Bone Metastases, Hormone Refractory Prostate Cancer
Conditions
Keywords
Hormone Refractory Prostate Cancer, Bone Metastases, Radium-223
Brief summary
ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.
Detailed description
The aim of the study was to compare, in patients with symptomatic hormone refractory prostate cancer (HRPC) and skeletal metastases, the efficacy of best standard of care plus Radium-223 dichloride versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS). Patients were randomised in a 2:1 allocation ratio (Radium-223 dichloride:Placebo). The study treatment consisted of 6 intravenous administrations of Radium-223 dichloride or placebo (saline) each separated by an interval of 4 weeks. The patient were followed until 3 years after first study drug administration. Within the U.S., the trial was conducted under an IND sponsored by Bayer HealthCare Pharmaceuticals. All patients received BSoC (Best Standard of Care). This study has the original PCD as 14 October 2010, when a total of 316 deaths had been observed; this resulted in the Independent Data Monitoring Committee's (IDMC's) recommendation to stop the study as the primary efficacy analysis of overall survival had crossed the pre-specified boundary for efficacy. Later an updated analysis of primary endpoint in the first addendum was done with cut-off of 15 July 2011.
Interventions
DRUGRadium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals.
DRUGPlacebo
Isotonic saline 6 IV administrations separated by 4 weeks intervals.
DRUGBest standard of care (BSoC)
Best standard of care is regarded as the routine standard of care at each center, for example local EBRT (External Beam Radiation Therapy), corticosteroids, antiandrogens, estrogens (e.g., stilboestrol), estramustine or ketoconazole.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the prostate * Known hormone refractory disease * Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy * No intention to use cytotoxic chemotherapy within the next 6 months * Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain
Exclusion criteria
* Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period * Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available * Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago * Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks * Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer) * History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From randomization to death due to any cause until approximately 3 years after start of enrollment, the data was collected up to the second data analysis date (15 JUL 2011) | Overall survival was defined as the time from date of randomization to the date of death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Total Alkaline Phosphatase (ALP) Progression | From randomization to first ALP progression until approximately 3 years after start of enrollment | The time from the first study drug administration to when ALP progression was observed, defined as: 1) In subjects with no ALP decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial ALP decline from baseline; the time from start of treatment to first ALP increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later |
| Percentage of Participants With Total ALP Response at Week 12 | At Baseline and Week 12 | ALP levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed total ALP response (either \>/= 30% or 50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later. |
| Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase) | ALP levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed total ALP response (\>/=50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later. |
| Percentage of Participants With Total ALP Normalization at Week 12 | At Baseline and Week 12 | The return of total ALP value to within normal range at 12 weeks in 2 consecutive measurements (at least 2 weeks apart) after start of treatment in subjects who had ALP above the upper limit of normal (ULN) at baseline. |
| Percentage Change From Baseline in Total ALP at Week 12 | At Baseline and Week 12 | ALP level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (ALP level at week 12 minus ALP level at baseline)/(ALP level at baseline)\*100 |
| Maximum Percentage Decrease From Baseline in Total ALP up to Week 12 | From baseline to Week 12 | ALP level was measured in participant's blood up to week 12 and the maximum percent decrease from the baseline up to Week 12 value was calculated as the minimum value of \[(ALP level up to week 12 minus ALP level at baseline)/(ALP level at baseline)\*100\] by participant, and set to zero if no decrease from baseline. |
| Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase) | ALP level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (ALP level at EOT minus ALP level at baseline)/(ALP level at baseline)\*100 |
| Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment | From baseline During the 24 Week Treatment | ALP level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 week treatment value was calculated as the minimum value of \[(ALP level up to week 24 minus ALP level at baseline)/(ALP level at baseline)\*100\] by participant, and set to zero if no decrease from baseline. |
| Time to Prostate Specific Antigen (PSA) Progression | From randomization to first PSA progression until approximately 3 years after start of enrollment | The time from the first study drug administration to when PSA progression was observed, defined as: 1) In subjects with no PSA decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial PSA decline from baseline; the time from start of treatment to first PSA increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later |
| Percentage of Participants With PSA Response at Week 12 | At Baseline and Week 12 | PSA levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed PSA response (\>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later. |
| Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase) | PSA levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed PSA response (\>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later. |
| Percentage Change From Baseline in PSA at Week 12 | At Baseline and Week 12 | PSA level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (PSA level at week 12 minus PSA level at baseline)/(PSA level at baseline)\*100 |
| Maximum Percentage Decrease From Baseline in PSA up to Week 12 | From baseline up to Week 12 | PSA level was measured in participant's blood up to Week 12 and the maximum percent decrease from the baseline up to week 12 value was calculated as the minimum value of \[(PSA level up to week 12 minus PSA level at baseline)/(PSA level at baseline)\*100\] by participant, and set to zero if no decrease from baseline. |
| Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase) | PSA level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (PSA level at EOT minus PSA level at baseline)/(PSA level at baseline)\*100 |
| Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period | From baseline to End of Treatment (Week 24; 4 weeks post last injection) | PSA level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 Week treatment value was calculated as the minimum value of \[(PSA level up to week 24 minus PSA level at baseline)/(PSA level at baseline)\*100\] by participant, and set to zero if no decrease from baseline. |
| Time to First Skeletal Related Event (SRE) | From randomization to first first SRE until approximately 3 years after start of enrollment | A skeletal related event is the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumour related orthopaedic surgical intervention. For all other events, the start date of the event/medication/therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date. |
| Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms | From randomization to first EBRT until approximately 3 years after start of enrollment | The start date of therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date. |
| Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms | From randomization to first use of radioisotopes until approximately 3 years after start of enrollment | The start date of the radioisotopes was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date. |
| Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral | From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment | The start date of the event was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date. |
| Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention | From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment | The start date of the intervention was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date. |
| Time to Occurrence of First Spinal Cord Compression | From randomization to first spinal cord compression until approximately 3 years after start of enrollment | The start date of the compression was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date. |
| Time to Occurrence of First Start of Any Other Anti-cancer Treatment | From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment | The start date of the treatment was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date. |
| Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline | From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment | ECOG scores were: 0 = fully active; 1 = restricted in physically strenuous activity; 2 = ambulatory and capable of all self-care but unable to work; 3 = capable of only limited self-care; 4 = completely disabled; 5 = death. The visit at which a 2-point or more deterioration in PS was observed was the time of the event. ECOG was assessed at every visit. If a marked deterioration in PS has not occurred at the time of the analysis or the participant was lost to follow-up, the time-to-event variables were censored at the last assessment date. |
Countries
Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Hong Kong, Israel, Italy, Netherlands, Norway, Poland, Singapore, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
STUDY_CHAIRChristopher Parker, MD
The Royal Marsden Hospital, UK
Participant flow
Recruitment details
Subjects with progressive symptomatic hormone refractory prostate cancer (HRPC), with at least 2 skeletal metastases on bone scan and no known visceral metastases, could participate in the study.
Pre-assignment details
Subjects were to be randomized in a 2:1, a total of 921 subjects were enrolled in the study and were randomized to receive either Alpharadin \[Radium-223 dichloride (Xofigo, BAY88-8223)\] or placebo study treatment, which resulted in 614 subjects enrolled in the Alpharadin group and 307 enrolled in the placebo group.
Participants by arm
| Arm | Count |
|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC. | 614 |
| Placebo Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC. | 307 |
| Total | 921 |
Baseline characteristics
| Characteristic | Radium-223 Dichloride (Xofigo, BAY88-8223) | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 70.2 Years STANDARD_DEVIATION 8.1 | 70.8 Years STANDARD_DEVIATION 7.87 | 70.4 Years STANDARD_DEVIATION 8.03 |
| Any prior use of docetaxel No | 262 Participants | 133 Participants | 395 Participants |
| Any prior use of docetaxel Yes | 352 Participants | 174 Participants | 526 Participants |
| Current use of bisphosphonates No | 364 Participants | 183 Participants | 547 Participants |
| Current use of bisphosphonates Yes | 250 Participants | 124 Participants | 374 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 614 Participants | 307 Participants | 921 Participants |
| Total Alkaline Phosphatase (ALP) < 220 U/L | 348 Participants | 169 Participants | 517 Participants |
| Total Alkaline Phosphatase (ALP) ≥ 220 U/L | 266 Participants | 138 Participants | 404 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| other Total, other adverse events | 524 / — | 254 / — | 23 / — |
| serious Total, serious adverse events | 286 / — | 185 / — | 17 / — |
Outcome results
Primary
Overall Survival
Overall survival was defined as the time from date of randomization to the date of death.
Time frame: From randomization to death due to any cause until approximately 3 years after start of enrollment, the data was collected up to the second data analysis date (15 JUL 2011)
Population: The intent-to-treat (ITT) population was defined as all randomized subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Overall Survival | 14.9 Months |
| Placebo | Overall Survival | 11.3 Months |
Comparison: The null hypothesis for the comparison of overall survival, and also for the secondary endpoints, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: 0.0000595% CI: [0.578, 0.827]Log Rank
Secondary
Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period
PSA level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 Week treatment value was calculated as the minimum value of \[(PSA level up to week 24 minus PSA level at baseline)/(PSA level at baseline)\*100\] by participant, and set to zero if no decrease from baseline.
Time frame: From baseline to End of Treatment (Week 24; 4 weeks post last injection)
Population: Participants in The ITT population and had no missing values for this outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period | -16.4 Percentage change | Standard Error 1.01 |
| Placebo | Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period | -9.3 Percentage change | Standard Error 1.45 |
Comparison: The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001ANCOVA
Secondary
Maximum Percentage Decrease From Baseline in PSA up to Week 12
PSA level was measured in participant's blood up to Week 12 and the maximum percent decrease from the baseline up to week 12 value was calculated as the minimum value of \[(PSA level up to week 12 minus PSA level at baseline)/(PSA level at baseline)\*100\] by participant, and set to zero if no decrease from baseline.
Time frame: From baseline up to Week 12
Population: Participants in The ITT population and had no missing values for this outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Maximum Percentage Decrease From Baseline in PSA up to Week 12 | -13.0 Percentage change | Standard Error 0.9 |
| Placebo | Maximum Percentage Decrease From Baseline in PSA up to Week 12 | -7.8 Percentage change | Standard Error 1.28 |
Comparison: The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline up to Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: 0.004ANCOVA
Secondary
Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment
ALP level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 week treatment value was calculated as the minimum value of \[(ALP level up to week 24 minus ALP level at baseline)/(ALP level at baseline)\*100\] by participant, and set to zero if no decrease from baseline.
Time frame: From baseline During the 24 Week Treatment
Population: Participants in The ITT population and had no missing values for this outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment | -44.4 Percentage change | Standard Error 0.8 |
| Placebo | Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment | -7.5 Percentage change | Standard Error 1.14 |
Comparison: The null hypothesis for the comparison of Maximum Percentage decrease from baseline during the 24 week treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001ANCOVA
Secondary
Maximum Percentage Decrease From Baseline in Total ALP up to Week 12
ALP level was measured in participant's blood up to week 12 and the maximum percent decrease from the baseline up to Week 12 value was calculated as the minimum value of \[(ALP level up to week 12 minus ALP level at baseline)/(ALP level at baseline)\*100\] by participant, and set to zero if no decrease from baseline.
Time frame: From baseline to Week 12
Population: Participants in The ITT population and had no missing values for this outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Maximum Percentage Decrease From Baseline in Total ALP up to Week 12 | -38.9 Percentage change | Standard Error 0.76 |
| Placebo | Maximum Percentage Decrease From Baseline in Total ALP up to Week 12 | -5.9 Percentage change | Standard Error 1.09 |
Comparison: The null hypothesis for the comparison of Maximum Percentage decrease from baseline to week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001ANCOVA
Secondary
Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)
PSA level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (PSA level at EOT minus PSA level at baseline)/(PSA level at baseline)\*100
Time frame: At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Population: Participants in The ITT population and had no missing values for this outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | 144.3 Percentage change | Standard Error 15.38 |
| Placebo | Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | 191.1 Percentage change | Standard Error 22.1 |
Comparison: The null hypothesis for the comparison of Percentage change from baseline in PSA at EOT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: 0.009ANCOVA
Secondary
Percentage Change From Baseline in PSA at Week 12
PSA level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (PSA level at week 12 minus PSA level at baseline)/(PSA level at baseline)\*100
Time frame: At Baseline and Week 12
Population: Participants in The ITT population and had no missing values for this outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage Change From Baseline in PSA at Week 12 | 83.3 Percent change | Standard Error 152.48 |
| Placebo | Percentage Change From Baseline in PSA at Week 12 | 543.8 Percent change | Standard Error 233.69 |
Comparison: The null hypothesis for the comparison of Percentage change from baseline in PSA at Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: 0.16ANCOVA
Secondary
Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)
ALP level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (ALP level at EOT minus ALP level at baseline)/(ALP level at baseline)\*100
Time frame: At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Population: Participants in The ITT population and had no missing values for this outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | -29.9 Percent change | Standard Error 3.13 |
| Placebo | Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | 62.1 Percent change | Standard Error 4.48 |
Comparison: The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001ANCOVA
Secondary
Percentage Change From Baseline in Total ALP at Week 12
ALP level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (ALP level at week 12 minus ALP level at baseline)/(ALP level at baseline)\*100
Time frame: At Baseline and Week 12
Population: Participants in The ITT population and had no missing values for this outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage Change From Baseline in Total ALP at Week 12 | -32.2 Percentage change | Standard Error 1.8 |
| Placebo | Percentage Change From Baseline in Total ALP at Week 12 | 37.2 Percentage change | Standard Error 2.77 |
Comparison: The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001ANCOVA
Secondary
Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)
PSA levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed PSA response (\>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.
Time frame: At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Population: Participants in The ITT population and had no missing values for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | >=30% reduction in blood level | 14.2 Percentage of participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | >=50% reduction in blood level | 9 Percentage of participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | Confirmed PSA Response (>=50%) | 6.1 Percentage of participants |
| Placebo | Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | >=30% reduction in blood level | 4.5 Percentage of participants |
| Placebo | Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | >=50% reduction in blood level | 3.1 Percentage of participants |
| Placebo | Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | Confirmed PSA Response (>=50%) | 1.7 Percentage of participants |
Comparison: The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: 0.002Cochran-Mantel-Haenszel
Comparison: The null hypothesis for the comparison of Confirmed PSA Response(\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: 0.005Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With PSA Response at Week 12
PSA levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed PSA response (\>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.
Time frame: At Baseline and Week 12
Population: Participants in The ITT population and had no missing values for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With PSA Response at Week 12 | >=30% reduction of PSA in blood level | 16.4 Percentage of participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With PSA Response at Week 12 | >=50% reduction of PSA in blood level | 7.7 Percentage of participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With PSA Response at Week 12 | Confirmed PSA Response (>=50%) | 5.7 Percentage of participants |
| Placebo | Percentage of Participants With PSA Response at Week 12 | >=30% reduction of PSA in blood level | 6.2 Percentage of participants |
| Placebo | Percentage of Participants With PSA Response at Week 12 | >=50% reduction of PSA in blood level | 4.3 Percentage of participants |
| Placebo | Percentage of Participants With PSA Response at Week 12 | Confirmed PSA Response (>=50%) | 1.9 Percentage of participants |
Comparison: The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: 0.106Cochran-Mantel-Haenszel
Comparison: The null hypothesis for the comparison of Confirmed PSA Response(\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: 0.032Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Total ALP Normalization at Week 12
The return of total ALP value to within normal range at 12 weeks in 2 consecutive measurements (at least 2 weeks apart) after start of treatment in subjects who had ALP above the upper limit of normal (ULN) at baseline.
Time frame: At Baseline and Week 12
Population: Participants in The ITT population and had no missing values for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With Total ALP Normalization at Week 12 | 34 Percentage of participants |
| Placebo | Percentage of Participants With Total ALP Normalization at Week 12 | 1.4 Percentage of participants |
Comparison: The null hypothesis for the comparison of Total ALP normalization, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)
ALP levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed total ALP response (\>/=50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.
Time frame: At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Population: Participants in The ITT population and had no missing values for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | >=50% reduction of ALP in blood level | 34.6 Percentage of participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | Confirmed Total ALP Response (>=50%) | 13.9 Percentage of participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | >=30% reduction of ALP in blood level | 59.9 Percentage of participants |
| Placebo | Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | >=50% reduction of ALP in blood level | 1.7 Percentage of participants |
| Placebo | Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | >=30% reduction of ALP in blood level | 4.5 Percentage of participants |
| Placebo | Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) | Confirmed Total ALP Response (>=50%) | 1 Percentage of participants |
Comparison: The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: The null hypothesis for the comparison of Confirmed Total ALP Response (\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Total ALP Response at Week 12
ALP levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed total ALP response (either \>/= 30% or 50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.
Time frame: At Baseline and Week 12
Population: Participants in The ITT population and had no missing values for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With Total ALP Response at Week 12 | >=30% reduction of ALP in blood level | 59.4 Percentage of participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With Total ALP Response at Week 12 | >=50% reduction of ALP in blood level | 32.6 Percentage of participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With Total ALP Response at Week 12 | Confirmed Total ALP Response (>=30%) | 47.1 Percentage of participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Percentage of Participants With Total ALP Response at Week 12 | Confirmed Total ALP Response (>=50%) | 27.4 Percentage of participants |
| Placebo | Percentage of Participants With Total ALP Response at Week 12 | Confirmed Total ALP Response (>=50%) | 0.9 Percentage of participants |
| Placebo | Percentage of Participants With Total ALP Response at Week 12 | >=30% reduction of ALP in blood level | 6.2 Percentage of participants |
| Placebo | Percentage of Participants With Total ALP Response at Week 12 | Confirmed Total ALP Response (>=30%) | 3.3 Percentage of participants |
| Placebo | Percentage of Participants With Total ALP Response at Week 12 | >=50% reduction of ALP in blood level | 1.4 Percentage of participants |
Comparison: The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: The null hypothesis for the comparison of Confirmed Total ALP Response (\>=30%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: The null hypothesis for the comparison of Confirmed Total ALP Response (\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Time to First Skeletal Related Event (SRE)
A skeletal related event is the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumour related orthopaedic surgical intervention. For all other events, the start date of the event/medication/therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time frame: From randomization to first first SRE until approximately 3 years after start of enrollment
Population: The ITT population was all randomized subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Time to First Skeletal Related Event (SRE) | 16.4 Months |
| Placebo | Time to First Skeletal Related Event (SRE) | 8.1 Months |
Comparison: The null hypothesis for the comparison of time to first SRE, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference existsp-value: 0.0001295% CI: [0.529, 0.814]Log Rank
Secondary
Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline
ECOG scores were: 0 = fully active; 1 = restricted in physically strenuous activity; 2 = ambulatory and capable of all self-care but unable to work; 3 = capable of only limited self-care; 4 = completely disabled; 5 = death. The visit at which a 2-point or more deterioration in PS was observed was the time of the event. ECOG was assessed at every visit. If a marked deterioration in PS has not occurred at the time of the analysis or the participant was lost to follow-up, the time-to-event variables were censored at the last assessment date.
Time frame: From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment
Population: The ITT population was all randomized subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline | 23.4 Months |
| Placebo | Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline | 18.4 Months |
Comparison: The null hypothesis for the comparison of Time to Marked Deterioration of ECOG PS, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: 0.0018795% CI: [0.546, 0.873]Log Rank
Secondary
Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral
The start date of the event was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time frame: From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment
Population: The ITT population was all randomized subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral | NA Months |
| Placebo | Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral | NA Months |
Comparison: The null hypothesis for the comparison of Time to Pathological Bone Fracture, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference existsp-value: 0.5327795% CI: [0.504, 1.426]Log Rank
Secondary
Time to Occurrence of First Spinal Cord Compression
The start date of the compression was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time frame: From randomization to first spinal cord compression until approximately 3 years after start of enrollment
Population: The ITT population was all randomized subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Time to Occurrence of First Spinal Cord Compression | NA Months |
| Placebo | Time to Occurrence of First Spinal Cord Compression | NA Months |
Comparison: The null hypothesis for the comparison of Time to Spinal Cord Compression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: 0.1448695% CI: [0.404, 1.145]Log Rank
Secondary
Time to Occurrence of First Start of Any Other Anti-cancer Treatment
The start date of the treatment was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time frame: From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment
Population: The ITT population was all randomized subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Time to Occurrence of First Start of Any Other Anti-cancer Treatment | 15.4 Months |
| Placebo | Time to Occurrence of First Start of Any Other Anti-cancer Treatment | 12.7 Months |
Comparison: The null hypothesis for the comparison of Time to Other Cancer Treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: 0.0093295% CI: [0.571, 0.925]Log Rank
Secondary
Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention
The start date of the intervention was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time frame: From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment
Population: The ITT population was all randomized subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention | NA Months |
| Placebo | Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention | NA Months |
Comparison: The null hypothesis for the comparison of Time to Surgical Intervention, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference existsp-value: 0.8956795% CI: [0.435, 2.07]Log Rank
Secondary
Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms
The start date of therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time frame: From randomization to first EBRT until approximately 3 years after start of enrollment
Population: The ITT population was all randomized subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms | 18 Months |
| Placebo | Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms | 10.7 Months |
Comparison: The null hypothesis for the comparison of time to EBRT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference existsp-value: 0.0000895% CI: [0.511, 0.8]Log Rank
Secondary
Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms
The start date of the radioisotopes was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time frame: From randomization to first use of radioisotopes until approximately 3 years after start of enrollment
Population: The ITT population was all randomized subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms | NA Months |
| Placebo | Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms | NA Months |
Comparison: The null hypothesis for the comparison of Time to Receiving Radio-isotope, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference existsp-value: 0.0019195% CI: [0.17, 0.695]Log Rank
Secondary
Time to Prostate Specific Antigen (PSA) Progression
The time from the first study drug administration to when PSA progression was observed, defined as: 1) In subjects with no PSA decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial PSA decline from baseline; the time from start of treatment to first PSA increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later
Time frame: From randomization to first PSA progression until approximately 3 years after start of enrollment
Population: The ITT population was all randomized subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Time to Prostate Specific Antigen (PSA) Progression | 3.6 Months |
| Placebo | Time to Prostate Specific Antigen (PSA) Progression | 3.4 Months |
Comparison: The null hypothesis for the comparison of Time to PSA progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.0000195% CI: [0.539, 0.768]Log Rank
Secondary
Time to Total Alkaline Phosphatase (ALP) Progression
The time from the first study drug administration to when ALP progression was observed, defined as: 1) In subjects with no ALP decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial ALP decline from baseline; the time from start of treatment to first ALP increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later
Time frame: From randomization to first ALP progression until approximately 3 years after start of enrollment
Population: The ITT population was all randomized subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Time to Total Alkaline Phosphatase (ALP) Progression | 7.4 Months |
| Placebo | Time to Total Alkaline Phosphatase (ALP) Progression | 3.8 Months |
Comparison: The null hypothesis for the comparison of time to total ALP progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.p-value: <0.0000195% CI: [0.131, 0.22]Log Rank
Other Pre-specified
Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score of the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) was calculated at Week 16, Week 24, and Follow-up Visit 2.FACT-P Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 156 (best).
Time frame: At Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Population: The ITT population was all randomized subjects
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 16 | 100.68 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 24 | 98.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Follow-up Visit 2 (Week 42) | 97.83 Scores on a scale |
| Placebo | Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 16 | 99.90 Scores on a scale |
| Placebo | Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 24 | 97.5 Scores on a scale |
| Placebo | Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Follow-up Visit 2 (Week 42) | 97.38 Scores on a scale |
Other Pre-specified
Absolute Scores for Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)
The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. The FACT-G absolute total score (physical, social/family, emotional, and functional well-being) was calculated at Week 16, Week 24, and Follow-up Visit 2. FACT-G Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB). Score ranges from 0 (worst) to 108 (best).
Time frame: At Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Population: The ITT population was all randomized subjects
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 16 | 73.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 24 | 71.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Follow-up Visit 2 (Week 42) | 70.00 Scores on a scale |
| Placebo | Absolute Scores for Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 16 | 72.00 Scores on a scale |
| Placebo | Absolute Scores for Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 24 | 69.00 Scores on a scale |
| Placebo | Absolute Scores for Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Follow-up Visit 2 (Week 42) | 70.25 Scores on a scale |
Other Pre-specified
Absolute Scores for Functional Assessment of Cancer Therapy - Prostate (FACT-P) Trial Outcome Index (TOI)
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Prostate Cancer Trial Outcome Index (TOI): Physical Well-being (PWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 104 (best).
Time frame: Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Population: The ITT population was all randomized subjects
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Functional Assessment of Cancer Therapy - Prostate (FACT-P) Trial Outcome Index (TOI) | Week 16 | 65.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Functional Assessment of Cancer Therapy - Prostate (FACT-P) Trial Outcome Index (TOI) | Week 0 (Baseline) | 65.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Functional Assessment of Cancer Therapy - Prostate (FACT-P) Trial Outcome Index (TOI) | Week 24 | 61.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Functional Assessment of Cancer Therapy - Prostate (FACT-P) Trial Outcome Index (TOI) | Follow-up Visit 2 (Week 42) | 61.00 Scores on a scale |
| Placebo | Absolute Scores for Functional Assessment of Cancer Therapy - Prostate (FACT-P) Trial Outcome Index (TOI) | Follow-up Visit 2 (Week 42) | 60.5 Scores on a scale |
| Placebo | Absolute Scores for Functional Assessment of Cancer Therapy - Prostate (FACT-P) Trial Outcome Index (TOI) | Week 24 | 60.00 Scores on a scale |
| Placebo | Absolute Scores for Functional Assessment of Cancer Therapy - Prostate (FACT-P) Trial Outcome Index (TOI) | Week 0 (Baseline) | 64.00 Scores on a scale |
| Placebo | Absolute Scores for Functional Assessment of Cancer Therapy - Prostate (FACT-P) Trial Outcome Index (TOI) | Week 16 | 61.31 Scores on a scale |
Other Pre-specified
Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42)
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Follow-up Visit 2.
Time frame: At Follow-up Visit 2 (Week 42)
Population: The ITT population was all randomized subjects
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42) | social/family well being | 22.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42) | functional well being | 14.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42) | emotional well being | 17.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42) | the prostate cancer subscale | 28.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42) | physical well being | 19.00 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42) | the prostate cancer subscale | 29.00 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42) | physical well being | 18.00 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42) | social/family well being | 22.00 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42) | emotional well being | 16.00 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42) | functional well being | 14.00 Scores on a scale |
Other Pre-specified
Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 16.
Time frame: At Week 16
Population: The ITT population was all randomized subjects
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16 | physical well being | 20.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16 | functional well being | 16.0 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16 | emotional well being | 18.0 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16 | the prostate cancer subscale | 29.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16 | social/family well being | 22.00 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16 | the prostate cancer subscale | 27.60 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16 | physical well being | 19.83 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16 | social/family well being | 21.50 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16 | emotional well being | 16.80 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16 | functional well being | 15.0 Scores on a scale |
Other Pre-specified
Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 24.
Time frame: At Week 24
Population: The ITT population was all randomized subjects
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24 | social/family well being | 21.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24 | functional well being | 15.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24 | emotional well being | 17.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24 | the prostate cancer subscale | 28.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24 | physical well being | 19.00 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24 | the prostate cancer subscale | 27.64 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24 | physical well being | 18.67 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24 | social/family well being | 21.00 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24 | emotional well being | 16.00 Scores on a scale |
| Placebo | Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24 | functional well being | 14.00 Scores on a scale |
Other Pre-specified
Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)
The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. Total possible score was 108; a higher score indicates a better quality of life. The changes from baseline in the FACT-G total score (physical, social/family, emotional, and functional well-being) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -108 to 108.
Time frame: Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Population: The ITT population was all randomized subjects
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 16 | -1.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 24 | -4.08 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Follow-up Visit 2 (Week 42) | -3.67 Scores on a scale |
| Placebo | Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 16 | -4.00 Scores on a scale |
| Placebo | Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 24 | -7.00 Scores on a scale |
| Placebo | Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Follow-up Visit 2 (Week 42) | -6.00 Scores on a scale |
Other Pre-specified
Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. Total possible score was 156; a higher score indicates a better quality of life. The changes from baseline in the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -156 to 156.
Time frame: Baseline, Week 16, Week 24, and Follow-up Visit 2 (week 42)
Population: The ITT population was all randomized subjects
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Follow-up Visit 2 (Week 42) | -6.17 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 16 | -2.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 24 | -5.00 Scores on a scale |
| Placebo | Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Follow-up Visit 2 (Week 42) | -7.00 Scores on a scale |
| Placebo | Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 16 | -5.67 Scores on a scale |
| Placebo | Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 24 | -9.40 Scores on a scale |
Other Pre-specified
Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42)
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Possible scores were 0 to 104; the higher the score, the better the quality of life. The changes from baseline (range -104 to 104) in the domain FACT-P TOI were summarized using descriptive statistics at Week 16, Week 24, and Follow-up Visit 2.
Time frame: Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Population: The ITT population was all randomized subjects
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Follow-up Visit 2 (Week 42) | -5.00 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 16 | -1.55 Scores on a scale |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 24 | -4.00 Scores on a scale |
| Placebo | Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 16 | -4.15 Scores on a scale |
| Placebo | Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Week 24 | -5.67 Scores on a scale |
| Placebo | Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42) | At Follow-up Visit 2 (Week 42) | -5.5 Scores on a scale |
Other Pre-specified
Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139)
The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at follow-up visit 8, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems').
Time frame: Follow-up Visit 8 (Week 139)
Population: The ITT population was all randomized subjects with with EQ-5D analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | usual activities - Missing | 1 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | mobility - Missing | 1 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | self-care - Grade 2 | 12 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | pain/discomfort - Grade 2 | 32 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | self-care - Grade 3 | 2 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | self-care - MIssing | 1 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | usual activities - Grade 2 | 19 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | usual activities - Grade 1 | 13 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | pain/discomfort - Grade 3 | 3 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | anxiety/depression - Grade 1 | 24 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | pain/discomfort - Grade 1 | 5 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | anxiety/depression - Grade 2 | 15 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | anxiety/depression - Missing | 1 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | pain/discomfort - Missing | 1 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | self-care - Grade 1 | 26 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | mobility - Grade 2 | 30 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | usual activities - Grade 3 | 8 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | anxiety/depression - Grade 3 | 1 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | mobility - Grade 3 | 1 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | mobility - Grade 1 | 9 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | anxiety/depression - Missing | 0 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | self-care - Grade 2 | 3 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | self-care - Grade 3 | 3 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | usual activities - Grade 2 | 7 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | usual activities - Missing | 0 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | pain/discomfort - Grade 2 | 11 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | mobility - Grade 1 | 2 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | mobility - Grade 2 | 10 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | mobility - Grade 3 | 1 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | mobility - Missing | 0 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | self-care - Grade 1 | 7 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | self-care - MIssing | 0 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | usual activities - Grade 1 | 2 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | usual activities - Grade 3 | 4 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | pain/discomfort - Grade 1 | 1 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | pain/discomfort - Grade 3 | 1 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | pain/discomfort - Missing | 0 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | anxiety/depression - Grade 1 | 6 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | anxiety/depression - Grade 2 | 7 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139) | anxiety/depression - Grade 3 | 0 Participants |
Other Pre-specified
Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16
The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 16, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems').
Time frame: Week 16
Population: The ITT population was all randomized subjects with with EQ-5D analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | usual activities - Grade 2 | 233 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | anxiety/depression - Missing | 6 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | mobility - Grade 1 | 191 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | mobility - Grade 2 | 278 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | mobility - Grade 3 | 7 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | mobility - Missing | 1 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | self-care - Grade 1 | 346 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | self-care - Grade 2 | 123 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | self-care - Grade 3 | 7 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | self-care - Missing | 1 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | usual activities - Grade 1 | 199 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | usual activities - Grade 3 | 44 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | usual activities - Missing | 1 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | pain/discomfort - Grade 1 | 79 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | pain/discomfort - Grade 2 | 351 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | pain/discomfort - Grade 3 | 46 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | pain/discomfort - Missing | 1 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | anxiety/depression - Grade 1 | 285 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | anxiety/depression - Grade 2 | 171 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | anxiety/depression - Grade 3 | 15 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | anxiety/depression - Grade 1 | 104 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | usual activities - Grade 2 | 105 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | anxiety/depression - Grade 3 | 4 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | usual activities - Grade 1 | 67 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | pain/discomfort - Grade 3 | 22 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | mobility - Grade 1 | 64 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | usual activities - Grade 3 | 32 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | mobility - Grade 2 | 129 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | anxiety/depression - Missing | 2 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | mobility - Grade 3 | 10 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | usual activities - Missing | 1 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | mobility - Missing | 2 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | pain/discomfort - Missing | 1 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | self-care - Grade 1 | 140 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | pain/discomfort - Grade 1 | 23 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | self-care - Grade 2 | 54 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | anxiety/depression - Grade 2 | 95 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | self-care - Grade 3 | 10 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | pain/discomfort - Grade 2 | 159 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16 | self-care - Missing | 1 Participants |
Other Pre-specified
Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24
The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 24, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems').
Time frame: Week 24
Population: The ITT population was all randomized subjects with with EQ-5D analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | mobility - Grade 2 | 225 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | usual activities - Grade 2 | 187 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | self-care - Grade 1 | 256 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | usual activities - Grade 3 | 37 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | mobility - Grade 1 | 129 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | usual activities - Missing | 4 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | self-care - Grade 2 | 102 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | pain/discomfort - Grade 1 | 56 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | mobility - Grade 3 | 11 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | pain/discomfort - Grade 2 | 270 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | self-care - Grade 3 | 6 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | pain/discomfort - Grade 3 | 39 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | anxiety/depression - Missing | 4 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | pain/discomfort - Missing | 3 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | self-care - Missing | 4 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | anxiety/depression - Grade 1 | 195 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | mobility - Missing | 3 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | usual activities - Grade 1 | 140 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | anxiety/depression - Grade 3 | 10 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | anxiety/depression - Grade 2 | 159 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | anxiety/depression - Missing | 3 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | anxiety/depression - Grade 3 | 2 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | mobility - Grade 1 | 39 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | mobility - Grade 2 | 93 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | mobility - Grade 3 | 5 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | mobility - Missing | 3 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | self-care - Grade 1 | 89 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | self-care - Grade 2 | 46 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | self-care - Grade 3 | 3 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | self-care - Missing | 2 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | usual activities - Grade 1 | 38 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | usual activities - Grade 2 | 79 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | usual activities - Grade 3 | 20 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | usual activities - Missing | 3 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | pain/discomfort - Grade 1 | 21 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | pain/discomfort - Grade 2 | 95 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | pain/discomfort - Grade 3 | 21 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | pain/discomfort - Missing | 3 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | anxiety/depression - Grade 1 | 64 Participants |
| Placebo | Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24 | anxiety/depression - Grade 2 | 71 Participants |
Other Pre-specified
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0.
ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.
Time frame: Week 0
Population: Participants in The ITT population and with ECOG analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | ECOG Grade 2 | 82 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | ECOG Grade 4 | 0 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | ECOG Grade 1 | 376 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | ECOG Grade 5 | 0 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | ECOG Grade 3 | 6 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | Missing | 0 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | ECOG Grade 0 | 136 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | Missing | 1 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | ECOG Grade 0 | 72 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | ECOG Grade 1 | 191 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | ECOG Grade 2 | 40 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | ECOG Grade 3 | 1 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | ECOG Grade 4 | 0 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0. | ECOG Grade 5 | 0 Participants |
Other Pre-specified
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16.
ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.
Time frame: Week 16
Population: Participants in The ITT population and with ECOG analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | ECOG Grade 2 | 85 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | ECOG Grade 4 | 4 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | ECOG Grade 1 | 257 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | ECOG Grade 5 | 0 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | ECOG Grade 3 | 19 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | Missing | 5 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | ECOG Grade 0 | 101 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | Missing | 1 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | ECOG Grade 0 | 29 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | ECOG Grade 1 | 113 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | ECOG Grade 2 | 42 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | ECOG Grade 3 | 11 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | ECOG Grade 4 | 0 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16. | ECOG Grade 5 | 0 Participants |
Other Pre-specified
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24.
ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.
Time frame: Week 24
Population: Participants in The ITT population and with ECOG analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | ECOG Grade 2 | 85 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | ECOG Grade 4 | 5 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | ECOG Grade 1 | 181 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | ECOG Grade 5 | 0 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | ECOG Grade 3 | 17 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | Missing | 1 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | ECOG Grade 0 | 74 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | Missing | 0 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | ECOG Grade 0 | 22 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | ECOG Grade 1 | 66 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | ECOG Grade 2 | 36 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | ECOG Grade 3 | 10 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | ECOG Grade 4 | 4 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24. | ECOG Grade 5 | 0 Participants |
Other Pre-specified
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8.
ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.
Time frame: Week 8
Population: Participants in The ITT population and with ECOG analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | ECOG Grade 2 | 103 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | ECOG Grade 4 | 0 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | ECOG Grade 1 | 315 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | ECOG Grade 5 | 1 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | ECOG Grade 3 | 13 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | Missing | 4 Participants |
| Radium-223 Dichloride (Xofigo, BAY88-8223) | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | ECOG Grade 0 | 133 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | Missing | 4 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | ECOG Grade 0 | 49 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | ECOG Grade 1 | 142 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | ECOG Grade 2 | 53 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | ECOG Grade 3 | 15 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | ECOG Grade 4 | 3 Participants |
| Placebo | Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8. | ECOG Grade 5 | 1 Participants |