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| ID | Type | Description | Link |
|---|---|---|---|
| C3431002 | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
| Medivation LLC, a wholly owned subsidiary of Pfizer Inc. | INDUSTRY |
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The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDV3100 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDV3100 | Drug | 4 x 40 mg capsules, orally, once per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Required Study Drug Dose Reduction During Treatment Periods 1 and 2 | Percentage of participants that required dose reductions of Docetaxel and Enzalutamide treatment were reported in this outcome measure. Dose modifications (interruptions or dose reductions) were permitted for participants who had adverse events that were intolerable or could not be improved by other means. Dose reductions or delays were determined according to the prescribing information and at the discretion of the investigator. | Treatment Period 1 (Day 1) up to end of Treatment Period 2 (42 days) |
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) | AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Percentage of participants that discontinued study drug due to adverse events were reported in this outcome measure. | Treatment Period 1 (Day 1) up to end of study treatment (maximum 70 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Criteria:1)systolic blood pressure (SBP):a) absolute result(AR)>=180millimeters of mercury(mmHg) and increase from baseline(BL)greater than(>)40mmHg,b)less than(<)90mmHg and decrease from BL>30mmHg,c)most extreme post-BL result>=140mmHg,d)most extreme post-BL result>=180mmHg,e)most extreme result(MER)>=180mmHg and >=20mmHg change from BL,f)MER>=140mmHg and >=20mmHg change from BL;2)diastolic blood pressure(DBP):a)AR>105mmHg and increase from BL,b)AR<50mmHg and decrease from BL>20mmHg;c)most extreme post-BL result>=90mmHg,d)MER>=90mmHg and >=15mmHg change from BL,e)most extreme post-BL result>=105mmHg,f)MER>=105mmHg and>=15mmHg change from BL;3)heart rate:a)AR>120 beats per minute(bpm) and increase from BL>30bpm,b) AR<50 bpm and decrease from BL>20bpm.Only those categories in which at least 1 participant had clinically significant vital sign abnormality, were reported in this outcome measure.T1 = Timeframe for "Combination Therapy" and T2 = Time frame for "Post-Docetaxel Enzalutamide". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States | ||
| Memorial Sloan-Kettering Cancer Center |
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel 75 mg/m^2+ Enzalutamide 160 mg | Docetaxel 75 milligrams per square meter (mg/m^2) was administered as intravenous (IV) infusion for 1 hour on Day 1 of each treatment period (each treatment period was of 21 days). From Day 2 of treatment period 1, participants received a single oral dose of Enzalutamide (MDV3100) 160 milligrams (mg) (4 capsules of 40 mg each) once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone (5 mg) once daily on the days of Docetaxel administration then twice daily every day thereafter as long as Docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide continued to receive the combined therapy. Participants who discontinued Docetaxel were allowed to continue the treatment with Enzalutamide 160 mg once daily up to the end of study treatment (maximum of Month 70). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat (ITT) population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel 75 mg/m^2+ Enzalutamide 160 mg | Docetaxel 75 milligrams per square meter (mg/m^2) was administered as intravenous (IV) infusion for 1 hour on Day 1 of each treatment period (each treatment period was of 21 days). From Day 2 of treatment period 1, participants received a single oral dose of Enzalutamide (MDV3100) 160 milligrams (mg) (4 capsules of 40 mg each) once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone (5 mg) once daily on the days of Docetaxel administration then twice daily every day thereafter as long as Docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide continued to receive the combined therapy. Participants who discontinued Docetaxel were allowed to continue the treatment with Enzalutamide 160 mg once daily up to the end of study treatment (maximum of Month 70). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Who Required Study Drug Dose Reduction During Treatment Periods 1 and 2 | Percentage of participants that required dose reductions of Docetaxel and Enzalutamide treatment were reported in this outcome measure. Dose modifications (interruptions or dose reductions) were permitted for participants who had adverse events that were intolerable or could not be improved by other means. Dose reductions or delays were determined according to the prescribing information and at the discretion of the investigator. | Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel). | Posted | Number | percentage of participants | Treatment Period 1 (Day 1) up to end of Treatment Period 2 (42 days) |
|
Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide
An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
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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 | Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg | Docetaxel 75 mg/m^2 was administered as IV infusion for 1 hour on Day 1 in each treatment period (each treatment period was of 21 days). From Day 2 of treatment Period 1 participants received a single oral dose of Enzalutamide 160 mg once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone 5 mg once daily on the days of docetaxel administration then twice daily every day thereafter as long as docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide received the both. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
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| T1= Baseline (Day 1) up to a maximum of approximately Month 12; T2 = From Month 10.6 up to a maximum of approximately Month 71.5 |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiograms (ECG) | Clinically significant changes from baseline in ECG findings was based up on investigator's discretion. T1 = Timeframe for "Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg" and T2 = Time frame for "Post-Docetaxel Enzalutamide 160 mg". | T1= Baseline (Day 1) up to a maximum of approximately Month 12; T2 = From Month 10.6 up to a maximum of approximately Month 71.5 |
| Maximum Plasma Concentration (Cmax) of Docetaxel With and Without Enzalutamide Treatment | Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Docetaxel With and Without Enzalutamide Treatment | AUClast was observed using a linear mixed-effects model. | Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2 |
| Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of Docetaxel With and Without Enzalutamide Treatment | AUCinf was observed using a linear mixed-effects model. | Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2 |
| New York |
| New York |
| 10065 |
| United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Withdrawal by Subject |
|
| Death |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) | AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Percentage of participants that discontinued study drug due to adverse events were reported in this outcome measure. | Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel). | Posted | Number | percentage of participants | Treatment Period 1 (Day 1) up to end of study treatment (maximum 70 months) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Criteria:1)systolic blood pressure (SBP):a) absolute result(AR)>=180millimeters of mercury(mmHg) and increase from baseline(BL)greater than(>)40mmHg,b)less than(<)90mmHg and decrease from BL>30mmHg,c)most extreme post-BL result>=140mmHg,d)most extreme post-BL result>=180mmHg,e)most extreme result(MER)>=180mmHg and >=20mmHg change from BL,f)MER>=140mmHg and >=20mmHg change from BL;2)diastolic blood pressure(DBP):a)AR>105mmHg and increase from BL,b)AR<50mmHg and decrease from BL>20mmHg;c)most extreme post-BL result>=90mmHg,d)MER>=90mmHg and >=15mmHg change from BL,e)most extreme post-BL result>=105mmHg,f)MER>=105mmHg and>=15mmHg change from BL;3)heart rate:a)AR>120 beats per minute(bpm) and increase from BL>30bpm,b) AR<50 bpm and decrease from BL>20bpm.Only those categories in which at least 1 participant had clinically significant vital sign abnormality, were reported in this outcome measure.T1 = Timeframe for "Combination Therapy" and T2 = Time frame for "Post-Docetaxel Enzalutamide". | Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel). | Posted | Count of Participants | Participants | T1= Baseline (Day 1) up to a maximum of approximately Month 12; T2 = From Month 10.6 up to a maximum of approximately Month 71.5 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Electrocardiograms (ECG) | Clinically significant changes from baseline in ECG findings was based up on investigator's discretion. T1 = Timeframe for "Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg" and T2 = Time frame for "Post-Docetaxel Enzalutamide 160 mg". | Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel). | Posted | Count of Participants | Participants | T1= Baseline (Day 1) up to a maximum of approximately Month 12; T2 = From Month 10.6 up to a maximum of approximately Month 71.5 |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of Docetaxel With and Without Enzalutamide Treatment | Pharmacokinetic (PK) population included all enrolled participants who received at least 2 doses of Docetaxel (75 mg/m^2) and underwent PK sampling after both doses. Here, 'Number analyzed' signifies number of participants who were evaluable for the specified category. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2 |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Docetaxel With and Without Enzalutamide Treatment | AUClast was observed using a linear mixed-effects model. | PK population included all enrolled participants who received at least 2 doses of Docetaxel (75 mg/m^2) and underwent PK sampling after both doses. Here, 'Number analyzed' signifies number of participants who were evaluable for the specified category. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter | Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2 |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of Docetaxel With and Without Enzalutamide Treatment | AUCinf was observed using a linear mixed-effects model. | PK population included all enrolled participants who received at least 2 doses of Docetaxel (75 mg/m^2) and underwent PK sampling after both doses. Here, 'Number analyzed' signifies number of participants who were evaluable for the specified category. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter | Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2 |
|
|
|
| 8 |
| 22 |
| 21 |
| 22 |
| EG001 | Post-Docetaxel Enzalutamide 160 mg | Participants who had received the combination therapy of Docetaxel and Enzalutamide but discontinued the Docetaxel treatment and continued to receive a single oral dose of Enzalutamide 160 mg (4 capsule each of 40 mg) once daily up to the end of the study treatment (maximum of 70 months). | 7 | 21 | 18 | 21 |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 15 | Non-systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 15 | Non-systematic Assessment |
|
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 15 | Non-systematic Assessment |
|
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA 15 | Non-systematic Assessment |
|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 15 | Non-systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| DEATH | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| IMPAIRED HEALING | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 15 | Non-systematic Assessment |
|
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 15 | Non-systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA 15 | Non-systematic Assessment |
|
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 15 | Non-systematic Assessment |
|
| OBSTRUCTIVE UROPATHY | Renal and urinary disorders | MedDRA 15 | Non-systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 15 | Non-systematic Assessment |
|
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| ARTERIOSCLEROSIS | Vascular disorders | MedDRA 15 | Non-systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 15 | Non-systematic Assessment |
|
| Hepatic Failure | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15 | Non-systematic Assessment |
|
| CATARACT | Eye disorders | MedDRA 15 | Non-systematic Assessment |
|
| LACRIMATION INCREASED | Eye disorders | MedDRA 15 | Non-systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 15 | Non-systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| OEDEMA | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| PAIN | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| OSTEOMYELITIS | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| BLOOD PHOSPHORUS DECREASED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15 | Non-systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 15 | Non-systematic Assessment |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Non-systematic Assessment |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Non-systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| MUSCULOSKELETAL DISCOMFORT | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 15 | Non-systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 15 | Non-systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 15 | Non-systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 15 | Non-systematic Assessment |
|
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | MedDRA 15 | Non-systematic Assessment |
|
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 15 | Non-systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 15 | Non-systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 15 | Non-systematic Assessment |
|
| HAEMORRHAGE URINARY TRACT | Renal and urinary disorders | MedDRA 15 | Non-systematic Assessment |
|
| INCONTINENCE | Renal and urinary disorders | MedDRA 15 | Non-systematic Assessment |
|
| POLLAKIURIA | Renal and urinary disorders | MedDRA 15 | Non-systematic Assessment |
|
| URETHRAL PAIN | Renal and urinary disorders | MedDRA 15 | Non-systematic Assessment |
|
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA 15 | Non-systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA 15 | Non-systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 15 | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 15 | Non-systematic Assessment |
|
| INTERMITTENT CLAUDICATION | Vascular disorders | MedDRA 15 | Non-systematic Assessment |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15 | Non-systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 15 | Non-systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 15 | Non-systematic Assessment |
|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 15 | Non-systematic Assessment |
|
| DEAFNESS | Ear and labyrinth disorders | MedDRA 15 | Non-systematic Assessment |
|
| TINNITUS | Ear and labyrinth disorders | MedDRA 15 | Non-systematic Assessment |
|
| BLEPHAROSPASM | Eye disorders | MedDRA 15 | Non-systematic Assessment |
|
| DRY EYE | Eye disorders | MedDRA 15 | Non-systematic Assessment |
|
| EYE IRRITATION | Eye disorders | MedDRA 15 | Non-systematic Assessment |
|
| EYE PRURITUS | Eye disorders | MedDRA 15 | Non-systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| FAECES DISCOLOURED | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| GASTRIC HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| IMPAIRED GASTRIC EMPTYING | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| OESOPHAGEAL PAIN | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| OESOPHAGITIS | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| ORAL DISORDER | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| PARAESTHESIA ORAL | Gastrointestinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| CATHETER SITE ERYTHEMA | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| CHILLS | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| GAIT DISTURBANCE | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| GENERALISED OEDEMA | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| IMPAIRED HEALING | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| MEDICAL DEVICE PAIN | General disorders | MedDRA 15 | Non-systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 15 | Non-systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| FURUNCLE | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| HEPATOSPLENIC CANDIDIASIS | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| INFUSION SITE INFECTION | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| LOCALISED INFECTION | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| MUCOSAL INFECTION | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| ORAL INFECTION | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| SKIN INFECTION | Infections and infestations | MedDRA 15 | Non-systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 15 | Non-systematic Assessment |
|
| LACERATION | Injury, poisoning and procedural complications | MedDRA 15 | Non-systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 15 | Non-systematic Assessment |
|
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 15 | Non-systematic Assessment |
|
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA 15 | Non-systematic Assessment |
|
| VASCULAR ACCESS COMPLICATION | Injury, poisoning and procedural complications | MedDRA 15 | Non-systematic Assessment |
|
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA 15 | Non-systematic Assessment |
|
| BLOOD CALCIUM DECREASED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| BLOOD CHOLESTEROL INCREASED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| BLOOD GLUCOSE DECREASED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| BLOOD MAGNESIUM DECREASED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| BLOOD POTASSIUM INCREASED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| BLOOD URIC ACID INCREASED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 15 | Non-systematic Assessment |
|
| ACIDOSIS | Metabolism and nutrition disorders | MedDRA 15 | Non-systematic Assessment |
|
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA 15 | Non-systematic Assessment |
|
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Non-systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Non-systematic Assessment |
|
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA 15 | Non-systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| OSTEONECROSIS OF JAW | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| PAIN IN JAW | Musculoskeletal and connective tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| AMNESIA | Nervous system disorders | MedDRA 15 | Non-systematic Assessment |
|
| APHASIA | Nervous system disorders | MedDRA 15 | Non-systematic Assessment |
|
| BALANCE DISORDER | Nervous system disorders | MedDRA 15 | Non-systematic Assessment |
|
| COGNITIVE DISORDER | Nervous system disorders | MedDRA 15 | Non-systematic Assessment |
|
| HYPOKINESIA | Nervous system disorders | MedDRA 15 | Non-systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 15 | Non-systematic Assessment |
|
| AGITATION | Psychiatric disorders | MedDRA 15 | Non-systematic Assessment |
|
| BLADDER SPASM | Renal and urinary disorders | MedDRA 15 | Non-systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA 15 | Non-systematic Assessment |
|
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 15 | Non-systematic Assessment |
|
| NIPPLE DISORDER | Reproductive system and breast disorders | MedDRA 15 | Non-systematic Assessment |
|
| SCROTAL OEDEMA | Reproductive system and breast disorders | MedDRA 15 | Non-systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Non-systematic Assessment |
|
| NAIL DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| ONYCHOMADESIS | Skin and subcutaneous tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 15 | Non-systematic Assessment |
|
| ARTERIOSCLEROSIS | Vascular disorders | MedDRA 15 | Non-systematic Assessment |
|
| FLUSHING | Vascular disorders | MedDRA 15 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| SBP: Most extreme post- BL result >= 140 mmHg |
|
| SBP: Most extreme post- BL result >= 180 mmHg |
|
| SBP: MER >= 180 mmHg, >= 20 mmHg change from BL |
|
| SBP: MER >= 140 mmHg, >= 20 mmHg change from BL |
|
| DBP: Most extreme post-BL result >= 90 mmHg |
|
| DBP: Most extreme post-BL result >= 105 mmHg |
|
| DBP: MER >= 105 mmHg,>= 15 mmHg change from BL |
|
| DBP: MER >= 90 mmHg,>= 15 mmHg change from BL |
|
| Heart Rate: AR >120 bpm, increase from BL >30 bpm |
|
| Heart Rate: AR <50 bpm, decrease from BL >30 bpm |
|
|
|
|