Trial Outcomes & Findings for Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma (NCT NCT02928029)
NCT ID: NCT02928029
Last Updated: 2020-02-26
Results Overview
Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) determined by incidence of dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for the severity grade
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
7 participants
Primary outcome timeframe
From the start of study medication through 3 weeks after administration of the second dose of radium-223 dichloride, assessed up to 9 weeks
Results posted on
2020-02-26
Participant Flow
The study was conducted in 7 study centers, the first participant first visit was on 10/Feb/2017 and last participant last visit on 20/Mar/2019
10 participants were screened in the study; 4 participants in Cohort 1 and 6 participants in Cohort 2. 3 of these participants failed screening procedures, all for the reason "inclusion criteria not met". No participants were started in the Phase 2 part of the study prior to study termination.
Participant milestones
| Measure |
Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone
Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
|
Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone
Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone
Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
|
Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone
Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Radiological progression
|
1
|
0
|
|
Overall Study
Clinical progression
|
1
|
2
|
|
Overall Study
AE not related to clinical progression
|
1
|
1
|
Baseline Characteristics
Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone
n=3 Participants
Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
|
Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone
n=4 Participants
Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.0 years
STANDARD_DEVIATION 5.0 • n=99 Participants
|
68.3 years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
66.9 years
STANDARD_DEVIATION 8.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From the start of study medication through 3 weeks after administration of the second dose of radium-223 dichloride, assessed up to 9 weeksPopulation: The safety analysis set including all participants who received at least one administration of study treatment
Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) determined by incidence of dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for the severity grade
Outcome measures
| Measure |
Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone
n=3 Participants
Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
|
Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone
n=4 Participants
Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
|
|---|---|---|
|
Phase 1: MTD/RP2D Determined by the Incidence of DLTs
|
NA KBq/kg
This study was stopped prior to the MTD being defined. Accordingly, there was no RP2D determined
|
NA KBq/kg
This study was stopped prior to the MTD being defined. Accordingly, there was no RP2D determined
|
PRIMARY outcome
Timeframe: From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 yearsPopulation: The safety analysis set including all participants who received at least one administration of study treatment
A treatment-emergent adverse event (TEAE) is defined as any event arising or worsening after start of study drug administration until the end of the treatment period
Outcome measures
| Measure |
Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone
n=3 Participants
Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
|
Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone
n=4 Participants
Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
|
|---|---|---|
|
Phase 1: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Drug-related TEAEs, and Treatment-emergent Serious AE
Any drug-related TEAE
|
3 Participants
|
4 Participants
|
|
Phase 1: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Drug-related TEAEs, and Treatment-emergent Serious AE
Any treatment-emergent serious AE
|
2 Participants
|
1 Participants
|
|
Phase 1: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Drug-related TEAEs, and Treatment-emergent Serious AE
Any TEAE
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The safety analysis set including all participants who received at least one administration of study treatment
Determined by International Myeloma Working Group (IMWG) uniform response criteria. CR: Negative immunofixation of serum and urine, disappearance of any soft-tissue plasmacytomas, and \<5% plasma cells in bone marrow; in patients for whom only measurable disease is by serum free light chain (FLC) level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria is required; 2 consecutive assessments are needed. VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-component plus urine M-component \<100 mg/24 hours (hrs); in patients for whom only measurable disease is by serum FLC level, \>90% decrease in difference between involved and uninvolved FLC levels, in addition to VGPR criteria, is required; 2 consecutive assessments are needed
Outcome measures
| Measure |
Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone
n=3 Participants
Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
|
Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone
n=4 Participants
Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
|
|---|---|---|
|
Phase 1: The Number of Subjects With Complete Response (CR) and Very Good Partial Response (VGPR)
|
NA Participants
Participants were not evaluable per International Myeloma Working Group (IMWG) uniform response criteria
|
NA Participants
Participants were not evaluable per International Myeloma Working Group (IMWG) uniform response criteria
|
Adverse Events
Radium-223 33 kBq/kg + BOR/DEX
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Radium-223 55 kBq/kg + BOR/DEX
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radium-223 33 kBq/kg + BOR/DEX
n=3 participants at risk
Subjects received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223dichloride doses in combination with BOR and DEX
|
Radium-223 55 kBq/kg + BOR/DEX
n=4 participants at risk
Subjects received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223dichloride doses in combination with BOR and DEX
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Nervous system disorders
Spinal cord compression
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
Other adverse events
| Measure |
Radium-223 33 kBq/kg + BOR/DEX
n=3 participants at risk
Subjects received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223dichloride doses in combination with BOR and DEX
|
Radium-223 55 kBq/kg + BOR/DEX
n=4 participants at risk
Subjects received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223dichloride doses in combination with BOR and DEX
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 11 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Eye disorders
Eye discharge
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Eye disorders
Eyelid oedema
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Eye disorders
Periorbital oedema
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
50.0%
2/4 • Number of events 2 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Eye disorders
Visual acuity reduced
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 2 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 2 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
75.0%
3/4 • Number of events 3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 2 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
75.0%
3/4 • Number of events 3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
General disorders
Asthenia
|
66.7%
2/3 • Number of events 4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
50.0%
2/4 • Number of events 2 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
General disorders
Chest pain
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
General disorders
Face oedema
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
50.0%
2/4 • Number of events 2 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
General disorders
Oedema peripheral
|
66.7%
2/3 • Number of events 4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Infections and infestations
Gastroenteritis
|
33.3%
1/3 • Number of events 2 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Infections and infestations
Rhinovirus infection
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Infections and infestations
Septic arthritis streptobacillus
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
50.0%
2/4 • Number of events 2 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
50.0%
2/4 • Number of events 18 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
50.0%
2/4 • Number of events 16 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Number of events 2 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
50.0%
2/4 • Number of events 2 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Nervous system disorders
Cognitive disorder
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
75.0%
3/4 • Number of events 3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
33.3%
1/3 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
0.00%
0/4 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
25.0%
1/4 • Number of events 1 • From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60