Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002271-17 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medivation LLC, a wholly owned subsidiary of Pfizer Inc. | INDUSTRY |
Not provided
Not provided
Not provided
The objective of this study was to evaluate the efficacy and safety of enzalutamide treatment in patients with progressive metastatic castration-resistant prostate cancer previously treated with abiraterone acetate.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide | Experimental | Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | Participants received 160 mg of enzalutamide (soft capsules) orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Progression-free Survival (rPFS) | Radiographic PFS, was defined as the time from first dose to the first objective evidence of radiographic disease progression or death from any cause, whichever occurred first. For patients with no documented progression event, it was censored on the date of the last disease assessment performed prior to the analysis data cut-off point. Radiographic progression (RP) for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria. RP for bone disease was determined according to the consensus guidelines of a modification of the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) guidelines. The 50th percentile of Kaplan-Meier (KM) estimates was used as the estimate of the rPFS median. A 2-sided 95% Confidence Interval (CI) was provided for this estimate using the Brookmeyer & Crowley (BC) method. | From the first dose of study drug administration up to treatment discontinuation or the data cut-off date of 08 May 2016, whichever occurred first; the median duration of treatment was 5.7 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from first dose to death from any cause. All events of death were included. If patients discontinued study drug before the analysis data cut-off point, only OS status was assessed every 12 weeks until the data cut-off point date or until death, whichever occurred first. For patients who were alive at the time of the analysis data cut-off point, the OS time was censored on the last date the patient was known to be alive. Death from any cause was included, regardless of whether the event occurred while the patient was still taking study drug or after the patient discontinued study drug. OS median was estimated using the KM method. A 2-sided 95% CI was provided for this estimate using the BC method. |
Not provided
Inclusion Criteria:
Subject has histologically confirmed adenocarcinoma of the prostate without neuro-endocrine differentiation or small cell features.
Subject has metastatic disease documented by bone scan or by soft tissue disease observed by Computed Tomography/Magnetic Resonance Imaging (CT/MRI) at screening, or within ≤30 days prior to Day 1.
In the setting of castrate levels of testosterone ≤1.7 nmol/L (or ≤50 ng/dL), subject has progressive disease at study entry defined as PSA rise determined by a minimum of 2 rising PSA levels with an interval of ≥ 1 week between each assessment. The PSA value at the screening visit should be ≥ 2 ng/mL WITH or WITHOUT:
Subject must have received a minimum of 24 weeks of treatment with abiraterone acetate within its approved label indication and has discontinued use at least 4 weeks prior to start of study drug at Day 1.
If the subject has received previous treatment with chemotherapy for prostate cancer, this must be limited to no more than one prior line of docetaxel, and must have been used prior to abiraterone acetate therapy.
Subject receives and will continue to receive ongoing androgen deprivation with Luteinizing-hormone-releasing hormone (LHRH) analogue therapy throughout the course of the study or has had a bilateral orchiectomy.
Subject is asymptomatic or mildly symptomatic from prostate cancer:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site BE32001 | Brussels | Flemish Brabant | 1200 | Belgium | ||
| Site BE32004 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28844372 | Derived | de Bono JS, Chowdhury S, Feyerabend S, Elliott T, Grande E, Melhem-Bertrandt A, Baron B, Hirmand M, Werbrouck P, Fizazi K. Antitumour Activity and Safety of Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer Previously Treated with Abiraterone Acetate Plus Prednisone for >/=24 weeks in Europe. Eur Urol. 2018 Jul;74(1):37-45. doi: 10.1016/j.eururo.2017.07.035. Epub 2017 Aug 23. |
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website | View source |
Not provided
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
A total of 272 participants were screened for enrollment & signed an informed consent form, & 57 of those screen failed. The primary reason for screening failure was not fulfilling inclusion/exclusion criteria (52 participants, 19.1%), followed by withdrawal (5 participants, 1.8%).
Male participants with progressive metastatic castration-resistant prostate cancer were enrolled in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enzalutamide | Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From the first dose of study drug administration up to the data cut-off date of 08 May 2016; up to 2 years. |
| Percentage of Participants With a Prostate-specific Antigen (PSA) Response | PSA response was defined as at least a 50% decrease from baseline in PSA, and was a binary variable for achieving this criteria (or not) based on the lowest PSA value observed postbaseline. Participants with no postbaseline PSA value were regarded as non-responders. 95% CI for PSA response rate was computed using the Clopper-Pearson method based on the exact binomial distribution. | From the first dose of study drug administration up to the data cut-off date for end-of-study completion 29 Sep 2017; the median duration of treatment was 5.7 months. |
| Time to PSA Progression | The time to PSA progression was calculated as the time interval from the date of first dose to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 μg/L (i.e., 2 ng/mL or more) above the nadir or above the baseline value for patients who did not have a decline in PSA postbaseline values, and which was confirmed by a second consecutive value obtained at least 3 or more weeks later (i.e., a confirmed rising trend) (PCWG2 criteria). The 50th percentile of KM estimates was used as the estimate of the time to PSA progression median. A 2-sided 95% CI was provided for this estimate using the BC method. | From the first dose of study drug administration up to the data cut-off date of 08 May 2016; the median duration of treatment was 5.7 months. |
| Number of Participants With Adverse Events (AEs) | A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03). | From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months. |
| Ghent |
| 9000 |
| Belgium |
| Site BE32007 | Hasselt | 3500 | Belgium |
| Site BE32003 | Kortrijk | 8500 | Belgium |
| Site BE32002 | Liège | 4000 | Belgium |
| Site FR33015 | Angers | 49055 | France |
| Site FR33009 | Caen | 14076 | France |
| Site FR33010 | Créteil | 94010 | France |
| Site FR33014 | Le Mans | 72015 | France |
| Site FR33013 | Lyon | 69003 | France |
| Site FR33003 | Marseille | 13273 | France |
| Site FR33008 | Nantes Saint Herblain Cedex | 44805 | France |
| Site FR33002 | Nîmes | 30029 | France |
| Site FR33011 | Paris | 75005 | France |
| Site FR33001 | Paris | 75908 | France |
| Site FR33007 | Rennes | 35042 | France |
| Site FR33005 | Suresnes | 92151 | France |
| Site FR33012 | Villejiuf | 94805 | France |
| Site DE49005 | Nürtingen | Baden-Wurttemberg | 72622 | Germany |
| Site DE49017 | Duisburg | North Rhine-Westphalia | 47179 | Germany |
| Site DE49015 | Bergisch Gladbach | Northwest | 51427 | Germany |
| Site DE49014 | Berlin | 10247 | Germany |
| Site DE49003 | Berlin | 12200 | Germany |
| Site DE49009 | Bonn | 53111 | Germany |
| Site DE49010 | Dresden | 01307 | Germany |
| Site DE49016 | Düsseldorf | 40225 | Germany |
| Site DE49004 | Göttingen | 37075 | Germany |
| Site DE49001 | Hamburg | 22081 | Germany |
| Site DE49008 | Hamburg | 22399 | Germany |
| Site DE49007 | Hanover | 30625 | Germany |
| Site DE49002 | Heidelberg | 69120 | Germany |
| Site DE49012 | Münster | 48149 | Germany |
| Site DE49006 | Tübingen | 72076 | Germany |
| Site ES34004 | Santiago de Compostela | A Coruna | 15706 | Spain |
| Site ES34009 | Badalona | 8916 | Spain |
| Site ES34011 | Barcelona | 08003 | Spain |
| Site ES34006 | Barcelona | 08025 | Spain |
| Site ES34008 | Barcelona | 08035 | Spain |
| Site ES34001 | Madrid | 28007 | Spain |
| Site ES34003 | Madrid | 28034 | Spain |
| Site ES34002 | Madrid | 28040 | Spain |
| Site ES34010 | Madrid | 28044 | Spain |
| Site GB44001 | Sutton | Surrey | SM2 5PT | United Kingdom |
| Site GB44004 | Birmingham | B15 2TT | United Kingdom |
| Site GB44009 | Brighton | BN2 5BE | United Kingdom |
| Site GB44002 | Glasgow | G12 0YN | United Kingdom |
| Site GB44007 | London | SE1 9RT | United Kingdom |
| Site GB44003 | Northwood, Middlesex | HA6 2RN | United Kingdom |
| Site GB44010 | Plymouth | PL6 8DH | United Kingdom |
| Site GB44006 | Withington | M204BX | United Kingdom |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The analysis population for all baseline measures consisted of all participants who were enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enzalutamide | Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria. |
| 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 | This was an all male study. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Race/Ethnicity, Customized | Race was not collected in France, because of country regulations. Ethnicity was not collected for this study. | Number | 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 | Radiographic Progression-free Survival (rPFS) | Radiographic PFS, was defined as the time from first dose to the first objective evidence of radiographic disease progression or death from any cause, whichever occurred first. For patients with no documented progression event, it was censored on the date of the last disease assessment performed prior to the analysis data cut-off point. Radiographic progression (RP) for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria. RP for bone disease was determined according to the consensus guidelines of a modification of the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) guidelines. The 50th percentile of Kaplan-Meier (KM) estimates was used as the estimate of the rPFS median. A 2-sided 95% Confidence Interval (CI) was provided for this estimate using the Brookmeyer & Crowley (BC) method. | The analysis population consisted of the safety analysis set (SAF) which consisted of all participants who took at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | Months | From the first dose of study drug administration up to treatment discontinuation or the data cut-off date of 08 May 2016, whichever occurred first; the median duration of treatment was 5.7 months. |
|
|
| |||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from first dose to death from any cause. All events of death were included. If patients discontinued study drug before the analysis data cut-off point, only OS status was assessed every 12 weeks until the data cut-off point date or until death, whichever occurred first. For patients who were alive at the time of the analysis data cut-off point, the OS time was censored on the last date the patient was known to be alive. Death from any cause was included, regardless of whether the event occurred while the patient was still taking study drug or after the patient discontinued study drug. OS median was estimated using the KM method. A 2-sided 95% CI was provided for this estimate using the BC method. | The analysis population consisted of the SAF. | Posted | Median | 95% Confidence Interval | Months | From the first dose of study drug administration up to the data cut-off date of 08 May 2016; up to 2 years. |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Prostate-specific Antigen (PSA) Response | PSA response was defined as at least a 50% decrease from baseline in PSA, and was a binary variable for achieving this criteria (or not) based on the lowest PSA value observed postbaseline. Participants with no postbaseline PSA value were regarded as non-responders. 95% CI for PSA response rate was computed using the Clopper-Pearson method based on the exact binomial distribution. | The analysis population consisted of the SAF. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the first dose of study drug administration up to the data cut-off date for end-of-study completion 29 Sep 2017; the median duration of treatment was 5.7 months. |
|
| ||||||||||||||||||||||||||
| Secondary | Time to PSA Progression | The time to PSA progression was calculated as the time interval from the date of first dose to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 μg/L (i.e., 2 ng/mL or more) above the nadir or above the baseline value for patients who did not have a decline in PSA postbaseline values, and which was confirmed by a second consecutive value obtained at least 3 or more weeks later (i.e., a confirmed rising trend) (PCWG2 criteria). The 50th percentile of KM estimates was used as the estimate of the time to PSA progression median. A 2-sided 95% CI was provided for this estimate using the BC method. | The analysis population consisted of the SAF. | Posted | Median | 95% Confidence Interval | Months | From the first dose of study drug administration up to the data cut-off date of 08 May 2016; the median duration of treatment was 5.7 months. |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03). | The analysis population consisted of the SAF. | Posted | Number | Participants | From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months. |
|
|
From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enzalutamide Total | Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria. | 73 | 214 | 82 | 214 | 182 | 214 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Device occlusion | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Dental fistula | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Procedural intestinal perforation | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Monoclonal immunoglobulin present | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Oral neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Ureteric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nerve root compression | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vertebral artery thrombosis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bladder tamponade | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Epiglottic mass | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ileostomy closure | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Shoulder arthroplasty | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
For participants on treatment after the primary analysis data cut-off point (08 May 2016), only AEs were assessed every 24 weeks until treatment discontinuation or death, this was not required for those that enrolled into 9785-CL-0123 (NCT02960022).
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director | Astellas Pharma Europe B.V. | +31 (0) 71 5455 050 | Astellas.resultsdisclosure@astellas.com |
| ID | Term |
|---|---|
| C540278 | enzalutamide |
Not provided
Not provided
Not provided
| Other |
|
| Not Reported |
|
|
|
|
|