Trial · NCT01360840
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) Time | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | Intention-to-treat (ITT) analysis set included all the subjects who were randomized in the study. | months | MEDIAN |
| SECONDARY | Overall Survival | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. | months | MEDIAN |
| SECONDARY | Time to Tumor Progression | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. | months | MEDIAN |
| SECONDARY | Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. N signifies the total number of subjects evaluable for this outcome measure. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With New Bone Lesions Compared to Baseline | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects randomized in the study. N signifies the total number of subjects evaluable for this outcome measure. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Presence of DC in Bone Lesions | At Weeks 13, 19 and 25 | ITT analysis set included all the subjects randomized in the study. | Subjects | NUMBER |
| SECONDARY | Bone and Soft Tissue Lesions Composite Tumor Response | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Presence of Skeletal Related Events | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. N signifies the total number of subjects evaluable for this outcome measure. | Subjects | NUMBER |
| SECONDARY | Minimum Percentage Change From Baseline in PSA Serum Concentration | Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. N signifies the total number of subjects evaluable for this outcome measure. | Percent change | MEAN |
| SECONDARY | Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs) | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. N signifies the total number of subjects evaluable for this outcome measure. | Percent change | MEAN |
| SECONDARY | Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC) | Cycle 1, Day 1 (Week 1): pre-dose, Cycle 3, Day 1 (Week 7): pre-dose, and Cycle 5, Day 1 (Week 13): pre-dose | ITT analysis set included all the subjects who were randomized in the study. N signifies the total number of subjects evaluable for this outcome measure. | Percent change | MEAN |
| SECONDARY | Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation | From the first dose of study drug administration until 50 days after the last dose of study drug administration or until cut-off date (30 April 2013), assessed up to 2 years | The Safety analysis set included all the randomized subjects who received at least 1 dose of planned trial treatment and had at least one safety assessment following the trial treatment. | Subjects | NUMBER |
| SECONDARY | Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss) | Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI | Pharmacokinetic Analysis Set (PKA) included all the randomized subjects who received at least the first dose of the trial drug and provided sufficient data for a concentration time profile for EMD 525797. n signifies the number of subjects evaluable for each category in the evaluated group, respectively. | Liter per hour | MEAN |
| SECONDARY | Pharmacokinetic Parameter: Volume of Distribution of EMD 525797 After the First Dose (V) and in Steady State After the Fifth Dose (Vss) of Intravenous Infusion | Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI | PKA included all the randomized subjects who received at least the first dose of the trial drug and provided sufficient data for a concentration time profile for EMD 525797. n signifies the number of subjects evaluable for each category in the evaluated group, respectively. | liter | MEAN |
| OTHER_PRE_SPECIFIED | To Explore the Relationship Between Number and/or Changes of Numbers of Biomarker and the Clinical Outcome | From the date of randomization up to data cut-off date (30 April 2013), assessed up to 2 years | Data for this outcome measure was presented graphically as per planned analysis but not statistically summarized. |
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.
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