Trial · NCT00519285
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival Time | From randomization up to the cut-off date (median follow-up of 35.4 months) | The analysis was performed on the Intent-to-treat (ITT) population (i.e all randomized participants according to the treatment assigned regardless of the drug actually received).~At the cut-off date, 873 deaths had occurred, 445 in the Placebo group and 428 in the Aflibercept group. | months | MEDIAN |
| SECONDARY | Prostate Specific Antigen Response Rate | Before randomization (baseline) then every 3 weeks up to PSA progression (≥25% increase) or the cut-off date, whichever occurred first | The analysis was performed on the ITT population evaluable for PSA response (i.e. with a baseline PSA ≥10 ng/mL). | percentage of participants | NUMBER |
| SECONDARY | Time to Skeletal Related Events | From randomization up to the cut-off date (median follow-up of 35.4 months) | The analysis was performed on the ITT population.~At the cut-off date, SRE or death had occurred in 1013 participants, 516 in the Placebo group and 497 in the Aflibercept group. | months | MEDIAN |
| SECONDARY | Progression Free Survival Time | From randomization up to the cut-off date (median follow-up of 35.4 months) | The analysis was performed on the ITT population.~At the cut-off date, disease progression or death had occurred in 1184 participants, 592 in each treatment group. | months | MEDIAN |
| SECONDARY | Tumor Response Rate in Participants With Measurable Disease | Before randomization (baseline) then every 3 months up to tumor progression (≥25% increase) or the cut-off date, whichever occurred first | The analysis was performed on the ITT population evaluable for tumor response (i.e. received at least one dose of study drugs (aflibercept/placebo or docetaxel), had no important deviations to protocol and was evaluable for response as per RECIST version 1.0). | percentage of participants | NUMBER |
| SECONDARY | Prostate Specific Antigen Progression-free Survival Time | From randomization up to the cut-off date (median follow-up of 35.4 months) | The analysis was performed in the ITT population evaluable for PSA progression (i.e. with an evaluable baseline PSA).~At the cut-off date, PSA progression or death had occurred in 1138 participants, 571 in the Placebo group and 567 in the Aflibercept group. | months | MEDIAN |
| SECONDARY | Pain Progression-free Survival Time | From randomization up to the cut-off date (median follow-up of 35.4 months) | The analysis was performed on the ITT population evaluable for pain progression (i.e. with no pain or with stable pain at baseline).~At the cut-off date, pain progression or death had occurred in 507 participants, 263 in the Placebo group and 244 in the Aflibercept group. | months | MEDIAN |
| SECONDARY | Pain Response Rate | Before randomization (baseline) then every 3 weeks up to pain progression or the cut-off date, whichever occurred first | The analysis was performed in the ITT population evaluable for pain response (i.e. stable analgesia at baseline and, baseline PPI ≥2 and/or baseline AS ≥10 points). | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate Total Score as a Measure of Health Related Quality of Life | Before randomization (baseline) then every 3 weeks until disease progression or administration of further antitumor therapy, whichever came first | The analysis was performed on the ITT population evaluable for Health related quality of life (i.e. with baseline and at least one post-baseline evaluable FACT-P questionnaire). | units on a scale | MEAN |
| SECONDARY | Number of Participants With Adverse Events as a Measure of Safety | From first dose of study treatment (aflibercept/placebo or docetaxel whichever came first) to last dose of study treatment (aflibercept/placebo or docetaxel whichever came last) + 30 days | The analysis was performed on the safety population (i.e. all randomized and treated participants according to the treatment actually received). Six participants in the Placebo group who received at least one dose of aflibercept in error were considered in the Aflibercept group. | participants | NUMBER |
| SECONDARY | Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept | Pre-dose of cycle 1 (baseline), pre-dose of each every other cycle, then 30 and 90 days after the last administration of the study drug | The analysis was performed on the safety population evaluable for immunogenicity (i.e. exposed to aflibercept with serum samples evaluable for immunogenicity). | 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/NCT00519285/outcomes