Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's Disease
Brief Summary: 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.


Options:
A: Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation (Week 6)
B: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)
C: Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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)
D: N/A

Answer: C