94 | 50.7 ± 16.81 | 53.8 ± 18.76 | 51.9 ± 19.02 | 51.9 ± 16.53 | 52.2 ± 19.18 | 56.5 ± 20.68 | 55.3 ± 16.49 |
| Change at Week 100 | 20.4 ± 27.47 | 20.7 ± 17.45 | 26.4 ± 21.82 | 26.9 ± 22.39 | 29.4 ± 23.09 | 26.9 ± 21.76 | 22.3 ± 20.11 | 23.1 ± 21.82 | 19.4 ± 26.78 | 16.6 ± 21.92 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 7.33 ± 1.271 | 7.24 ± 1.329 | 7.61 ± 1.406 | 8.14 ± 1.457 | 7.62 ± 1.423 | 7.69 ± 1.446 | 7.73 ± 1.441 | 7.65 ± 1.510 | 7.28 ± 1.223 | 7.54 ± 1.401 |
| Change at Week 124 | -1.52 ± 1.805 | -1.07 ± 1.566 | -1.52 ± 1.539 | -1.70 ± 1.655 | -1.60 ± 1.690 | -1.69 ± 1.560 | -0.85 ± 1.662 | -1.05 ± 1.637 | -1.34 ± 1.560 | -1.07 ± 1.639 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 61.2 ± 21.60 | 61.6 ± 16.98 | 52.0 ± 16.58 | 50.0 ± 16.87 | 54.8 ± 17.87 | 52.4 ± 19.58 | 51.8 ± 16.77 | 52.8 ± 19.62 | 56.1 ± 20.59 | 55.6 ± 15.81 |
| Change at Week 124 | 24.0 ± 25.45 | 19.7 ± 18.12 | 23.8 ± 21.39 | 29.4 ± 21.15 | 28.1 ± 20.71 | 24.5 ± 28.36 | 21.1 ± 21.77 | 23.8 ± 21.41 | 22.2 ± 26.13 | 18.1 ± 24.00 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 7.33 ± 1.271 | 7.20 ± 1.337 | 7.64 ± 1.415 | 8.17 ± 1.447 | 7.60 ± 1.450 | 7.65 ± 1.370 | 7.75 ± 1.434 | 7.72 ± 1.541 | 7.31 ± 1.376 | 7.52 ± 1.396 |
| Change at Week 148 | -1.30 ± 1.589 | -1.26 ± 1.544 | -1.62 ± 1.417 | -1.66 ± 1.559 | -1.74 ± 1.774 | -1.67 ± 1.175 | -1.11 ± 1.740 | -1.36 ± 1.679 | -1.47 ± 1.591 | -1.24 ± 1.644 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 61.2 ± 21.60 | 61.5 ± 17.24 | 51.4 ± 16.62 | 49.4 ± 17.04 | 54.3 ± 18.04 | 52.1 ± 19.63 | 51.5 ± 16.66 | 52.0 ± 19.73 | 56.2 ± 20.93 | 55.6 ± 16.31 |
| Change at Week 148 | 23.4 ± 27.31 | 21.9 ± 18.53 | 28.7 ± 19.43 | 28.2 ± 20.56 | 28.2 ± 21.30 | 24.7 ± 22.11 | 24.9 ± 25.63 | 24.6 ± 22.24 | 23.9 ± 23.40 | 21.1 ± 22.50 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 7.28 ± 1.308 | 7.17 ± 1.326 | 7.67 ± 1.449 | 8.03 ± 1.385 | 7.65 ± 1.446 | 7.70 ± 1.337 | 7.71 ± 1.436 | 7.81 ± 1.548 | 7.33 ± 1.407 | 7.62 ± 1.428 |
| Change at Week 172 | -1.24 ± 1.535 | -1.19 ± 1.665 | -1.45 ± 1.569 | -1.76 ± 1.747 | -1.74 ± 1.747 | -1.72 ± 1.098 | -1.07 ± 1.722 | -1.27 ± 1.695 | -1.52 ± 1.546 | -1.23 ± 1.653 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 61.6 ± 22.40 | 62.1 ± 16.84 | 51.3 ± 16.87 | 49.7 ± 17.87 | 54.2 ± 17.79 | 52.4 ± 20.42 | 51.3 ± 16.58 | 50.9 ± 19.40 | 55.9 ± 20.95 | 55.4 ± 15.90 |
| Change at Week 172 | 19.8 ± 27.91 | 20.3 ± 21.59 | 25.9 ± 21.53 | 29.2 ± 22.92 | 29.4 ± 21.40 | 25.9 ± 25.70 | 26.0 ± 20.30 | 23.9 ± 23.72 | 25.2 ± 22.04 | 22.2 ± 21.21 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 7.33 ± 1.271 | 7.14 ± 1.325 | 7.54 ± 1.312 | 8.11 ± 1.487 | 7.68 ± 1.474 | 7.66 ± 1.389 | 7.71 ± 1.476 | 7.82 ± 1.579 | 7.34 ± 1.292 | 7.61 ± 1.297 |
| Change at Week 196 | -1.30 ± 1.436 | -1.06 ± 1.490 | -1.52 ± 1.426 | -1.89 ± 1.449 | -1.85 ± 1.783 | -1.90 ± 1.375 | -1.12 ± 1.687 | -1.42 ± 1.555 | -1.44 ± 1.656 | -1.37 ± 1.697 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 61.2 ± 21.60 | 61.3 ± 16.63 | 52.5 ± 17.01 | 49.0 ± 18.41 | 54.2 ± 17.71 | 52.8 ± 20.56 | 51.5 ± 16.72 | 51.5 ± 19.58 | 56.7 ± 20.21 | 56.5 ± 14.35 |
| Change at Week 196 | 22.9 ± 28.01 | 21.6 ± 17.20 | 26.4 ± 20.17 | 31.9 ± 23.39 | 29.1 ± 22.45 | 29.2 ± 22.32 | 24.6 ± 21.32 | 23.3 ± 26.17 | 22.1 ± 22.91 | 23.2 ± 18.14 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 7.48 ± 1.365 | 7.21 ± 1.119 | 7.69 ± 1.215 | 8.09 ± 1.510 | 7.66 ± 1.450 | 7.84 ± 1.463 | 7.63 ± 1.532 | 7.89 ± 1.541 | 7.33 ± 1.155 | 7.75 ± 1.500 |
| Change at Week 248 | -1.67 ± 1.653 | -1.03 ± 1.619 | -1.58 ± 1.339 | -2.03 ± 1.425 | -1.81 ± 1.554 | -1.97 ± 1.538 | -1.05 ± 2.039 | -1.57 ± 1.521 | -2.00 ± 1.000 | -2.00 ± 1.414 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) | Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Vedolizumab 300 mg (C13008 De Novo Participants - CD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 57.2 ± 21.28 | 61.6 ± 16.17 | 52.1 ± 16.63 | 47.2 ± 18.17 | 52.3 ± 16.40 | 53.2 ± 19.72 | 50.8 ± 17.39 | 49.0 ± 19.37 | 61.3 ± 28.11 | 47.5 ± 7.33 |
| Change at Week 248 | 27.5 ± 25.77 | 17.7 ± 18.62 | 28.0 ± 22.14 | 34.9 ± 18.79 | 32.1 ± 19.98 | 29.9 ± 24.37 | 24.7 ± 25.34 | 28.9 ± 27.65 | 28.7 ± 32.72 | 34.3 ± 11.44 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) |
|---|---|---|---|---|---|---|---|---|
| Baseline | 8.14 ± 1.069 | 7.50 ± 0.941 | 8.08 ± 1.115 | 8.33 ± 1.803 | 7.88 ± 1.356 | 7.94 ± 1.063 | 7.75 ± 2.062 | 7.00 ± 0.000 |
| Change at Week 300 | -2.29 ± 1.799 | -1.43 ± 2.065 | -1.77 ± 1.363 | -2.11 ± 1.965 | -2.00 ± 2.138 | -2.25 ± 1.438 | -1.50 ± 1.291 | 0.50 ± 2.121 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Vedolizumab 300 mg (C13011 Placebo) | Vedolizumab 300 mg (C13011 Vedolizumab) |
|---|---|---|---|---|---|---|---|---|
| Baseline | 58.1 ± 20.27 | 64.9 ± 11.82 | 55.7 ± 10.10 | 50.4 ± 22.34 | 53.1 ± 15.80 | 42.9 ± 19.54 | 43.5 ± 19.12 | 52.0 ± 24.04 |
| Change at Week 300 | 23.6 ± 29.14 | 20.4 ± 17.92 | 28.4 ± 14.78 | 33.2 ± 25.83 | 31.3 ± 17.47 | 43.6 ± 23.17 | 40.3 ± 9.50 | 13.0 ± 11.31 |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) |
|---|---|---|---|---|---|---|
| Baseline | 8.00 ± NA | 8.00 ± NA | 8.33 ± 0.577 | 12.00 ± NA | 8.00 ± 1.414 | 9.00 ± NA |
| Change at Week 352 | -2.00 ± NA | -3.00 ± NA | -1.33 ± 1.528 | -6.00 ± NA | -1.00 ± 0.000 | -4.00 ± NA |
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.
| score on a scale | Vedolizumab 300 mg (C13006 Placebo) | Vedolizumab 300 mg (C13006 Vedolizumab Q8W) | Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Vedolizumab 300 mg (C13007 Placebo) | Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Vedolizumab 300 mg (C13007 Vedolizumab Q4W) |
|---|---|---|---|---|---|---|
| Baseline | 52.0 ± NA | 50.0 ± NA | 48.0 ± 8.19 | 15.0 ± NA | 50.0 ± 14.14 | 31.0 ± NA |
| Change at Week 352 | 46.0 ± NA | 40.0 ± NA | 24.3 ± 20.11 | 64.0 ± NA | 24.0 ± 8.49 | 59.0 ± NA |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vedolizumab 300 mg | 10/2,243 (0.4%) | 825/2,243 (36.8%) | 1,820/2,243 (81.1%) |
| Event | Vedolizumab 300 mg |
|---|---|
| Crohn's diseaseGastrointestinal disorders | 225/2243 |
| Colitis ulcerativeGastrointestinal disorders | 120/2243 |
| Abdominal painGastrointestinal disorders | 50/2243 |
| Anal abscessInfections and infestations | 33/2243 |
| Small intestinal obstructionGastrointestinal disorders | 29/2243 |
| PneumoniaInfections and infestations | 21/2243 |
| GastroenteritisInfections and infestations | 19/2243 |
| Intestinal obstructionGastrointestinal disorders | 17/2243 |
| AppendicitisInfections and infestations | 17/2243 |
| Anal fistulaGastrointestinal disorders | 15/2243 |
| Event | Vedolizumab 300 mg |
|---|---|
| NasopharyngitisInfections and infestations | 594/2243 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 482/2243 |
| HeadacheNervous system disorders | 452/2243 |
| Abdominal painGastrointestinal disorders | 393/2243 |
| Upper respiratory tract infectionInfections and infestations | 379/2243 |
| Crohn's diseaseGastrointestinal disorders | 333/2243 |
| NauseaGastrointestinal disorders | 333/2243 |
| DiarrhoeaGastrointestinal disorders | 284/2243 |
| PyrexiaGeneral disorders | 277/2243 |
| Colitis ulcerativeGastrointestinal disorders | 251/2243 |
Safety population was defined as all participants who received any amount of vedolizumab in this study.
| Age, Continuous(years) | Vedolizumab 300 mg (C13006) | Vedolizumab 300 mg (C13007) | Vedolizumab 300 mg (C13011) | Vedolizumab 300 mg (C13004) | Vedolizumab 300 mg (C13008 De Novo Participants) | Total |
|---|---|---|---|---|---|---|
| Mean | 41.2 ± 13.27 | 37.3 ± 12.26 | 38.3 ± 12.87 | 43.9 ± 14.24 | 39.3 ± 14.23 | 39.1 ± 13.19 |
| Age, Customized(Participants) | Vedolizumab 300 mg (C13006) | Vedolizumab 300 mg (C13007) | Vedolizumab 300 mg (C13011) | Vedolizumab 300 mg (C13004) | Vedolizumab 300 mg (C13008 De Novo Participants) | Total |
|---|---|---|---|---|---|---|
| <65 | 646 | 710 | 376 | 35 | 400 | 2167 |
| >=65 | 29 | 16 | 8 | 2 | 21 | 76 |
| Sex: Female, Male(Participants) | Vedolizumab 300 mg (C13006) | Vedolizumab 300 mg (C13007) | Vedolizumab 300 mg (C13011) | Vedolizumab 300 mg (C13004) | Vedolizumab 300 mg (C13008 De Novo Participants) | Total |
|---|---|---|---|---|---|---|
| Female | 280 | 384 | 216 | 20 | 215 | 1115 |
| Male | 395 | 342 | 168 | 17 | 206 | 1128 |
| Ethnicity (NIH/OMB)(Participants) | Vedolizumab 300 mg (C13006) | Vedolizumab 300 mg (C13007) | Vedolizumab 300 mg (C13011) | Vedolizumab 300 mg (C13004) | Vedolizumab 300 mg (C13008 De Novo Participants) | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 29 | 12 | 7 | 0 | 19 | 67 |
| Not Hispanic or Latino | 631 | 700 | 372 | 36 | 400 | 2139 |
| Unknown or Not Reported | 15 | 14 | 5 | 1 | 2 | 37 |
| Race/Ethnicity, Customized(Participants) | Vedolizumab 300 mg (C13006) | Vedolizumab 300 mg (C13007) | Vedolizumab 300 mg (C13011) | Vedolizumab 300 mg (C13004) | Vedolizumab 300 mg (C13008 De Novo Participants) | Total |
|---|---|---|---|---|---|---|
| White | 557 | 641 | 349 | 36 | 398 | 1981 |
| Black | 10 | 17 | 7 | 0 | 8 | 42 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 1 | 0 | 0 | 3 |
| Asian | 98 | 66 | 14 | 0 | 9 | 187 |
| American Indian or Alaskan Native | 2 | 0 | 0 | 1 | 0 | 3 |
| Other | 6 | 2 | 11 | 0 | 5 | 24 |
| Not Reported | 0 | 0 | 2 | 0 | 1 | 3 |
| Region of Enrollment(Participants) | Vedolizumab 300 mg (C13006) | Vedolizumab 300 mg (C13007) | Vedolizumab 300 mg (C13011) | Vedolizumab 300 mg (C13004) | Vedolizumab 300 mg (C13008 De Novo Participants) | Total |
|---|---|---|---|---|---|---|
| Australia | 41 | 30 | 8 | 0 | 21 | 100 |
| Hong Kong | 1 | 2 | 0 | 0 | 0 | 3 |
| India | 39 | 24 | 0 | 0 | 0 | 63 |
| Malaysia | 8 | 6 | 3 | 0 | 0 | 17 |
| New Zealand | 9 | 8 | 1 | 0 | 8 | 26 |
| Singapore | 1 | 1 | 0 | 0 | 0 | 2 |
| South Africa | 13 | 15 | 8 | 0 | 0 | 36 |
| Korea, Republic Of | 34 | 18 | 7 | 0 | 0 | 59 |
| Taiwan, Province Of China | 1 | 3 | 0 | 0 | 0 | 4 |
| Czech Republic | 34 | 67 | 36 | 0 | 69 | 206 |
| Greece | 5 | 0 | 0 | 0 | 0 | 5 |
| Hungary | 12 | 47 | 22 | 0 | 17 | 98 |
| Poland | 53 | 20 | 9 | 0 | 0 | 82 |
| Romania | 0 | 4 | 0 | 0 | 0 | 4 |
| Serbia | 0 | 2 | 0 | 0 | 0 | 2 |
| Slovakia | 0 | 14 | 17 | 0 | 0 | 31 |
| Bulgaria | 5 | 6 | 0 | 0 | 0 | 11 |
| Estonia | 9 | 5 | 0 | 0 | 0 | 14 |
| Israel | 2 | 12 | 21 | 0 | 21 | 56 |
| Latvia | 0 | 1 | 0 | 0 | 0 | 1 |
| Russia | 46 | 24 | 0 | 15 | 0 | 85 |
| Turkey | 6 | 3 | 0 | 0 | 0 | 9 |
| Ukraine | 0 | 9 | 0 | 0 | 0 | 9 |
| Canada | 73 | 98 | 75 | 22 | 87 | 355 |
| United States | 169 | 166 | 109 | 0 | 147 | 591 |
| Austria | 13 | 9 | 3 | 0 | 0 | 25 |
| Belgium | 48 | 48 | 33 | 0 | 46 | 175 |
| Denmark | 2 | 0 | 0 | 0 | 0 | 2 |
| France | 11 | 25 | 10 | 0 | 0 | 46 |
| Germany | 10 | 25 | 4 | 0 | 5 | 44 |
| Iceland | 3 | 3 | 0 | 0 | 0 | 6 |
| Ireland | 1 | 1 | 0 | 0 | 0 | 2 |
| Italy | 12 | 7 | 4 | 0 | 0 | 23 |
| Netherlands | 2 | 5 | 12 | 0 | 0 | 19 |
| Norway | 7 | 5 | 2 | 0 | 0 | 14 |
| Spain | 1 | 4 | 0 | 0 | 0 | 5 |
| Sweden | 0 | 5 | 0 | 0 | 0 | 5 |
| Switzerland | 2 | 4 | 0 | 0 | 0 | 6 |
| United Kingdom | 2 | 0 | 0 | 0 | 0 | 2 |
| Body Weight(kg) | Vedolizumab 300 mg (C13006) | Vedolizumab 300 mg (C13007) | Vedolizumab 300 mg (C13011) | Vedolizumab 300 mg (C13004) | Vedolizumab 300 mg (C13008 De Novo Participants) | Total |
|---|---|---|---|---|---|---|
| Mean | 74.10 ± 17.934 | 71.70 ± 19.600 | 71.29 ± 18.951 | 77.66 ± 18.907 | 75.45 ± 18.814 | 73.15 ± 18.900 |
| BMI(kg/m^2) | Vedolizumab 300 mg (C13006) | Vedolizumab 300 mg (C13007) | Vedolizumab 300 mg (C13011) | Vedolizumab 300 mg (C13004) | Vedolizumab 300 mg (C13008 De Novo Participants) | Total |
|---|---|---|---|---|---|---|
| Mean | 25.39 ± 5.391 | 24.61 ± 6.039 | 24.56 ± 5.783 | 27.11 ± 6.523 | — | 24.94 ± 5.779 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: 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.
Data sharing details ↗ · vivli.org
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Studies of the drug tested here: Vedolizumab