| ID | Type | Description | Link |
|---|---|---|---|
| COU-AA-003 | |||
| COU-AA-003EXT | |||
| NCT01798615 | Other Identifier | ClinicalTrials.gov Identifier |
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The purpose of this study is to assess the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer (a disease in which cells in the prostate gland [a gland in the male reproductive system found below the bladder and in front of the rectum] become abnormal and start to grow uncontrollably, forming tumors) who have failed taxane (docetaxel)-based chemotherapy.
This is an open-label (all people know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with cancer who have failed taxane (docetaxel)-based chemotherapy. Abiraterone acetate 1000 milligram (mg) tablet or capsule will be administered orally (by mouth), once daily after an overnight fast until disease progression, lack of disease response after six 28-day cycles of treatment, or when unacceptable toxicity is encountered. Participants will be treated for up to 12 cycles. All participants will receive a concurrent low-dose glucocorticoid (such as prednisone 5 mg tablet twice daily/prednisolone 0.5 mg tablet once daily). Treatment will be continued in responding participants until death, or disease progression, or end of the study (which is Week 148). Efficacy will primarily be assessed through prostate specific antigen response according to Prostate Specific Antigen Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study. Participants who have completed 12 cycles of abiraterone acetate treatment, and continue to receive clinical benefit from such treatment, will be eligible to enter the extension study. Participants who enter the extension study will continue taking abiraterone acetate at the dose they were receiving at the end of the main study together with low-dose glucocorticoid. Efficacy and safety will be monitored throughout the extension study. Study treatment will end when the patient dies, is lost to follow-up, withdraws informed consent, experiences sustained side-effects, has disease progression, or the sponsor discontinues the extension study. After the end of study visit is completed for the extension study, participants will be followed every 12 weeks for survival for up to 3 years following entry into the extension study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone acetate | Experimental | Abiraterone acetate 1000 milligram (mg) tablet or capsule will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone acetate | Drug | Abiraterone acetate 1000 milligram (mg) capsule or tablet will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12 | The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response | The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later. | Baseline up to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cougar Biotechnology, Inc. Clinical Trial | Cougar Biotechnology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21802835 | Derived | Danila DC, Anand A, Sung CC, Heller G, Leversha MA, Cao L, Lilja H, Molina A, Sawyers CL, Fleisher M, Scher HI. TMPRSS2-ERG status in circulating tumor cells as a predictive biomarker of sensitivity in castration-resistant prostate cancer patients treated with abiraterone acetate. Eur Urol. 2011 Nov;60(5):897-904. doi: 10.1016/j.eururo.2011.07.011. Epub 2011 Jul 14. |
| Label | URL |
|---|---|
| NATIONAL CANCER INSTITUTE | View source |
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The 5 participants in the Extension Study received treatment until they experienced progressive disease.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abiraterone Acetate (Main Study) | Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Study |
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| Glucocorticoid | Drug | Prednisone/prednisolone 5 mg tablet orally twice daily/dexamethasone 0.5 mg tablet orally once daily continuously in 28-day cycle up to disease progression, death, or end of study. |
|
| Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) | The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD. | Baseline until first documented disease progression or end of study visit (Week 148; assessed on Day 1 of Cycle 4, 7, 10, and thereafter Day 1 of each cycle) |
| Time to PSA Progression | The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement. | Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle) |
| Duration of PSA Response | Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement. | Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle) |
| Progression Free Survival Time | Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Baseline until first documented disease progression or death or up to end of study (Week 148; assessed on Day 1 of each cycle) |
| Overall Survival | Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death. | Baseline until death, or end of study (Week 148) |
| Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148) | The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair >50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead. | Baseline until first documented disease progression or up to end of study (Week 148; assessed on Day 1 of each cycle) |
| New York |
| New York |
| United States |
| Sutton | United Kingdom |
| PROSTATE CANCER | View source |
| Arbitarone Acetate (Extension) |
Participants who received abiraterone acetate 1000 milligram (mg) capsule or tablet orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily in Main study, continued the same treatment until disease progression, death, or end of study (Week 148). |
| COMPLETED |
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| NOT COMPLETED |
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| Between Main Study and Extension |
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| Extension |
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| ID | Title | Description |
|---|---|---|
| BG000 | Abiraterone Acetate | Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily. |
| 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 |
|
| 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 | Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12 | The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later. | The Intent-to-treat (ITT) population included all the participants who were enrolled into the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 12 |
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| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response | The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later. | The Intent-to-treat (ITT) population included all the participants who were enrolled into the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) | The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD. | The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until first documented disease progression or end of study visit (Week 148; assessed on Day 1 of Cycle 4, 7, 10, and thereafter Day 1 of each cycle) |
|
| ||||||||||||||||||||||||||
| Secondary | Time to PSA Progression | The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement. | The ITT population included all the participants who were enrolled into the study. | Posted | Median | 95% Confidence Interval | days | Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle) |
|
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| Secondary | Duration of PSA Response | Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement. | The ITT population included all the participants who were enrolled into the study. | Posted | Median | 95% Confidence Interval | days | Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival Time | Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline. | Posted | Median | 95% Confidence Interval | days | Baseline until first documented disease progression or death or up to end of study (Week 148; assessed on Day 1 of each cycle) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death. | The ITT population included all the participants who were enrolled into the study. | Posted | Median | 95% Confidence Interval | days | Baseline until death, or end of study (Week 148) |
|
| ||||||||||||||||||||||||||
| Secondary | Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148) | The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair >50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead. | The ITT population included all the participants who were enrolled into the study. | Posted | Number | participants | Baseline until first documented disease progression or up to end of study (Week 148; assessed on Day 1 of each cycle) |
|
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From the first dose of study medication until 30 days after the last dose of study medication
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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 | Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily. | 27 | 47 | 46 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Disease progression | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pitting oedema | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
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| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
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| Transaminases increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Fluid retention | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Spinal cord compression | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Blood albumin decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Blood creatine increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Blood sodium increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director | Clinical Research, Janssen R&D, 10990 Wilshire Blvd, Suite 1200, Los Angeles, CA 90024. | 310-943-8040 | 2917 |
| 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 |
|---|---|
| D000069501 | Abiraterone Acetate |
| D005938 | Glucocorticoids |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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