Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 15 of 15

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival: Time From Randomization to Date of Death	From randomization to death or date of last contact (maximum reached: 45 months)	All participants who were randomized to receive any treatment	Months	MEDIAN
SECONDARY	Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)	At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing)	Participants with at least 1 target lesion at baseline	Percentage of participants	NUMBER
SECONDARY	Time to First Skeletal-related Event (SRE)	From day of randomization to date of first SRE or to last SRE assessment, if subsequent cancer therapy begun or no SRE (maximum reached: 42 months)	All participants who were randomized to receive any treatment	Months	MEDIAN
SECONDARY	Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline	At baseline, prior to each docetaxel infusion (every 3 weeks) to end of treatment, at end of treatment, and at follow-up (within 14 days of end of dosing)	Participants who entered the study with baseline urinary N-telopeptide values higher than the upper limit of normal (ULN), or ≥60 nmol/mmol creatinine, if ULN was missing	Percentage of participants	NUMBER
SECONDARY	Progression-free Survival (PFS)	From day of randomization to disease progression or death (or to last clinical assessment, if subsequent cancer therapy started or no progression or death) (maximum reached: approximately 43 months)	All participants who were randomized to receive any treatment	Months	MEDIAN
SECONDARY	Time to Prostate Specific Antigen (PSA) Progression	From randomization to date of first PSA measurement leading to confirmed PSA progression (or to last bone scan assessment, if no progression or if cancer therapy started) (maximum reached: 30 months)	All participants who were randomized to receive any treatment	Months	MEDIAN
SECONDARY	Percentage of Participants With a Reduction in Pain Intensity From Baseline	At baseline, prior to each docetaxel infusion (every 3 weeks), at end of treatment, and at follow-up (within 14 days of end of dosing)	Participants with a baseline pain intensity of 2 or greater	Percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	Number of Participants With Serious Adverse Event (SAEs), Drug-related SAEs, Drug-related AEs, Drug-related AEs Leading to Discontinuation, and All Deaths	Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days	All participants who received treatment	Participants	NUMBER
OTHER_PRE_SPECIFIED	Number of Participants With Drug-Related Adverse Events (AEs) of Special Interest	Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days	All participants who received treatment	Participants	NUMBER
OTHER_PRE_SPECIFIED	Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology	At baseline, within 3 days prior to each infusion of docetaxel (each cycle) and at end of treatment. If docetaxel is discontinued, every other cycle.	All participants who received treatment	Participants	NUMBER
OTHER_PRE_SPECIFIED	Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes	At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.	All participants who received treatment	Participants	NUMBER
OTHER_PRE_SPECIFIED	Number of Participants With Abnormal Results in Urinalysis	At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.	All participants who received treatment.	Participants	NUMBER
OTHER_PRE_SPECIFIED	Number of Participants by Maximal On-study Fridericia-corrected QTc Interval	At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing	All participants who received treatment. n=number evaluable	Participants	NUMBER
OTHER_PRE_SPECIFIED	Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval	At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing	All participants who received treatment. n=number evaluable	Participants	NUMBER
OTHER_PRE_SPECIFIED	Number of Participants With and Without Pericardial Effusion at Baseline and On-study and With Left Ventricular Ejection Fraction (LVEF) <40% and >=40% On-study	At baseline, approximately 12 weeks after start of treatment, and thereafter whenever clinically indicated	All participants who were randomized to receive any treatment	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.

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