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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00103776 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| MacroGenics | INDUSTRY |
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This study evaluates the safety, anti-tumor effect, and immunogenicity of Enoblituzumab given before radical prostatectomy. All patients will receive Enoblituzumab for 6 weekly doses beginning 50 days prior to radical prostatectomy.
This is a single-center, single arm, open-label phase II study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant MGA271 given prior to radical prostatectomy in men with intermediate and high-risk localized prostate cancer. Eligible patients will receive MGA271 at a dose of 15mg/kg IV given weekly for 6 doses beginning 50 days prior to radical prostatectomy. 14 days after the last dose of MGA271, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Follow-up evaluation for adverse events will occur 30 days and 90 days after surgery. Patients will then be followed by their urologists according to standard institutional practices, but will require PSA evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.
In Amendment 1, the study was expanded to enroll an additional 16 patients for a total of 32 patients to continue evaluating safety and better estimate the clinical benefit of Enoblituzumab in terms of undetectable PSA level (<0.1 ng/mL) at 12 months following radical prostatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enoblituzumab | Experimental | Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV weekly for 6 weeks followed by radical prostatectomy on day 50, with follow-up visits 30 days and 90 days post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoblituzumab | Drug | Enoblituzumab 15mg/kg IV (in the vein) weekly for 6 doses beginning 50 days prior to radical prostatectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events | Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE)v4.0 | 2 years |
| Efficacy of Neoadjuvant Enoblituzumab as Assessed by PSA0 Response Rate | Number of participants with undetectable Prostate Specific Antigen (PSA <0.1 ng/mL) at 12 months following radical prostatectomy | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quantify Markers of Apoptosis in Prostate Tumor Specimens of Treated Patients | Quantify markers of apoptosis in prostate tumor specimens of treated patients using TUNEL staining and expressed as the mean staining percentage in tumor tissue | up to 5 years post-prostatectomy |
| Mean Staining Percentage of Markers of Cell Proliferation |
| Measure | Description | Time Frame |
|---|---|---|
| Androgen Receptor (AR) Quantification | Mean staining percentage of AR in harvested prostate tissue, assessed by immunohistochemistry (IHC) staining for AR protein. | up to 3 years post-prostatectomy |
| Tissue Androgen Concentrations |
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0, M0) without involvement of lymph nodes, bone, or visceral organs
Initial prostate biopsy is available for central pathologic review, and is confirmed to show at least 2 positive cores and a Gleason sum of ≥7
Radical prostatectomy has been scheduled at Johns Hopkins Hospital
Age ≥18 years
ECOG performance status 0-1, or Karnofsky score ≥ 70% (see Appendix A)
Adequate bone marrow, hepatic, and renal function:
The etiology of abnormal bilirubin and transaminase levels should be evaluated prior to study entry.
Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)
Willingness to use barrier contraception from the time of first dose of MGA271 until the time of prostatectomy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Shenderov, MD, PhD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37012549 | Derived | Shenderov E, De Marzo AM, Lotan TL, Wang H, Chan S, Lim SJ, Ji H, Allaf ME, Chapman C, Moore PA, Chen F, Sorg K, White AM, Church SE, Hudson B, Fields PA, Hu S, Denmeade SR, Pienta KJ, Pavlovich CP, Ross AE, Drake CG, Pardoll DM, Antonarakis ES. Neoadjuvant enoblituzumab in localized prostate cancer: a single-arm, phase 2 trial. Nat Med. 2023 Apr;29(4):888-897. doi: 10.1038/s41591-023-02284-w. Epub 2023 Apr 3. |
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33 subjects signed consent to be screened for eligibility.
- 1 subject signed consent, but did not meet the eligibility criteria to start the study (screen failure)
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| ID | Title | Description |
|---|---|---|
| FG000 | Enoblituzumab | Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV weekly for 6 weeks followed by radical prostatectomy on day 50, with follow-up visits 30 days and 90 days post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who met eligibility criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | Enoblituzumab | Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV weekly for 6 weeks followed by radical prostatectomy on day 50, with follow-up visits 30 days and 90 days post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy. |
| 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 | Number of Participants With Treatment-related Adverse Events | Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE)v4.0 | Posted | Count of Participants | Participants | 2 years |
|
|
2 years
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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 | Enoblituzumab | Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV weekly for 6 weeks followed by radical prostatectomy on day 50, with follow-up visits 30 days and 90 days post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion related reaction | Immune system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emmanuel Antonarakis | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | 410-502-8341 | eantona1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2021 | Jul 6, 2021 | Prot_SAP_000.pdf |
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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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Quantify markers of cell proliferation in prostate tumor specimens of treated patients using Ki-67 staining and expressed by the mean staining percentage in tumor tissue |
| 3 years post-prostatectomy |
| CD8+ T Cell Infiltration | Mean staining percentage of CD8+ T-cells in harvested prostate glands from treated patients | 3 years post-prostatectomy |
| PD-L1 Expression | Mean staining percentage of PD-L1 in tumor tissue, assessed by immunohistochemistry (IHC) in the primary core specimens (pre-treatment) and the prostatectomy surgical specimens (post-treatment). | 3 years post-prostatectomy |
| Regulatory T Cell (Treg) Infiltration | Mean staining percentage of Treg cells in tumor tissue of treated patients, assessed through immunohistochemistry. | 3 years post-prostatectomy |
| CD4+ T Cell Infiltration | Mean staining percentage of CD4+ T-cells in tumor tissue of treated patients, assessed through immunohistochemistry. | 3 years post-prostatectomy |
| Natural Killer (NK) Cell Density | Mean staining percentage of NK cells in harvested prostate glands. | 3 years post-prostatectomy |
| Enoblituzumab (MGA271) Drug Distribution Evaluated by Detection of MGA271 in Tumor Tissue | Number of participants with positive or negative MGA271 detection in post-treatment prostate tumor specimens, as evaluated by IHC of fresh frozen sections. | 3 years |
| Pathological Complete Responses (pCR) | Number of participants who achieve pCR, defined as absence of tumor identification on standard histological analysis of resected prostate specimens. | 3 years |
| PSA Response Rates | Number of participants with undetectable PSA (<0.1 ng/mL) at 3 months after prostatectomy. | 3 months post-prostatectomy |
| Time to PSA Recurrence | Median time (months) from prostatectomy to time when PSA is ≥ 0.2 ng/mL. Estimated using Kaplan-Meier method. | up to 37 months post-prostatectomy |
| Gleason Grade Group Change | Number of participants with change in Gleason grade group from pre-treatment biopsy vs. post-treatment biopsy. "Downgrade" refers to a net grade group change less than zero, "upgrade" refers to net grade group change more than zero, and "no change" refers to stable Gleason grade group. Gleason grade groups are defined as grade group 1 (Gleason score ≤ 6), grade group 2 (Gleason score 3+4=7), grade group 3 (Gleason score 4+3=7), grade group 4 (Gleason score 8), and grade group 5 (Gleason scores 9-10).The lower the grade group, the better the outcome. | Day 50 |
| Number of Participants With PSA Percentage Decrease Prior to Radical Prostatectomy. | The PSA percentage change is calculated as the difference from the PSA at day 50 prior to prostatectomy and PSA at screening. A negative value of PSA percentage change ("PSA percentage < 0") indicates a decrease in PSA from screening, and a positive value (PSA percentage change >= 0) indicates an increase in PSA from screening. | 50 Days |
Concentration (picogram/3 mg) of testosterone and 5α-dihydrotestosterone (DHT) in prostate tissue.
| up to 3 years post prostatectomy |
| Global Expression Profiling of Tumor Tissues | Number of participants with changes in cellular composition, upregulation and downregulation of immune checkpoints, and other markers of activity versus exhaustion. | up to 3 years post-prostatectomy |
| IHC Analyses of CD137, CD16 and/or CD107A | CD137, CD107A, and CD16 expression in prostate tumor specimens will be assessed by immunohistochemistry (IHC) in the prostatectomy surgical specimens (post-treatment). This endpoint will be expressed as the mean staining percentage of each of these in tumor tissue | up to 3 years post-prostatectomy |
| TCR Repertoire | Fraction of peripherally expanded clones that are tumor associated for each participant. | 3 years post-prostatectomy |
| FC Receptor Genotyping | Number of participants with CD16A, CD32A, and CD32B on Fc receptor. | up to 3 years post-prostatectomy |
| PBLs | Number of participants with upregulation and downregulation of immune checkpoints and other markers of activity versus exhaustion, as assessed by flow cytometry at treatment day 1 (pre-treatment), treatment day 36 (post-treatment), and 30 days post-prostatectomy. | 3 years post-prostatectomy |
| B7-H3 Expression | Number of participants with B7-H3 expression in prostate tumor specimens will be assessed by IHC (immunohistochemistry) in the primary core specimens (pre-treatment) and in the prostatectomy surgical specimens (post-treatment). | 3 years post-prostatectomy |
| PD-1, LAG3, and TIM3 Expression | PD-1, LAG3, and TIM3 expression in prostate tumor specimens will be assessed by IHC (immunohistochemistry) in the primary core specimens (pre-treatment) and in the prostatectomy surgical specimens (post-treatment). This endpoint will be expressed as the mean staining percentage in tumor tissue. | 3 Years post-prostatectomy |
| Quantify Antigen-spread | Number of participants with antigen-spread to on-target and off-target antigens. | 3 years post-prostatectomy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Smoking History | Count of Participants | Participants |
|
| Family History of Prostate Cancer | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) performance status | The Eastern Cooperative Oncology Group (ECOG) scale measures performance status, with scores ranging from 0-5; 0= fully active, performs without restriction, 1= can ambulate, but restricted in physically strenuous activity, 2= ambulatory and capable of self-care, but unable to work, active for >50% of waking hours, 3= limited self-care, confined to bed or chair for >50% of waking hours, 4= completely disabled, totally confined to bed/chair, 5= deceased | Count of Participants | Participants |
|
| Body-mass index (kg/m^2) | Count of Participants | Participants |
|
| Gleason Group / Gleason sum at biopsy | Gleason grade groups are defined as grade group 1 (Gleason score ≤ 6), grade group 2 (Gleason score 3+4=7), grade group 3 (Gleason score 4+3=7), grade group 4 (Gleason score 8), and grade group 5 (Gleason scores 9-10). A higher grade group reflects a worse outcome. | Count of Participants | Participants |
|
| Previous Therapy | Number of subjects who received therapy for prostate cancer prior to enrollment. | Count of Participants | Participants |
|
| Stage T3 at initial diagnosis | Stage T3 is defined as cancer growth outside of the prostate and possibly spread to the seminal vesicles. | Count of Participants | Participants |
|
|
|
| Primary | Efficacy of Neoadjuvant Enoblituzumab as Assessed by PSA0 Response Rate | Number of participants with undetectable Prostate Specific Antigen (PSA <0.1 ng/mL) at 12 months following radical prostatectomy | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Quantify Markers of Apoptosis in Prostate Tumor Specimens of Treated Patients | Quantify markers of apoptosis in prostate tumor specimens of treated patients using TUNEL staining and expressed as the mean staining percentage in tumor tissue | Not Posted | up to 5 years post-prostatectomy | Participants |
| Secondary | Mean Staining Percentage of Markers of Cell Proliferation | Quantify markers of cell proliferation in prostate tumor specimens of treated patients using Ki-67 staining and expressed by the mean staining percentage in tumor tissue | Only 30 of the 32 participants enrolled in the trial had evaluable tissue samples. | Posted | Mean | Standard Deviation | staining percentage | 3 years post-prostatectomy |
|
|
|
| Secondary | CD8+ T Cell Infiltration | Mean staining percentage of CD8+ T-cells in harvested prostate glands from treated patients | Only 30 of the 32 participants enrolled in the trial had evaluable tissue samples. | Posted | Mean | Standard Deviation | staining percentage | 3 years post-prostatectomy |
|
|
|
| Secondary | PD-L1 Expression | Mean staining percentage of PD-L1 in tumor tissue, assessed by immunohistochemistry (IHC) in the primary core specimens (pre-treatment) and the prostatectomy surgical specimens (post-treatment). | Only 30 of the 32 participants enrolled in the trial had evaluable tissue samples. | Posted | Mean | Standard Deviation | staining percentage | 3 years post-prostatectomy |
|
|
|
| Secondary | Regulatory T Cell (Treg) Infiltration | Mean staining percentage of Treg cells in tumor tissue of treated patients, assessed through immunohistochemistry. | Only 30 of the 32 participants enrolled in the trial had evaluable tissue samples. | Posted | Mean | Standard Deviation | staining percentage | 3 years post-prostatectomy |
|
|
|
| Secondary | CD4+ T Cell Infiltration | Mean staining percentage of CD4+ T-cells in tumor tissue of treated patients, assessed through immunohistochemistry. | Only 30 of the 32 participants enrolled in the trial had evaluable tissue samples. | Posted | Mean | Standard Deviation | staining percentage | 3 years post-prostatectomy |
|
|
|
| Secondary | Natural Killer (NK) Cell Density | Mean staining percentage of NK cells in harvested prostate glands. | Only 30 of the 32 participants enrolled in the trial had evaluable tissue samples. | Posted | Mean | Standard Deviation | staining percentage | 3 years post-prostatectomy |
|
|
|
| Secondary | Enoblituzumab (MGA271) Drug Distribution Evaluated by Detection of MGA271 in Tumor Tissue | Number of participants with positive or negative MGA271 detection in post-treatment prostate tumor specimens, as evaluated by IHC of fresh frozen sections. | The Overall Number of Participants Analyzed represents those evaluable for this outcome. Of the 32 participants who received study treatment, data from 2 subjects was not evaluable. | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Pathological Complete Responses (pCR) | Number of participants who achieve pCR, defined as absence of tumor identification on standard histological analysis of resected prostate specimens. | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | PSA Response Rates | Number of participants with undetectable PSA (<0.1 ng/mL) at 3 months after prostatectomy. | Posted | Count of Participants | Participants | 3 months post-prostatectomy |
|
|
|
| Secondary | Time to PSA Recurrence | Median time (months) from prostatectomy to time when PSA is ≥ 0.2 ng/mL. Estimated using Kaplan-Meier method. | Posted | Median | Full Range | months | up to 37 months post-prostatectomy |
|
|
|
| Secondary | Gleason Grade Group Change | Number of participants with change in Gleason grade group from pre-treatment biopsy vs. post-treatment biopsy. "Downgrade" refers to a net grade group change less than zero, "upgrade" refers to net grade group change more than zero, and "no change" refers to stable Gleason grade group. Gleason grade groups are defined as grade group 1 (Gleason score ≤ 6), grade group 2 (Gleason score 3+4=7), grade group 3 (Gleason score 4+3=7), grade group 4 (Gleason score 8), and grade group 5 (Gleason scores 9-10).The lower the grade group, the better the outcome. | Posted | Count of Participants | Participants | Day 50 |
|
|
|
| Secondary | Number of Participants With PSA Percentage Decrease Prior to Radical Prostatectomy. | The PSA percentage change is calculated as the difference from the PSA at day 50 prior to prostatectomy and PSA at screening. A negative value of PSA percentage change ("PSA percentage < 0") indicates a decrease in PSA from screening, and a positive value (PSA percentage change >= 0) indicates an increase in PSA from screening. | Posted | Count of Participants | Participants | 50 Days |
|
|
|
| Other Pre-specified | Androgen Receptor (AR) Quantification | Mean staining percentage of AR in harvested prostate tissue, assessed by immunohistochemistry (IHC) staining for AR protein. | Not Posted | up to 3 years post-prostatectomy | Participants |
| Other Pre-specified | Tissue Androgen Concentrations | Concentration (picogram/3 mg) of testosterone and 5α-dihydrotestosterone (DHT) in prostate tissue. | Not Posted | up to 3 years post prostatectomy | Participants |
| Other Pre-specified | Global Expression Profiling of Tumor Tissues | Number of participants with changes in cellular composition, upregulation and downregulation of immune checkpoints, and other markers of activity versus exhaustion. | Not Posted | up to 3 years post-prostatectomy | Participants |
| Other Pre-specified | IHC Analyses of CD137, CD16 and/or CD107A | CD137, CD107A, and CD16 expression in prostate tumor specimens will be assessed by immunohistochemistry (IHC) in the prostatectomy surgical specimens (post-treatment). This endpoint will be expressed as the mean staining percentage of each of these in tumor tissue | Not Posted | up to 3 years post-prostatectomy | Participants |
| Other Pre-specified | TCR Repertoire | Fraction of peripherally expanded clones that are tumor associated for each participant. | Only 30 of the 32 participants enrolled in the trial had evaluable samples. | Posted | Count of Participants | Participants | 3 years post-prostatectomy |
|
|
|
| Other Pre-specified | FC Receptor Genotyping | Number of participants with CD16A, CD32A, and CD32B on Fc receptor. | Not Posted | up to 3 years post-prostatectomy | Participants |
| Other Pre-specified | PBLs | Number of participants with upregulation and downregulation of immune checkpoints and other markers of activity versus exhaustion, as assessed by flow cytometry at treatment day 1 (pre-treatment), treatment day 36 (post-treatment), and 30 days post-prostatectomy. | Not Posted | 3 years post-prostatectomy | Participants |
| Other Pre-specified | B7-H3 Expression | Number of participants with B7-H3 expression in prostate tumor specimens will be assessed by IHC (immunohistochemistry) in the primary core specimens (pre-treatment) and in the prostatectomy surgical specimens (post-treatment). | Posted | Count of Participants | Participants | 3 years post-prostatectomy |
|
|
|
| Other Pre-specified | PD-1, LAG3, and TIM3 Expression | PD-1, LAG3, and TIM3 expression in prostate tumor specimens will be assessed by IHC (immunohistochemistry) in the primary core specimens (pre-treatment) and in the prostatectomy surgical specimens (post-treatment). This endpoint will be expressed as the mean staining percentage in tumor tissue. | Not Posted | 3 Years post-prostatectomy | Participants |
| Other Pre-specified | Quantify Antigen-spread | Number of participants with antigen-spread to on-target and off-target antigens. | Posted | Count of Participants | Participants | 3 years post-prostatectomy |
|
|
|
| 0 |
| 32 |
| 3 |
| 32 |
| 32 |
| 32 |
| Ascites | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac Disorders - Other, Non-ST-Elevation, Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Pericarditis | Cardiac disorders | Non-systematic Assessment |
|
| Myocarditis | Cardiac disorders | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| Flu like symptoms | General disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Edema limbs | General disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | Non-systematic Assessment |
|
| Erectile dysfunction | Renal and urinary disorders | Non-systematic Assessment |
|
| Creatinine increased | Investigations | Non-systematic Assessment |
|
| CD4 lymphocytes decreased | Investigations | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Serum amylase increased | Investigations | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Left knee weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lipase increased | Investigations | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Infusion related reaction | General disorders | Non-systematic Assessment |
|
| IV infiltration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Cold symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Weight gain | Investigations | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
|
| Right eye stye | Eye disorders | Non-systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | Non-systematic Assessment |
|
| Hemoglobinuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Bladder anastomotic leak | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Lymphocele | Vascular disorders | Non-systematic Assessment |
|
| Skin infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Discolored urine | Renal and urinary disorders | Non-systematic Assessment |
|
| Eye pain | Eye disorders | Non-systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Flushing | Vascular disorders | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
|
| Pericarditis | Cardiac disorders | Non-systematic Assessment |
|
| Myocarditis | Cardiac disorders | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
|
| Loss of dental filling | Surgical and medical procedures | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Left meniscus tear/injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | Non-systematic Assessment |
|
| Tachycardia | Vascular disorders | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Incision site tenderness and erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|