Trial Outcomes & Findings for Safety and Efficacy of TAK-385 for Patients With Localized Prostate Cancer (NCT NCT02135445)
NCT ID: NCT02135445
Last Updated: 2017-04-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
Day 1 Week 5 up to Day 1 Week 25
Results posted on
2017-04-13
Participant Flow
Participants took part in the study at 23 investigative sites in the United States (US) and the United Kingdom (UK).
Participants with a diagnosis of localized prostate cancer were enrolled in 1 of the 2 treatment groups to receive TAK-385 120 milligram (mg) or degarelix 80 mg.
Participant milestones
| Measure |
Experimental: TAK-385 120 mg
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
38
|
|
Overall Study
COMPLETED
|
63
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Experimental: TAK-385 120 mg
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of TAK-385 for Patients With Localized Prostate Cancer
Baseline characteristics by cohort
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to 64 years
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Age, Customized
65 to 84 years
|
55 participants
n=5 Participants
|
31 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Age, Customized
Greater than or equal to (>=) 85 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
58 participants
n=5 Participants
|
31 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance status
Grade 0
|
60 participants
n=5 Participants
|
33 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance status
Grade 1
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance status
Missing
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Prostate Cancer Type
Adenocarcinoma insitu,Not otherwise specified(NOS)
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Prostate Cancer Type
Adenocarcinoma, NOS
|
59 participants
n=5 Participants
|
37 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Prostate Cancer Type
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Primary Gleason Score
Primary grade 3
|
28 participants
n=5 Participants
|
18 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Primary Gleason Score
Primary grade 4
|
24 participants
n=5 Participants
|
15 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Primary Gleason Score
Primary grade missing
|
13 participants
n=5 Participants
|
5 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Secondary Gleason Score
Secondary grade 3
|
22 participants
n=5 Participants
|
12 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Secondary Gleason Score
Secondary grade 4
|
28 participants
n=5 Participants
|
19 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Secondary Gleason Score
Secondary grade 5
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Secondary Gleason Score
Secondary grade missing
|
13 participants
n=5 Participants
|
5 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Total Gleason Score
Total Gleason score 6
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Total Gleason Score
Total Gleason score 7
|
40 participants
n=5 Participants
|
26 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Total Gleason Score
Total Gleason score 8
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Total Gleason Score
Total Gleason score 9
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Total Gleason Score
Total Gleason score missing
|
13 participants
n=5 Participants
|
5 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Initial diagnosis of Primary Tumor (T)
T1
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Initial diagnosis of Primary Tumor (T)
T1a
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Initial diagnosis of Primary Tumor (T)
T1c
|
24 participants
n=5 Participants
|
16 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Initial diagnosis of Primary Tumor (T)
T2
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Initial diagnosis of Primary Tumor (T)
T2a
|
13 participants
n=5 Participants
|
2 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Initial diagnosis of Primary Tumor (T)
T2b
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Initial diagnosis of Primary Tumor (T)
T2c
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Initial diagnosis of Primary Tumor (T)
T3
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Initial diagnosis of Primary Tumor (T)
Not available
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Initial diagnosis: Regional Lymph Nodes (N)
N0
|
41 participants
n=5 Participants
|
18 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Initial diagnosis: Regional Lymph Nodes (N)
NX
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Initial diagnosis: Regional Lymph Nodes (N)
Not available
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Initial diagnosis: Distant Metastasis (M)
M0
|
56 participants
n=5 Participants
|
34 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Initial diagnosis: Distant Metastasis (M)
Not available
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Diagnosis of Primary Tumor at Study entry
T1
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Diagnosis of Primary Tumor at Study entry
T1a
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnosis of Primary Tumor at Study entry
T1c
|
20 participants
n=5 Participants
|
10 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Diagnosis of Primary Tumor at Study entry
T2
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Diagnosis of Primary Tumor at Study entry
T2a
|
12 participants
n=5 Participants
|
3 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Diagnosis of Primary Tumor at Study entry
T2b
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Diagnosis of Primary Tumor at Study entry
T2c
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Diagnosis of Primary Tumor at Study entry
T3
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnosis of Primary Tumor at Study entry
T3a
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnosis of Primary Tumor at Study entry
TX
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnosis of Primary Tumor at Study entry
Not available
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Study entry: N
N0
|
39 participants
n=5 Participants
|
19 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Study entry: N
NX
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Study entry: N
Not available
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Study entry: M
M0
|
51 participants
n=5 Participants
|
28 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Study entry: M
Not available
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 Week 5 up to Day 1 Week 25Population: Safety population included all participants who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Percentage of Participants With Effective Castration Rate Over 25 Weeks
|
95 percentage of participants
Interval 87.1 to 99.0
|
89 percentage of participants
Interval 75.2 to 97.1
|
SECONDARY outcome
Timeframe: Baseline up to Week 29Population: Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 29Population: Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Number of Participants With TEAEs Related to Physical Findings
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 29Population: Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 29Population: Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis
Liver function analyses
|
0 participants
|
6 participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis
Reproductive hormone analyses
|
2 participants
|
4 participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis
Carbohydrate tolerance analyses inclusive diabetes
|
1 participants
|
0 participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis
Cell marker analyses
|
0 participants
|
1 participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis
Platelet analyses
|
0 participants
|
1 participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis
Red blood cell analyses
|
1 participants
|
0 participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis
Skeletal and cardiac muscle analyses
|
1 participants
|
0 participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis
Urinalysis not elsewhere classified (NEC)
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 29Population: Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs)
TEAEs (including SAEs and non-SAEs)
|
56 participants
|
37 participants
|
|
Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs)
SAEs
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 Week 9 to Day 1 Week 13Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Percent change in prostate size was assessed at a follow up visit between Day 1 Week 9 to Day 1 Week 13.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=57 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Average Percent Change in Prostate Size
|
-25.1 percent change
Standard Deviation 20.03
|
-27.2 percent change
Standard Deviation 25.88
|
SECONDARY outcome
Timeframe: Baseline up to Week 37Population: Safety population included all participants who received at least one dose of study medication.
Time to effective castration is defined as days from first dose to first testosterone measurement that is \<50 ng/dL.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Time to Achieve Effective Castration
|
4 days
Interval 2.0 to 4.0
|
3 days
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline up to Week 37Population: Safety population included all participants who received at least one dose of study medication.
Time to profound castration is defined as days from first dose to first testosterone measurement that is \<20 ng/dL.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Time to Achieve Profound Castration
|
15 days
Interval 8.0 to 15.0
|
12 days
Interval 8.0 to 15.0
|
SECONDARY outcome
Timeframe: Up to Day 1 Week 37Population: Safety population included all participants who received at least one dose of study medication.
TTR is defined as the time from 1 day after the last dose of TAK-385 or 4 weeks plus 1 day after the last dose of degarelix to testosterone recovery. Testosterone recovery is defined as back to baseline or \>280 ng/dL whichever occurs first. TTR was determined during 12 weeks after the discontinuation of androgen deprivation therapy (ADT).
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=6 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Estimated Time to Testosterone Recovery (TTR)
|
91 days
Interval 62.0 to 127.0
|
100 days
Interval 100.0 to 106.0
|
SECONDARY outcome
Timeframe: Up to Day 1 Week 37Population: Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Percentage of Participants Who Have Recovered to Baseline Value of Testosterone
|
25 percentage of participants
|
11 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 Week 25 up to Day 1 Week 37Population: Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Percentage of Participants Who Have Recovered to >280 ng/dL Testosterone
|
48 percentage of participants
|
13 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 Week 13Population: Safety population included all participants who received at least one dose of study medication.
Prostate-specific Antigen (PSA) response was defined as 50% and 90% reduction from baseline in serum PSA levels.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Number of Participants With PSA Response of >=50% and >=90% Reduction
>=50% reduction
|
64 participants
|
37 participants
|
|
Number of Participants With PSA Response of >=50% and >=90% Reduction
>=90% reduction
|
36 participants
|
18 participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Week 2, 3 , 5, 9, 13, 17, 21, 25, 29, 33 and 37Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Percent Change From Baseline in Serum PSA Concentration
Day 1 Week 2
|
-29.348 percent change
Standard Deviation 21.9312
|
-26.756 percent change
Standard Deviation 36.9407
|
|
Percent Change From Baseline in Serum PSA Concentration
Day 1 Week 3
|
-35.798 percent change
Standard Deviation 48.5347
|
-14.292 percent change
Standard Deviation 108.1051
|
|
Percent Change From Baseline in Serum PSA Concentration
Day 1 Week 5
|
-60.519 percent change
Standard Deviation 34.9460
|
-64.509 percent change
Standard Deviation 32.5843
|
|
Percent Change From Baseline in Serum PSA Concentration
Day 1 Week 9
|
-84.345 percent change
Standard Deviation 13.7231
|
-78.364 percent change
Standard Deviation 42.6674
|
|
Percent Change From Baseline in Serum PSA Concentration
Day 1 Week 13
|
-88.065 percent change
Standard Deviation 10.6750
|
-85.735 percent change
Standard Deviation 14.9181
|
|
Percent Change From Baseline in Serum PSA Concentration
Day 1 Week 17
|
-90.433 percent change
Standard Deviation 10.0884
|
-87.712 percent change
Standard Deviation 13.8226
|
|
Percent Change From Baseline in Serum PSA Concentration
Day 1 Week 21
|
-95.837 percent change
Standard Deviation 5.0062
|
-94.347 percent change
Standard Deviation 9.4243
|
|
Percent Change From Baseline in Serum PSA Concentration
Day 1 Week 25
|
-97.430 percent change
Standard Deviation 3.3650
|
-96.268 percent change
Standard Deviation 7.6796
|
|
Percent Change From Baseline in Serum PSA Concentration
Day 1 Week 29
|
-96.614 percent change
Standard Deviation 4.7552
|
-96.858 percent change
Standard Deviation 7.5198
|
|
Percent Change From Baseline in Serum PSA Concentration
Day 1 Week 33
|
-94.697 percent change
Standard Deviation 6.4998
|
-97.309 percent change
Standard Deviation 7.3210
|
|
Percent Change From Baseline in Serum PSA Concentration
Day 1 Week 37
|
-94.998 percent change
Standard Deviation 5.6555
|
-97.144 percent change
Standard Deviation 6.6127
|
SECONDARY outcome
Timeframe: Baseline up to Day 1 Week 25Population: Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
PSA Nadir
|
0.3 microgram per liter (mcg/L)
Standard Deviation 0.72
|
0.3 microgram per liter (mcg/L)
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Day 1 of Week 13, 25, 29, 33 and 37Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Serum PSA Concentration
Day 1 Week 13
|
1.104 mcg/L
Standard Deviation 1.3287
|
1.486 mcg/L
Standard Deviation 2.1381
|
|
Serum PSA Concentration
Day 1 Week 25
|
0.223 mcg/L
Standard Deviation 0.3343
|
0.274 mcg/L
Standard Deviation 0.4448
|
|
Serum PSA Concentration
Day 1 Week 29
|
0.268 mcg/L
Standard Deviation 0.3357
|
0.211 mcg/L
Standard Deviation 0.3653
|
|
Serum PSA Concentration
Day 1 Week 33
|
0.431 mcg/L
Standard Deviation 0.5455
|
0.183 mcg/L
Standard Deviation 0.3503
|
|
Serum PSA Concentration
Day 1 Week 37
|
0.410 mcg/L
Standard Deviation 0.4635
|
0.210 mcg/L
Standard Deviation 0.3325
|
SECONDARY outcome
Timeframe: Day 1 Week 1, 2, 3, 5, 9, 13, 17, 25, 33, 37: Pre-dose; Day 1 Week 5, 13: 2 hrs Post-dose; Day 4 Week 1: Pre-dosePopulation: Safety population where TAK-385 assessments were available. Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Plasma Concentrations of TAK-385
Day 1 Week 1: Predose
|
0.1 nanogram per milliliter (ng/mL)
Standard Deviation 0.84
|
—
|
|
Plasma Concentrations of TAK-385
Day 1 Week 2: Predose
|
11.9 nanogram per milliliter (ng/mL)
Standard Deviation 19.69
|
—
|
|
Plasma Concentrations of TAK-385
Day 1 Week 3: Predose
|
10.4 nanogram per milliliter (ng/mL)
Standard Deviation 10.16
|
—
|
|
Plasma Concentrations of TAK-385
Day 1 Week 5: Predose
|
9.3 nanogram per milliliter (ng/mL)
Standard Deviation 12.52
|
—
|
|
Plasma Concentrations of TAK-385
Day 1 Week 5: 2 hrs post-dose
|
36.4 nanogram per milliliter (ng/mL)
Standard Deviation 38.14
|
—
|
|
Plasma Concentrations of TAK-385
Day 1 Week 9: Predose
|
11.4 nanogram per milliliter (ng/mL)
Standard Deviation 18.48
|
—
|
|
Plasma Concentrations of TAK-385
Day 1 Week 13: Predose
|
8.2 nanogram per milliliter (ng/mL)
Standard Deviation 6.25
|
—
|
|
Plasma Concentrations of TAK-385
Day 1 Week 13: 2 hrs post-dose
|
35.8 nanogram per milliliter (ng/mL)
Standard Deviation 37.33
|
—
|
|
Plasma Concentrations of TAK-385
Day 1 Week 17: Predose
|
8.7 nanogram per milliliter (ng/mL)
Standard Deviation 7.44
|
—
|
|
Plasma Concentrations of TAK-385
Day 1 Week 25: Predose
|
9.5 nanogram per milliliter (ng/mL)
Standard Deviation 7.78
|
—
|
|
Plasma Concentrations of TAK-385
Day 1 Week 29: Predose
|
0.3 nanogram per milliliter (ng/mL)
Standard Deviation 0.38
|
—
|
|
Plasma Concentrations of TAK-385
Day 1 Week 33: Predose
|
0.1 nanogram per milliliter (ng/mL)
Standard Deviation 0.10
|
—
|
|
Plasma Concentrations of TAK-385
Day 1 Week 37: Predose
|
0.1 nanogram per milliliter (ng/mL)
Standard Deviation 0.05
|
—
|
|
Plasma Concentrations of TAK-385
Day 4 Week 1: Predose
|
10.5 nanogram per milliliter (ng/mL)
Standard Deviation 16.35
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Weeks 2, 3, 5, 9, 13, 17, 21, 25, 29, and 37Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Serum Luteinizing Hormone (LH) Level
Baseline
|
5.838 milli-international units per milliliter
Standard Deviation 5.0647
|
6.943 milli-international units per milliliter
Standard Deviation 7.6683
|
|
Serum Luteinizing Hormone (LH) Level
Day 1 Week 2
|
0.388 milli-international units per milliliter
Standard Deviation 0.4167
|
0.539 milli-international units per milliliter
Standard Deviation 0.7122
|
|
Serum Luteinizing Hormone (LH) Level
Day 1 Week 3
|
0.223 milli-international units per milliliter
Standard Deviation 0.3820
|
0.362 milli-international units per milliliter
Standard Deviation 0.5648
|
|
Serum Luteinizing Hormone (LH) Level
Day 1 Week 5
|
0.178 milli-international units per milliliter
Standard Deviation 0.2547
|
0.252 milli-international units per milliliter
Standard Deviation 0.3280
|
|
Serum Luteinizing Hormone (LH) Level
Day 1 Week 9
|
0.198 milli-international units per milliliter
Standard Deviation 0.4677
|
0.333 milli-international units per milliliter
Standard Deviation 0.5649
|
|
Serum Luteinizing Hormone (LH) Level
Day 1 Week 13
|
0.180 milli-international units per milliliter
Standard Deviation 0.3979
|
0.265 milli-international units per milliliter
Standard Deviation 0.5073
|
|
Serum Luteinizing Hormone (LH) Level
Day 1 Week 17
|
0.184 milli-international units per milliliter
Standard Deviation 0.3690
|
0.283 milli-international units per milliliter
Standard Deviation 0.5461
|
|
Serum Luteinizing Hormone (LH) Level
Day 1 Week 21
|
0.199 milli-international units per milliliter
Standard Deviation 0.4670
|
0.294 milli-international units per milliliter
Standard Deviation 0.5523
|
|
Serum Luteinizing Hormone (LH) Level
Day 1 Week 25
|
0.325 milli-international units per milliliter
Standard Deviation 0.7243
|
0.342 milli-international units per milliliter
Standard Deviation 0.6248
|
|
Serum Luteinizing Hormone (LH) Level
Day 1 Week 29
|
4.204 milli-international units per milliliter
Standard Deviation 3.3259
|
0.464 milli-international units per milliliter
Standard Deviation 0.5756
|
|
Serum Luteinizing Hormone (LH) Level
Day 1 Week 37
|
9.441 milli-international units per milliliter
Standard Deviation 5.6144
|
1.036 milli-international units per milliliter
Standard Deviation 1.4907
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Week 2, 5, 13, 25 and 29Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Serum Follicle-Stimulating Hormone (FSH) Level
Baseline
|
11.826 International units per liter (IU/L)
Standard Deviation 17.3909
|
11.716 International units per liter (IU/L)
Standard Deviation 14.7839
|
|
Serum Follicle-Stimulating Hormone (FSH) Level
Day 1 Week 2
|
2.363 International units per liter (IU/L)
Standard Deviation 2.9647
|
2.519 International units per liter (IU/L)
Standard Deviation 2.8180
|
|
Serum Follicle-Stimulating Hormone (FSH) Level
Day 1 Week 5
|
0.706 International units per liter (IU/L)
Standard Deviation 0.9289
|
0.973 International units per liter (IU/L)
Standard Deviation 1.0951
|
|
Serum Follicle-Stimulating Hormone (FSH) Level
Day 1 Week 13
|
0.849 International units per liter (IU/L)
Standard Deviation 1.1728
|
1.108 International units per liter (IU/L)
Standard Deviation 1.3469
|
|
Serum Follicle-Stimulating Hormone (FSH) Level
Day 1 Week 25
|
1.475 International units per liter (IU/L)
Standard Deviation 2.1842
|
1.471 International units per liter (IU/L)
Standard Deviation 1.7437
|
|
Serum Follicle-Stimulating Hormone (FSH) Level
Day 1 Week 29
|
7.427 International units per liter (IU/L)
Standard Deviation 5.4105
|
2.032 International units per liter (IU/L)
Standard Deviation 1.9114
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Week 2, 5, 13, 25 and 29Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Serum Sex Hormone-Binding Globulin (SHBG) Level
Baseline
|
45.528 nmol/L
Standard Deviation 21.3167
|
41.784 nmol/L
Standard Deviation 17.8412
|
|
Serum Sex Hormone-Binding Globulin (SHBG) Level
Day 1 Week 2
|
49.474 nmol/L
Standard Deviation 22.3975
|
43.386 nmol/L
Standard Deviation 15.9911
|
|
Serum Sex Hormone-Binding Globulin (SHBG) Level
Day 1 Week 5
|
46.797 nmol/L
Standard Deviation 22.6572
|
41.778 nmol/L
Standard Deviation 15.7575
|
|
Serum Sex Hormone-Binding Globulin (SHBG) Level
Day 1 Week 13
|
46.083 nmol/L
Standard Deviation 24.6853
|
42.992 nmol/L
Standard Deviation 19.2416
|
|
Serum Sex Hormone-Binding Globulin (SHBG) Level
Day 1 Week 25
|
46.258 nmol/L
Standard Deviation 25.0679
|
44.305 nmol/L
Standard Deviation 22.2005
|
|
Serum Sex Hormone-Binding Globulin (SHBG) Level
Day 1 Week 29
|
43.329 nmol/L
Standard Deviation 20.8000
|
42.739 nmol/L
Standard Deviation 21.9110
|
SECONDARY outcome
Timeframe: Day 1 of Weeks 5, 13, 25, 29, 33 and 37Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
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 none (1) to extremely severe (5) 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 |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score
Day 1 Week 5
|
17.347 percent change
Standard Deviation 36.1328
|
19.194 percent change
Standard Deviation 27.8573
|
|
Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score
Day 1 Week 13
|
31.461 percent change
Standard Deviation 41.4029
|
36.117 percent change
Standard Deviation 33.8115
|
|
Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score
Day 1 Week 25
|
43.558 percent change
Standard Deviation 52.4934
|
48.158 percent change
Standard Deviation 41.2365
|
|
Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score
Day 1 Week 29
|
33.692 percent change
Standard Deviation 44.8331
|
36.950 percent change
Standard Deviation 34.4352
|
|
Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score
Day 1, Week 33
|
24.273 percent change
Standard Deviation 40.0869
|
40.227 percent change
Standard Deviation 37.9232
|
|
Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score
Day 1 Week 37
|
14.562 percent change
Standard Deviation 30.0487
|
40.535 percent change
Standard Deviation 35.3799
|
SECONDARY outcome
Timeframe: Baseline and last post-baseline value up to Week 37Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
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 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'Very poor' to 7 'Excellent'). All domain scores were calculated as an average of item scores and transformed to 0-100 score range where a high score from 0-100 indicates: 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.
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score
Day 1 Week 25
|
-10.04 units on scale
Standard Error 1.842
|
-7.27 units on scale
Standard Error 2.349
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score
Day 1 Week 29
|
-7.11 units on scale
Standard Error 1.826
|
-8.14 units on scale
Standard Error 2.349
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score
Day 1 Week 5
|
-5.10 units on scale
Standard Error 1.833
|
-0.26 units on scale
Standard Error 2.370
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score
Day 1 Week 13
|
-4.29 units on scale
Standard Error 1.837
|
-4.33 units on scale
Standard Error 2.364
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score
Day 1 Week 33
|
-6.24 units on scale
Standard Error 1.830
|
-6.39 units on scale
Standard Error 2.349
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score
Day 1 Week 37
|
-7.84 units on scale
Standard Error 1.833
|
-6.61 units on scale
Standard Error 2.349
|
SECONDARY outcome
Timeframe: Baseline and last post-baseline value up to Week 37Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
EORTC QLQ-PR25 : EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer. It Consist 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 used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).
Outcome measures
| Measure |
Experimental: TAK-385 120 mg
n=65 Participants
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 Participants
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
Sexual activity: Day 1 Week 5
|
-9.78 units on scale
Standard Error 2.957
|
-9.53 units on scale
Standard Error 3.823
|
|
Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
Sexual activity: Day 1 Week 13
|
-17.43 units on scale
Standard Error 2.967
|
-11.54 units on scale
Standard Error 3.816
|
|
Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
Sexual activity: Day 1 Week 25
|
-19.32 units on scale
Standard Error 2.978
|
-12.57 units on scale
Standard Error 3.784
|
|
Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
Sexual activity: Day 1 Week 29
|
-19.06 units on scale
Standard Error 2.948
|
-5.12 units on scale
Standard Error 3.784
|
|
Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
Sexual activity: Day 1 Week 33
|
-12.40 units on scale
Standard Error 2.952
|
-9.94 units on scale
Standard Error 3.784
|
|
Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
Sexual activity: Day 1 Week 37
|
-6.60 units on scale
Standard Error 2.957
|
-6.00 units on scale
Standard Error 3.784
|
|
Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
HTRS: Day 1 Week 5
|
6.55 units on scale
Standard Error 1.275
|
7.02 units on scale
Standard Error 1.651
|
|
Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
HTRS: Day 1 Week 13
|
10.06 units on scale
Standard Error 1.275
|
9.98 units on scale
Standard Error 1.648
|
|
Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
HTRS: Day 1 Week 25
|
13.34 units on scale
Standard Error 1.276
|
12.48 units on scale
Standard Error 1.641
|
|
Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
HTRS: Day 1 Week 29
|
11.53 units on scale
Standard Error 1.270
|
10.43 units on scale
Standard Error 1.641
|
|
Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
HTRS: Day 1 Week 33
|
9.62 units on scale
Standard Error 1.273
|
10.72 units on scale
Standard Error 1.641
|
|
Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
HTRS: Day 1 Week 37
|
8.67 units on scale
Standard Error 1.276
|
11.31 units on scale
Standard Error 1.641
|
Adverse Events
Experimental: TAK-385 120 mg
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
Experimental: Degarelix 80 mg
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: TAK-385 120 mg
n=65 participants at risk
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 participants at risk
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.00%
0/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.00%
0/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
1.5%
1/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
1.5%
1/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Experimental: TAK-385 120 mg
n=65 participants at risk
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
|
Experimental: Degarelix 80 mg
n=38 participants at risk
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
|
|---|---|---|
|
Vascular disorders
Hot flush
|
56.9%
37/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
60.5%
23/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
26.2%
17/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.8%
6/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Cataract
|
15.4%
10/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.4%
7/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.5%
12/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.2%
5/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Nocturia
|
13.8%
9/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.2%
5/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
12.3%
8/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.8%
6/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Dysuria
|
7.7%
5/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.8%
6/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
9.2%
6/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.9%
3/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
9.2%
6/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
2/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
6.2%
4/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.9%
3/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
5/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood testosterone increased
|
3.1%
2/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
4/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
4.6%
3/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.9%
3/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Micturition urgency
|
7.7%
5/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
4/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
2/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sinusitis
|
6.2%
4/65 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
2/38 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER