Trial Outcomes & Findings for A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer (NCT NCT02083185)
NCT ID: NCT02083185
Last Updated: 2018-05-09
Results Overview
Effective Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (\<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter \[nmol/L\]) at all scheduled visits beginning after 4 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
136 participants
Primary outcome timeframe
Day 1 of Week 5 to Day 1 of Week 25
Results posted on
2018-05-09
Participant Flow
Participants took part in the study at 23 investigative sites in Canada and the United States from 26 March 2014 to 23 February 2017.
Participants with a diagnosis of prostate cancer were enrolled in 1 of 2 dose levels of TAK-385 (80 or 120 mg) or leuprorelin 22.5 mg.
Participant milestones
| Measure |
Relugolix 80 mg
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
24
|
|
Overall Study
Safety Population
|
56
|
54
|
24
|
|
Overall Study
COMPLETED
|
36
|
27
|
17
|
|
Overall Study
NOT COMPLETED
|
20
|
29
|
7
|
Reasons for withdrawal
| Measure |
Relugolix 80 mg
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
15
|
1
|
|
Overall Study
Death
|
2
|
2
|
1
|
|
Overall Study
Reason not Specified
|
9
|
6
|
5
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
1
|
0
|
|
Overall Study
Did not Receive Study Drug
|
0
|
2
|
0
|
Baseline Characteristics
A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72.3 years
FULL_RANGE 9.25 • n=5 Participants
|
72.1 years
FULL_RANGE 8.06 • n=7 Participants
|
68.3 years
FULL_RANGE 6.77 • n=5 Participants
|
70.9 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
51 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Height
|
176.92 cm
FULL_RANGE 8.855 • n=5 Participants
|
177.83 cm
FULL_RANGE 8.459 • n=7 Participants
|
177.63 cm
FULL_RANGE 7.580 • n=5 Participants
|
177.46 cm
n=4 Participants
|
|
Weight
|
90.49 kg
FULL_RANGE 21.632 • n=5 Participants
|
92.16 kg
FULL_RANGE 17.645 • n=7 Participants
|
96.10 kg
FULL_RANGE 17.297 • n=5 Participants
|
92.92 kg
n=4 Participants
|
|
Body Mass Index
|
28.815 kg/m^2
FULL_RANGE 5.9592 • n=5 Participants
|
29.077 kg/m^2
FULL_RANGE 4.6509 • n=7 Participants
|
30.452 kg/m^2
FULL_RANGE 4.9601 • n=5 Participants
|
29.448 kg/m^2
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Week 5 to Day 1 of Week 25Population: Safety population included all randomized participants who received at least 1 dose of study drug.
Effective Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (\<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter \[nmol/L\]) at all scheduled visits beginning after 4 weeks of treatment.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Percentage of Participants With Effective Castration Rate Over 24 Weeks
|
91 percentage of participants
Interval 80.4 to 97.0
|
91 percentage of participants
Interval 79.7 to 96.9
|
96 percentage of participants
Interval 78.9 to 99.9
|
SECONDARY outcome
Timeframe: From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeksPopulation: Safety population included all randomized participants who received at least 1 dose of study drug.
Vital signs included oral temperature, pulse rate, supine systolic and diastolic blood pressure, standing systolic and diastolic blood pressure, and weight. Any TEAEs that were associated with vital signs were reported.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs
Weight decreased
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs
Syncope
|
3 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs
Hypertension
|
1 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs
Hypotension
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs
Arrhythmia
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs
Bradycardia
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs
Tachycardia
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs
Heart rate irregular
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs
Weight increased
|
4 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs
Pyrexia
|
3 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeksPopulation: Safety population included all randomized participants who received at least 1 dose of study drug.
Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10) including slit lamp examination of the anterior eye. Any TEAEs Related to physical examination were reported.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Number of Participants With TEAEs Related to Physical Examination
Weight increased
|
4 participants
|
2 participants
|
0 participants
|
|
Number of Participants With TEAEs Related to Physical Examination
Weight decreased
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With TEAEs Related to Physical Examination
Ophthalmological examination abnormal
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeksPopulation: Safety population included all randomized participants who received at least 1 dose of study drug.
A single 12-lead ECG was performed. ECGs were read and interpreted locally and reviewed if indicated by the study monitor. ECG abnormalities were reported as AEs.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeksPopulation: Safety population included all randomized participants who received at least 1 dose of study drug.
Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Alanine aminotransferase increased
|
7 participants
|
3 participants
|
4 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Aspartate aminotransferase increased
|
6 participants
|
1 participants
|
3 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Gamma-glutamyltransferase increased
|
3 participants
|
1 participants
|
2 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Blood triglycerides increased
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Blood bilirubin increased
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Hepatic enzyme increased
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Prostatic specific antigen increased
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Blood cholesterol increased
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Low density lipoprotein increased
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Blood glucose increased
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Glycosylated haemoglobin increased
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Blood creatinine increased
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Blood lactate dehydrogenase increased
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Blood alkaline phosphatase increased
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Blood phosphorus increased
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Blood potassium increased
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Blood thyroid stimulating hormone increased
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Blood testosterone increased
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeksPopulation: Safety population included all randomized participants who received at least 1 dose of study drug.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any AE that results in death, is life threatening, requires hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any Adverse Event
|
53 participants
|
53 participants
|
23 participants
|
|
Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
10 participants
|
7 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 5, Day 1Population: Safety population included all randomized participants who received at least 1 dose of study drug.
PSA Response is defined as a reduction in PSA from Baseline and is reported for 2 categories: ≥ 50% reduction and ≥ 90% reduction.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks
≥ 50% PSA reduction
|
75 percentage of participants
|
83 percentage of participants
|
17 percentage of participants
|
|
Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks
≥ 90% PSA reduction
|
13 percentage of participants
|
6 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: During Weeks 1 to 24Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here number of participants analyzed are participants evaluable for this outcome measure.
PSA nadir is the lowest PSA achieved after treatment.
Outcome measures
| Measure |
Relugolix 80 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=53 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Prostate-Specific Antigen Nadir
|
1.8 micrograms per liter (µg/L)
Standard Deviation 7.20
|
5.2 micrograms per liter (µg/L)
Standard Deviation 26.15
|
0.6 micrograms per liter (µg/L)
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Day 1 of Weeks 13 and 25Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
Blood was collected and serum concentrations of PSA were obtained using a validated laboratory test at a central laboratory facility.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24
Week 13, Day 1
|
2.651 μg/L
Standard Deviation 10.0624
|
5.786 μg/L
Standard Deviation 26.4243
|
0.916 μg/L
Standard Deviation 1.4478
|
|
Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24
Week 25, Day 1
|
1.936 μg/L
Standard Deviation 7.5731
|
2.360 μg/L
Standard Deviation 7.3103
|
0.624 μg/L
Standard Deviation 1.0693
|
SECONDARY outcome
Timeframe: During Weeks 1 to 24Population: Safety population included all randomized participants who received at least 1 dose of study drug. If a participant has all post first dose testosterone measurements \>= 50 ng/dL, the participant's time to castration was censored at the last testosterone measurement that is \>= 50 ng/dL.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL
Time to Castration (< 50 ng/dL)
|
4 days
Interval 4.0 to 106.0
|
4 days
Interval 4.0 to 57.0
|
29 days
Interval 15.0 to 57.0
|
|
Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL
Time to Profound Castration (< 20 ng/dL)
|
15 days
Interval 4.0 to 141.0
|
15 days
Interval 4.0 to 189.0
|
29 days
Interval 15.0 to 113.0
|
SECONDARY outcome
Timeframe: Day 1 of Weeks 1, 2, 3, 5, 9, 13, 17, 25, 37, 49 pre-dose; Day 4 of Week 1 pre-dose; Day 1 of Weeks 5, 13, 2 hrs post-dosePopulation: Safety population included all randomized participants who received at least 1 dose of study drug (TAK-835). Here 'n' is the number of participants analyzed at the specific timepoint.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
TAK-385 Plasma Concentrations
Week 13, Day 1, 2 hours post-dose
|
24.1 nanograms per milliliter (ng/mL)
Standard Deviation 23.16
|
42.2 nanograms per milliliter (ng/mL)
Standard Deviation 37.04
|
—
|
|
TAK-385 Plasma Concentrations
Week 1, Day 1 pre-dose
|
0 nanograms per milliliter (ng/mL)
Standard Deviation 0
|
0 nanograms per milliliter (ng/mL)
Standard Deviation 0
|
—
|
|
TAK-385 Plasma Concentrations
Week 1, Day 4 pre-dose
|
9.9 nanograms per milliliter (ng/mL)
Standard Deviation 13.63
|
14.2 nanograms per milliliter (ng/mL)
Standard Deviation 18.52
|
—
|
|
TAK-385 Plasma Concentrations
Week 2, Day 1 pre-dose
|
6.3 nanograms per milliliter (ng/mL)
Standard Deviation 6.32
|
8.7 nanograms per milliliter (ng/mL)
Standard Deviation 10.10
|
—
|
|
TAK-385 Plasma Concentrations
Week 3, Day 1 pre-dose
|
5.4 nanograms per milliliter (ng/mL)
Standard Deviation 3.24
|
10.3 nanograms per milliliter (ng/mL)
Standard Deviation 14.77
|
—
|
|
TAK-385 Plasma Concentrations
Week 5, Day 1 pre-dose
|
5.2 nanograms per milliliter (ng/mL)
Standard Deviation 2.79
|
8.4 nanograms per milliliter (ng/mL)
Standard Deviation 9.85
|
—
|
|
TAK-385 Plasma Concentrations
Week 5, Day 1, 2 hours post-dose
|
25.3 nanograms per milliliter (ng/mL)
Standard Deviation 21.76
|
45.4 nanograms per milliliter (ng/mL)
Standard Deviation 42.67
|
—
|
|
TAK-385 Plasma Concentrations
Week 9, Day 1 pre-dose
|
4.9 nanograms per milliliter (ng/mL)
Standard Deviation 3.47
|
8.0 nanograms per milliliter (ng/mL)
Standard Deviation 5.82
|
—
|
|
TAK-385 Plasma Concentrations
Week 13, Day 1 pre-dose
|
5.5 nanograms per milliliter (ng/mL)
Standard Deviation 3.39
|
9.0 nanograms per milliliter (ng/mL)
Standard Deviation 7.15
|
—
|
|
TAK-385 Plasma Concentrations
Week 17, Day 1 pre-dose
|
6.3 nanograms per milliliter (ng/mL)
Standard Deviation 8.12
|
8.9 nanograms per milliliter (ng/mL)
Standard Deviation 6.80
|
—
|
|
TAK-385 Plasma Concentrations
Week 25, Day 1 pre-dose
|
7.3 nanograms per milliliter (ng/mL)
Standard Deviation 11.07
|
11.5 nanograms per milliliter (ng/mL)
Standard Deviation 14.15
|
—
|
|
TAK-385 Plasma Concentrations
Week 37, Day 1 pre-dose
|
6.3 nanograms per milliliter (ng/mL)
Standard Deviation 7.29
|
10.9 nanograms per milliliter (ng/mL)
Standard Deviation 16.94
|
—
|
|
TAK-385 Plasma Concentrations
Week 49, Day 1 pre-dose
|
5.9 nanograms per milliliter (ng/mL)
Standard Deviation 4.98
|
9.4 nanograms per milliliter (ng/mL)
Standard Deviation 8.32
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 4 of Week 1, Day 1 of Weeks 2, 3, 5,13, 25 and 49, End of Treatment (EOT - 106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
Blood was collected and serum concentrations of LH in milli international units per milliliters (mIU/mL) were obtained using a validated laboratory test at a central laboratory facility.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Serum Luteinizing Hormone (LH) Concentrations
Week 1, Day 4
|
0.665 mIU/mL
Standard Deviation 0.6982
|
0.595 mIU/mL
Standard Deviation 0.5467
|
17.551 mIU/mL
Standard Deviation 13.1433
|
|
Serum Luteinizing Hormone (LH) Concentrations
Week 2, Day 1
|
0.548 mIU/mL
Standard Deviation 0.6683
|
0.638 mIU/mL
Standard Deviation 1.3988
|
8.279 mIU/mL
Standard Deviation 5.8986
|
|
Serum Luteinizing Hormone (LH) Concentrations
Week 3, Day 1
|
0.341 mIU/mL
Standard Deviation 0.5851
|
0.388 mIU/mL
Standard Deviation 0.7887
|
3.171 mIU/mL
Standard Deviation 2.7636
|
|
Serum Luteinizing Hormone (LH) Concentrations
Week 5, Day 1
|
0.424 mIU/mL
Standard Deviation 1.4941
|
0.203 mIU/mL
Standard Deviation 0.3580
|
0.508 mIU/mL
Standard Deviation 0.4327
|
|
Serum Luteinizing Hormone (LH) Concentrations
Week 13, Day 1
|
0.229 mIU/mL
Standard Deviation 0.6003
|
0.183 mIU/mL
Standard Deviation 0.2542
|
0.277 mIU/mL
Standard Deviation 0.8253
|
|
Serum Luteinizing Hormone (LH) Concentrations
Week 25, Day 1
|
0.195 mIU/mL
Standard Deviation 0.2524
|
0.175 mIU/mL
Standard Deviation 0.1365
|
0.134 mIU/mL
Standard Deviation 0.0992
|
|
Serum Luteinizing Hormone (LH) Concentrations
Week 49, Day 1
|
0.341 mIU/mL
Standard Deviation 0.3948
|
0.288 mIU/mL
Standard Deviation 0.2479
|
0.138 mIU/mL
Standard Deviation 0.1677
|
|
Serum Luteinizing Hormone (LH) Concentrations
EOT
|
3.189 mIU/mL
Standard Deviation 3.6928
|
2.704 mIU/mL
Standard Deviation 2.5312
|
0.585 mIU/mL
Standard Deviation 1.6775
|
|
Serum Luteinizing Hormone (LH) Concentrations
Follow-Up
|
8.624 mIU/mL
Standard Deviation 5.3685
|
9.510 mIU/mL
Standard Deviation 5.2926
|
0.525 mIU/mL
Standard Deviation 1.0187
|
|
Serum Luteinizing Hormone (LH) Concentrations
End of Study
|
7.182 mIU/mL
Standard Deviation 8.0509
|
9.306 mIU/mL
Standard Deviation 7.9054
|
1.394 mIU/mL
Standard Deviation 1.7702
|
SECONDARY outcome
Timeframe: Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
Blood was collected and serum concentrations of FSH were obtained using a validated laboratory test at a central laboratory facility.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Serum Follicle Stimulating Hormone (FSH) Concentrations
Follow-Up
|
16.160 IU/L
Standard Deviation 11.0517
|
14.610 IU/L
Standard Deviation 6.1553
|
9.200 IU/L
Standard Deviation 0
|
|
Serum Follicle Stimulating Hormone (FSH) Concentrations
Week 2, Day 1
|
3.112 IU/L
Standard Deviation 3.0612
|
3.183 IU/L
Standard Deviation 2.8956
|
7.650 IU/L
Standard Deviation 5.4542
|
|
Serum Follicle Stimulating Hormone (FSH) Concentrations
Week 5, Day 1
|
1.248 IU/L
Standard Deviation 2.6737
|
1.035 IU/L
Standard Deviation 1.0479
|
2.946 IU/L
Standard Deviation 1.4428
|
|
Serum Follicle Stimulating Hormone (FSH) Concentrations
Week 13, Day 1
|
1.137 IU/L
Standard Deviation 2.4242
|
0.908 IU/L
Standard Deviation 0.8104
|
4.625 IU/L
Standard Deviation 2.5594
|
|
Serum Follicle Stimulating Hormone (FSH) Concentrations
Week 25, Day 1
|
1.090 IU/L
Standard Deviation 0.9932
|
1.344 IU/L
Standard Deviation 0.9675
|
5.043 IU/L
Standard Deviation 2.8221
|
|
Serum Follicle Stimulating Hormone (FSH) Concentrations
Week 49, Day 1
|
1.802 IU/L
Standard Deviation 1.3956
|
1.938 IU/L
Standard Deviation 1.2169
|
5.145 IU/L
Standard Deviation 2.8201
|
|
Serum Follicle Stimulating Hormone (FSH) Concentrations
EOT
|
5.377 IU/L
Standard Deviation 4.1261
|
5.691 IU/L
Standard Deviation 2.9528
|
5.250 IU/L
Standard Deviation 3.0406
|
|
Serum Follicle Stimulating Hormone (FSH) Concentrations
End of Study
|
11.441 IU/L
Standard Deviation 8.7613
|
15.768 IU/L
Standard Deviation 12.3329
|
5.943 IU/L
Standard Deviation 3.6185
|
SECONDARY outcome
Timeframe: Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
Blood was collected and serum concentrations of SHBG were obtained using a validated laboratory test at a central laboratory facility.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Serum Sex Hormone-binding Globulin (SHBG) Concentrations
Week 49, Day 1
|
50.607 nanomoles per liter (nmol/L)
Standard Deviation 18.0377
|
54.022 nanomoles per liter (nmol/L)
Standard Deviation 26.1070
|
38.237 nanomoles per liter (nmol/L)
Standard Deviation 18.6708
|
|
Serum Sex Hormone-binding Globulin (SHBG) Concentrations
Week 2, Day 1
|
50.811 nanomoles per liter (nmol/L)
Standard Deviation 15.8822
|
48.594 nanomoles per liter (nmol/L)
Standard Deviation 17.7492
|
39.029 nanomoles per liter (nmol/L)
Standard Deviation 16.8910
|
|
Serum Sex Hormone-binding Globulin (SHBG) Concentrations
Week 5, Day 1
|
49.641 nanomoles per liter (nmol/L)
Standard Deviation 16.7048
|
49.185 nanomoles per liter (nmol/L)
Standard Deviation 21.1707
|
43.786 nanomoles per liter (nmol/L)
Standard Deviation 20.0484
|
|
Serum Sex Hormone-binding Globulin (SHBG) Concentrations
Week 13, Day 1
|
49.210 nanomoles per liter (nmol/L)
Standard Deviation 19.3704
|
50.538 nanomoles per liter (nmol/L)
Standard Deviation 23.2109
|
41.858 nanomoles per liter (nmol/L)
Standard Deviation 18.1416
|
|
Serum Sex Hormone-binding Globulin (SHBG) Concentrations
Week 25, Day 1
|
47.998 nanomoles per liter (nmol/L)
Standard Deviation 18.8690
|
50.774 nanomoles per liter (nmol/L)
Standard Deviation 23.3292
|
40.839 nanomoles per liter (nmol/L)
Standard Deviation 16.3732
|
|
Serum Sex Hormone-binding Globulin (SHBG) Concentrations
EOT
|
50.013 nanomoles per liter (nmol/L)
Standard Deviation 21.5189
|
54.105 nanomoles per liter (nmol/L)
Standard Deviation 20.8439
|
23.000 nanomoles per liter (nmol/L)
Standard Deviation 0
|
|
Serum Sex Hormone-binding Globulin (SHBG) Concentrations
Follow-Up
|
45.433 nanomoles per liter (nmol/L)
Standard Deviation 14.7416
|
60.250 nanomoles per liter (nmol/L)
Standard Deviation 28.1206
|
—
|
|
Serum Sex Hormone-binding Globulin (SHBG) Concentrations
End of Study
|
51.103 nanomoles per liter (nmol/L)
Standard Deviation 17.8497
|
51.063 nanomoles per liter (nmol/L)
Standard Deviation 23.1018
|
39.014 nanomoles per liter (nmol/L)
Standard Deviation 13.1876
|
SECONDARY outcome
Timeframe: Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
EORTC QLQ-PR25 is an EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer consisting of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions use are answered using a 4-point scale: 1=Not at all to 4 =Very much. All raw domain scores are linearly transformed to a 0 to 100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual). A positive change from Baseline in activity or functioning scales and negative change from Baseline in symptom scales indicates improvement.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Activity: Week 5, Day 1
|
-6.0 score on a scale
Standard Deviation 29.25
|
-14.4 score on a scale
Standard Deviation 22.39
|
-7.6 score on a scale
Standard Deviation 20.25
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Activity: Week 13, Day 1
|
-9.3 score on a scale
Standard Deviation 18.49
|
-17.3 score on a scale
Standard Deviation 27.28
|
-11.1 score on a scale
Standard Deviation 19.45
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Activity: Week 25, Day 1
|
-9.4 score on a scale
Standard Deviation 25.24
|
-19.8 score on a scale
Standard Deviation 31.82
|
-18.8 score on a scale
Standard Deviation 20.90
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Activity: Week 37, Day 1
|
-12.0 score on a scale
Standard Deviation 27.81
|
-14.4 score on a scale
Standard Deviation 31.70
|
-14.3 score on a scale
Standard Deviation 21.27
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Activity: Week 49, Day 1
|
-13.0 score on a scale
Standard Deviation 28.40
|
-19.1 score on a scale
Standard Deviation 36.24
|
-17.5 score on a scale
Standard Deviation 31.39
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Activity: EOT
|
-15.7 score on a scale
Standard Deviation 18.05
|
-18.1 score on a scale
Standard Deviation 43.79
|
-30.8 score on a scale
Standard Deviation 27.09
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Activity: Follow-up
|
-9.2 score on a scale
Standard Deviation 18.32
|
-24.6 score on a scale
Standard Deviation 32.09
|
-14.3 score on a scale
Standard Deviation 34.50
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Activity: End of Study
|
-7.9 score on a scale
Standard Deviation 25.04
|
-15.5 score on a scale
Standard Deviation 35.89
|
-21.9 score on a scale
Standard Deviation 24.13
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Functioning: Week 5, Day 1
|
-9.9 score on a scale
Standard Deviation 24.53
|
-2.0 score on a scale
Standard Deviation 29.25
|
-4.2 score on a scale
Standard Deviation 14.43
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Functioning: Week 13, Day 1
|
-8.3 score on a scale
Standard Deviation 20.89
|
-1.4 score on a scale
Standard Deviation 29.27
|
0.8 score on a scale
Standard Deviation 27.34
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Functioning: Week 25, Day 1
|
-4.7 score on a scale
Standard Deviation 22.97
|
-12.5 score on a scale
Standard Deviation 33.80
|
-16.7 score on a scale
Standard Deviation 23.07
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Functioning: Week 37, Day 1
|
-10.7 score on a scale
Standard Deviation 18.90
|
-12.8 score on a scale
Standard Deviation 17.55
|
-19.8 score on a scale
Standard Deviation 17.22
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Functioning: Week 49, Day 1
|
-16.7 score on a scale
Standard Deviation 23.84
|
-13.9 score on a scale
Standard Deviation 27.95
|
6.0 score on a scale
Standard Deviation 23.43
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Functioning: EOT
|
-16.7 score on a scale
Standard Deviation 25.97
|
-10.7 score on a scale
Standard Deviation 6.30
|
37.5 score on a scale
Standard Deviation 53.03
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Functioning: Follow-up
|
3.1 score on a scale
Standard Deviation 21.33
|
-10.4 score on a scale
Standard Deviation 18.48
|
2.1 score on a scale
Standard Deviation 73.40
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Sexual Functioning: End of Study
|
-11.5 score on a scale
Standard Deviation 22.70
|
-4.2 score on a scale
Standard Deviation 21.96
|
-13.9 score on a scale
Standard Deviation 12.73
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Urinary Symptoms: Week 5, Day 1
|
2.0 score on a scale
Standard Deviation 12.60
|
1.8 score on a scale
Standard Deviation 7.84
|
4.2 score on a scale
Standard Deviation 7.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Urinary Symptoms: Week 13, Day 1
|
1.9 score on a scale
Standard Deviation 11.64
|
3.8 score on a scale
Standard Deviation 7.54
|
6.8 score on a scale
Standard Deviation 10.70
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Urinary Symptoms: Week 25, Day 1
|
3.6 score on a scale
Standard Deviation 15.46
|
5.1 score on a scale
Standard Deviation 12.28
|
7.2 score on a scale
Standard Deviation 10.60
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Urinary Symptoms: Week 37, Day 1
|
3.4 score on a scale
Standard Deviation 14.89
|
4.2 score on a scale
Standard Deviation 10.24
|
12.9 score on a scale
Standard Deviation 14.61
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Urinary Symptoms: Week 49, Day 1
|
4.0 score on a scale
Standard Deviation 11.98
|
6.5 score on a scale
Standard Deviation 11.18
|
9.9 score on a scale
Standard Deviation 11.45
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Urinary Symptoms: EOT
|
3.3 score on a scale
Standard Deviation 14.00
|
7.1 score on a scale
Standard Deviation 13.35
|
9.0 score on a scale
Standard Deviation 12.83
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Urinary Symptoms: Follow-up
|
-1.0 score on a scale
Standard Deviation 11.30
|
5.9 score on a scale
Standard Deviation 14.52
|
9.8 score on a scale
Standard Deviation 7.42
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Urinary Symptoms: End of study
|
2.2 score on a scale
Standard Deviation 10.84
|
4.5 score on a scale
Standard Deviation 14.04
|
6.8 score on a scale
Standard Deviation 13.08
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Bowel Symptoms: Week 5, Day 1
|
1.9 score on a scale
Standard Deviation 7.24
|
1.1 score on a scale
Standard Deviation 6.81
|
0.3 score on a scale
Standard Deviation 5.75
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Bowel Symptoms: Week 13, Day 1
|
1.0 score on a scale
Standard Deviation 4.95
|
1.8 score on a scale
Standard Deviation 8.55
|
2.4 score on a scale
Standard Deviation 7.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Bowel Symptoms: Week 25, Day 1
|
3.1 score on a scale
Standard Deviation 7.22
|
0.3 score on a scale
Standard Deviation 6.87
|
1.1 score on a scale
Standard Deviation 4.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Bowel Symptoms: Week 37, Day 1
|
3.8 score on a scale
Standard Deviation 7.80
|
1.5 score on a scale
Standard Deviation 7.60
|
3.2 score on a scale
Standard Deviation 7.21
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Bowel Symptoms: Week 49, Day 1
|
3.0 score on a scale
Standard Deviation 6.44
|
0.0 score on a scale
Standard Deviation 6.97
|
2.4 score on a scale
Standard Deviation 7.04
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Bowel Symptoms: EOT
|
2.1 score on a scale
Standard Deviation 6.18
|
2.4 score on a scale
Standard Deviation 7.98
|
2.6 score on a scale
Standard Deviation 6.26
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Bowel Symptoms: Follow-up
|
0.0 score on a scale
Standard Deviation 4.68
|
2.2 score on a scale
Standard Deviation 9.95
|
2.4 score on a scale
Standard Deviation 8.91
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Bowel Symptoms: End of Study
|
2.1 score on a scale
Standard Deviation 5.03
|
-0.3 score on a scale
Standard Deviation 6.49
|
1.0 score on a scale
Standard Deviation 9.56
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
HTRS: Week 5, Day 1
|
5.6 score on a scale
Standard Deviation 8.98
|
5.0 score on a scale
Standard Deviation 8.03
|
3.5 score on a scale
Standard Deviation 8.94
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
HTRS: Week 13, Day 1
|
9.2 score on a scale
Standard Deviation 9.95
|
10.8 score on a scale
Standard Deviation 10.80
|
7.2 score on a scale
Standard Deviation 9.48
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
HTRS: Week 25, Day 1
|
11.7 score on a scale
Standard Deviation 10.07
|
11.3 score on a scale
Standard Deviation 11.40
|
10.9 score on a scale
Standard Deviation 9.98
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
HTRS: Week 37, Day 1
|
13.3 score on a scale
Standard Deviation 10.51
|
12.2 score on a scale
Standard Deviation 13.17
|
13.2 score on a scale
Standard Deviation 13.32
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
HTRS: Week 49, Day 1
|
14.4 score on a scale
Standard Deviation 12.39
|
9.6 score on a scale
Standard Deviation 11.04
|
15.9 score on a scale
Standard Deviation 12.82
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
HTRS: EOT
|
12.9 score on a scale
Standard Deviation 12.33
|
14.0 score on a scale
Standard Deviation 16.13
|
17.9 score on a scale
Standard Deviation 12.25
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
HTRS: Follow-up
|
7.5 score on a scale
Standard Deviation 8.51
|
6.1 score on a scale
Standard Deviation 9.05
|
15.9 score on a scale
Standard Deviation 15.69
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
HTRS: End of Study
|
10.8 score on a scale
Standard Deviation 11.03
|
9.8 score on a scale
Standard Deviation 11.27
|
12.5 score on a scale
Standard Deviation 12.75
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Incontinence Aid: Week 5, Day 1
|
0.0 score on a scale
Standard Deviation 21.63
|
-1.9 score on a scale
Standard Deviation 17.98
|
-16.7 score on a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Incontinence Aid: Week 13, Day 1
|
0.0 score on a scale
Standard Deviation 22.22
|
-1.8 score on a scale
Standard Deviation 13.49
|
-16.7 score on a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Incontinence Aid: Week 25, Day 1
|
3.5 score on a scale
Standard Deviation 21.93
|
0.0 score on a scale
Standard Deviation 15.71
|
-16.7 score on a scale
Standard Deviation 23.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Incontinence Aid: Week 37, Day 1
|
8.3 score on a scale
Standard Deviation 25.82
|
-1.8 score on a scale
Standard Deviation 13.49
|
-16.7 score on a scale
Standard Deviation 23.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Incontinence Aid: Week 49, Day 1
|
7.0 score on a scale
Standard Deviation 23.78
|
-2.2 score on a scale
Standard Deviation 15.26
|
-22.2 score on a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Incontinence Aid: EOT
|
6.1 score on a scale
Standard Deviation 20.10
|
6.1 score on a scale
Standard Deviation 20.10
|
-16.7 score on a scale
Standard Deviation 23.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Incontinence Aid: Follow-up
|
0.0 score on a scale
Standard Deviation 21.08
|
-8.3 score on a scale
Standard Deviation 15.43
|
-33.3 score on a scale
Standard Deviation 0
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Incontinence Aid: End of Study
|
0.0 score on a scale
Standard Deviation 20.10
|
-4.8 score on a scale
Standard Deviation 22.10
|
-33.3 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
AMS scale is a self-administered questionnaire used to: 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between 1=none to 5=extremely severe for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Percent Change From Baseline of Aging Male Survey (AMS) Total Score
Week 5, Day 1
|
3.914 percent change
Standard Deviation 24.4749
|
10.872 percent change
Standard Deviation 29.6532
|
10.083 percent change
Standard Deviation 27.1933
|
|
Percent Change From Baseline of Aging Male Survey (AMS) Total Score
Week 13, Day 1
|
14.781 percent change
Standard Deviation 24.0185
|
17.259 percent change
Standard Deviation 33.9921
|
21.887 percent change
Standard Deviation 36.5551
|
|
Percent Change From Baseline of Aging Male Survey (AMS) Total Score
Week 25, Day 1
|
20.272 percent change
Standard Deviation 35.2952
|
20.353 percent change
Standard Deviation 34.2105
|
46.995 percent change
Standard Deviation 55.3558
|
|
Percent Change From Baseline of Aging Male Survey (AMS) Total Score
Week 37, Day 1
|
24.136 percent change
Standard Deviation 33.8595
|
24.466 percent change
Standard Deviation 35.6742
|
49.422 percent change
Standard Deviation 61.1264
|
|
Percent Change From Baseline of Aging Male Survey (AMS) Total Score
Week 49, Day 1
|
30.122 percent change
Standard Deviation 38.1093
|
24.377 percent change
Standard Deviation 33.6078
|
59.971 percent change
Standard Deviation 60.3579
|
|
Percent Change From Baseline of Aging Male Survey (AMS) Total Score
EOT
|
18.857 percent change
Standard Deviation 37.9260
|
28.644 percent change
Standard Deviation 35.6470
|
60.952 percent change
Standard Deviation 63.3615
|
|
Percent Change From Baseline of Aging Male Survey (AMS) Total Score
Follow-Up
|
15.754 percent change
Standard Deviation 21.8158
|
13.031 percent change
Standard Deviation 33.7754
|
53.834 percent change
Standard Deviation 61.6683
|
|
Percent Change From Baseline of Aging Male Survey (AMS) Total Score
End of Study
|
16.270 percent change
Standard Deviation 24.2582
|
21.304 percent change
Standard Deviation 46.0184
|
49.879 percent change
Standard Deviation 54.1540
|
SECONDARY outcome
Timeframe: Day 1 of Weeks 5, 13, 25, 37, 49, 73, 97, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
The EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. Most questions used a 4-point scale (1=Not at all to 4=Very much); 2 questions used a 7-point scale (1= Very poor to 7=Excellent). All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. A positive change from Baseline in quality og life or functioning scales and negative change from Baseline in symptom or difficulties scales indicates improvement.
Outcome measures
| Measure |
Relugolix 80 mg
n=56 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 Participants
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 Participants
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Change From Baseline in EORTC QLQ-C30
Emotional Functioning: Week 13, Day 1
|
-0.7 score on a scale
Standard Deviation 11.53
|
-1.1 score on a scale
Standard Deviation 12.70
|
-1.4 score on a scale
Standard Deviation 12.69
|
|
Change From Baseline in EORTC QLQ-C30
Pain: Week 25, Day 1
|
0.3 score on a scale
Standard Deviation 22.67
|
2.8 score on a scale
Standard Deviation 16.61
|
2.9 score on a scale
Standard Deviation 22.84
|
|
Change From Baseline in EORTC QLQ-C30
Pain: Week 37, Day 1
|
2.9 score on a scale
Standard Deviation 23.65
|
5.9 score on a scale
Standard Deviation 21.37
|
11.4 score on a scale
Standard Deviation 34.27
|
|
Change From Baseline in EORTC QLQ-C30
Pain: Follow-Up
|
9.2 score on a scale
Standard Deviation 21.95
|
10.5 score on a scale
Standard Deviation 23.05
|
1.2 score on a scale
Standard Deviation 28.84
|
|
Change From Baseline in EORTC QLQ-C30
Dyspnea: Week 49, Day 1
|
6.7 score on a scale
Standard Deviation 22.02
|
9.8 score on a scale
Standard Deviation 20.06
|
17.5 score on a scale
Standard Deviation 30.95
|
|
Change From Baseline in EORTC QLQ-C30
Insomnia: Week 13, Day 1
|
2.6 score on a scale
Standard Deviation 20.92
|
9.8 score on a scale
Standard Deviation 21.39
|
6.9 score on a scale
Standard Deviation 19.61
|
|
Change From Baseline in EORTC QLQ-C30
Insomnia: EOT
|
6.7 score on a scale
Standard Deviation 35.97
|
7.6 score on a scale
Standard Deviation 26.92
|
7.7 score on a scale
Standard Deviation 24.17
|
|
Change From Baseline in EORTC QLQ-C30
Constipation: End Of Study
|
3.7 score on a scale
Standard Deviation 19.15
|
5.7 score on a scale
Standard Deviation 17.97
|
0.0 score on a scale
Standard Deviation 17.21
|
|
Change From Baseline in EORTC QLQ-C30
Nausea and Vomiting: Week 13, Day 1
|
0.7 score on a scale
Standard Deviation 7.42
|
0.7 score on a scale
Standard Deviation 7.42
|
1.4 score on a scale
Standard Deviation 4.71
|
|
Change From Baseline in EORTC QLQ-C30
Nausea and Vomiting: Week 25, Day 1
|
0.0 score on a scale
Standard Deviation 9.10
|
0.0 score on a scale
Standard Deviation 3.44
|
2.9 score on a scale
Standard Deviation 6.46
|
|
Change From Baseline in EORTC QLQ-C30
Nausea and Vomiting: Week 37, Day 1
|
0.4 score on a scale
Standard Deviation 8.95
|
1.1 score on a scale
Standard Deviation 7.45
|
4.5 score on a scale
Standard Deviation 9.17
|
|
Change From Baseline in EORTC QLQ-C30
Nausea and Vomiting: Week 49, Day 1
|
-1.9 score on a scale
Standard Deviation 7.30
|
0.8 score on a scale
Standard Deviation 6.40
|
4.8 score on a scale
Standard Deviation 11.95
|
|
Change From Baseline in EORTC QLQ-C30
Nausea and Vomiting: Week 73, Day 1
|
0.0 score on a scale
Standard Deviation 4.45
|
0.7 score on a scale
Standard Deviation 3.33
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Nausea and Vomiting: Week 97, Day 1
|
5.3 score on a scale
Standard Deviation 14.75
|
1.8 score on a scale
Standard Deviation 9.45
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Nausea and Vomiting: Week EOT
|
-0.5 score on a scale
Standard Deviation 8.56
|
1.9 score on a scale
Standard Deviation 8.83
|
7.7 score on a scale
Standard Deviation 14.62
|
|
Change From Baseline in EORTC QLQ-C30
Nausea and Vomiting: Follow-Up
|
3.3 score on a scale
Standard Deviation 16.75
|
0.9 score on a scale
Standard Deviation 3.82
|
0.0 score on a scale
Standard Deviation 6.54
|
|
Change From Baseline in EORTC QLQ-C30
Nausea and Vomiting: End of Study
|
1.4 score on a scale
Standard Deviation 9.24
|
-1.1 score on a scale
Standard Deviation 4.30
|
0.0 score on a scale
Standard Deviation 6.09
|
|
Change From Baseline in EORTC QLQ-C30
Pain: Week 5, Day 1
|
-1.6 score on a scale
Standard Deviation 16.75
|
0.6 score on a scale
Standard Deviation 16.82
|
3.5 score on a scale
Standard Deviation 18.38
|
|
Change From Baseline in EORTC QLQ-C30
Pain: Week 13, Day 1
|
-1.0 score on a scale
Standard Deviation 17.77
|
3.3 score on a scale
Standard Deviation 18.86
|
4.2 score on a scale
Standard Deviation 26.12
|
|
Change From Baseline in EORTC QLQ-C30
Pain: Week 49, Day 1
|
3.3 score on a scale
Standard Deviation 23.19
|
6.5 score on a scale
Standard Deviation 18.59
|
7.9 score on a scale
Standard Deviation 31.46
|
|
Change From Baseline in EORTC QLQ-C30
Pain: Week 73, Day 1
|
6.9 score on a scale
Standard Deviation 18.64
|
7.3 score on a scale
Standard Deviation 14.50
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Pain: Week 97, Day 1
|
5.3 score on a scale
Standard Deviation 19.29
|
0.0 score on a scale
Standard Deviation 14.70
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Pain: EOT
|
-0.5 score on a scale
Standard Deviation 25.08
|
6.7 score on a scale
Standard Deviation 24.32
|
6.4 score on a scale
Standard Deviation 35.05
|
|
Change From Baseline in EORTC QLQ-C30
Pain: End of Study
|
6.5 score on a scale
Standard Deviation 17.03
|
6.9 score on a scale
Standard Deviation 19.17
|
-2.1 score on a scale
Standard Deviation 30.96
|
|
Change From Baseline in EORTC QLQ-C30
Dyspnea: Week 5, Day 1
|
-0.6 score on a scale
Standard Deviation 21.17
|
2.6 score on a scale
Standard Deviation 17.27
|
5.6 score on a scale
Standard Deviation 18.82
|
|
Change From Baseline in EORTC QLQ-C30
Dyspnea: Week 13, Day 1
|
5.9 score on a scale
Standard Deviation 22.81
|
6.5 score on a scale
Standard Deviation 21.10
|
8.3 score on a scale
Standard Deviation 20.26
|
|
Change From Baseline in EORTC QLQ-C30
Dyspnea: Week 25, Day 1
|
4.2 score on a scale
Standard Deviation 26.30
|
8.3 score on a scale
Standard Deviation 22.28
|
8.7 score on a scale
Standard Deviation 22.96
|
|
Change From Baseline in EORTC QLQ-C30
Dyspnea: Week 37, Day 1
|
6.5 score on a scale
Standard Deviation 21.80
|
11.1 score on a scale
Standard Deviation 22.47
|
22.7 score on a scale
Standard Deviation 26.00
|
|
Change From Baseline in EORTC QLQ-C30
Dyspnea: Week 73, Day 1
|
8.0 score on a scale
Standard Deviation 19.22
|
9.3 score on a scale
Standard Deviation 18.05
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Dyspnea: Week 97, Day 1
|
10.5 score on a scale
Standard Deviation 19.41
|
8.8 score on a scale
Standard Deviation 18.73
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Dyspnea: EOT
|
7.6 score on a scale
Standard Deviation 24.37
|
14.3 score on a scale
Standard Deviation 20.27
|
20.5 score on a scale
Standard Deviation 32.03
|
|
Change From Baseline in EORTC QLQ-C30
Dyspnea: Follow-Up
|
11.7 score on a scale
Standard Deviation 22.36
|
8.8 score on a scale
Standard Deviation 26.86
|
14.3 score on a scale
Standard Deviation 25.20
|
|
Change From Baseline in EORTC QLQ-C30
Dyspnea: End of Study
|
11.1 score on a scale
Standard Deviation 19.52
|
14.9 score on a scale
Standard Deviation 26.10
|
8.3 score on a scale
Standard Deviation 31.03
|
|
Change From Baseline in EORTC QLQ-C30
Insomnia: Week 5, Day 1
|
-1.3 score on a scale
Standard Deviation 24.43
|
3.2 score on a scale
Standard Deviation 17.79
|
1.4 score on a scale
Standard Deviation 18.33
|
|
Change From Baseline in EORTC QLQ-C30
Insomnia: Week 25, Day 1
|
6.3 score on a scale
Standard Deviation 30.49
|
12.5 score on a scale
Standard Deviation 24.43
|
8.7 score on a scale
Standard Deviation 22.96
|
|
Change From Baseline in EORTC QLQ-C30
Insomnia: Week 37, Day 1
|
2.2 score on a scale
Standard Deviation 24.75
|
8.1 score on a scale
Standard Deviation 22.65
|
18.2 score on a scale
Standard Deviation 32.08
|
|
Change From Baseline in EORTC QLQ-C30
Insomnia: Week 49, Day 1
|
6.7 score on a scale
Standard Deviation 29.81
|
7.3 score on a scale
Standard Deviation 22.99
|
6.3 score on a scale
Standard Deviation 32.69
|
|
Change From Baseline in EORTC QLQ-C30
Insomnia: Week 73, Day 1
|
2.3 score on a scale
Standard Deviation 33.25
|
10.7 score on a scale
Standard Deviation 23.01
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Insomnia: Week 97, Day 1
|
10.5 score on a scale
Standard Deviation 27.34
|
10.5 score on a scale
Standard Deviation 19.41
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Insomnia: Follow-Up
|
5.0 score on a scale
Standard Deviation 19.57
|
0.0 score on a scale
Standard Deviation 27.22
|
4.8 score on a scale
Standard Deviation 25.68
|
|
Change From Baseline in EORTC QLQ-C30
Insomnia: End of Study
|
1.9 score on a scale
Standard Deviation 28.67
|
5.7 score on a scale
Standard Deviation 21.95
|
10.4 score on a scale
Standard Deviation 29.11
|
|
Change From Baseline in EORTC QLQ-C30
Appetite Loss: Week 5, Day 1
|
-3.8 score on a scale
Standard Deviation 14.11
|
0.6 score on a scale
Standard Deviation 21.38
|
2.8 score on a scale
Standard Deviation 13.61
|
|
Change From Baseline in EORTC QLQ-C30
Appetite Loss: Week 13, Day 1
|
-0.7 score on a scale
Standard Deviation 18.25
|
-0.7 score on a scale
Standard Deviation 20.54
|
0.0 score on a scale
Standard Deviation 13.90
|
|
Change From Baseline in EORTC QLQ-C30
Appetite Loss: Week 25, Day 1
|
-3.5 score on a scale
Standard Deviation 19.74
|
0.0 score on a scale
Standard Deviation 19.45
|
2.9 score on a scale
Standard Deviation 17.15
|
|
Change From Baseline in EORTC QLQ-C30
Appetite Loss: Week 37, Day 1
|
-0.7 score on a scale
Standard Deviation 17.90
|
2.2 score on a scale
Standard Deviation 16.51
|
0.0 score on a scale
Standard Deviation 14.55
|
|
Change From Baseline in EORTC QLQ-C30
Appetite Loss: Week 49, Day 1
|
-0.7 score on a scale
Standard Deviation 16.65
|
0.8 score on a scale
Standard Deviation 15.79
|
4.8 score on a scale
Standard Deviation 15.94
|
|
Change From Baseline in EORTC QLQ-C30
Appetite Loss: Week 73, Day 1
|
-2.3 score on a scale
Standard Deviation 12.38
|
5.3 score on a scale
Standard Deviation 18.46
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Appetite Loss: Week 97, Day 1
|
0.0 score on a scale
Standard Deviation 15.71
|
3.5 score on a scale
Standard Deviation 15.29
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Appetite Loss: EOT
|
-3.8 score on a scale
Standard Deviation 15.70
|
8.6 score on a scale
Standard Deviation 16.85
|
2.6 score on a scale
Standard Deviation 16.45
|
|
Change From Baseline in EORTC QLQ-C30
Appetite Loss: Follow-Up
|
0.0 score on a scale
Standard Deviation 15.29
|
3.5 score on a scale
Standard Deviation 18.90
|
-2.4 score on a scale
Standard Deviation 15.82
|
|
Change From Baseline in EORTC QLQ-C30
Appetite Loss: End of Study
|
-1.9 score on a scale
Standard Deviation 13.67
|
3.4 score on a scale
Standard Deviation 13.64
|
0.0 score on a scale
Standard Deviation 24.34
|
|
Change From Baseline in EORTC QLQ-C30
Constipation: Week 5, Day 1
|
0.6 score on a scale
Standard Deviation 20.14
|
1.9 score on a scale
Standard Deviation 17.97
|
1.4 score on a scale
Standard Deviation 6.80
|
|
Change From Baseline in EORTC QLQ-C30
Constipation: Week 13, Day 1
|
3.9 score on a scale
Standard Deviation 21.75
|
5.2 score on a scale
Standard Deviation 19.29
|
5.6 score on a scale
Standard Deviation 12.69
|
|
Change From Baseline in EORTC QLQ-C30
Constipation: Week 25, Day 1
|
2.8 score on a scale
Standard Deviation 19.25
|
6.3 score on a scale
Standard Deviation 25.41
|
1.4 score on a scale
Standard Deviation 15.82
|
|
Change From Baseline in EORTC QLQ-C30
Constipation: Week 37, Day 1
|
5.8 score on a scale
Standard Deviation 20.25
|
8.1 score on a scale
Standard Deviation 26.74
|
1.5 score on a scale
Standard Deviation 12.50
|
|
Change From Baseline in EORTC QLQ-C30
Constipation: Week 49, Day 1
|
2.2 score on a scale
Standard Deviation 19.33
|
7.3 score on a scale
Standard Deviation 20.43
|
1.6 score on a scale
Standard Deviation 7.27
|
|
Change From Baseline in EORTC QLQ-C30
Constipation: Week 73, Day 1
|
1.1 score on a scale
Standard Deviation 18.86
|
1.3 score on a scale
Standard Deviation 17.95
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Constipation: Week 97, Day 1
|
1.8 score on a scale
Standard Deviation 26.00
|
3.5 score on a scale
Standard Deviation 21.93
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Constipation: EOT
|
3.8 score on a scale
Standard Deviation 22.54
|
1.9 score on a scale
Standard Deviation 17.97
|
0.0 score on a scale
Standard Deviation 13.61
|
|
Change From Baseline in EORTC QLQ-C30
Constipation: Follow-Up
|
5.0 score on a scale
Standard Deviation 24.84
|
10.5 score on a scale
Standard Deviation 24.98
|
0.0 score on a scale
Standard Deviation 13.07
|
|
Change From Baseline in EORTC QLQ-C30
Diarrhea: Week 5, Day 1
|
-1.9 score on a scale
Standard Deviation 12.08
|
1.9 score on a scale
Standard Deviation 13.87
|
1.4 score on a scale
Standard Deviation 11.95
|
|
Change From Baseline in EORTC QLQ-C30
Diarrhea: Week 13, Day 1
|
3.9 score on a scale
Standard Deviation 18.44
|
2.0 score on a scale
Standard Deviation 23.49
|
0.0 score on a scale
Standard Deviation 9.83
|
|
Change From Baseline in EORTC QLQ-C30
Diarrhea: Week 25, Day 1
|
2.8 score on a scale
Standard Deviation 17.97
|
5.6 score on a scale
Standard Deviation 19.85
|
2.9 score on a scale
Standard Deviation 13.90
|
|
Change From Baseline in EORTC QLQ-C30
Diarrhea: Week 37, Day 1
|
3.6 score on a scale
Standard Deviation 17.54
|
0.7 score on a scale
Standard Deviation 15.06
|
6.1 score on a scale
Standard Deviation 13.16
|
|
Change From Baseline in EORTC QLQ-C30
Diarrhea: Week 49, Day 1
|
3.0 score on a scale
Standard Deviation 17.15
|
-1.6 score on a scale
Standard Deviation 16.59
|
1.6 score on a scale
Standard Deviation 16.59
|
|
Change From Baseline in EORTC QLQ-C30
Diarrhea: Week 73, Day 1
|
4.6 score on a scale
Standard Deviation 17.19
|
1.3 score on a scale
Standard Deviation 15.15
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Diarrhea: Week 97, Day 1
|
7.0 score on a scale
Standard Deviation 17.84
|
0.0 score on a scale
Standard Deviation 15.71
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Diarrhea: EOT
|
4.8 score on a scale
Standard Deviation 14.33
|
2.9 score on a scale
Standard Deviation 16.90
|
5.1 score on a scale
Standard Deviation 18.49
|
|
Change From Baseline in EORTC QLQ-C30
Diarrhea: Follow-Up
|
3.3 score on a scale
Standard Deviation 10.26
|
0.0 score on a scale
Standard Deviation 19.25
|
4.8 score on a scale
Standard Deviation 12.10
|
|
Change From Baseline in EORTC QLQ-C30
Diarrhea: End Of Study
|
1.9 score on a scale
Standard Deviation 17.72
|
-1.1 score on a scale
Standard Deviation 18.86
|
2.1 score on a scale
Standard Deviation 19.12
|
|
Change From Baseline in EORTC QLQ-C30
Financial Difficulties:Week 5, Day 1
|
-1.3 score on a scale
Standard Deviation 9.16
|
2.6 score on a scale
Standard Deviation 21.74
|
-1.4 score on a scale
Standard Deviation 18.33
|
|
Change From Baseline in EORTC QLQ-C30
Financial Difficulties:Week 13, Day 1
|
-2.0 score on a scale
Standard Deviation 16.88
|
-0.7 score on a scale
Standard Deviation 20.54
|
2.8 score on a scale
Standard Deviation 23.91
|
|
Change From Baseline in EORTC QLQ-C30
Financial Difficulties:Week 25, Day 1
|
-3.5 score on a scale
Standard Deviation 12.38
|
0.7 score on a scale
Standard Deviation 20.03
|
4.3 score on a scale
Standard Deviation 23.15
|
|
Change From Baseline in EORTC QLQ-C30
Financial Difficulties:Week 37, Day 1
|
-2.9 score on a scale
Standard Deviation 19.66
|
1.5 score on a scale
Standard Deviation 18.74
|
7.6 score on a scale
Standard Deviation 20.40
|
|
Change From Baseline in EORTC QLQ-C30
Financial Difficulties:Week 49, Day 1
|
-5.2 score on a scale
Standard Deviation 20.04
|
0.8 score on a scale
Standard Deviation 18.99
|
3.2 score on a scale
Standard Deviation 17.97
|
|
Change From Baseline in EORTC QLQ-C30
Financial Difficulties:Week 73, Day 1
|
0.0 score on a scale
Standard Deviation 8.91
|
2.7 score on a scale
Standard Deviation 16.44
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Financial Difficulties: Week 97, Day 1
|
5.3 score on a scale
Standard Deviation 20.07
|
1.8 score on a scale
Standard Deviation 20.71
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Financial Difficulties: EOT
|
-3.8 score on a scale
Standard Deviation 19.42
|
5.7 score on a scale
Standard Deviation 20.59
|
2.6 score on a scale
Standard Deviation 16.45
|
|
Change From Baseline in EORTC QLQ-C30
Financial Difficulties: Follow-Up
|
5.0 score on a scale
Standard Deviation 12.21
|
1.8 score on a scale
Standard Deviation 20.71
|
11.9 score on a scale
Standard Deviation 33.61
|
|
Change From Baseline in EORTC QLQ-C30
Financial Difficulties: End of Study
|
-2.8 score on a scale
Standard Deviation 18.47
|
3.4 score on a scale
Standard Deviation 22.44
|
0.0 score on a scale
Standard Deviation 21.08
|
|
Change From Baseline in EORTC QLQ-C30
Quality of Life: Week 5, Day 1
|
-2.7 score on a scale
Standard Deviation 14.51
|
-4.0 score on a scale
Standard Deviation 17.50
|
-5.2 score on a scale
Standard Deviation 13.64
|
|
Change From Baseline in EORTC QLQ-C30
Quality of Life: Week 13, Day 1
|
-2.3 score on a scale
Standard Deviation 15.37
|
-2.0 score on a scale
Standard Deviation 14.87
|
-7.3 score on a scale
Standard Deviation 15.21
|
|
Change From Baseline in EORTC QLQ-C30
Quality of Life: Week 25, Day 1
|
-6.4 score on a scale
Standard Deviation 20.21
|
-2.3 score on a scale
Standard Deviation 15.45
|
-6.9 score on a scale
Standard Deviation 16.98
|
|
Change From Baseline in EORTC QLQ-C30
Quality of Life: Week 37, Day 1
|
-6.0 score on a scale
Standard Deviation 20.69
|
-7.4 score on a scale
Standard Deviation 20.58
|
-11.7 score on a scale
Standard Deviation 18.84
|
|
Change From Baseline in EORTC QLQ-C30
Quality of Life: Week 49, Day 1
|
-7.2 score on a scale
Standard Deviation 19.18
|
-7.3 score on a scale
Standard Deviation 18.18
|
-8.3 score on a scale
Standard Deviation 17.87
|
|
Change From Baseline in EORTC QLQ-C30
Quality of Life: Week 73, Day 1
|
-3.4 score on a scale
Standard Deviation 17.18
|
-12.0 score on a scale
Standard Deviation 13.19
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Quality of Life: Week 97, Day 1
|
-6.6 score on a scale
Standard Deviation 20.71
|
-2.2 score on a scale
Standard Deviation 18.18
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Quality of Life: EOT
|
-4.8 score on a scale
Standard Deviation 16.82
|
-7.1 score on a scale
Standard Deviation 15.80
|
-13.5 score on a scale
Standard Deviation 24.19
|
|
Change From Baseline in EORTC QLQ-C30
Quality of Life: Follow-Up
|
-5.4 score on a scale
Standard Deviation 12.17
|
-8.8 score on a scale
Standard Deviation 22.13
|
-13.7 score on a scale
Standard Deviation 19.50
|
|
Change From Baseline in EORTC QLQ-C30
Quality of Life: End of Study
|
-7.9 score on a scale
Standard Deviation 18.14
|
-10.1 score on a scale
Standard Deviation 15.49
|
-10.9 score on a scale
Standard Deviation 13.85
|
|
Change From Baseline in EORTC QLQ-C30
Physical Functioning: Week 5, Day 1
|
0.9 score on a scale
Standard Deviation 9.87
|
-0.9 score on a scale
Standard Deviation 7.70
|
-0.8 score on a scale
Standard Deviation 8.41
|
|
Change From Baseline in EORTC QLQ-C30
Physical Functioning: Week 13, Day 1
|
0.3 score on a scale
Standard Deviation 9.23
|
-4.4 score on a scale
Standard Deviation 8.50
|
-0.3 score on a scale
Standard Deviation 14.77
|
|
Change From Baseline in EORTC QLQ-C30
Physical Functioning: Week 25, Day 1
|
-2.8 score on a scale
Standard Deviation 15.24
|
-5.3 score on a scale
Standard Deviation 10.20
|
-2.0 score on a scale
Standard Deviation 14.42
|
|
Change From Baseline in EORTC QLQ-C30
Physical Functioning: Week 37, Day 1
|
-4.8 score on a scale
Standard Deviation 13.60
|
-6.2 score on a scale
Standard Deviation 12.26
|
-4.2 score on a scale
Standard Deviation 16.78
|
|
Change From Baseline in EORTC QLQ-C30
Physical Functioning: Week 49, Day 1
|
-4.3 score on a scale
Standard Deviation 13.79
|
-5.2 score on a scale
Standard Deviation 9.95
|
-7.0 score on a scale
Standard Deviation 17.32
|
|
Change From Baseline in EORTC QLQ-C30
Physical Functioning: Week 73, Day 1
|
-5.1 score on a scale
Standard Deviation 9.20
|
-8.5 score on a scale
Standard Deviation 8.72
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Physical Functioning: Week 97, Day 1
|
-8.1 score on a scale
Standard Deviation 9.58
|
-6.0 score on a scale
Standard Deviation 8.86
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Physical Functioning: EOT
|
-3.4 score on a scale
Standard Deviation 15.37
|
-9.3 score on a scale
Standard Deviation 14.66
|
-2.6 score on a scale
Standard Deviation 22.20
|
|
Change From Baseline in EORTC QLQ-C30
Physical Functioning: Follow-Up
|
-4.0 score on a scale
Standard Deviation 9.02
|
-6.3 score on a scale
Standard Deviation 19.18
|
-3.8 score on a scale
Standard Deviation 21.52
|
|
Change From Baseline in EORTC QLQ-C30
Physical Functioning: End of Study
|
-8.9 score on a scale
Standard Deviation 13.52
|
-9.0 score on a scale
Standard Deviation 13.48
|
-2.9 score on a scale
Standard Deviation 20.22
|
|
Change From Baseline in EORTC QLQ-C30
Role Functioning: Week 5, Day 1
|
0.3 score on a scale
Standard Deviation 14.43
|
-0.3 score on a scale
Standard Deviation 15.30
|
2.8 score on a scale
Standard Deviation 8.03
|
|
Change From Baseline in EORTC QLQ-C30
Role Functioning: Week 13, Day 1
|
-1.0 score on a scale
Standard Deviation 17.13
|
-3.6 score on a scale
Standard Deviation 16.09
|
1.4 score on a scale
Standard Deviation 21.93
|
|
Change From Baseline in EORTC QLQ-C30
Role Functioning: Week 25, Day 1
|
-4.9 score on a scale
Standard Deviation 21.18
|
-6.3 score on a scale
Standard Deviation 19.03
|
-2.2 score on a scale
Standard Deviation 23.19
|
|
Change From Baseline in EORTC QLQ-C30
Role Functioning: Week 37, Day 1
|
-10.9 score on a scale
Standard Deviation 23.10
|
-10.0 score on a scale
Standard Deviation 16.82
|
-4.5 score on a scale
Standard Deviation 24.22
|
|
Change From Baseline in EORTC QLQ-C30
Role Functioning: Week 49, Day 1
|
-8.1 score on a scale
Standard Deviation 23.20
|
-8.9 score on a scale
Standard Deviation 22.70
|
-7.1 score on a scale
Standard Deviation 19.42
|
|
Change From Baseline in EORTC QLQ-C30
Role Functioning: Week 73, Day 1
|
-8.0 score on a scale
Standard Deviation 13.08
|
-6.7 score on a scale
Standard Deviation 14.43
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Role Functioning: Week 97, Day 1
|
-8.8 score on a scale
Standard Deviation 15.08
|
-4.4 score on a scale
Standard Deviation 12.22
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Role Functioning: EOT
|
-9.5 score on a scale
Standard Deviation 21.88
|
-8.6 score on a scale
Standard Deviation 20.76
|
-5.1 score on a scale
Standard Deviation 29.17
|
|
Change From Baseline in EORTC QLQ-C30
Role Functioning: Follow-Up
|
-10.0 score on a scale
Standard Deviation 16.58
|
-10.5 score on a scale
Standard Deviation 31.04
|
-7.1 score on a scale
Standard Deviation 29.75
|
|
Change From Baseline in EORTC QLQ-C30
Role Functioning: End of Study
|
-10.6 score on a scale
Standard Deviation 12.69
|
-13.2 score on a scale
Standard Deviation 21.99
|
-1.0 score on a scale
Standard Deviation 26.15
|
|
Change From Baseline in EORTC QLQ-C30
Emotional Functioning: Week 5, Day 1
|
1.9 score on a scale
Standard Deviation 8.59
|
0.3 score on a scale
Standard Deviation 12.45
|
1.7 score on a scale
Standard Deviation 10.98
|
|
Change From Baseline in EORTC QLQ-C30
Emotional Functioning: Week 37, Day 1
|
-4.3 score on a scale
Standard Deviation 12.26
|
-1.7 score on a scale
Standard Deviation 11.73
|
-9.8 score on a scale
Standard Deviation 20.35
|
|
Change From Baseline in EORTC QLQ-C30
Emotional Functioning: Week 49, Day 1
|
-3.0 score on a scale
Standard Deviation 14.01
|
-1.4 score on a scale
Standard Deviation 12.06
|
-4.4 score on a scale
Standard Deviation 18.56
|
|
Change From Baseline in EORTC QLQ-C30
Emotional Functioning: Week 73, Day 1
|
-2.0 score on a scale
Standard Deviation 9.36
|
-2.3 score on a scale
Standard Deviation 16.578
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Emotional Functioning: Week 97, Day 1
|
-2.6 score on a scale
Standard Deviation 12.44
|
2.6 score on a scale
Standard Deviation 7.88
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Emotional Functioning: EOT
|
-3.6 score on a scale
Standard Deviation 11.30
|
-7.4 score on a scale
Standard Deviation 17.12
|
-14.1 score on a scale
Standard Deviation 24.15
|
|
Change From Baseline in EORTC QLQ-C30
Emotional Functioning: Follow-Up
|
-3.3 score on a scale
Standard Deviation 8.72
|
-1.3 score on a scale
Standard Deviation 19.50
|
-8.9 score on a scale
Standard Deviation 23.22
|
|
Change From Baseline in EORTC QLQ-C30
Emotional Functioning: End of Study
|
-5.3 score on a scale
Standard Deviation 12.62
|
-0.6 score on a scale
Standard Deviation 14.42
|
-8.3 score on a scale
Standard Deviation 17.74
|
|
Change From Baseline in EORTC QLQ-C30
Cognitive Functioning: Week 5, Day 1
|
-0.9 score on a scale
Standard Deviation 11.97
|
-4.2 score on a scale
Standard Deviation 14.71
|
-2.8 score on a scale
Standard Deviation 10.62
|
|
Change From Baseline in EORTC QLQ-C30
Cognitive Functioning: Week 13, Day 1
|
-1.0 score on a scale
Standard Deviation 13.50
|
-7.5 score on a scale
Standard Deviation 16.44
|
-5.6 score on a scale
Standard Deviation 16.05
|
|
Change From Baseline in EORTC QLQ-C30
Cognitive Functioning: Week 25, Day 1
|
-0.7 score on a scale
Standard Deviation 14.16
|
-3.8 score on a scale
Standard Deviation 15.08
|
-2.9 score on a scale
Standard Deviation 11.95
|
|
Change From Baseline in EORTC QLQ-C30
Cognitive Functioning: Week 37, Day 1
|
-5.8 score on a scale
Standard Deviation 12.28
|
-5.6 score on a scale
Standard Deviation 16.67
|
-9.8 score on a scale
Standard Deviation 15.99
|
|
Change From Baseline in EORTC QLQ-C30
Cognitive Functioning: Week 49, Day 1
|
-2.6 score on a scale
Standard Deviation 12.29
|
-6.1 score on a scale
Standard Deviation 13.82
|
-11.9 score on a scale
Standard Deviation 16.79
|
|
Change From Baseline in EORTC QLQ-C30
Cognitive Functioning: Week 73, Day 1
|
-5.7 score on a scale
Standard Deviation 15.61
|
-7.3 score on a scale
Standard Deviation 13.68
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Cognitive Functioning: Week 97, Day 1
|
-6.1 score on a scale
Standard Deviation 8.26
|
-7.0 score on a scale
Standard Deviation 13.96
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Cognitive Functioning: EOT
|
-2.9 score on a scale
Standard Deviation 14.84
|
-10.0 score on a scale
Standard Deviation 23.64
|
-12.8 score on a scale
Standard Deviation 21.68
|
|
Change From Baseline in EORTC QLQ-C30
Cognitive Functioning: Follow-Up
|
-0.8 score on a scale
Standard Deviation 14.78
|
-7.0 score on a scale
Standard Deviation 21.74
|
-10.7 score on a scale
Standard Deviation 15.48
|
|
Change From Baseline in EORTC QLQ-C30
Cognitive Functioning: End of Study
|
-2.3 score on a scale
Standard Deviation 16.01
|
-7.5 score on a scale
Standard Deviation 18.14
|
-3.1 score on a scale
Standard Deviation 16.35
|
|
Change From Baseline in EORTC QLQ-C30
Social Functioning: Week 5, Day 1
|
0.3 score on a scale
Standard Deviation 16.50
|
-1.3 score on a scale
Standard Deviation 14.33
|
4.2 score on a scale
Standard Deviation 16.48
|
|
Change From Baseline in EORTC QLQ-C30
Social Functioning: Week 13, Day 1
|
1.6 score on a scale
Standard Deviation 13.85
|
-3.3 score on a scale
Standard Deviation 12.48
|
-0.7 score on a scale
Standard Deviation 18.04
|
|
Change From Baseline in EORTC QLQ-C30
Social Functioning: Week 25, Day 1
|
-1.0 score on a scale
Standard Deviation 16.98
|
-6.3 score on a scale
Standard Deviation 20.23
|
-202 score on a scale
Standard Deviation 22.08
|
|
Change From Baseline in EORTC QLQ-C30
Social Functioning: Week 37, Day 1
|
-2.5 score on a scale
Standard Deviation 18.58
|
-5.9 score on a scale
Standard Deviation 16.34
|
-7.6 score on a scale
Standard Deviation 20.40
|
|
Change From Baseline in EORTC QLQ-C30
Social Functioning: Week 49, Day 1
|
-3.7 score on a scale
Standard Deviation 15.85
|
-9.8 score on a scale
Standard Deviation 20.74
|
-8.7 score on a scale
Standard Deviation 26.15
|
|
Change From Baseline in EORTC QLQ-C30
Social Functioning: Week 73, Day 1
|
-2.9 score on a scale
Standard Deviation 11.84
|
-6.0 score on a scale
Standard Deviation 15.12
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Social Functioning: Week 97, Day 1
|
-5.3 score on a scale
Standard Deviation 15.77
|
-4.4 score on a scale
Standard Deviation 14.53
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Social Functioning: EOT
|
-5.2 score on a scale
Standard Deviation 16.55
|
-10.0 score on a scale
Standard Deviation 21.08
|
-6.4 score on a scale
Standard Deviation 30.84
|
|
Change From Baseline in EORTC QLQ-C30
Social Functioning: Follow-Up
|
-3.3 score on a scale
Standard Deviation 10.26
|
-8.8 score on a scale
Standard Deviation 25.07
|
-4.8 score on a scale
Standard Deviation 22.10
|
|
Change From Baseline in EORTC QLQ-C30
Social Functioning: End of Study
|
-3.7 score on a scale
Standard Deviation 16.48
|
-9.2 score on a scale
Standard Deviation 19.20
|
0.0 score on a scale
Standard Deviation 14.91
|
|
Change From Baseline in EORTC QLQ-C30
Fatigue: Week 5, Day 1
|
1.9 score on a scale
Standard Deviation 13.74
|
4.3 score on a scale
Standard Deviation 14.95
|
3.2 score on a scale
Standard Deviation 15.19
|
|
Change From Baseline in EORTC QLQ-C30
Fatigue: Week 13, Day 1
|
6.1 score on a scale
Standard Deviation 17.40
|
8.9 score on a scale
Standard Deviation 15.72
|
8.3 score on a scale
Standard Deviation 11.47
|
|
Change From Baseline in EORTC QLQ-C30
Fatigue: Week 25, Day 1
|
6.3 score on a scale
Standard Deviation 21.12
|
13.2 score on a scale
Standard Deviation 15.66
|
13.5 score on a scale
Standard Deviation 18.94
|
|
Change From Baseline in EORTC QLQ-C30
Fatigue: Week 37, Day 1
|
9.7 score on a scale
Standard Deviation 21.55
|
14.1 score on a scale
Standard Deviation 19.30
|
16.7 score on a scale
Standard Deviation 21.89
|
|
Change From Baseline in EORTC QLQ-C30
Fatigue: Week 49, Day 1
|
10.9 score on a scale
Standard Deviation 24.33
|
11.1 score on a scale
Standard Deviation 16.67
|
20.1 score on a scale
Standard Deviation 23.47
|
|
Change From Baseline in EORTC QLQ-C30
Fatigue: Week 73, Day 1
|
10.0 score on a scale
Standard Deviation 24.19
|
14.7 score on a scale
Standard Deviation 13.88
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Fatigue: Week 97, Day 1
|
5.8 score on a scale
Standard Deviation 22.94
|
9.9 score on a scale
Standard Deviation 18.48
|
—
|
|
Change From Baseline in EORTC QLQ-C30
Fatigue: EOT
|
12.1 score on a scale
Standard Deviation 27.53
|
15.9 score on a scale
Standard Deviation 20.22
|
20.5 score on a scale
Standard Deviation 18.62
|
|
Change From Baseline in EORTC QLQ-C30
Fatigue: Follow-up
|
7.2 score on a scale
Standard Deviation 15.41
|
6.4 score on a scale
Standard Deviation 19.71
|
13.5 score on a scale
Standard Deviation 21.87
|
|
Change From Baseline in EORTC QLQ-C30
Fatigue: End of study
|
11.4 score on a scale
Standard Deviation 17.72
|
12.3 score on a scale
Standard Deviation 22.88
|
8.3 score on a scale
Standard Deviation 19.25
|
|
Change From Baseline in EORTC QLQ-C30
Nausea and Vomiting: Week 5, Day 1
|
-1.3 score on a scale
Standard Deviation 6.41
|
0.6 score on a scale
Standard Deviation 9.88
|
3.5 score on a scale
Standard Deviation 6.91
|
Adverse Events
Relugolix 80 mg
Serious events: 10 serious events
Other events: 53 other events
Deaths: 0 deaths
Relugolix 120 mg
Serious events: 7 serious events
Other events: 50 other events
Deaths: 0 deaths
Leuprorelin 22.5 mg
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Relugolix 80 mg
n=56 participants at risk
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 participants at risk
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 participants at risk
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
3.6%
2/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.9%
1/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.9%
1/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.9%
1/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.9%
1/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.00%
0/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.9%
1/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Sudden death
|
0.00%
0/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.9%
1/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.9%
1/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.9%
1/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Relugolix 80 mg
n=56 participants at risk
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Relugolix 120 mg
n=54 participants at risk
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
|
Leuprorelin 22.5 mg
n=24 participants at risk
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.9%
1/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
12.5%
3/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
57.1%
32/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
64.8%
35/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
62.5%
15/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
7.4%
4/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
19.6%
11/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
35.2%
19/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
29.2%
7/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
5.4%
3/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.1%
9/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
11.1%
6/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
3/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
3.7%
2/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
5.4%
3/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
5.6%
3/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
4/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
3.7%
2/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
7.4%
4/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
12.5%
3/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
4/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
9.3%
5/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
8.9%
5/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
3.7%
2/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
5.4%
3/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
3.7%
2/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
5.6%
3/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Cataract
|
12.5%
7/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
24.1%
13/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Visual acuity reduced
|
3.6%
2/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
7.4%
4/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Dry eye
|
5.4%
3/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
7/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
5.6%
3/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
16.7%
4/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
10.7%
6/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.9%
1/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
12.5%
3/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.4%
3/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.9%
1/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
7.1%
4/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
3.7%
2/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood triglycerides increased
|
5.4%
3/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
3.6%
2/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
9.3%
5/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
3/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
5.6%
3/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
7.4%
4/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
9.3%
5/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Libido decreased
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
5.6%
3/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
5.6%
3/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
3/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
7.4%
4/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.8%
1/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
3.7%
2/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
3.6%
2/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
7.4%
4/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
3.6%
2/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
5.6%
3/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.4%
3/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
4/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
3.7%
2/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
5.6%
3/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
5.4%
3/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
5.6%
3/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.6%
2/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
1.9%
1/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
12.5%
3/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
3.6%
2/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
12.5%
3/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
5.4%
3/56 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER