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| ID | Type | Description | Link |
|---|---|---|---|
| 56021927PCR4007 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to compare the improvement in time to prostate specific antigen (PSA) progression (TTPP, as defined by Prostate Cancer Working Group 2 [PCWG2]) of apalutamide versus placebo in Chinese participants with high-risk non-metastatic castration resistant prostate cancer (NM-CRPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apalutamide 240 milligram (mg) plus ADT | Experimental | Participants will receive apalutamide 240 mg orally daily from Day 1 of Cycle 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study along with androgen-deprivation therapy (ADT). Each treatment cycle will consist of 28 days. |
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| Placebo plus ADT | Placebo Comparator | Participants will receive matching placebo daily along with ADT from Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Participants who do not have distant metastasis will switch to treatment with apalutamide after completion of 5 cycles of placebo treatment. Participants who have prostate-specific antigen (PSA) progression prior to completion of 5 cycles of study treatment, will cross over to apalutamide at the time of PSA progression. Each treatment cycle will consist of 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apalutamide | Drug | Apalutamide 240 mg (4*60 mg tablets) will be administrated orally once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Prostate Specific Antigen (PSA) Progression (TTPP) Based on Prostate Cancer Working Group 2 (PCWG2) Criteria | Time to prostate specific antigen progression (TTPP) was defined as the time from randomization to the first date of documented PSA progression based on PCWG2 criteria. PCWG2 was defined as the PSA progression as 1) the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) or more from the Nadir was documented, which was confirmed by a second value obtained 3 or more weeks later. 2) Where no decline from baseline was documented as a 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 week of treatment. Kaplan-Meier method was used for the analysis. | From randomization until first documented PSA progression (up to 3 years 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Up to 6 years 4 months | |
| Number of Participants With Grade 3 or Higher Abnormalities in Laboratory Values | Up to 6 years 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | 100021 | China | |||
| Peking University First Hospital |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Results are currently reported till primary completion date (01 Jun 2023). Post completing end of treatment (EoT, 30 days after last dose of study treatment) visit, participants entered post-treatment followup phase and remained in study until death, recording of development of symptomatic progression, initiation of any new systemic anticancer therapies, withdrawal of consent or study termination. Follow-up phase is still ongoing and thus remaining results will be posted upon study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Plus Androgen-deprivation Therapy (ADT) | Participants received placebo matching to apalutamide tablets orally once daily along with ADT of Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days. Participants who did not have distant metastasis were switched to receive apalutamide + ADT from Cycle 6 Day 1 and those who had prostate-specific antigen (PSA) prior to completion of first 5 cycles crossed over to receive apalutamide + ADT at the time of PSA progression. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study by the sponsor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 20, 2022 | Mar 7, 2025 |
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| Placebo | Drug | Matching placebo will be administered orally. |
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| Androgen-deprivation Therapy (ADT) | Drug | Participants will continue to receive ADT with gonadotrophin-releasing hormone agonists (GnRHa) who have not been surgically castrated. |
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| Percentage of Participants Who Achieved Prostate Specific Antigen (PSA) Response (>=50% PSA Reduction) | Up to 6 years 4 months |
| Plasma Concentration of Apalutamide and Its Metabolite (N-desmethyl Apalutamide) | Presdose: Day 1 of Cycles 1, 2, 3, and 6; 2 hours postdose: Day 1 of Cycles 1 and 3 |
| Beijing |
| 100034 |
| China |
| Peking University People's Hospital | Beijing | 100044 | China |
| Beijing Friendship Hospital | Beijing | 100050 | China |
| Peking University Third Hospital | Beijing | 100191 | China |
| Beijing Hospital | Beijing | 100730 | China |
| Hunan Cancer hospital | Changsha | 410013 | China |
| Sichuan Provincial Peoples Hospital | Chengdu | 610072 | China |
| Chongqing University Cancer Hospital | Chongqing | 400030 | China |
| Fujian Medical University Union Hospital | Fuzhou | 350001 | China |
| Sun Yat-Sen Memorial Hospital Sun Yat-sen University | Guangzhou | 510120 | China |
| Guangzhou First Municipal People's Hospital | Guangzhou | 510180 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | 310000 | China |
| The First Affiliated Hospital Zhejiang University College of Medicine | Hangzhou | 310003 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Nanjing Drum Tower Hospital | Nanjing | 210008 | China |
| The First Affiliated Hospital of Ningbo University | Ningbo | 315010 | China |
| Cancer Hospital, FuDan University | Shanghai | 200032 | China |
| Shanghai Zhongshan Hospital | Shanghai | 200032 | China |
| Huashan Hospital Fudan University | Shanghai | 200040 | China |
| Renji Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | 200240 | China |
| The Fifth People's Hospital of Shanghai, Fudan University | Shanghai | 200240 | China |
| Huadong Hospital Affiliated to Fudan University | Shanghai | 200400 | China |
| First Affiliated Hospital SooChow University | Suzhou | 215006 | China |
| TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology | Wuhan | 430030 | China |
| Wuxi People s Hospital | Wuxi | 214023 | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | 710061 | China |
| FG001 | Apalutamide 240 mg Plus ADT | Participants received apalutamide 240 milligrams (mg) tablets (4 tablets of 60 mg) orally once daily along with ADT from Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days. |
| Crossed-over to Apalutamide |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Plus Androgen-deprivation Therapy (ADT) | Participants received placebo matching to apalutamide tablets orally once daily along with ADT of Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days. Participants who did not have distant metastasis were switched to receive apalutamide + ADT from Cycle 6 Day 1 and those who had prostate-specific antigen (PSA) prior to completion of first 5 cycles crossed over to receive apalutamide + ADT at the time of PSA progression. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study by the sponsor. |
| BG001 | Apalutamide 240 mg Plus ADT | Participants received apalutamide 240 milligrams (mg) tablets (4 tablets of 60 mg) orally once daily along with ADT from Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Time to Prostate Specific Antigen (PSA) Progression (TTPP) Based on Prostate Cancer Working Group 2 (PCWG2) Criteria | Time to prostate specific antigen progression (TTPP) was defined as the time from randomization to the first date of documented PSA progression based on PCWG2 criteria. PCWG2 was defined as the PSA progression as 1) the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) or more from the Nadir was documented, which was confirmed by a second value obtained 3 or more weeks later. 2) Where no decline from baseline was documented as a 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 week of treatment. Kaplan-Meier method was used for the analysis. | The Intent-to-Treat (ITT) analysis set included all randomized participants and were classified according to their assigned treatment group, regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | Months | From randomization until first documented PSA progression (up to 3 years 3 months) |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Not Posted | Jun 2027 | Up to 6 years 4 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3 or Higher Abnormalities in Laboratory Values | Not Posted | Jun 2027 | Up to 6 years 4 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Prostate Specific Antigen (PSA) Response (>=50% PSA Reduction) | Not Posted | Jun 2027 | Up to 6 years 4 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Apalutamide and Its Metabolite (N-desmethyl Apalutamide) | Not Posted | Jun 2027 | Presdose: Day 1 of Cycles 1, 2, 3, and 6; 2 hours postdose: Day 1 of Cycles 1 and 3 | Participants |
Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Plus Androgen-deprivation Therapy (ADT) | Participants received placebo matching to apalutamide tablets orally once daily along with ADT of Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days. Participants who did not have distant metastasis were switched to receive apalutamide + ADT from Cycle 6 Day 1 and those who had prostate-specific antigen (PSA) prior to completion of first 5 cycles crossed over to receive apalutamide + ADT at the time of PSA progression. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study by the sponsor. | 1 | 25 | 4 | 25 | 11 | 25 |
| EG001 | Apalutamide 240 mg Plus ADT | Participants received apalutamide 240 milligrams (mg) tablets (4 tablets of 60 mg) orally once daily along with ADT from Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days. | 4 | 50 | 20 | 50 | 47 | 50 |
| EG002 | Placebo + ADT to Apalutamide + ADT | In placebo arm, participants who did not have distant metastasis after completion of 5 cycles of placebo plus ADT treatment and participants who had PSA progression prior to completion of 5 cycles of study treatment were crossed over to apalutamide 240 mg + ADT treatment and were treated until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. | 0 | 22 | 5 | 22 | 21 | 22 |
| EG003 | All Participants: Apalutamide 240 mg Plus ADT | All participants who received apalutamide 240 mg in arm 'Apalutamide 240 mg Plus ADT' and arm 'Placebo + ADT to Apalutamide + ADT". | 4 | 72 | 25 | 72 | 68 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Atrioventricular Block Complete | Cardiac disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Mixed Deafness | Ear and labyrinth disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Gastritis Erosive | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Pancreatitis Acute | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
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| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
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| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
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| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
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| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
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| Thoracic Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
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| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
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| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Osteoporotic Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Gastrointestinal Stromal Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Non-systematic Assessment |
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| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Non-systematic Assessment |
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| Small Cell Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Non-systematic Assessment |
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| Cerebral Infarction | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Hypoxic-Ischaemic Encephalopathy | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Suicide Attempt | Psychiatric disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Calculus Bladder | Renal and urinary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Angiolymphoid Hyperplasia with Eosinophilia | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Dermatitis Exfoliative Generalised | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Suspected Covid-19 | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
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| Rib Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Blood Thyroid Stimulating Hormone Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Low Density Lipoprotein Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Weight Decreased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2023 | Jan 23, 2025 | SAP_001.pdf |
| 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 |
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| ID | Term |
|---|---|
| C572045 | apalutamide |
| D000726 | Androgen Antagonists |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|