Trial Outcomes & Findings for A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer (NCT NCT02085252)

NCT ID: NCT02085252

Last Updated: 2019-06-28

Results Overview

Staging biopsy of at least 12 cores were sampled and analyzed according to a centralized biopsy procedure which confirm the results of the first biopsy \[presence of positive cores, the absence of core with tumor length \> 3 millimeters (mm), and absence Grade 4 cells (Gleason score \< 7)\]. The Gleason score grades prostate cancer tissue, based on its appearance under a microscope. Scores range from 2 to 10, with a higher score meaning that the cancer tissue is more likely to spread.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 116 participants
• Primary outcome timeframe: Month 12
• Results posted on: 2019-06-28

Participant Flow

Participants took part in the study at 22 investigative sites in France from 03 June 2013 to 08 November 2016.

Participants with a diagnosis of Prostate Cancer were randomised equally to one of two arms: leuprorelin 11.25 mg or active surveillance. 116 participants were randomized but 1 patient was excluded due to absence of prostate cancer before treatment.

Participant milestones

Measure	Leuprorelin 11.25 mg Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.	Active Surveillance Active surveillance is close medical monitoring of prostate cancer for any changes.
Overall Study STARTED	58	57
Overall Study COMPLETED	57	53
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	Leuprorelin 11.25 mg Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.	Active Surveillance Active surveillance is close medical monitoring of prostate cancer for any changes.
Overall Study Withdrawal of Consent	1	0
Overall Study Adverse Event	0	1
Overall Study Discontinuation Due to Patient Decision	0	1
Overall Study Reason Not Specified	0	1
Overall Study Reason Unknown	0	1

Baseline Characteristics

Number analyzed is the number of participants with data available for analysis for this baseline measure.

Baseline characteristics by cohort

Measure	Leuprorelin 11.25 mg n=58 Participants Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.	Active Surveillance n=57 Participants Active surveillance is close medical monitoring of prostate cancer for any changes.	Total n=115 Participants Total of all reporting groups
Age, Continuous	66.22 years STANDARD_DEVIATION 5.76 • n=58 Participants	63.60 years STANDARD_DEVIATION 5.56 • n=57 Participants	64.92 years STANDARD_DEVIATION 5.79 • n=115 Participants
Sex: Female, Male Female	0 Participants n=58 Participants	0 Participants n=57 Participants	0 Participants n=115 Participants
Sex: Female, Male Male	58 Participants n=58 Participants	57 Participants n=57 Participants	115 Participants n=115 Participants
Region of Enrollment France	58 Participants n=58 Participants	57 Participants n=57 Participants	115 Participants n=115 Participants
Height	171.85 centimeters (cm) STANDARD_DEVIATION 6.55 • n=54 Participants • Number analyzed is the number of participants with data available for analysis for this baseline measure.	173.69 centimeters (cm) STANDARD_DEVIATION 8.08 • n=54 Participants • Number analyzed is the number of participants with data available for analysis for this baseline measure.	172.77 centimeters (cm) STANDARD_DEVIATION 7.38 • n=108 Participants • Number analyzed is the number of participants with data available for analysis for this baseline measure.

PRIMARY outcome

Timeframe: Month 12

Population: Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised. Participants with missing biopsy results have been excluded from the analysis.

Staging biopsy of at least 12 cores were sampled and analyzed according to a centralized biopsy procedure which confirm the results of the first biopsy [presence of positive cores, the absence of core with tumor length > 3 millimeters (mm), and absence Grade 4 cells (Gleason score < 7)]. The Gleason score grades prostate cancer tissue, based on its appearance under a microscope. Scores range from 2 to 10, with a higher score meaning that the cancer tissue is more likely to spread.

Outcome measures

Measure	Leuprorelin 11.25 mg n=53 Participants Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.	Active Surveillance n=54 Participants Active surveillance is close medical monitoring of prostate cancer for any changes.
Number of Participants With Negative Biopsies at Month 12	28 Participants	17 Participants

SECONDARY outcome

Timeframe: Month 12

Population: Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised. Participants with missing Gleason score data are excluded.

Gleason score grades prostate cancer tissue, based on its appearance under a microscope. Scores range from 2 to 10, with a higher score meaning that the cancer tissue is more likely to spread.

Outcome measures

Measure	Leuprorelin 11.25 mg n=26 Participants Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.	Active Surveillance n=34 Participants Active surveillance is close medical monitoring of prostate cancer for any changes.
Number of Participants With Gleason Score ≥ 7	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline and Months 3, 6, 9 and 12

Population: Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised.

The I-PSS is an 8-question tool used to measure prostate symptoms (≤7: mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic). The first 7 symptom questions answered on a scale of 0 (never) to 5 (almost always) are used to determine the I-PSS Total S Score for a total possible score of 0 to 35. The 8th question is quality of life and is not reported here. A negative change from baseline indicates improvement. An Analysis of Covariance (ANCOVA) model fitted with baseline I-PSS total score and age as covariates was used for analysis.

Outcome measures

Measure	Leuprorelin 11.25 mg n=58 Participants Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.	Active Surveillance n=57 Participants Active surveillance is close medical monitoring of prostate cancer for any changes.
Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score Change at Month 3	0.37 score on a scale Interval -0.7 to 1.43	1.03 score on a scale Interval -0.05 to 2.11
Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score Change at Month 6	-0.38 score on a scale Interval -1.27 to 0.51	0.32 score on a scale Interval -0.59 to 1.24
Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score Change at Month 9	-1.13 score on a scale Interval -1.97 to -0.28	0.64 score on a scale Interval -0.23 to 1.52
Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score Change at Month 12	-0.48 score on a scale Interval -1.52 to 0.56	0.93 score on a scale Interval -0.14 to 2.01

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised. Participants with missing MRI data are excluded from analyses. Number analyzed is the number of participants with prostatic volume data at the given time-point.

MRI is an imaging technique used to investigate the anatomy and function of the body. Measurements were taken to calculate the prostatic volume in cubic millimeters (mm^3).

Outcome measures

Measure	Leuprorelin 11.25 mg n=56 Participants Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.	Active Surveillance n=57 Participants Active surveillance is close medical monitoring of prostate cancer for any changes.
Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI) Baseline	48.48 mm^3 Standard Deviation 25.09	49.44 mm^3 Standard Deviation 25.88
Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI) Month 12	51.47 mm^3 Standard Deviation 28.15	48.33 mm^3 Standard Deviation 20.18

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomized and for whom MRI was performed. Participants with missing MRI data are excluded from analyses. Number analyzed is the number of participants with diameter data at the given time-point.

MRI is an imaging technique used to investigate the anatomy and function of the body. Measurements were taken to determine the diameter of the lesions in millimeters (mm).

Outcome measures

Measure	Leuprorelin 11.25 mg n=56 Participants Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.	Active Surveillance n=57 Participants Active surveillance is close medical monitoring of prostate cancer for any changes.
Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI Baseline	6.39 mm Standard Deviation 2.80	7.78 mm Standard Deviation 2.02
Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI Month 12	6.25 mm Standard Deviation 3.62	7.69 mm Standard Deviation 2.56

SECONDARY outcome

Timeframe: Baseline and Months 3, 6, 9 and 12

Population: Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised.

Blood was collected and sent to a central laboratory for analysis of PSA reported in milligrams/milliliter (mg/mL). A negative change from baseline indicates improvement. An ANCOVA model fitted with baseline PSA Level and age as covariates was used for analyses.

Outcome measures

Measure	Leuprorelin 11.25 mg n=58 Participants Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.	Active Surveillance n=57 Participants Active surveillance is close medical monitoring of prostate cancer for any changes.
Change From Baseline in Prostate-specific Antigen (PSA) Levels Change at Month 3	-4.61 mg/mL Interval -5.07 to -4.15	0.22 mg/mL Interval -0.25 to 0.7
Change From Baseline in Prostate-specific Antigen (PSA) Levels Change at Month 6	-3.27 mg/mL Interval -3.95 to -2.59	0.85 mg/mL Interval 0.15 to 1.55
Change From Baseline in Prostate-specific Antigen (PSA) Levels Change at Month 9	-1.46 mg/mL Interval -1.96 to -0.95	0.71 mg/mL Interval 0.2 to 1.21
Change From Baseline in Prostate-specific Antigen (PSA) Levels Change at Month 12	0.17 mg/mL Interval -0.69 to 1.04	0.76 mg/mL Interval -0.13 to 1.66

SECONDARY outcome

Timeframe: Baseline and Months 3, 6, 9 and 12

Population: Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised.

The HADS is a 14-item scale that measures anxiety (7-items) and depression (7-items) over the previous week. Each question is answered on a scale of 0 (best) to 3 (worst) for a total possible score of 0 to 42, with higher scores indicating more anxiety and depression. A negative change from baseline indicates improvement. An ANCOVA model fitted with baseline HADS score and age as covariates was used for analyses.

Outcome measures

Measure	Leuprorelin 11.25 mg n=58 Participants Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.	Active Surveillance n=57 Participants Active surveillance is close medical monitoring of prostate cancer for any changes.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score Change at Month 6	-1.44 score on a scale Interval -2.53 to -0.35	-1.58 score on a scale Interval -2.69 to -0.47
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score Change at Month 12	-1.87 score on a scale Interval -2.98 to -0.76	-1.95 score on a scale Interval -3.09 to -0.8
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score Change at Month 3	-0.83 score on a scale Interval -1.76 to 0.11	-1.20 score on a scale Interval -2.17 to -0.24
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score Change at Month 9	-2.06 score on a scale Interval -3.21 to -0.91	-1.76 score on a scale Interval -2.95 to -0.56

SECONDARY outcome

Timeframe: Baseline and Months 3, 6, 9 and 12

Population: Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised.

The IIEF-5, a 5 question patient completed questionnaire, is a measure of erectile dysfunction over the past 6 months. Each question is answered on a scale of 1 (worst) to 5 (best). Total score ranges from 5 to 25 with higher scores indicating better function (5-7: severe; 8-11: moderate; 12-16: mild to moderate;17-21: mild; 22-25: none). A positive change from baseline indicates improvement. A negative change from baseline indicates a worsening. An ANCOVA model fitted with baseline IIEF-5 score and age as covariates was used for analyses.

Outcome measures

Measure	Leuprorelin 11.25 mg n=58 Participants Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.	Active Surveillance n=57 Participants Active surveillance is close medical monitoring of prostate cancer for any changes.
Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score Change at Month 3	-7.40 score on a scale Interval -9.02 to -5.78	0.00 score on a scale Interval -1.65 to 1.65
Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score Change at Month 6	-5.87 score on a scale Interval -7.52 to -4.22	0.01 score on a scale Interval -1.69 to 1.71
Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score Change at Month 9	-1.94 score on a scale Interval -3.2 to -0.67	-0.38 score on a scale Interval -1.69 to 0.94
Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score Change at Month 12	-1.68 score on a scale Interval -3.11 to -0.24	-0.02 score on a scale Interval -1.49 to 1.46

Adverse Events

Leuprorelin 11.25 mg

Serious events: 4 serious events

Other events: 40 other events

Deaths: 0 deaths

Active Surveillance

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Leuprorelin 11.25 mg n=58 participants at risk Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.	Active Surveillance n=57 participants at risk Active surveillance is close medical monitoring of prostate cancer for any changes.
Cardiac disorders Atrial flutter	1.7% 1/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	0.00% 0/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Vascular disorders Fatigue	1.7% 1/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	0.00% 0/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Vascular disorders Dizziness	1.7% 1/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	0.00% 0/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Ear and labyrinth disorders Deafness	1.7% 1/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	0.00% 0/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Infections and infestations Erysipelas	0.00% 0/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	1.8% 1/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Renal and urinary disorders Urinary tract disorder	0.00% 0/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	1.8% 1/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Gastrointestinal disorders Pancreatic neoplasm	0.00% 0/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	1.8% 1/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.

Other adverse events

Measure	Leuprorelin 11.25 mg n=58 participants at risk Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.	Active Surveillance n=57 participants at risk Active surveillance is close medical monitoring of prostate cancer for any changes.
General disorders Fatigue	6.9% 4/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	0.00% 0/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Infections and infestations Bronchitis	5.2% 3/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	3.5% 2/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Nervous system disorders Headache	5.2% 3/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	0.00% 0/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Psychiatric disorders Erectile dysfunction	12.1% 7/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	3.5% 2/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Renal and urinary disorders Dysuria	6.9% 4/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	3.5% 2/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Reproductive system and breast disorders Erectile dysfunction	5.2% 3/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	0.00% 0/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Reproductive system and breast disorders Hot flush	29.3% 17/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	0.00% 0/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Reproductive system and breast disorders Libido decreased	10.3% 6/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	0.00% 0/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Vascular disorders Hot flush	10.3% 6/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	0.00% 0/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Vascular disorders Flushing	15.5% 9/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	0.00% 0/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Vascular disorders Hypertension	1.7% 1/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	5.3% 3/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
Musculoskeletal and connective tissue disorders Back pain	3.4% 2/58 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.	7.0% 4/57 • First dose of study drug to the End of Study Visit (Up to 12 Months) At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

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