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| ID | Type | Description | Link |
|---|---|---|---|
| BC1-06 | Other Identifier | Algeta ASA | |
| 2007-006195-11 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Experimental | Participants received radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC). |
|
| Placebo | Placebo Comparator | Participants received isotonic saline for 6 IV administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was defined as the time from date of randomization to the date of death. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Parker, MD | The Royal Marsden Hospital, UK | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90048-0750 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23863050 | Result | Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzen L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland OS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. doi: 10.1056/NEJMoa1213755. | |
| 25439694 |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Radium-223 Dichloride (Xofigo, BAY88-8223) | Participants received BSoC plus radium223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Without/Before Drug Switch |
|
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|
| Placebo | Drug | Isotonic saline 6 IV administrations separated by 4 weeks intervals. |
|
| Best standard of care (BSoC) | Drug | 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. |
|
| From randomization to first ALP progression until approximately 3 years after start of enrollment |
| 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. | At Baseline and Week 12 |
| 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. | At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase) |
| 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. | At Baseline and Week 12 |
| 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 | At Baseline and Week 12 |
| 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. | From baseline to Week 12 |
| 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 | At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase) |
| 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. | From baseline During the 24 Week Treatment |
| 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 | From randomization to first PSA progression until approximately 3 years after start of enrollment |
| 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. | At Baseline and Week 12 |
| 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. | At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase) |
| 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 | At Baseline and Week 12 |
| 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. | From baseline up to Week 12 |
| 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 | At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase) |
| 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. | From baseline to End of Treatment (Week 24; 4 weeks post last injection) |
| 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. | From randomization to first first SRE until approximately 3 years after start of enrollment |
| 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. | From randomization to first EBRT until approximately 3 years after start of enrollment |
| 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. | From randomization to first use of radioisotopes until approximately 3 years after start of enrollment |
| 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. | From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment |
| 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. | From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment |
| 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. | From randomization to first spinal cord compression until approximately 3 years after start of enrollment |
| 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. | From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment |
| 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. | From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment |
| Week 0 |
| 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. | Week 8 |
| 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. | Week 16 |
| 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. | Week 24 |
| 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). | Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42) |
| 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. | Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42) |
| 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. | At Week 16 |
| 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. | At Week 24 |
| 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. | At Follow-up Visit 2 (Week 42) |
| 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). | At Week 16, Week 24, and Follow-up Visit 2 (Week 42) |
| 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. | Baseline, Week 16, Week 24, and Follow-up Visit 2 (week 42) |
| 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). | At Week 16, Week 24, and Follow-up Visit 2 (Week 42) |
| 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. | Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42) |
| 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'). | Week 16 |
| 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'). | Week 24 |
| 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'). | Follow-up Visit 8 (Week 139) |
| Roseville |
| California |
| 95661 |
| United States |
| Tampa | Florida | 33612-9416 | United States |
| New Orleans | Louisiana | 70112 | United States |
| St Louis | Missouri | 63110 | United States |
| Las Vegas | Nevada | 89169 | United States |
| Philadelphia | Pennsylvania | 19111-2497 | United States |
| Liverpool | New South Wales | 2170 | Australia |
| Randwick | New South Wales | 2031 | Australia |
| St Leonards | New South Wales | 2065 | Australia |
| Sydney | New South Wales | 2010 | Australia |
| Wahroonga | New South Wales | 2076 | Australia |
| Wollongong | New South Wales | 2521 | Australia |
| Herston | Queensland | 4006 | Australia |
| Toowoomba | Queensland | 4350 | Australia |
| Adelaide | South Australia | 5000 | Australia |
| Woodville South | South Australia | 5011 | Australia |
| Hobart | Tasmania | 7000 | Australia |
| Fitzroy | Victoria | 3065 | Australia |
| Nedlands | Western Australia | 6009 | Australia |
| Kortrijk | 8500 | Belgium |
| Ottignies | 1340 | Belgium |
| Salvador | Estado de Bahia | 41950-640 | Brazil |
| Belo Horizonte | Minas Gerais | 30110-090 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 20551 030 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Barretos | São Paulo | 14784-400 | Brazil |
| Piracicaba | São Paulo | Brazil |
| São Paulo | São Paulo | 05403-000 | Brazil |
| Belo Horizonte | 30380490 | Brazil |
| Edmonton | Alberta | T6G 1Z2 | Canada |
| London | Ontario | N6A 4G5 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Brno | 65653 | Czechia |
| Chomutov | 430 12 | Czechia |
| Olomouc | 77900 | Czechia |
| Ostrava | 708 52 | Czechia |
| Plzen - Bory | 305 99 | Czechia |
| Prague | 140 59 | Czechia |
| Usti n/Labem | 401 13 | Czechia |
| La Roche-sur-Yon | 85925 | France |
| Montbéliard | 25209 | France |
| Saint-Cloud | 92210 | France |
| Ulm | Baden-Wurttemberg | 89075 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
| Frankfurt am Main | Hesse | 60590 | Germany |
| Marburg | Hesse | 35043 | Germany |
| Göttingen | Lower Saxony | 37075 | Germany |
| Hanover | Lower Saxony | 30625 | Germany |
| Dortmund | North Rhine-Westphalia | 44137 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Berlin | State of Berlin | 10967 | Germany |
| Berlin | State of Berlin | 14197 | Germany |
| Chai Wan | Hong Kong |
| Hong Kong | Hong Kong |
| Kowloon | Hong Kong |
| Beersheba | 8410101 | Israel |
| Kfar Saba | 4428164 | Israel |
| Tel Aviv | 6423906 | Israel |
| Zrifin | 7030000 | Israel |
| Forlì Cesena | Emilia-Romagna | 47014 | Italy |
| Reggio Emilia | Emilia-Romagna | 42123 | Italy |
| Bergamo | Lombardy | 24128 | Italy |
| Milan | Lombardy | 20162 | Italy |
| Turin | Piedmont | 10060 | Italy |
| Alkmaar | 1815 JD | Netherlands |
| Nijmegen | 6532 SZ | Netherlands |
| Rotterdam | 3015 CE | Netherlands |
| Ã…lesund | TBC | Norway |
| Bergen | 5021 | Norway |
| Bodø | 8092 | Norway |
| Kristiansand | N-4604 | Norway |
| Oslo | 0379 | Norway |
| Oslo | 450 | Norway |
| Tromsø | 9038 | Norway |
| Trondheim | 7030 | Norway |
| Bydgoszcz | 85-165 | Poland |
| Gliwice | 44-101 | Poland |
| Kielce | 25-734 | Poland |
| Krakow | 31-051 | Poland |
| Luiblin | 20-954 | Poland |
| Warsaw | 02-781 | Poland |
| Wroclaw | 50 - 556 | Poland |
| Wroclaw | 50-981 | Poland |
| Singapore | 258499 | Singapore |
| Singapore | 308433 | Singapore |
| Banská Bystrica | 97517 | Slovakia |
| Bratislava | 82606 | Slovakia |
| Bratislava | 83305 | Slovakia |
| Martin | 03659 | Slovakia |
| Prešov | 08181 | Slovakia |
| Trnava | 917 01 | Slovakia |
| Santiago de Compostela | A Coruña | 15706 | Spain |
| Barcelona | Barcelona | 08023 | Spain |
| Barcelona | Barcelona | 8036 | Spain |
| Barcelona | Barcelona | 8041 | Spain |
| Córdoba | Córdoba | 14004 | Spain |
| Alcorcón | Madrid | 28922 | Spain |
| Pamplona | Pamplona | 31008 | Spain |
| Valencia | Valencia | 46026 | Spain |
| Barakaldo | Vizcaya | 48903 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
| Gothenburg | 413 45 | Sweden |
| Jönköping | 551 85 | Sweden |
| Kalmar | 391 85 | Sweden |
| Malmö | 205 02 | Sweden |
| Sandviken | 80187 | Sweden |
| Stockholm | 171 76 | Sweden |
| Sundsvall | 851 86 | Sweden |
| Umeå | 901 85 | Sweden |
| Bristol | Bristol | BS2 8ED | United Kingdom |
| Romford | Essex | RM7 0AG | United Kingdom |
| Leicester | Leicestershire | LE1 5WW | United Kingdom |
| Manchester | Manchester | M20 4BX | United Kingdom |
| Bebington | Merseyside | CH63 4JY | United Kingdom |
| Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| Taunton | Somerset | TA1 5DA | United Kingdom |
| Ipswich | Suffolk | IP4 5PD | United Kingdom |
| Guildford | Surrey | GU2 7XX | United Kingdom |
| Sutton | Surrey | SM2 5PT | United Kingdom |
| Coventry | Warwickshire | CV2 2DX | United Kingdom |
| Birmingham | West Midlands | B15 2TH | United Kingdom |
| Belfast | BT9 7AB | United Kingdom |
| Brighton | BN2 5BD | United Kingdom |
| Cardiff | United Kingdom |
| Derby | DE22 3NE | United Kingdom |
| Hull | HU16 5JQ | United Kingdom |
| Leeds | LS9 7TF | United Kingdom |
| Northwood | HA6 2RN | United Kingdom |
| Plymouth | PL6 8DH | United Kingdom |
| Sheffield | S10 2SJ | United Kingdom |
| Southampton | SO16 6YD | United Kingdom |
| Wolverhampton | WV10 0QP | United Kingdom |
| Result |
| Hoskin P, Sartor O, O'Sullivan JM, Johannessen DC, Helle SI, Logue J, Bottomley D, Nilsson S, Vogelzang NJ, Fang F, Wahba M, Aksnes AK, Parker C. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. Lancet Oncol. 2014 Nov;15(12):1397-406. doi: 10.1016/S1470-2045(14)70474-7. Epub 2014 Oct 17. |
| 24836273 | Result | Sartor O, Coleman R, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Widmark A, Johannessen DC, Hoskin P, James ND, Solberg A, Syndikus I, Vogelzang NJ, O'Bryan-Tear CG, Shan M, Bruland OS, Parker C. Effect of radium-223 dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial. Lancet Oncol. 2014 Jun;15(7):738-46. doi: 10.1016/S1470-2045(14)70183-4. Epub 2014 May 13. |
| 25840395 | Result | Delacruz A, Arauz G, Curley T, Lindo A, Jensen T. Nursing management of patients with castration-resistant prostate cancer undergoing radium-223 dichloride treatment. Clin J Oncol Nurs. 2015 Apr;19(2):E31-5. doi: 10.1188/15.CJON.E31-E35. |
| 25832684 | Result | Humm JL, Sartor O, Parker C, Bruland OS, Macklis R. Radium-223 in the treatment of osteoblastic metastases: a critical clinical review. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):898-906. doi: 10.1016/j.ijrobp.2014.12.061. |
| 24857093 | Result | Nilsson S. Alpha-emitter radium-223 in the management of solid tumors: current status and future directions. Am Soc Clin Oncol Educ Book. 2014:e132-9. doi: 10.14694/EdBook_AM.2014.34.e132. |
| 24775727 | Result | Den RB, Doyle LA, Knudsen KE. Practical guide to the use of radium 223 dichloride. Can J Urol. 2014 Apr;21(2 Supp 1):70-6. |
| 24610703 | Result | Shirley M, McCormack PL. Radium-223 dichloride: a review of its use in patients with castration-resistant prostate cancer with symptomatic bone metastases. Drugs. 2014 Apr;74(5):579-86. doi: 10.1007/s40265-014-0198-4. |
| 24052017 | Result | Wissing MD, van Leeuwen FW, van der Pluijm G, Gelderblom H. Radium-223 chloride: Extending life in prostate cancer patients by treating bone metastases. Clin Cancer Res. 2013 Nov 1;19(21):5822-7. doi: 10.1158/1078-0432.CCR-13-1896. Epub 2013 Sep 19. |
| 23977665 | Result | Joung JY, Ha YS, Kim IY. Radium Ra 223 dichloride in castration-resistant prostate cancer. Drugs Today (Barc). 2013 Aug;49(8):483-90. doi: 10.1358/dot.2013.49.8.1968670. |
| 27930924 | Derived | Parker C, Zhan L, Cislo P, Reuning-Scherer J, Vogelzang NJ, Nilsson S, Sartor O, O'Sullivan JM, Coleman RE. Effect of radium-223 dichloride (Ra-223) on hospitalisation: An analysis from the phase 3 randomised Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial. Eur J Cancer. 2017 Jan;71:1-6. doi: 10.1016/j.ejca.2016.10.020. Epub 2016 Dec 6. |
| Integrating radium-223 therapy into the management of metastatic prostate cancer care: a plain language summary | View source |
Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study.
| Participants received treatment |
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| Entered 3-Year Follow-up Period |
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| Completed 3-Year Follow-up Period |
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| COMPLETED |
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| NOT COMPLETED |
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| Period 2:Switched From Placebo to Xofigo |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo | Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Total Alkaline Phosphatase (ALP) | The total amount of ALP in the blood was determined at baseline. | Number | Participants |
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| Current use of bisphosphonates | Subjects may have been on bisphosphonate therapy during the study. | Number | Participants |
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| Any prior use of docetaxel | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival | Overall survival was defined as the time from date of randomization to the date of death. | The intent-to-treat (ITT) population was defined as all randomized subjects. | Posted | Median | 95% Confidence Interval | Months | 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) |
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| 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 | The ITT population was all randomized subjects. | Posted | Median | 95% Confidence Interval | Months | From randomization to first ALP progression until approximately 3 years after start of enrollment |
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| 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. | Participants in The ITT population and had no missing values for this outcome measure | Posted | Number | Percentage of participants | At Baseline and Week 12 |
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| 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. | Participants in The ITT population and had no missing values for this outcome measure | Posted | Number | Percentage of participants | At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase) |
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| 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. | Participants in The ITT population and had no missing values for this outcome measure | Posted | Number | Percentage of participants | At Baseline and Week 12 |
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| 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 | Participants in The ITT population and had no missing values for this outcome measure | Posted | Least Squares Mean | Standard Error | Percentage change | At Baseline and Week 12 |
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| 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. | Participants in The ITT population and had no missing values for this outcome measure | Posted | Least Squares Mean | Standard Error | Percentage change | From baseline to Week 12 |
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| 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 | Participants in The ITT population and had no missing values for this outcome measure | Posted | Least Squares Mean | Standard Error | Percent change | At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase) |
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| 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. | Participants in The ITT population and had no missing values for this outcome measure | Posted | Least Squares Mean | Standard Error | Percentage change | From baseline During the 24 Week Treatment |
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| 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 | The ITT population was all randomized subjects | Posted | Median | 95% Confidence Interval | Months | From randomization to first PSA progression until approximately 3 years after start of enrollment |
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| 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. | Participants in The ITT population and had no missing values for this outcome measure | Posted | Number | Percentage of participants | At Baseline and Week 12 |
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| 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. | Participants in The ITT population and had no missing values for this outcome measure | Posted | Number | Percentage of participants | At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase) |
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| 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 | Participants in The ITT population and had no missing values for this outcome measure | Posted | Least Squares Mean | Standard Error | Percent change | At Baseline and Week 12 |
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| 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. | Participants in The ITT population and had no missing values for this outcome measure | Posted | Least Squares Mean | Standard Error | Percentage change | From baseline up to Week 12 |
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| 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 | Participants in The ITT population and had no missing values for this outcome measure | Posted | Least Squares Mean | Standard Error | Percentage change | At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase) |
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| 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. | Participants in The ITT population and had no missing values for this outcome measure | Posted | Least Squares Mean | Standard Error | Percentage change | From baseline to End of Treatment (Week 24; 4 weeks post last injection) |
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| 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. | The ITT population was all randomized subjects | Posted | Median | 95% Confidence Interval | Months | From randomization to first first SRE until approximately 3 years after start of enrollment |
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| 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. | The ITT population was all randomized subjects | Posted | Median | 95% Confidence Interval | Months | From randomization to first EBRT until approximately 3 years after start of enrollment |
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| 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. | The ITT population was all randomized subjects | Posted | Median | 95% Confidence Interval | Months | From randomization to first use of radioisotopes until approximately 3 years after start of enrollment |
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| 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. | The ITT population was all randomized subjects | Posted | Median | 95% Confidence Interval | Months | From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment |
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| 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. | The ITT population was all randomized subjects | Posted | Median | 95% Confidence Interval | Months | From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment |
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| 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. | The ITT population was all randomized subjects | Posted | Median | 95% Confidence Interval | Months | From randomization to first spinal cord compression until approximately 3 years after start of enrollment |
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| 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. | The ITT population was all randomized subjects | Posted | Median | 95% Confidence Interval | Months | From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment |
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| 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. | The ITT population was all randomized subjects | Posted | Median | 95% Confidence Interval | Months | From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment |
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| 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. | Participants in The ITT population and with ECOG analyzed | Posted | Number | Participants | Week 0 |
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| 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. | Participants in The ITT population and with ECOG analyzed | Posted | Number | Participants | Week 8 |
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| 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. | Participants in The ITT population and with ECOG analyzed | Posted | Number | Participants | Week 16 |
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| 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. | Participants in The ITT population and with ECOG analyzed | Posted | Number | Participants | Week 24 |
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| 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). | The ITT population was all randomized subjects | Posted | Median | Full Range | Scores on a scale | Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42) |
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| 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. | The ITT population was all randomized subjects | Posted | Median | Full Range | Scores on a scale | Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42) |
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| 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. | The ITT population was all randomized subjects | Posted | Median | Full Range | Scores on a scale | At Week 16 |
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| 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. | The ITT population was all randomized subjects | Posted | Median | Full Range | Scores on a scale | At Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | The ITT population was all randomized subjects | Posted | Median | Full Range | Scores on a scale | At Follow-up Visit 2 (Week 42) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | The ITT population was all randomized subjects | Posted | Median | Full Range | Scores on a scale | At Week 16, Week 24, and Follow-up Visit 2 (Week 42) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | The ITT population was all randomized subjects | Posted | Median | Full Range | Scores on a scale | Baseline, Week 16, Week 24, and Follow-up Visit 2 (week 42) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | The ITT population was all randomized subjects | Posted | Median | Full Range | Scores on a scale | At Week 16, Week 24, and Follow-up Visit 2 (Week 42) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | The ITT population was all randomized subjects | Posted | Median | Full Range | Scores on a scale | Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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'). | The ITT population was all randomized subjects with with EQ-5D analyzed. | Posted | Number | Participants | Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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'). | The ITT population was all randomized subjects with with EQ-5D analyzed. | Posted | Number | Participants | Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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'). | The ITT population was all randomized subjects with with EQ-5D analyzed. | Posted | Number | Participants | Follow-up Visit 8 (Week 139) |
|
|
Treatment-emergent AEs (TEAEs) data were collected after the first injection of study treatment and within 12 weeks after the last injection of study treatment.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radium-223 Dichloride (Xofigo, BAY88-8223) | Subjects received BSoC plus radium-223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals. | 286 | 524 | ||||
| EG001 | Placebo | Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase. | 185 | 254 | ||||
| EG002 | Placebo Randomized, Then Switched to Radium-223 Dichloride | Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study. | 17 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Erosive duodenitis | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Death | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Malaise | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Oedema | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Sudden death | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Drug intolerance | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Listeriosis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pyonephrosis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Abscess jaw | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cystitis radiation | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Stent occlusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Medical device complication | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Device dislocation | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Benign neoplasm of bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bone marrow tumour cell infiltration | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Benign urinary tract neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Facial palsy | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Radicular syndrome | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nerve root compression | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Paresis cranial nerve | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Prostatic haemorrhage | Reproductive system and breast disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
No PI may disclose or publish information from the trial before publication of the principal and first communication arising from the trial, unless 12 months has elapsed after completion of the trial. There is restriction on the PI that the sponsor can review results communication prior to public release and can embargo regarding trial results for a period that is less/or equal to 60 days from the time submitted to the sponsor for review. Sponsor cannot require changes or extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
Not provided
Not provided
Not provided
| Completion page not expected |
|
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| ≥ 220 U/L |
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| No |
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| No |
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| Participants |
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