|
Demographics
|
|
|
|
| Weight |
82.9 |
81.95 |
83.85 |
| Body Surface Area |
1.86 |
1.84 |
1.88 |
| Mean number of injections radium-223 |
6 |
5.87 |
6.13 |
|
Efficacy data
|
|
|
|
| Overall Survival BSC scale |
3.8849 |
|
|
| Overall Survival BSC shape |
-0.1165 |
|
|
| Overall Survival radium-223 scale |
4.1465 |
|
|
| Overall Survival radium-223 shape |
-0.1035 |
|
|
| Progression Free Survival BSC scale |
2.5385 |
|
|
| Progression Free Survival BSC shape |
-0.4314 |
|
|
| Progression Free Survival radium-223 scale |
3.8067 |
|
|
| Progression Free Survival radium-223 shape |
-0.0116 |
|
|
| Symptomatic skeletal event BSC scale |
3.8319 |
|
|
| Symptomatic skeletal event BSC shape |
0.2994 |
|
|
| Symptomatic skeletal event radium-223 scale |
4.2223 |
|
|
| Symptomatic skeletal event radium-223 shape |
0.2494 |
|
|
|
Adverse Event
|
|
|
|
| Anaemia BSC |
0.58% |
0.40% |
0.76% |
| Anaemia radium-223 |
0.07% |
0.03% |
0.11% |
| Bone Pain BSC |
1.22% |
0.96% |
1.51% |
| Bone Pain radium-223 |
0.02% |
0.00% |
0.04% |
| Diarrhoea BSC |
0.07% |
0.01% |
0.13% |
| Diarrhoea radium-223 |
0.97% |
0.80% |
1.14% |
| Fatigue BSC |
0.26% |
0.14% |
0.38% |
| Fatigue radium-223 |
0.01% |
0.00% |
0.02% |
| Febrile neutropenia BSC |
0.01% |
0.00% |
0.04% |
| Febrile neutropenia radium-223 |
0.09% |
0.04% |
0.14% |
| Hypokalemia BSC |
0.01% |
0.00% |
0.04% |
| Hypokalemia radium-223 |
0.27% |
0.19% |
0.36% |
| Nausea BSC |
0.07% |
0.01% |
0.13% |
| Nausea radium-223 |
0.17% |
0.10% |
0.24% |
| Neutropenia BSC |
0.03% |
0.00% |
0.07% |
|
Neutropenia radium-223
|
|
|
|
| Thrombocytopenia BSC |
0.08% |
0.02% |
0.15% |
| Thrombocytopenia radium-223 |
0.57% |
0.45% |
0.70% |
| Vomiting BSC |
0.10% |
0.03% |
0.17% |
| Vomiting radium-223 |
0.07% |
0.03% |
0.11% |
|
Distribution of Skeletal Related Events
|
|
|
|
| External beam radiation BSC |
78.51% |
|
|
| External beam radiation radium-223 |
79.23% |
|
|
| Pathologic bone fracture BSC |
9.92% |
|
|
| Pathologic bone fracture radium-223 |
12.08% |
|
|
| Spinal cord compression BSC |
11.57% |
|
|
| Spinal Cord Compression radium-223 |
7.73% |
|
|
| Surgical intervention BSC |
0.00% |
|
|
| Surgical intervention radium-223 |
0.97% |
|
|
| Second line treatment BSC |
53.70% |
0.38 |
0.7 |
| Second line treatment radium-223 |
62.70% |
0.44 |
0.82 |
|
|
|
|