Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000160-15 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (< 50 nanograms/deciliter [ng/dL]) in participants with androgen-sensitive advanced prostate cancer.
This is a phase 3, multinational, randomized, open-label, parallel group study to evaluate the efficacy and safety of oral daily relugolix 120 mg in participants with androgen-sensitive advanced prostate cancer who require at least 1 year of continuous androgen-deprivation therapy. Relugolix 120 mg orally once daily or leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan based on local labels), every 3 months by subcutaneous injection will be administered to participants.
There are 2 analyses for this study, a primary analysis and a final analysis.
Primary Analysis:
The primary analysis of efficacy and safety has been completed (N=934). Participants were randomized 2:1 to receive relugolix or leuprolide for 48 weeks, followed by a 30-day safety follow-up visit or early termination 30-day safety follow-up.
Final Analysis:
The final analysis will occur after additional participants with metastatic disease (approximately 130) have been enrolled and randomized from any sites to the study, and have completed the 48-week treatment period. A cohort of participants enrolled in China and Taiwan will be analyzed separately once they have completed treatment to support registration in China.
Eligible participants were randomized 2:1 to relugolix or leuprolide arm and will attend visits monthly (every 4 weeks) where serum testosterone and prostate-specific antigen will be assessed. Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, and 12-lead electrocardiograms.
Castration resistance-free survival will be assessed up to Week 49, Day 1 of the study and reported as part of the final analysis.
The study enrolled 1134 participants, including 139 participants with metastatic advanced prostate cancer to support the analysis of the secondary endpoint of castration resistance-free survival and 93 Chinese participants (enrolled in China and Taiwan) to support registration in China.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relugolix | Experimental | Relugolix for 48 weeks |
|
| Leuprolide Acetate | Active Comparator | Leuprolide acetate for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relugolix | Drug | Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Castration Rate | Sustained castration rate defined as the cumulative probability of testosterone suppression to < 50 nanogram (ng)/deciliter (dL). The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. The lower bound of the 95% confidence interval (CI) for the cumulative probability of sustained testosterone suppression in the relugolix treatment group must have been ≥ 90% to meet evaluation criteria for efficacy. | From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337) |
| Measure | Description | Time Frame |
|---|---|---|
| Castration Rate At Week 1 Day 4 | Castration rate was defined as the cumulative probability of testosterone suppression to < 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. | Week 1 Day 4 (Day 4) |
| Castration Rate At Week 3 Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Major Adverse Cardiovascular Events (MACE) | MACE were defined as nonfatal myocardial infarction, nonfatal stroke, and death from any cause. | From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337) |
Key Inclusion Criteria:
Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with 1 of the following clinical disease state presentations:
Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nanomoles [nmol]/liter [L]).
Has a serum PSA concentration at the Screening visit of > 2.0 ng/milliliter (mL) (2.0 microgram [μg]/L), or, when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 μg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0 μg/L) above the post interventional nadir.
Has an Eastern Cooperative Oncology Group performance status of 0 or 1 at initial screening and at baseline.
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Myovant Medical Monitor | Myovant Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Tucson | Arizona | 85741 | United States | ||
| Orange |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32469183 | Background | Shore ND, Saad F, Cookson MS, George DJ, Saltzstein DR, Tutrone R, Akaza H, Bossi A, van Veenhuyzen DF, Selby B, Fan X, Kang V, Walling J, Tombal B; HERO Study Investigators. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. N Engl J Med. 2020 Jun 4;382(23):2187-2196. doi: 10.1056/NEJMoa2004325. Epub 2020 May 29. | |
| 37713020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary analysis of efficacy and safety included 934 participants. The primary analysis excluded additional participants with metastatic disease and a cohort of participants enrolled in China and Taiwan who will be included in the final analysis of the study (N=200).
To support registration in China, the study continued to enroll additional nonmetastatic or metastatic participants from China after the final analysis to reach the target enrollment of approximately 90 participants.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Relugolix | Relugolix 120-milligram (mg) tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1. |
| FG001 | Leuprolide Acetate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 23, 2018 | Dec 1, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Leuprolide Acetate | Drug | Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, Taiwan, and China), every 3 months by subcutaneous injection |
|
|
Castration rate was defined as the cumulative probability of testosterone suppression to < 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. |
| Week 3 Day 1 (Day 15) |
| Confirmed Prostate-specific Antigen (PSA) Response Rate | Confirmed PSA response defined as > 50% reduction in PSA from baseline at Week 3 Day 1 followed with confirmation at Week 5 Day 1. | Week 3 Day 1 (Day 15) and Week 5 Day 1 (Day 29) |
| Profound Castration Rate At Week 3 Day 1 (Day 15) | Castration rate defined as the cumulative probability of testosterone suppression to < 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. | Week 3 Day 1 (Day 15) |
| Follicle-stimulating Hormone (FSH) Level | To evaluate the effect of relugolix and leuprolide acetate on FSH suppression. | Week 25 Day 1 (Day 169) |
| PSA Response Rate At Week 3 Day 1 | PSA response defined as > 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. | Week 3 Day 1 (Day 15) |
| PSA Response Rate At Week 5 Day 1 | PSA response defined as > 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. | Week 5 Day 1 (Day 29) |
| Testosterone Recovery Rate | The cumulative probability of testosterone recovery back to > 280 ng/dL (lower limit of the normal range), back to ≥ 50 ng/dL (definition of castration), and back to > 280 ng/dL or baseline at 90 days after drug discontinuation was assessed. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. | Day 90 follow-up |
| Sustained Profound Castration Rate From Week 5 Day 1 Through Week 49 Day 1 | Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to < 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants. | Week 5 Day 1 (Day 29) through Week 49 Day 1 (Day 337) |
| Profound Castration Rate At Week 1 Day 4 (Day 4) | Castration rate defined as the cumulative probability of testosterone suppression to < 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. | At Week 1 Day 4 (Day 4) |
| Sustained Profound Castration Rate From Week 25 Day 1 Through Week 49 Day 1 | Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to < 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants. | Week 25 Day 1 (Day 169) through Week 49 Day 1 (Day 337) |
| Undetectable PSA Rate | Defined as the proportion of participants with PSA concentration < 0.02 ng/milliliter (mL).The rate was estimated by the Kaplan-Meier method and reported as percentage of participants. | Week 25 Day 1 (Day 169) |
| Rate Of PSA Progression-free Survival | PSA progression was defined as the first increase in PSA of 25% or greater and 2 ng/mL or greater above the nadir with confirmation by a second consecutive PSA measurement at least 3 weeks later. For participants without declining PSA from baseline, a PSA increase of ≥ 25% and ≥ 2 ng/mL from baseline beyond 12 weeks was considered PSA progression. The rate of progression-free survival was estimated using the Kaplan-Meier method and reported as percentage of participants. | Week 49 Day 1 (Day 337) |
| Change From Baseline In Quality Of Life (QoL) Total Score As Assessed By The Global Health Domain Of The European Organisation Of Research And Treatment Of Cancer (EORTC)-Quality Of Life Questionnaire (QLQ)-C30 | The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. The global health and quality of life domain is presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems). | Baseline, Week 49 Day 1 (Day 337) |
| Change From Baseline In QoL Total Score For Remaining Domain Scores As Assessed By The EORTC-QLQ-C30 | The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. All domains except for the global health and quality are presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems). | Baseline, Week 49 Day 1 (Day 337) |
| Change From Baseline In QoL Total Score As Assessed By The EORTC-QLQ-PR25 Sexual Activity And Functioning And Hormonal-Treatment-Related Symptom Subdomains | Subscales for assessment of hormonal treatment-related symptoms (6 items) and sexual activity and function (6 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. 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. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems). | Baseline, Week 49 Day 1 (Day 337) |
| Change From Baseline In QoL Total Score For Urinary And Bowel Symptoms Domains As Assessed By The EORTC-QLQ-PR25 | Subscale assessments of urinary symptoms (9 items) and bowel symptoms (4 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. 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. A decrease in symptom scores indicates improvement (lower level of symptoms/problems). | Baseline, Week 49 Day 1 (Day 337) |
| Change From Baseline In QoL Total Score As Assessed By The European Quality Of Life 5-Dimension 5-Level Questionnaire (EuroQoL EQ-5D-5L) | The EuroQoL EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems (1 as numerical score), slight problems (2 as numerical score), moderate problems (3 as numerical score), severe problems (4 as numerical score), and extreme problems (5 as numerical score). The total score ranges from 0 to 100. A decrease in score indicates improvement. | Baseline, Week 49 Day 1 (Day 337) |
| Percent Change From Baseline In Serum Concentrations Of Luteinizing Hormone | Blood samples were collected from participants for hormonal measurements. | Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337) |
| Percent Change From Baseline In Serum Concentrations Of FSH | Blood samples were collected from participants for hormonal measurements. | Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337) |
| Percent Change From Baseline In Serum Concentrations Of Dihydrotestosterone | Blood samples were collected from participants for hormonal measurements. | Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337) |
| Percent Change From Baseline In Serum Concentrations Of Sex Hormone-Binding Globulin | Blood samples were collected from participants for hormonal measurements. | Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337) |
| Maximum Observed Plasma Concentration (Cmax) Of Relugolix | The Cmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose pharmacokinetics (PK) was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks. | Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2 |
| Area Under The Concentration-Time Curve (AUC0-τ) Of Relugolix | The AUC0-τ of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks. | Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2 |
| Time To Maximum Observed Plasma Concentration (Tmax) Of Relugolix | The Tmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks. | Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2 |
| Orange |
| California |
| 92868 |
| United States |
| Denver | Denver | Colorado | 80211 | United States |
| Pompano Beach | Pompano Beach | Florida | 33060 | United States |
| Jeffersonville | Jeffersonville | Indiana | 47130 | United States |
| Des Moines | Des Moines | Iowa | 50266 | United States |
| Wichita | Wichita | Kansas | 67226 | United States |
| Baltimore | Baltimore | Maryland | 21204 | United States |
| Troy | Troy | Michigan | 48084 | United States |
| Omaha | Omaha | Nebraska | 68130 | United States |
| Las Vegas | Las Vegas | Nevada | 89135 | United States |
| Brick | Brick | New Jersey | 08724 | United States |
| Albuquerque | Albuquerque | New Mexico | 87109 | United States |
| Albany | Albany | New York | 12208 | United States |
| Garden City | Garden City | New York | 11530 | United States |
| Plainview | Plainview | New York | 11803 | United States |
| Poughkeepsie | Poughkeepsie | New York | 12601 | United States |
| Syracuse | Syracuse | New York | 13210 | United States |
| Durham | Durham | North Carolina | 27710 | United States |
| Greensboro | Greensboro | North Carolina | 27403 | United States |
| Cincinnati | Cincinnati | Ohio | 45212 | United States |
| Middleburg Heights | Middleburg Heights | Ohio | 44130 | United States |
| Oklahoma City | Oklahoma City | Oklahoma | 73104 | United States |
| Lancaster | Lancaster | Pennsylvania | 17604 | United States |
| Myrtle Beach | Myrtle Beach | South Carolina | 29572 | United States |
| Nashville | Nashville | Tennessee | 37209 | United States |
| San Antonio | San Antonio | Texas | 78258 | United States |
| Camperdown | Camperdown | New South Wales | 2050 | Australia |
| Tweed Heads | Tweed Heads | New South Wales | 2485 | Australia |
| Wahroonga | Wahroonga | New South Wales | 2076 | Australia |
| Redcliffe | Redcliffe | Queensland | 4020 | Australia |
| Southport | Southport | Queensland | 4215 | Australia |
| Linz | Linz | 402 | Austria |
| Gent | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Brussels | Brussels | 1200 | Belgium |
| Kortrijk | Kortrijk | 8500 | Belgium |
| Itabuna | Itabuna | Estado de Bahia | 45602-650 | Brazil |
| Salvador | Salvador | Estado de Bahia | 41253-190 | Brazil |
| Salvador | Salvador | Estado de Bahia | 41820-021 | Brazil |
| Teresina | Teresina | Piauí | 64001-280 | Brazil |
| Natal | Natal | Rio Grande do Norte | 59062-000 | Brazil |
| Ijuí | Ijuí | Rio Grande do Sul | 98700 | Brazil |
| Passo Fundo | Passo Fundo | Rio Grande do Sul | 99010-080 | Brazil |
| Porto Alegre | Porto Alegre | Rio Grande do Sul | 90110-270 | Brazil |
| Porto Alegre | Porto Alegre | Rio Grande do Sul | 90430-090 | Brazil |
| Joinville | Joinville | Santa Catarina | 89201-260 | Brazil |
| São José Do Rio Preto | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Curitiba | Curitiba | 81520-060 | Brazil |
| Calgary | Calgary | Alberta | T2V4R6 | Canada |
| Vancouver | Vancouver | British Columbia | V5Z1M9 | Canada |
| Halifax | Halifax | Nova Scotia | B3H2Y9 | Canada |
| Hamilton | Hamilton | Ontario | L8N4A6 | Canada |
| London | London | Ontario | N6A4G5 | Canada |
| Montreal | Montreal | Quebec | H2X0A9 | Canada |
| Sherbrooke | Sherbrooke | Quebec | J1H5N4 | Canada |
| Quebec | Québec | G1R 3S3 | Canada |
| Nanjing | Nanjing | Jiangsu | 210008 | China |
| Changchun | Changchun | Jilin | 130021 | China |
| Shanghai | Shanghai | Shanghai Municipality | 020043 | China |
| Taiyuan | Taiyuan | Shanxi | 030001 | China |
| Beijing | Beijing | 100041 | China |
| Beijing | Beijing | 100050 | China |
| Beijing Shi | Beijing | 100730 | China |
| Chongqing | Chongqing | 400030 | China |
| Hangzhou | Hangzhou | 310003 | China |
| Lanzhou | Lanzhou | 730030 | China |
| Nanchang | Nanchang | 330006 | China |
| Shanghai | Shanghai | 200040 | China |
| Suzhou | Suzhou | 215004 | China |
| Alborg | Aalborg | DK-9000 | Denmark |
| Aarhus | Aarhus | 8200 | Denmark |
| Herlev | Herlev | 2730 | Denmark |
| Vejle | Vejle | DK-7100 | Denmark |
| Helsinki | Helsinki | FI-00029 | Finland |
| Seinajoki | Seinäjoki | FI-60220 | Finland |
| Tampere | Tampere | FI-33520 | Finland |
| Turku | Turku | FI-20520 | Finland |
| Strasbourg | Strasbourg | Bas-Rhin | 67091 | France |
| Pierre Benite | Pierre-Bénite | Rhone | 69495 | France |
| Creteil | Créteil | Val-de-Marne | 94010 | France |
| Lyon | Lyon | 69437 | France |
| Emmendingen | Emmendingen | Baden-Wurttemberg | 79312 | Germany |
| Planegg | Planegg | Bavaria | 82152 | Germany |
| Braunschweig | Braunschweig | Lower Saxony | 38100 | Germany |
| Dresden | Dresden | 01307 | Germany |
| Lubeck | Lübeck | 23538 | Germany |
| Munster | Münster | 48149 | Germany |
| Meldola | Meldola | Emilia-Romagna | 47014 | Italy |
| Rome | Rome | Lazio | 00152 | Italy |
| Cremona | Cremona | Lombardy | 26100 | Italy |
| Candiolo | Candiolo | Piedmont | 10060 | Italy |
| Orbassano | Orbassano | Piedmont | 10043 | Italy |
| Arezzo | Arezzo | Tuscany | 52100 | Italy |
| Milano | Milan | 20162 | Italy |
| Kanazawa-shi | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Yokohama | Yokohama | Kanagawa | 232-0024 | Japan |
| Sendai | Sendai | Miyagi | 9808574 | Japan |
| Sendai | Sendai | Miyagi | 9818563 | Japan |
| Osaka-sayama | Ōsaka-sayama | Osaka | 589-8511 | Japan |
| Suita | Suita | Osaka | 565-0871 | Japan |
| Bunkyō-Ku | Bunkyō-Ku | Tokyo | 113-8655 | Japan |
| Nakano-ku | Nakano-ku | Tokyo | 164-8541 | Japan |
| Sumida-ku | Sumida-ku | Tokyo | 130-8587 | Japan |
| Chiba | Chiba | 260-0801 | Japan |
| Fukuoka | Fukuoka | 812-0033 | Japan |
| Hiroshima | Hiroshima | 730-8518 | Japan |
| Kita-gun | Kita-ku | 761-0793 | Japan |
| Kyoto | Kyoto | 606-8507 | Japan |
| Maebashi | Maebashi | 371-8511 | Japan |
| Nagasaki | Nagasaki | 852-8501 | Japan |
| Osaka | Osaka | 541-8567 | Japan |
| Sapporo | Sapporo | 003-0804 | Japan |
| Tokyo | Tokyo | 285-8741 | Japan |
| Ube | Ube | 7558505 | Japan |
| Eindhoven | Eindhoven | North Brabant | 5623EJ | Netherlands |
| Amsterdam | Amsterdam | North Holland | 1105AZ | Netherlands |
| Sneek | Sneek | 8601 ZK | Netherlands |
| Christchurch | Christchurch | 8013 | New Zealand |
| Dunedin | Dunedin | 9016 | New Zealand |
| Hamilton | Hamilton | 3204 | New Zealand |
| Tauranga | Tauranga | 3112 | New Zealand |
| Lublin | Lublin | Lublin Voivodeship | 20-582 | Poland |
| Siedlce | Siedlce | Masovian Voivodeship | 08-110 | Poland |
| Warszawa | Warsaw | Masovian Voivodeship | 02-797 | Poland |
| Gdynia | Gdynia | Pomeranian Voivodeship | 81-519 | Poland |
| Katowice | Katowice | 40611 | Poland |
| Bratislava | Bratislava | 851 05 | Slovakia |
| Kosice | Košice | 040 01 | Slovakia |
| Kosice | Košice | 041 91 | Slovakia |
| Martin | Martin | 036 59 | Slovakia |
| Nitra | Nitra | 949 01 | Slovakia |
| Poprad | Poprad | 058 45 | Slovakia |
| Presov | Prešov | 080 01 | Slovakia |
| Sala | Šaľa | 927 01 | Slovakia |
| Trencin | Trenčín | 911 01 | Slovakia |
| Goyang-Si | Goyang-si | Gyeonggido | 10408 | South Korea |
| Busan | Busan | 49241 | South Korea |
| Daegu | Daegu | 41404 | South Korea |
| Hwasun | Hwasun | 58128 | South Korea |
| Seoul | Seoul | 03080 | South Korea |
| Seoul | Seoul | 05505 | South Korea |
| Seoul | Seoul | 06273 | South Korea |
| Seoul | Seoul | 06351 | South Korea |
| A Coruna | A Coruña | A Coruna | 15706 | Spain |
| Oviedo | Oviedo | Principality of Asturias | 33011 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Madrid | Madrid | 28007 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Salamanca | Salamanca | 37007 | Spain |
| Valencia | Valencia | 46009 | Spain |
| Orebro | Örebro | Orebro Ian | SE-70185 | Sweden |
| Stockholm | Stockholm | Sodermandlands Ian | SE-17176 | Sweden |
| Uppsala | Uppsala | Uppsala County | SE-751-85 | Sweden |
| Malmo | Malmö | SE-20502 | Sweden |
| Kaohsiung City | Kaohsiung City | 807 | Taiwan |
| Taipei | Taipei | 100 | Taiwan |
| Taipei | Taipei | 111 | Taiwan |
| Taipei | Taipei | 11490 | Taiwan |
| Exeter | Exeter | Devon | EX2 5DW | United Kingdom |
| Scunthorpe | Scunthorpe | North Lincolnshire | DN157BH | United Kingdom |
| Nottingham | Nottingham | NG5 1PB | United Kingdom |
| Rhyl | Rhyl | LL18 5UJ | United Kingdom |
| Shore ND, Mehlhaff BA, Cookson MS, Saltzstein DR, Tutrone R, Brown B, Lu S, Fallick M, Hanson S, Saad F. Impact of Concomitant Cardiovascular Therapies on Efficacy and Safety of Relugolix vs Leuprolide: Subgroup Analysis from HERO Study in Advanced Prostate Cancer. Adv Ther. 2023 Nov;40(11):4919-4927. doi: 10.1007/s12325-023-02634-7. Epub 2023 Sep 15. |
| 35587650 | Derived | Shore ND, Sutton J. Plain language summary of the HERO study comparing relugolix with leuprolide for men with advanced prostate cancer. Future Oncol. 2022 Jul;18(21):2575-2584. doi: 10.2217/fon-2022-0172. Epub 2022 May 19. |
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
| Received at Least 1 Dose of Study Drug | Four participants (2 in each treatment group) were randomized but did not receive study drug. |
|
| COMPLETED | Completed 48 weeks of treatment. |
|
| NOT COMPLETED |
|
|
All randomized participants who received at least 1 dose of study drug in the primary analysis part of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Relugolix | Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1. |
| BG001 | Leuprolide Acetate | Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sustained Castration Rate | Sustained castration rate defined as the cumulative probability of testosterone suppression to < 50 nanogram (ng)/deciliter (dL). The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. The lower bound of the 95% confidence interval (CI) for the cumulative probability of sustained testosterone suppression in the relugolix treatment group must have been ≥ 90% to meet evaluation criteria for efficacy. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Castration Rate At Week 1 Day 4 | Castration rate was defined as the cumulative probability of testosterone suppression to < 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 Day 4 (Day 4) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Castration Rate At Week 3 Day 1 | Castration rate was defined as the cumulative probability of testosterone suppression to < 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 3 Day 1 (Day 15) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Confirmed Prostate-specific Antigen (PSA) Response Rate | Confirmed PSA response defined as > 50% reduction in PSA from baseline at Week 3 Day 1 followed with confirmation at Week 5 Day 1. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 3 Day 1 (Day 15) and Week 5 Day 1 (Day 29) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Profound Castration Rate At Week 3 Day 1 (Day 15) | Castration rate defined as the cumulative probability of testosterone suppression to < 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 3 Day 1 (Day 15) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Follicle-stimulating Hormone (FSH) Level | To evaluate the effect of relugolix and leuprolide acetate on FSH suppression. | All randomized participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | IU/L | Week 25 Day 1 (Day 169) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PSA Response Rate At Week 3 Day 1 | PSA response defined as > 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 3 Day 1 (Day 15) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PSA Response Rate At Week 5 Day 1 | PSA response defined as > 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 5 Day 1 (Day 29) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Testosterone Recovery Rate | The cumulative probability of testosterone recovery back to > 280 ng/dL (lower limit of the normal range), back to ≥ 50 ng/dL (definition of castration), and back to > 280 ng/dL or baseline at 90 days after drug discontinuation was assessed. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. | All randomized participants who received at least 1 dose of study drug and were followed in the testosterone recovery phase. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 90 follow-up |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sustained Profound Castration Rate From Week 5 Day 1 Through Week 49 Day 1 | Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to < 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 5 Day 1 (Day 29) through Week 49 Day 1 (Day 337) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Profound Castration Rate At Week 1 Day 4 (Day 4) | Castration rate defined as the cumulative probability of testosterone suppression to < 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 1 Day 4 (Day 4) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sustained Profound Castration Rate From Week 25 Day 1 Through Week 49 Day 1 | Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to < 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants. | All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 25 Day 1 (Day 169) through Week 49 Day 1 (Day 337) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Undetectable PSA Rate | Defined as the proportion of participants with PSA concentration < 0.02 ng/milliliter (mL).The rate was estimated by the Kaplan-Meier method and reported as percentage of participants. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 25 Day 1 (Day 169) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate Of PSA Progression-free Survival | PSA progression was defined as the first increase in PSA of 25% or greater and 2 ng/mL or greater above the nadir with confirmation by a second consecutive PSA measurement at least 3 weeks later. For participants without declining PSA from baseline, a PSA increase of ≥ 25% and ≥ 2 ng/mL from baseline beyond 12 weeks was considered PSA progression. The rate of progression-free survival was estimated using the Kaplan-Meier method and reported as percentage of participants. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 49 Day 1 (Day 337) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline In Quality Of Life (QoL) Total Score As Assessed By The Global Health Domain Of The European Organisation Of Research And Treatment Of Cancer (EORTC)-Quality Of Life Questionnaire (QLQ)-C30 | The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. The global health and quality of life domain is presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems). | All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 49 Day 1 (Day 337) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline In QoL Total Score For Remaining Domain Scores As Assessed By The EORTC-QLQ-C30 | The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. All domains except for the global health and quality are presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems). | All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 49 Day 1 (Day 337) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline In QoL Total Score As Assessed By The EORTC-QLQ-PR25 Sexual Activity And Functioning And Hormonal-Treatment-Related Symptom Subdomains | Subscales for assessment of hormonal treatment-related symptoms (6 items) and sexual activity and function (6 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. 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. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems). | All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 49 Day 1 (Day 337) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline In QoL Total Score For Urinary And Bowel Symptoms Domains As Assessed By The EORTC-QLQ-PR25 | Subscale assessments of urinary symptoms (9 items) and bowel symptoms (4 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. 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. A decrease in symptom scores indicates improvement (lower level of symptoms/problems). | All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 49 Day 1 (Day 337) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline In QoL Total Score As Assessed By The European Quality Of Life 5-Dimension 5-Level Questionnaire (EuroQoL EQ-5D-5L) | The EuroQoL EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems (1 as numerical score), slight problems (2 as numerical score), moderate problems (3 as numerical score), severe problems (4 as numerical score), and extreme problems (5 as numerical score). The total score ranges from 0 to 100. A decrease in score indicates improvement. | All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 49 Day 1 (Day 337) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline In Serum Concentrations Of Luteinizing Hormone | Blood samples were collected from participants for hormonal measurements. | All randomized participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Percent change | Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline In Serum Concentrations Of FSH | Blood samples were collected from participants for hormonal measurements. | All randomized participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | percent change | Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline In Serum Concentrations Of Dihydrotestosterone | Blood samples were collected from participants for hormonal measurements. | All randomized participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | percent change | Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline In Serum Concentrations Of Sex Hormone-Binding Globulin | Blood samples were collected from participants for hormonal measurements. | All randomized participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | percent change | Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Plasma Concentration (Cmax) Of Relugolix | The Cmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose pharmacokinetics (PK) was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks. | A subset of Japanese participants enrolled in study were included in the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under The Concentration-Time Curve (AUC0-τ) Of Relugolix | The AUC0-τ of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks. | A subset of Japanese participants enrolled in study were included in the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng⸳hr/mL | Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time To Maximum Observed Plasma Concentration (Tmax) Of Relugolix | The Tmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks. | A subset of Japanese participants enrolled in study were included in the PK analysis. | Posted | Median | Full Range | hours | Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Who Experienced Major Adverse Cardiovascular Events (MACE) | MACE were defined as nonfatal myocardial infarction, nonfatal stroke, and death from any cause. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337) |
|
|
Day 1 (after dosing) through up to 52 weeks
All randomized participants who received at least 1 dose of study drug in the primary analysis part of the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Relugolix | Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1. | 7 | 622 | 76 | 622 | 493 | 622 |
| EG001 | Leuprolide Acetate | Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, and Taiwan), every 3 months by subcutaneous injection. | 9 | 308 | 47 | 308 | 239 | 308 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 22.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | 22.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | 22.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | 22.0 | Systematic Assessment |
| |
| Hypercalcaemia of malignancy | Endocrine disorders | 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 22.0 | Systematic Assessment |
| |
| Abdominal incarcerated hernia | Gastrointestinal disorders | 22.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | 22.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 22.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | 22.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 22.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 22.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 22.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | 22.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | 22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 22.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | 22.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | 22.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 22.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Pulmonary contusion | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Brachial plexus injury | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Cystitis radiation | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Shunt aneurysm | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Subcutaneous haematoma | Injury, poisoning and procedural complications | 22.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | 22.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | 22.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | 22.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 22.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 22.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 22.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | 22.0 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | 22.0 | Systematic Assessment |
| |
| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | 22.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 22.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 22.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | 22.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | 22.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Malignant melanoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Schwannoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Transitional cell cancer of the renal pelvis and ureter | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | 22.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Bladder obstruction | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Bladder neck obstruction | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Bladder outlet obstruction | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Lower urinary tract symptoms | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Urinary bladder polyp | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | 22.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 22.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 22.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 22.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 22.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 22.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 22.0 | Systematic Assessment |
| |
| Homicide | Social circumstances | 22.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | 22.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | 22.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Weight increased | Investigations | 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 22.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | 22.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 22.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 22.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials at Myovant | Myovant Sciences GmbH | 650-278-8743 | ClinicalTrials@Myovant.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2019 | Nov 27, 2020 | SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C561634 | relugolix |
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of superiority was conducted. | t-test, 2 sided | Two-sided type I error of 0.05. | < 0.0001 | Superiority | If non-inferiority was demonstrated, superiority could be claimed if the lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups also excluded 0%. The p value was calculated post hoc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|