Trial Outcomes & Findings for I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW). (NCT NCT03939689)
NCT ID: NCT03939689
Last Updated: 2025-10-14
Results Overview
The percentage of participants with a PSA response according to PCWG3 criteria. PCWG3 defines PSA response as the first occurrence of a 50 percent or more decline in PSA from baseline, confirmed by a second measurement at least 3 weeks later.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Up to 53 weeks
Results posted on
2025-10-14
Participant Flow
Participants were recruited by physician referral at academic medical centers in the United States and Canada. Of 28 sites activated, 23 sites (16 in the United States and 7 in Canada) enrolled at least 1 participant. The study was initiated on 30May2019. The first participant consented on 07Jun2019 and last participant consented on 10Jun2022.
A total of 177 participants were screened. Of 132 participants who underwent piflufolastat imaging, 123 met the inclusion criterion of PSMA avidity.
Participant milestones
| Measure |
Enzalutamide
Enzalutamide: Enzalutamide will be given orally once daily as prescribed by the physician as standard of care.
|
I-131-1095 in Combination With Enzalutamide
I-131-1095: I-131-1095 will be administered intravenously at 100 mCi for the initial therapeutic dose, and up to 3 additional dose(s) at 75 mCi or 100 mCi each, administered at least 8 weeks apart as determined by dosimetry evaluation and occurrence of dose-limiting events.
Enzalutamide: Enzalutamide will be given orally once daily as prescribed by the physician as standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
76
|
|
Overall Study
COMPLETED
|
13
|
29
|
|
Overall Study
NOT COMPLETED
|
26
|
47
|
Reasons for withdrawal
| Measure |
Enzalutamide
Enzalutamide: Enzalutamide will be given orally once daily as prescribed by the physician as standard of care.
|
I-131-1095 in Combination With Enzalutamide
I-131-1095: I-131-1095 will be administered intravenously at 100 mCi for the initial therapeutic dose, and up to 3 additional dose(s) at 75 mCi or 100 mCi each, administered at least 8 weeks apart as determined by dosimetry evaluation and occurrence of dose-limiting events.
Enzalutamide: Enzalutamide will be given orally once daily as prescribed by the physician as standard of care.
|
|---|---|---|
|
Overall Study
Radiographic progression
|
14
|
17
|
|
Overall Study
Treatment is no longer benefiting participant
|
5
|
6
|
|
Overall Study
Adverse Event
|
1
|
8
|
|
Overall Study
Unequivocal clinical progression
|
2
|
5
|
|
Overall Study
Other
|
1
|
4
|
|
Overall Study
Death
|
0
|
3
|
|
Overall Study
Participant decision
|
0
|
3
|
|
Overall Study
Withdrawal of consent
|
2
|
1
|
|
Overall Study
Investigator decision
|
1
|
0
|
Baseline Characteristics
I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW).
Baseline characteristics by cohort
| Measure |
Enzalutamide
n=39 Participants
Participants received the labeled dosage of enzalutamide once daily for up to 53 weeks.
|
I-131-1095 in Combination With Enzalutamide
n=76 Participants
Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) were reduced to 75 mCi for participants experiencing any of the dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle.
Participants also received the label dosage of enzalutamide once daily for up to 53 weeks..
|
Total
n=115 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
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 8.97 • n=99 Participants
|
70.9 years
STANDARD_DEVIATION 8.96 • n=107 Participants
|
70.7 years
STANDARD_DEVIATION 8.93 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
10 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Height
|
174.3 cm
STANDARD_DEVIATION 6.52 • n=99 Participants
|
174.7 cm
STANDARD_DEVIATION 7.53 • n=107 Participants
|
174.6 cm
STANDARD_DEVIATION 7.18 • n=206 Participants
|
|
Weight
|
90.77 kg
STANDARD_DEVIATION 18.280 • n=99 Participants
|
90.58 kg
STANDARD_DEVIATION 17.467 • n=107 Participants
|
90.64 kg
STANDARD_DEVIATION 18.008 • n=206 Participants
|
|
Body mass index
|
29.73 kg/m2
STANDARD_DEVIATION 5.350 • n=99 Participants
|
29.66 kg/m2
STANDARD_DEVIATION 4.629 • n=107 Participants
|
29.68 kg/m2
STANDARD_DEVIATION 4.861 • n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 53 weeksThe percentage of participants with a PSA response according to PCWG3 criteria. PCWG3 defines PSA response as the first occurrence of a 50 percent or more decline in PSA from baseline, confirmed by a second measurement at least 3 weeks later.
Outcome measures
| Measure |
Enzalutamide
n=39 Participants
Participants received the labeled dosage of enzalutamide once daily for up to 53 weeks.
|
I-131-1095 in Combination With Enzalutamide
n=76 Participants
Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) were reduced to 75 mCi for participants experiencing any of the dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks.
|
|---|---|---|
|
PSA Response Rate
|
10 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Up to 53 weeksThe proportion of participants who have a partial response (PR) or complete response (CR) based on RECIST 1.1 for soft tissue or PCWG3 for bone (PCWG3-modified RECIST 1.1).
Outcome measures
| Measure |
Enzalutamide
n=39 Participants
Participants received the labeled dosage of enzalutamide once daily for up to 53 weeks.
|
I-131-1095 in Combination With Enzalutamide
n=76 Participants
Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) were reduced to 75 mCi for participants experiencing any of the dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years.Time from randomization to the first occurrence of radiographic progression based on RECIST 1.1 for soft tissue (≥20% increase in the sum of the longest diameter of the target lesions \[relative to the smallest value recorded since the treatment started\] or the appearance of ≥1 new lesion) or PCWG3-modified RECIST 1.1 for bone, respectively, or unequivocal clinical progression, or death on study from any cause.
Outcome measures
| Measure |
Enzalutamide
n=39 Participants
Participants received the labeled dosage of enzalutamide once daily for up to 53 weeks.
|
I-131-1095 in Combination With Enzalutamide
n=76 Participants
Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) were reduced to 75 mCi for participants experiencing any of the dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks.
|
|---|---|---|
|
Radiographic Progression Free Survival (rPFS)
|
11.5 Months
Interval 2.79 to 18.43
|
14.0 Months
Interval 8.64 to 18.2
|
SECONDARY outcome
Timeframe: Up to 5 yearsOverall Survival is defined as time from randomization to death from any cause.
Outcome measures
| Measure |
Enzalutamide
n=39 Participants
Participants received the labeled dosage of enzalutamide once daily for up to 53 weeks.
|
I-131-1095 in Combination With Enzalutamide
n=76 Participants
Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) were reduced to 75 mCi for participants experiencing any of the dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks.
|
|---|---|---|
|
Overall Survival (OS)
|
22.0 Months
Interval 14.59 to
The upper limit of the 95% confidence interval could not be calculated because too few participants had reached the endpoint.
|
18.8 Months
Interval 15.34 to 29.47
|
SECONDARY outcome
Timeframe: Up to 53 weeksTime from randomization to the date of the first PSA increase from baseline ≥ 25 percent and ≥ 2 ng/ml above nadir confirmed by a second PSA assessment defining progression ≥ 3 weeks later per PCWG3.
Outcome measures
| Measure |
Enzalutamide
n=39 Participants
Participants received the labeled dosage of enzalutamide once daily for up to 53 weeks.
|
I-131-1095 in Combination With Enzalutamide
n=76 Participants
Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) were reduced to 75 mCi for participants experiencing any of the dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks.
|
|---|---|---|
|
PSA Progression
|
10 Months
Interval 3.45 to
The upper limit of the 95% confidence interval could not be calculated because not enough participants had reached the endpoint.
|
NA Months
Interval 6.97 to
The median cannot be calculated until at least 50% of the participants have reached the endpoint. The upper limit of the 95% confidence interval could not be calculated because not enough participants had reached the endpoint.
|
SECONDARY outcome
Timeframe: Up to 5 years.Time from the first date of complete response (CR) or partial response (PR) to the first occurrence of radiographic progression based on PCWG3-modified RECIST 1.1, or unequivocal clinical progression. Complete response was defined as disappearance of all target lesions. Partial response was defined as ≥30% decrease from baseline in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Enzalutamide
n=39 Participants
Participants received the labeled dosage of enzalutamide once daily for up to 53 weeks.
|
I-131-1095 in Combination With Enzalutamide
n=76 Participants
Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) were reduced to 75 mCi for participants experiencing any of the dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks.
|
|---|---|---|
|
Duration of Response
|
15.1 Months
Interval 3.29 to
The upper limit of the 95% confidence interval could not be calculated because not enough participants had reached the endpoint
|
15.0 Months
Interval 3.29 to
The upper limit of the 95% confidence interval could not be calculated because not enough participants had reached the endpoint.
|
SECONDARY outcome
Timeframe: Up to 5 yearsTime from randomization to initiation of any new treatment for prostate cancer.
Outcome measures
| Measure |
Enzalutamide
n=39 Participants
Participants received the labeled dosage of enzalutamide once daily for up to 53 weeks.
|
I-131-1095 in Combination With Enzalutamide
n=76 Participants
Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) were reduced to 75 mCi for participants experiencing any of the dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks.
|
|---|---|---|
|
Time to Initiation of Next Treatment for Prostate Cancer
|
10.9 Time to event, months
Interval 5.16 to 13.6
|
18.3 Time to event, months
Interval 13.14 to
The upper limit of the 95% confidence interval could not be calculated because not enough participants had reached the endpoint.
|
Adverse Events
Enzalutamide
Serious events: 11 serious events
Other events: 37 other events
Deaths: 1 deaths
I-131-1095 in Combination With Enzalutamide
Serious events: 29 serious events
Other events: 72 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Enzalutamide
n=39 participants at risk
Participants received the labeled dosage of enzalutamide once daily for up to 53 weeks.
|
I-131-1095 in Combination With Enzalutamide
n=76 participants at risk
Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) reduced to 75 mCi for participants experiencing any of the dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
2.6%
2/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
2.6%
2/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
Platelet count decreased/Thrombocytopenia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
2.6%
2/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
White blood cell count decreased/Leukopenia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Cardiac disorders
Atrial tachycardia
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
General disorders
Fatigue/Asthenia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
2.6%
2/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Abdominal infection
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
2.6%
2/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Investigations
Platelet count decreased/Thrombocytopenia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
2.6%
2/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
2.6%
2/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
3.9%
3/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
2.6%
2/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord compression
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
2.6%
2/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Renal and urinary disorders
Haematuria
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
Other adverse events
| Measure |
Enzalutamide
n=39 participants at risk
Participants received the labeled dosage of enzalutamide once daily for up to 53 weeks.
|
I-131-1095 in Combination With Enzalutamide
n=76 participants at risk
Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) reduced to 75 mCi for participants experiencing any of the dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks.
|
|---|---|---|
|
General disorders
Fatigue
|
51.3%
20/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
71.1%
54/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Nausea
|
30.8%
12/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
57.9%
44/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.9%
7/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
47.4%
36/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
43.6%
17/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
30.3%
23/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
47.4%
36/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.8%
12/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
30.3%
23/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
15.4%
6/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
35.5%
27/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
9/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
23.7%
18/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Immune system disorders
Weight decreased
|
15.4%
6/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
26.3%
20/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
6/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
25.0%
19/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
30.3%
23/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Nervous system disorders
Headache
|
15.4%
6/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
19.7%
15/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Nervous system disorders
Dysgeusia
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
22.4%
17/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Constipation
|
12.8%
5/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
17.1%
13/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
19.7%
15/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Nervous system disorders
Dizziness
|
10.3%
4/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
15.8%
12/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
3/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
17.1%
13/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
19.7%
15/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
General disorders
Oedema peripheral
|
7.7%
3/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
14.5%
11/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
17.1%
13/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.3%
4/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
10.5%
8/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Psychiatric disorders
Insomnia
|
10.3%
4/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
9.2%
7/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
15.4%
6/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
5.3%
4/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
11.8%
9/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
3/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
7.9%
6/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
10.5%
8/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Renal and urinary disorders
Haematuria
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
7.9%
6/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
9.2%
7/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
3/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
6.6%
5/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
3/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
6.6%
5/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
9.2%
7/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
General disorders
Chills
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
7.9%
6/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
7.9%
6/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Vascular disorders
Hot flush
|
10.3%
4/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
3.9%
3/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
9.2%
7/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
9.2%
7/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
5.3%
4/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
7.9%
6/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
7.9%
6/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Nervous system disorders
Paraesthesia
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
5.3%
4/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Psychiatric disorders
Anxiety
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
5.3%
4/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
3/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
2.6%
2/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Vascular disorders
Hypertension
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
3.9%
3/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
6.6%
5/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
3.9%
3/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
5.3%
4/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
6.6%
5/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
5.3%
4/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
5.3%
4/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Psychiatric disorders
Depression
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
2.6%
2/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
5.3%
4/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
5.3%
4/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
5.3%
4/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
General disorders
Pain
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
5.3%
4/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
5.3%
4/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
5.3%
4/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Investigations
Cardiac murmur
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
General disorders
Malaise
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
3/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
1.3%
1/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
|
Gastrointestinal disorders
Swollen tongue
|
5.1%
2/39 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
0.00%
0/76 • Randomized treatment phase (up to 53 weeks)
Adverse events were recorded during the randomized treatment phase (up to 53 weeks). Participants were also followed for clinical progression or death for up to 5 years after start of treatment.
|
Additional Information
June Li, Vice President, Biometrics and Data Sciences
Lantheus
Phone: 978-671-8107
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place