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| ID | Type | Description | Link |
|---|---|---|---|
| 212082PCR2036 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the efficacy, based on prostate-specific antigen (PSA) progression, of abiraterone acetate in participants with metastatic (spread of cancer cells from one part of the body to another) castration (any action, surgical, chemical, or otherwise, by which a male loses the functions of the testes) resistant prostate cancer (cancer in prostrate; a gland that makes fluid that aids movement of sperm) (mCRPC), chemo-naive (treatment of cancer is not done using drugs), who received a prior diethylstilbestrol therapy (DES).
This is a Phase 2, multinational (when medical research study takes place in more than one country), multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), and single arm study to determine benefits of abiraterone acetate and low-dose prednisone to androgen deprivation therapy (ADT) in mCRPC participants who failed to prior DES therapy. The study will consist of a Screening Phase of up to 28 days before enrollment; a PSA Evaluation Phase; and a Follow-up Phase of up to 24 months. Each cycle of abiraterone therapy will be of 28 days. Participants will receive 1000 milligram (mg) abiraterone acetate orally once daily plus prednisone 5 mg orally once daily plus stable regimen of ADT (luteinizing hormone-releasing hormone [LHRH] agonists) as per Investigator's discretion. Treatment will continue until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity. Efficacy will primarily be assessed by time to PSA progression. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone Acetate | Experimental | Participants will receive abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone acetate | Drug | Participants will receive abiraterone acetate 1000 mg (4*250 mg tablets) orally once daily until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Prostate-specific Antigen (PSA) Progression | Time to PSA progression was calculated from date of enrollment to the date of first documentation of PSA progression. As per Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, PSA progression was defined as greater than or equal to (>=) 25 percent (%) and >=2 nanogram/milliliter (ng/mL) after 12 weeks (in case of no decline in PSA from Baseline), or first PSA increase that is >=25% and >=2 ng/mL above the nadir, and which was confirmed by a second value 3 or more weeks later (in case of decline of PSA from Baseline). | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response | The PSA response according to Prostate Specific Antigen Working Group 3 criteria was defined as at least 50% decrease in PSA level from Baseline. | Week 12 to any time up to 2 years |
| Overall Survival |
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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 |
|---|---|---|---|---|---|---|
| Porto Alegre | Brazil | |||||
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A total of 46 participants were enrolled into the study and were treated with abiraterone acetate and prednisone. Out of 46 participants, 6 did not fulfill all eligibility criteria and included in the safety population. Thirty-five (35) participants completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abiraterone Acetate | Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2018 |
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|
| Prednisone | Drug | Participants will prednisone 5 mg orally once daily from Day 1 of Cycle 1 and continues until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity. |
|
| Androgen deprivation therapy (ADT) | Drug | Participants will remain on a stable regimen of ADT, that is, luteinizing hormone-releasing hormone (LHRH) agonists including leuprolide acetate and goserelin acetate as per Investigator's discretion. |
|
Overall survival was defined as the time from date of the first dose of abiraterone acetate to the date of death due to any cause. For participants who did not die until the time of analysis, survival time was censored at the time of last contact alive. |
| Up to 4 years |
| Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score | The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression was defined as an increase in score of 30% or greater from baseline without decrease in analgesic use. | Up to 2 years |
| Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Interference Score | The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain interference score is mean value for the 7 BPI-SF questions (questions inquiring about the extent of interference with activities by pain) where the extent is ranked from 0 (does not interfere) to 10 (completely interferes). Pain interference progression was defined as an increase in score of 50% or greater from baseline without decrease in analgesic use. | Up to 2 years |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant who will receive study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly. | Up to 4 years |
| Rio de Janeiro |
| Brazil |
| Santo André | Brazil |
| São Paulo | Brazil |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Abiraterone Acetate | Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity. |
| 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 |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | 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 | Time to Prostate-specific Antigen (PSA) Progression | Time to PSA progression was calculated from date of enrollment to the date of first documentation of PSA progression. As per Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, PSA progression was defined as greater than or equal to (>=) 25 percent (%) and >=2 nanogram/milliliter (ng/mL) after 12 weeks (in case of no decline in PSA from Baseline), or first PSA increase that is >=25% and >=2 ng/mL above the nadir, and which was confirmed by a second value 3 or more weeks later (in case of decline of PSA from Baseline). | The efficacy population included all eligible participants who received at least one dose of any study drug. | Posted | Median | 95% Confidence Interval | Months | Up to 2 years |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response | The PSA response according to Prostate Specific Antigen Working Group 3 criteria was defined as at least 50% decrease in PSA level from Baseline. | The efficacy population included all eligible participants who received at least one dose of any study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 to any time up to 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time from date of the first dose of abiraterone acetate to the date of death due to any cause. For participants who did not die until the time of analysis, survival time was censored at the time of last contact alive. | The efficacy population included all eligible participants who received at least one dose of any study drug. | Posted | Median | 95% Confidence Interval | Months | Up to 4 years |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score | The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression was defined as an increase in score of 30% or greater from baseline without decrease in analgesic use. | The efficacy population included all eligible participants who received at least one dose of any study drug and with at least 2 BPI-SF assessments after baseline. | Posted | Number | Percentage of participants | Up to 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Interference Score | The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain interference score is mean value for the 7 BPI-SF questions (questions inquiring about the extent of interference with activities by pain) where the extent is ranked from 0 (does not interfere) to 10 (completely interferes). Pain interference progression was defined as an increase in score of 50% or greater from baseline without decrease in analgesic use. | The efficacy population included all eligible participants who received at least one dose of any study drug and with at least 2 BPI-SF assessments after baseline. | Posted | Number | Percentage of participants | Up to 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant who will receive study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly. | The safety population included all participants who received at least 1 dose of any study drug. | Posted | Count of Participants | Participants | Up to 4 years |
|
|
Up to 4 years
Safety population included all participants who received at least 1 dose of any study drug.
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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 | Abiraterone Acetate | Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity. | 3 | 46 | 11 | 46 | 45 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Amaurosis | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gastrointestinal Obstruction | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Ulna Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Atrioventricular Block | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Bundle Branch Block Left | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Conjunctival Haemorrhage | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Ocular Hyperaemia | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abdominal Wall Haematoma | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Anal Incontinence | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Anorectal Discomfort | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Aphthous Ulcer | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Face Oedema | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Localised Oedema | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Strongyloidiasis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Eye Injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Sciatic Nerve Injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| ECG Electrically Inactive Area | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| International Normalised Ratio | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vitamin B12 Deficiency | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Osteonecrosis of Jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Motor Dysfunction | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lower Urinary Tract Symptoms | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Urethral Haemorrhage | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Urethral Pain | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Penile Burning Sensation | Reproductive system and breast disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nasal Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tracheal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hyperaemia | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Varicose Vein | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
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 in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regional Medical Affairs Director | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Jan 9, 2020 |
| Prot_SAP_000.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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| D000726 | Androgen Antagonists |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
| Other |
|
| White/Caucasian |
|
|
|
|
|
|
|
|