Trial · NCT00385580
Outcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Response | Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks. | All treated participants. | participants | NUMBER |
| PRIMARY | Percentage of Participants With a Response | Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks. | All treated participants. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With a Decrease in PSA by at Least 50% From Baseline | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements. | participants | NUMBER |
| SECONDARY | Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Months of Decrease in PSA by at Least 50% From Baseline | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | Participants with a decrease in PSA by at least 50% from baseline | months | NUMBER |
| SECONDARY | Number of Participants With Decrease in PSA Velocity | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements. | participants | NUMBER |
| SECONDARY | Number of Participants With Decrease in PSA Log Slope | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements. | participants | NUMBER |
| SECONDARY | Number of Participants With Increase in PSA Doubling Time | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements and positive log slope pre-treatment and on-study measurements. | participants | NUMBER |
| SECONDARY | Number of Participants With CR or PR | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | All response-evaluable participants. | participants | NUMBER |
| SECONDARY | Number of Participants With CR, PR or SD | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | All response-evaluable participants. | participants | NUMBER |
| SECONDARY | Number of Participants With a Confirmed Improved Bone Scan | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | All response-evaluable participants. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Confirmed Improved Bone Scan | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | Participants with confirmed improved bone scan. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With Disease Progression | Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment. | All treated participants. | participants | NUMBER |
| SECONDARY | Median Number of Months to Disease Progression | Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment. | All treated participants. | months | MEDIAN |
| SECONDARY | Median Change From Baseline in Individual FAPSI Scores at Week 12 | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | All treated participants. | Units on a scale | MEDIAN |
| SECONDARY | Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36 | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | All treated participants. | Units on a scale | MEDIAN |
| SECONDARY | Median Change From Baseline in Individual FAPSI Scores at Week 24 | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | All treated participants. | Units on a scale | MEDIAN |
| SECONDARY | Median Change From Baseline in Individual FAPSI Scores at Week 36 | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | All treated participants. The number of participants for whom this data are available is too small for analysis. | ||
| SECONDARY | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs | From start of study drug therapy up to 30 days after the last dose. | All treated participants. | participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. | From start of study drug therapy up to 30 days after the last dose. | All treated participants. | 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/NCT00385580/outcomes