Trial · NCT04006457
Outcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 37
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until Follow-up Visit | From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40) | SAS was defined as all participants who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit | From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40) | SAS was defined as all participants who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit | From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40) | SAS was defined as all participants who took at least 1 dose of study intervention. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Main Study: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Until Follow-up Visit | From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40) | SAS was defined as all participants who took at least 1 dose of study intervention. Here, the Overall number of participants analyzed signifies the total number of participants evaluable for laboratory abnormalities, i.e. the number with at least one observation of the given laboratory test while on study treatment or during lag time (35 days after the last dose). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Vaccine Sub-study: Percentage of Participants With Tetanus Booster Response | Month 1 | Safety Analysis Set (SAS) was defined as all participants from this sub-study who received at least 1 vaccine (Tdap or meningococcal ACWY). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until End of Study | From start of study intervention (Day 1) until end of study | |||
| SECONDARY | Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until End of Study | From start of study intervention (Day 1) until end of study | |||
| SECONDARY | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Until End of Study | From start of study intervention (Day 1) until end of study | |||
| SECONDARY | Main Study: Number of Participants With Clinically Significant Laboratory Abnormalities Until End of Study | From start of study intervention (Day 1) until end of study | |||
| SECONDARY | Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | Full Analysis Set (FAS) was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points. | Percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Overall Number Analyzed signifies number of participants evaluable at specified time points. | Percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points. | Percentage of Participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points. | Percentage of Participants | NUMBER |
| SECONDARY | Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | FAS was defined as all participants regardless of whether they received study intervention. Here, Number Analyzed signifies number of participants evaluable at specified time points. | Units on a scale | MEAN |
| SECONDARY | Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points. | Units on a scale | MEAN |
| SECONDARY | Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points. | Percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points. | Percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyebrow Assessment (EBA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal EBA Score at Baseline | At Months 1, 3, 6, 12, 18, 24 and 36 | FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Number of Participants Analyzed included all participants from FAS without normal EBA score at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points. | Percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyelash Assessment (ELA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal ELA Score at Baseline | At Months 1, 3, 6, 12, 18, 24 and 36 | FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed included all participants from FAS without normal ELA score at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points. | Percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving Patient's Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Months 1, 3, 6, 9, 12, 18, 24 and 36 | At Months 1, 3, 6, 9, 12, 18, 24 and 36 | FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points. | Percentage of participants | NUMBER |
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/NCT04006457/outcomes