Trial · NCT02118584
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 weeks | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. | percentage of participants | NUMBER |
| PRIMARY | Part 1: Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) | At OLE Week 108 | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. Overall number analyzed is the number of participants with data available for analysis. | percentage of participants | NUMBER |
| PRIMARY | Part 1: Percentage of Participants With Endoscopic Remission | At OLE Week 108 | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. Overall number analyzed is the number of participants with data available for analysis. | percentage of participants | NUMBER |
| PRIMARY | Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0] | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Serious Adverse Events (SAEs) | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Serious Infection Related AES | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0 | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With AEs Leading to Etrolizumab Discontinuation | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Malignancies | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0 | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2: Number of Participants With Confirmed Progressive Multifocal Leukoencephalopathy (PML) During the Post-Treatment PML Monitoring Period | From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks | PML Safety Monitoring population included all participants who entered the PML SM period. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02118584/outcomes