Phase 4
N=255
Radium-223 Dichloride Long-term Follow-up Program
Neoplasm Metastasis / Bone and Bones
Bottom Line
View on ClinicalTrials.gov: NCT02312960 ↗Enrolled (actual)
255
Serious AEs
12.6%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) — 0; 1; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Data Collection (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) |
0; 1; 1; 0; 0; 0 | — |
| PRIMARY Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Leukemia |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Myelodysplastic Syndrome |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Aplastic Anemia |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Primary Bone Cancer |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Any Other New Primary Malignancy |
1; 1; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Bone Fractures |
3; 6; 1; 1; 3; 0 | — |
| PRIMARY Number of Participants With Bone-associated Events |
1; 2; 1; 2; 0; 0 | — |
| PRIMARY Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy |
0; 0; 0; 0; 0; 0 | — |
Summary
Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo.
Eligibility Criteria
Inclusion Criteria
- Subject was previously enrolled in a selected company sponsored feeder trial, and has received at least 1 dose of radium 223 dichloride or placebo in the feeder trial
Exclusion Criteria
- Not applicable to this follow up study
Data sourced from ClinicalTrials.gov (NCT02312960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.