Trial · NCT00141102
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) | 6 month treatment duration | Intent-to-Treat (ITT) = included all randomized subjects. n = number of subjects with events confirmed by the committee. | participants | NUMBER |
| SECONDARY | Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs) | 6 month treatment duration | ITT. n = number of subjects with CSULGIEs or SUs as confirmed by the committee. | participants | NUMBER |
| SECONDARY | Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET) | Month 6/Early Termination (ET) | ITT. Number of Participants Analyzed = number of subjects with data available for the analysis. Last Observation Carried Forward (LOCF) method was used. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects With SUs | 6 month treatment duration | ITT. | participants | NUMBER |
| SECONDARY | Number of Subjects With CSULGIEs by History of GD Ulceration | 6 month treatment duration | ITT. n = number of subjects who had history or no history of GD ulceration. | participants | NUMBER |
| SECONDARY | Number of Subjects With Moderate to Severe Abdominal Symptoms | 6 month treatment duration | ITT | participants | NUMBER |
| SECONDARY | Number of Subjects Withdrawn Due to GI Adverse Events (AEs) | 6 month treatment duration | ITT | participants | NUMBER |
| SECONDARY | Change From Baseline in Hemoglobin at Month 6/ET | Month 6/ET | Safety population = all randomized subjects who received at least 1 dose of study medication. Number of Participants Analyzed = number of subjects with analyzable data. | grams (g)/deciliter (dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hematocrit at Month 6/ET | Month 6/ET | Safety population. Number of Participants Analyzed = number of subjects with analyzable data. | percent | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin | 6 month treatment duration | Safety population. Number of Participants Analyzed = number of subjects with analyzable data. | participants | NUMBER |
| SECONDARY | Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN) | 6 month treatment duration | Safety population. Number of participants analyzed = number of subjects with analyzable data. | participants | NUMBER |
| SECONDARY | Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET | Month 6/ET | Safety population. Number of participants analyzed = number of subjects with analyzable data. | IU/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Iron Binding Capacity to Month 6/ET | Month 6/ET | Safety population. Number of participants analyzed = number of subjects with analyzable data. | microgram (ug)/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Ferretin to Month 6/ET | Month 6/ET | Safety population. Number of participants analyzed = number of subjects with analyzable data. | ug/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in C-Reactive Protein to Month 6/ET | Month 6/ET | Safety population. Number of participants analyzed = number of subjects with analyzable data. | mg/dL | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Number of Subjects Alive at the Post Trial Interview | 6 months following last dose | Safety population. Number of participants analyzed = number of subjects with follow-up information available. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview | 6 months following last dose | Safety population. Number of participants analyzed = number of subjects with follow-up information available. | 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
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GET https://conductscience.org/api/trials/v1/NCT00141102/outcomes