Trial Outcomes & Findings for A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients (NCT NCT04237584)
NCT ID: NCT04237584
Last Updated: 2022-10-07
Results Overview
SSE-FS is a composite endpoint, composed of 4 events that indicate disease progression: * the first use of external-beam radiation therapy to relieve skeletal tumor-related symptoms * the occurrence of new symptomatic pathologic bone fractures. * the occurrence of new symptomatic spinal cord compression * a tumor-related orthopedic surgical intervention
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
approximately 1 year and 8 months
Results posted on
2022-10-07
Participant Flow
Recruitment occurred from Jun 2020- Jul 2021 at selected medical centers that specialized in the treatment of advanced prostate cancer.
23 subjects signed ICF. 2/23 subjects screen failed without reporting any adverse events and received no study treatments. 21/23 subjects signing ICF met all entry criteria and were randomized to Lead-in ARB (R1). 5 subjects discontinued the study during Lead-in ARB. Although 16 subjects randomized to R2, 2 of the subjects randomized to Enzalutamide + Placebo did not receive any cycles due to the early termination of the study and are reported only in the Lead-in Enzalutamide safety group.
Participant milestones
| Measure |
Enzalutamide + Ra-223
Lead-in Enzalutamide 12 weeks followed by Ra-223 up to 6 cycles (at 4 week intervals) with continued Enzalutamide.
|
Darolutamide + Ra-223
Lead-in Darolutamide 12 weeks followed by Ra-223 up to 6 cycles (at 4 week intervals) with continued Darolutamide.
|
Enzalutamide + Placebo
Lead-in Enzalutamide 12 weeks followed by Placebo (normal saline) up to 6 cycles (at 4 week intervals) with continued Enzalutamide.
|
Darolutamide + Placebo
Lead-in Darolutamide 12 weeks followed by Placebo (normal saline) up to 6 cycles (at 4 week intervals) with continued Darolutamide.
|
|---|---|---|---|---|
|
R1- Lead-in ARB Treatment (12 Weeks)
STARTED
|
5
|
5
|
6
|
5
|
|
R1- Lead-in ARB Treatment (12 Weeks)
COMPLETED
|
4
|
4
|
3
|
3
|
|
R1- Lead-in ARB Treatment (12 Weeks)
NOT COMPLETED
|
1
|
1
|
3
|
2
|
|
R2- ARB Treatment With Ra-223 or Placebo
STARTED
|
4
|
4
|
3
|
3
|
|
R2- ARB Treatment With Ra-223 or Placebo
COMPLETED
|
0
|
0
|
0
|
0
|
|
R2- ARB Treatment With Ra-223 or Placebo
NOT COMPLETED
|
4
|
4
|
3
|
3
|
Reasons for withdrawal
| Measure |
Enzalutamide + Ra-223
Lead-in Enzalutamide 12 weeks followed by Ra-223 up to 6 cycles (at 4 week intervals) with continued Enzalutamide.
|
Darolutamide + Ra-223
Lead-in Darolutamide 12 weeks followed by Ra-223 up to 6 cycles (at 4 week intervals) with continued Darolutamide.
|
Enzalutamide + Placebo
Lead-in Enzalutamide 12 weeks followed by Placebo (normal saline) up to 6 cycles (at 4 week intervals) with continued Enzalutamide.
|
Darolutamide + Placebo
Lead-in Darolutamide 12 weeks followed by Placebo (normal saline) up to 6 cycles (at 4 week intervals) with continued Darolutamide.
|
|---|---|---|---|---|
|
R1- Lead-in ARB Treatment (12 Weeks)
Adverse Event
|
0
|
0
|
1
|
1
|
|
R1- Lead-in ARB Treatment (12 Weeks)
Did not meet R2 entry criteria
|
1
|
1
|
0
|
1
|
|
R1- Lead-in ARB Treatment (12 Weeks)
Randomized R2 (no cycles given)
|
0
|
0
|
2
|
0
|
|
R2- ARB Treatment With Ra-223 or Placebo
Sponsor Decision
|
4
|
4
|
2
|
3
|
|
R2- ARB Treatment With Ra-223 or Placebo
Physician Decision
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients
Baseline characteristics by cohort
| Measure |
Lead-in Enzalutamide Followed by Radium-223/Enzalutamide
n=5 Participants
12-week lead-in of open-label Enzalutamide followed by radium-223. Participants continued on their randomized, open-label Enzalutamide.
|
Lead-in Darolutamide Followed by Radium-223/Darolutamide
n=5 Participants
12-week lead-in of open-label Darolutamide followed by radium-223. Participants continued on their randomized, open-label Darolutamide.
|
Lead-in Enzalutamide Followed by Placebo/Enzalutamide
n=6 Participants
12-week lead-in of open-label Enzalutamide followed by placebo. Participants continued on their randomized, open-label Enzalutamide.
|
Lead-in Darolutamide Followed by Placebo/Darolutamide
n=5 Participants
12-week lead-in of open-label Darolutamide followed by placebo. Participants continued on their randomized, open-label Darolutamide.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Males
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
6 participants
n=206 Participants
|
5 participants
n=7 Participants
|
21 participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
6 participants
n=206 Participants
|
5 participants
n=7 Participants
|
21 participants
n=31 Participants
|
|
Concomitant use of bone health agents (osteoclast inhibitors)
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: approximately 1 year and 8 monthsPopulation: No analysis was performed. Outcome measure includes only number (%) of subjects that met primary endpoint (occurrence of SSE-FS).
SSE-FS is a composite endpoint, composed of 4 events that indicate disease progression: * the first use of external-beam radiation therapy to relieve skeletal tumor-related symptoms * the occurrence of new symptomatic pathologic bone fractures. * the occurrence of new symptomatic spinal cord compression * a tumor-related orthopedic surgical intervention
Outcome measures
| Measure |
Lead-in Enzalutamide Only (no Cycles)
n=4 Participants
Lead-in Enzalutamide only. No Cycles.
|
Lead-in Darolutamide Only (no Cycles)
n=3 Participants
Lead-in Darolutamide only. No Cycles.
|
Lead-in Enzalutamide Followed by Radium-223/Enzalutamide
n=4 Participants
Randomized, Open-label Lead-in ARB (enzalutamide) followed by Radium-223 + Enzalutamide.
|
Lead-in Darolutamide Followed by Radium-223/Darolutamide
n=4 Participants
Randomized, Open-label Lead-in ARB (darolutamide) followed by Radium-223 + Darolutamide.
|
Lead-in Enzalutamide Followed by Placebo/Enzalutamide
n=3 Participants
Randomized, Open-label Lead-in ARB (enzalutamide) followed by Placebo + Enzalutamide.
|
Lead-in Darolutamide Followed by Placebo/Darolutamide
n=3 Participants
Randomized, Open-label Lead-in ARB (darolutamide) followed by Placebo + Darolutamide.
|
|---|---|---|---|---|---|---|
|
Symptomatic Skeletal Event-free Survival (SSE-FS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: approximately 1 year and 8 monthsPopulation: No analysis was performed. Outcome measure includes only number (%) of subjects with who survived.
Number of subjects who survived between RT2 randomization through data cut-off.
Outcome measures
| Measure |
Lead-in Enzalutamide Only (no Cycles)
n=4 Participants
Lead-in Enzalutamide only. No Cycles.
|
Lead-in Darolutamide Only (no Cycles)
n=3 Participants
Lead-in Darolutamide only. No Cycles.
|
Lead-in Enzalutamide Followed by Radium-223/Enzalutamide
n=4 Participants
Randomized, Open-label Lead-in ARB (enzalutamide) followed by Radium-223 + Enzalutamide.
|
Lead-in Darolutamide Followed by Radium-223/Darolutamide
n=4 Participants
Randomized, Open-label Lead-in ARB (darolutamide) followed by Radium-223 + Darolutamide.
|
Lead-in Enzalutamide Followed by Placebo/Enzalutamide
n=3 Participants
Randomized, Open-label Lead-in ARB (enzalutamide) followed by Placebo + Enzalutamide.
|
Lead-in Darolutamide Followed by Placebo/Darolutamide
n=3 Participants
Randomized, Open-label Lead-in ARB (darolutamide) followed by Placebo + Darolutamide.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: approximately 1 year and 8 monthsPopulation: No analysis was performed. Outcome measure includes only number (%) of subjects who started docetaxel or cabazitaxel treatment during the study.
Number of subjects who began docetaxel or cabazitaxel treatment during the study.
Outcome measures
| Measure |
Lead-in Enzalutamide Only (no Cycles)
n=4 Participants
Lead-in Enzalutamide only. No Cycles.
|
Lead-in Darolutamide Only (no Cycles)
n=3 Participants
Lead-in Darolutamide only. No Cycles.
|
Lead-in Enzalutamide Followed by Radium-223/Enzalutamide
n=4 Participants
Randomized, Open-label Lead-in ARB (enzalutamide) followed by Radium-223 + Enzalutamide.
|
Lead-in Darolutamide Followed by Radium-223/Darolutamide
n=4 Participants
Randomized, Open-label Lead-in ARB (darolutamide) followed by Radium-223 + Darolutamide.
|
Lead-in Enzalutamide Followed by Placebo/Enzalutamide
n=3 Participants
Randomized, Open-label Lead-in ARB (enzalutamide) followed by Placebo + Enzalutamide.
|
Lead-in Darolutamide Followed by Placebo/Darolutamide
n=3 Participants
Randomized, Open-label Lead-in ARB (darolutamide) followed by Placebo + Darolutamide.
|
|---|---|---|---|---|---|---|
|
Time to Chemotherapy Initiation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: approximately 1 year and 8 monthsPopulation: No analysis was performed. Outcome measure includes only number (%) of subjects who experienced radiological progression.
Number of subjects with bone scan progression per PCWG3 criteria, and/or progression by CT/MRI per RECIST 1.1 criteria, or death from any cause following RT2. Radiological progression is interpreted by local assessment only.
Outcome measures
| Measure |
Lead-in Enzalutamide Only (no Cycles)
n=4 Participants
Lead-in Enzalutamide only. No Cycles.
|
Lead-in Darolutamide Only (no Cycles)
n=3 Participants
Lead-in Darolutamide only. No Cycles.
|
Lead-in Enzalutamide Followed by Radium-223/Enzalutamide
n=4 Participants
Randomized, Open-label Lead-in ARB (enzalutamide) followed by Radium-223 + Enzalutamide.
|
Lead-in Darolutamide Followed by Radium-223/Darolutamide
n=4 Participants
Randomized, Open-label Lead-in ARB (darolutamide) followed by Radium-223 + Darolutamide.
|
Lead-in Enzalutamide Followed by Placebo/Enzalutamide
n=3 Participants
Randomized, Open-label Lead-in ARB (enzalutamide) followed by Placebo + Enzalutamide.
|
Lead-in Darolutamide Followed by Placebo/Darolutamide
n=3 Participants
Randomized, Open-label Lead-in ARB (darolutamide) followed by Placebo + Darolutamide.
|
|---|---|---|---|---|---|---|
|
Radiographic Progression-free Survival (rPFS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: approximately 1 year and 8 monthsPopulation: No analysis was performed. Outcome measure includes only number (%) of subjects followed for safety. Safety data reported in AE section.
Safety profile of androgen receptor blockers (enzalutamide or darolutamide) with or without radium-223; number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Reported only in the AE reporting module.
Outcome measures
| Measure |
Lead-in Enzalutamide Only (no Cycles)
n=4 Participants
Lead-in Enzalutamide only. No Cycles.
|
Lead-in Darolutamide Only (no Cycles)
n=3 Participants
Lead-in Darolutamide only. No Cycles.
|
Lead-in Enzalutamide Followed by Radium-223/Enzalutamide
n=4 Participants
Randomized, Open-label Lead-in ARB (enzalutamide) followed by Radium-223 + Enzalutamide.
|
Lead-in Darolutamide Followed by Radium-223/Darolutamide
n=4 Participants
Randomized, Open-label Lead-in ARB (darolutamide) followed by Radium-223 + Darolutamide.
|
Lead-in Enzalutamide Followed by Placebo/Enzalutamide
n=3 Participants
Randomized, Open-label Lead-in ARB (enzalutamide) followed by Placebo + Enzalutamide.
|
Lead-in Darolutamide Followed by Placebo/Darolutamide
n=3 Participants
Randomized, Open-label Lead-in ARB (darolutamide) followed by Placebo + Darolutamide.
|
|---|---|---|---|---|---|---|
|
Safety Profile of Androgen Receptor Blocker (ARB) Therapy With or Without Radium-223.
|
4 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: approximately 1 year and 8 monthsPopulation: No analysis was performed. Outcome measure includes only number (%) of subjects with AESI.
Assess occurrence of AESI: fractures (pathologic and non-pathologic).
Outcome measures
| Measure |
Lead-in Enzalutamide Only (no Cycles)
n=11 Participants
Lead-in Enzalutamide only. No Cycles.
|
Lead-in Darolutamide Only (no Cycles)
n=10 Participants
Lead-in Darolutamide only. No Cycles.
|
Lead-in Enzalutamide Followed by Radium-223/Enzalutamide
n=4 Participants
Randomized, Open-label Lead-in ARB (enzalutamide) followed by Radium-223 + Enzalutamide.
|
Lead-in Darolutamide Followed by Radium-223/Darolutamide
n=4 Participants
Randomized, Open-label Lead-in ARB (darolutamide) followed by Radium-223 + Darolutamide.
|
Lead-in Enzalutamide Followed by Placebo/Enzalutamide
n=3 Participants
Randomized, Open-label Lead-in ARB (enzalutamide) followed by Placebo + Enzalutamide.
|
Lead-in Darolutamide Followed by Placebo/Darolutamide
n=3 Participants
Randomized, Open-label Lead-in ARB (darolutamide) followed by Placebo + Darolutamide.
|
|---|---|---|---|---|---|---|
|
Occurrence of AESI: Bone Fractures (Pathologic and Non-pathologic)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
12 Weeks Lead-in Enzalutamide Only (No Cycles)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
12 Weeks Lead-in Darolutamide Only (No Cycles)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Lead-in Enzalutamide Followed by Ra-223/Enzalutamide
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Lead-in Darolutamide Followed by Ra-223/Darolutamide
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Lead-in Enzalutamide Followed by Placebo/Enzalutamide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lead-in Darolutamide Followed by Placebo/Darolutamide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
12 Weeks Lead-in Enzalutamide Only (No Cycles)
n=4 participants at risk
12 weeks of Lead-in Enzalutamide without any cycles
|
12 Weeks Lead-in Darolutamide Only (No Cycles)
n=3 participants at risk
12 weeks of Lead-in Darolutamide without any cycles
|
Lead-in Enzalutamide Followed by Ra-223/Enzalutamide
n=4 participants at risk
12 weeks Lead-in Enzalutamide followed by up to 6 (once monthly) Ra-223 cycles + continued Enzalutamide
|
Lead-in Darolutamide Followed by Ra-223/Darolutamide
n=4 participants at risk
12 weeks Lead-in Darolutamide followed by up to 6 (once monthly) Ra-223 cycles + continued Darolutamide
|
Lead-in Enzalutamide Followed by Placebo/Enzalutamide
n=3 participants at risk
12 weeks Lead-in Enzalutamide followed by up to 6 (once monthly) Placebo cycles + continued Enzalutamide
|
Lead-in Darolutamide Followed by Placebo/Darolutamide
n=3 participants at risk
12 weeks Lead-in Darolutamide followed by up to 6 (once monthly) Placebo cycles + continued Darolutamide
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Syncope
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
Other adverse events
| Measure |
12 Weeks Lead-in Enzalutamide Only (No Cycles)
n=4 participants at risk
12 weeks of Lead-in Enzalutamide without any cycles
|
12 Weeks Lead-in Darolutamide Only (No Cycles)
n=3 participants at risk
12 weeks of Lead-in Darolutamide without any cycles
|
Lead-in Enzalutamide Followed by Ra-223/Enzalutamide
n=4 participants at risk
12 weeks Lead-in Enzalutamide followed by up to 6 (once monthly) Ra-223 cycles + continued Enzalutamide
|
Lead-in Darolutamide Followed by Ra-223/Darolutamide
n=4 participants at risk
12 weeks Lead-in Darolutamide followed by up to 6 (once monthly) Ra-223 cycles + continued Darolutamide
|
Lead-in Enzalutamide Followed by Placebo/Enzalutamide
n=3 participants at risk
12 weeks Lead-in Enzalutamide followed by up to 6 (once monthly) Placebo cycles + continued Enzalutamide
|
Lead-in Darolutamide Followed by Placebo/Darolutamide
n=3 participants at risk
12 weeks Lead-in Darolutamide followed by up to 6 (once monthly) Placebo cycles + continued Darolutamide
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Eye disorders
Cataract
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 2 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Nervous system disorders
Confusional state
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 2 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
General disorders
Decreased appetite
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
50.0%
2/4 • Number of events 2 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Renal and urinary disorders
Dysuria
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
66.7%
2/3 • Number of events 2 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
50.0%
2/4 • Number of events 2 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Reproductive system and breast disorders
Hot flush
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
General disorders
Hot flush
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 2 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
66.7%
2/3 • Number of events 2 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Nervous system disorders
Paraesthesia
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Renal and urinary disorders
Pollakiuria
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory syncytial virus infection
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Eye disorders
Uveitis
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Gastrointestinal disorders
Dyspesia
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
33.3%
1/3 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Eye disorders
Vision blurred
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
|
Psychiatric disorders
Confusional State
|
25.0%
1/4 • Number of events 1 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/4 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
0.00%
0/3 • Adverse event collection started at the time each subject signed informed consent and continued to be collected until each subject was 30 days post-last dose of study medication (enzalutamide, darolutamide, Ra-223, or placebo). The duration of the study was approximately 1 year and 8 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place