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The purpose of this research study is to determine if the addition of dutasteride to a regimen with abiraterone acetate and prednisone will improve on therapy in patients with castrate-resistant prostate cancer and metastatic disease. This study will also help determine the side effects of the study treatment and how often they occur.
Patients will receive abiraterone acetate and prednisone orally, once daily for 2 months (2 cycles) on an outpatient basis. At the start of cycle 3, dutasteride will be taken once daily. Patients will return to the clinic on Day 14 of the first 3 cycles for routine blood tests.
Patients will come to the clinic every 12 weeks for a CT scan and/or x-ray of the chest, CT scan or MRI of the abdomen and pelvis, bone scan, and blood test for testosterone and other specialized blood test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone+prednisone+dutasteride | Experimental | Abiraterone acetate 1000mg orally once per day + prednisone 5mg orally once per day for two months, followed by abiraterone 1000mg orally once per day + prednisone 5mg orally once per day + dutasteride 3.5mg orally once per day in 28-day cycles until symptomatic or radiographic progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone acetate | Drug |
|
| |
| Dutasteride |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Androgen Receptor (AR) Related Mutations | AR related mutation was defined as presence of T878A mutation. Expression of T878A was measured by established methods. | Pairs of patients samples were evaluated at baseline and time of progression. In this study cohort, participants were followed up to 48 months for this endpoint. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Levels of Testosterone | Serum testosterone levels were estimated based on established methods. The change from baseline to progression was calculated for each participant. | Samples for testosterone analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary-Ellen Taplin, M.D. | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States | ||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25091040 | Result | McKay RR, Zukotynski KA, Werner L, Voznesensky O, Wu JS, Smith SE, Jiang Z, Melnick K, Yuan X, Kantoff PW, Montgomery B, Balk SP, Taplin ME. Imaging, procedural and clinical variables associated with tumor yield on bone biopsy in metastatic castration-resistant prostate cancer. Prostate Cancer Prostatic Dis. 2014 Dec;17(4):325-31. doi: 10.1038/pcan.2014.28. Epub 2014 Aug 5. | |
| 27683182 |
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This will not be done.
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Patients enrolled from September 2011 through October 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Abiraterone + Prednisone + Dutasteride | Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression Abiraterone acetate: 1000 mg orally, once per day Dutasteride: 3.5 mg orally once per day Prednisone: 5 mg orally once per day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Abiraterone + Prednisone + Dutasteride | Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression Abiraterone acetate: 1000 mg orally, once per day Dutasteride: 3.5 mg orally once per day Prednisone: 5 mg orally once per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants With Androgen Receptor (AR) Related Mutations | AR related mutation was defined as presence of T878A mutation. Expression of T878A was measured by established methods. | The analysis dataset is comprised of all patients evaluable for AR mutation. | Posted | Count of Participants | Participants | Pairs of patients samples were evaluated at baseline and time of progression. In this study cohort, participants were followed up to 48 months for this endpoint. |
|
Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated. Patients appear once for a given toxicity type. Serious and Other Adverse Events (AEs) were defined as events of grades 3-5 and grades 1-2, respectively, based on Common Terminology Criteria for Adverse Events version 4 (CTCAEv4). 'Other' events have no further specification.
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 | Abiraterone + Prednisone + Dutasteride | Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression Abiraterone acetate: 1000 mg orally, once per day Dutasteride: 3.5 mg orally once per day Prednisone: 5 mg orally once per day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow cellularity | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary-Ellen Taplin | Dana-Farber Cancer Institute | 617-582-7221 | mary_taplin@dfci.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D000068538 | Dutasteride |
| D011241 | Prednisone |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Prednisone | Drug |
|
|
| Prostate-Specific Antigen (PSA) Response | PSA response was defined as decline of 50% from baseline confirmed by a PSA at least 4 weeks later based on Prostate-specific Antigen Working Group-2 (PSAWG-2) (2008) criteria. | PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint. |
| Time to PSA Progression | Time to PSA progression based on the Kaplan-Meier method was defined as the time between registration and documented PSA progression. PSA progression based on Prostate-Specific Antigen Working Group-2 (PSAWG-2) (2008) criteria was an increase of >/=25% and >/= 2 ng/ml after 12 weeks for patients without a PSA decline from baseline and an increase of >/=25% and >/= 2 ng/ml above the nadir, confirmed by a 2nd value 3 weeks or later for patients with a PSA decline from baseline. PSA progression was reported not duration of response. | PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint. |
| Best Overall Response | Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. | Disease was evaluated radiologically at baseline and every 12 weeks cycles on treatment. In this study cohort, participants were followed up to 48 months for this endpoint. |
| Time to Progression (TTP) | TTP based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD). Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | Disease evaluation occurred every 12 weeks while patients were receiving treatment. In this study cohort, participants were followed up to 48 months for this endpoint. |
| Presence of AR Amplification | Presence of AR amplification was measured by established methods. | Patients' samples were evaluated at baseline and every 12 weeks on treatment. In this study cohort, participants were followed up to 48 months for this endpoint. |
| Change in Serum Androgen Levels | Serum androgen levels measured based on established methods. The change from baseline to progression was calculated for each participant. | Pairs of patients' samples for androgen analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint. |
| Change in Circulating Tumor Cells (CTCs) Levels | CTCs were measured based on established methods. | Pairs of patients' samples were evaluated at baseline and time of progression. In this study cohort, participants were followed up to 48 months for this endpoint. |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Result |
| McKay RR, Werner L, Mostaghel EA, Lis R, Voznesensky O, Zhang Z, Marck BT, Matsumoto AM, Domachevsky L, Zukotynski KA, Bhasin M, Bubley GJ, Montgomery B, Kantoff PW, Balk SP, Taplin ME. A Phase II Trial of Abiraterone Combined with Dutasteride for Men with Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2017 Feb 15;23(4):935-945. doi: 10.1158/1078-0432.CCR-16-0987. Epub 2016 Sep 28. |
| 25320358 | Result | Chen EJ, Sowalsky AG, Gao S, Cai C, Voznesensky O, Schaefer R, Loda M, True LD, Ye H, Troncoso P, Lis RL, Kantoff PW, Montgomery RB, Nelson PS, Bubley GJ, Balk SP, Taplin ME. Abiraterone treatment in castration-resistant prostate cancer selects for progesterone responsive mutant androgen receptors. Clin Cancer Res. 2015 Mar 15;21(6):1273-80. doi: 10.1158/1078-0432.CCR-14-1220. Epub 2014 Oct 15. |
| 32134978 | Derived | Wang Z, Deng T, Long X, Lin X, Wu S, Wang H, Ge R, Zhang Z, Wu CL, Taplin ME, Olumi AF. Methylation of SRD5A2 promoter predicts a better outcome for castration-resistant prostate cancer patients undergoing androgen deprivation therapy. PLoS One. 2020 Mar 5;15(3):e0229754. doi: 10.1371/journal.pone.0229754. eCollection 2020. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Serum Levels of Testosterone | Serum testosterone levels were estimated based on established methods. The change from baseline to progression was calculated for each participant. | The analysis dataset is comprised of all treated patients. | Posted | Median | Inter-Quartile Range | ng/dL | Samples for testosterone analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint. |
|
|
|
| Secondary | Prostate-Specific Antigen (PSA) Response | PSA response was defined as decline of 50% from baseline confirmed by a PSA at least 4 weeks later based on Prostate-specific Antigen Working Group-2 (PSAWG-2) (2008) criteria. | The analysis dataset is comprised of all treated patients. | Posted | Count of Participants | Participants | PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint. |
|
|
|
| Secondary | Time to PSA Progression | Time to PSA progression based on the Kaplan-Meier method was defined as the time between registration and documented PSA progression. PSA progression based on Prostate-Specific Antigen Working Group-2 (PSAWG-2) (2008) criteria was an increase of >/=25% and >/= 2 ng/ml after 12 weeks for patients without a PSA decline from baseline and an increase of >/=25% and >/= 2 ng/ml above the nadir, confirmed by a 2nd value 3 weeks or later for patients with a PSA decline from baseline. PSA progression was reported not duration of response. | The analysis dataset is comprised of all treated patients. | Posted | Median | 95% Confidence Interval | months | PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint. |
|
|
|
| Secondary | Best Overall Response | Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. | The analysis dataset is comprised of all treated patients. | Posted | Count of Participants | Participants | Disease was evaluated radiologically at baseline and every 12 weeks cycles on treatment. In this study cohort, participants were followed up to 48 months for this endpoint. |
|
|
|
| Secondary | Time to Progression (TTP) | TTP based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD). Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | The analysis dataset is comprised of all treated patients. | Posted | Median | 95% Confidence Interval | Months | Disease evaluation occurred every 12 weeks while patients were receiving treatment. In this study cohort, participants were followed up to 48 months for this endpoint. |
|
|
|
| Secondary | Presence of AR Amplification | Presence of AR amplification was measured by established methods. | The analysis dataset is comprised of all evaluable patients. | Posted | Count of Participants | Participants | Patients' samples were evaluated at baseline and every 12 weeks on treatment. In this study cohort, participants were followed up to 48 months for this endpoint. |
|
|
|
| Secondary | Change in Serum Androgen Levels | Serum androgen levels measured based on established methods. The change from baseline to progression was calculated for each participant. | The analysis dataset is comprised of all treated patients. | Posted | Median | Inter-Quartile Range | ng/dl | Pairs of patients' samples for androgen analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint. |
|
|
|
| Secondary | Change in Circulating Tumor Cells (CTCs) Levels | CTCs were measured based on established methods. | Data were not collected for this secondary endpoint. | Posted | Pairs of patients' samples were evaluated at baseline and time of progression. In this study cohort, participants were followed up to 48 months for this endpoint. |
|
|
| 0 |
| 38 |
| 12 |
| 38 |
| 38 |
| 38 |
| Lipase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Conduction abnormality/Atrioventricular heart block - AV block-second degree Mobitz Type II | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Ureter | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Vagina | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Thrombosis/embolism (vascular access-related) | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Lipase | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Bone: spine-scoliosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Neuropathy: cranial - CN III Pupil, upper eyelid, extra ocular movements" | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood/Bone Marrow-Other (Specify) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Conduction abnormality/Atrioventricular heart block - Wolff-Parkinson-White syndrome | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | CTCAE (4.0) | Systematic Assessment |
|
| External ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear and labyrinth disorders | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cataract | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Eye disorders - Other, specify | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Fistula, GI - Anus" | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Fistula, GI - Esophagus" | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Fistula, GI - Ileum" | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Fistula, GI - Jejunum" | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Fistula, GI - Stomach" | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Obstruction, GI - Esophagus" | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Stricture/stenosis (including anastomotic), GI - Duodenum" | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Fatigue (asthenia, lethargy, malaise)" | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Obesity | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sweating (diaphoresis) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weight gain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Localized edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infection (documented clinically/microbiologically) w/Grade 3/4 neutrophils -Brain | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Liver | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Nerve-peripheral | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Peristomal | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection (documented clinically/microbiologically) w/Grade 3/4 neutrophils -Upper aerodigestive NOS | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Bicarbonate, serum-low" | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Glucose, serum-high (hyperglycemia)" | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone: spine-scoliosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Extremity-lower (gait/walking) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Extremity-upper (function) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fibrosis-cosmesis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Local complication - device/prosthesis-related | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-upper" | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Soft tissue necrosis - Abdomen | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Soft tissue necrosis - Head | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Soft tissue necrosis - Neck | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal/Soft Tissue-Other (Specify) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Irritability (children <3 years of age) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Leak, cerebrospinal fluid (CSF)" | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Neuropathy: cranial - CN III Pupil, upper eyelid, extra ocular movements" | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Leak (including anastomotic), GU - Kidney" | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Leak (including anastomotic), GU - Spermatic cord" | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Leak (including anastomotic), GU - Ureter" | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gynecomastia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Laryngeal fistula | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Prolonged intubation after pulmonary resection (>24 hrs after surgery) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Burn | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash: dermatitis associated with radiation - Chemoradiation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Striae | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dermatology/Skin-Other (Specify) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intra-operative injury - Pharynx | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Phlebitis (including superficial thrombosis) | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Portal vein flow | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |