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| ID | Type | Description | Link |
|---|---|---|---|
| PSMA-617 | Other Identifier | Weill Cornell Medical College |
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The purpose of this study is to find the highest dose level of the study drug, 177Lu-PSMA-617 that can be given without severe side effects for advanced prostate cancer.
Phase I dose escalation study with 177Lu-PSMA-617 using dose fractionation regimen will be performed in patients with documented progressive metastatic CRPC. The cumulative 177Lu dose [100 mCi (3.7 GBq) - 600 mCi (22.2 GBq)] will be escalated in up to 6 different dose levels (3 + 3 study design). Additional 10 subjects will be enrolled at the MTD dose level to further assess safety and tolerability and to obtain a preliminary assessment of efficacy. The study will enroll adult males 18 years of age or older with documented progressive metastatic CRPC. The primary objectives are: - To determine the dose limiting toxicity (DLT) of fractionated dose of 177Lu-PSMA-617 - To determine the maximal tolerated and recommended phase II dose of 177Lu-PSMA-617 in a 2-week dose-fractionation regimen Subjects will receive the following study interventions:
The treatment phase comprises of 8 visits over 12 weeks. Patients will be followed until death for survival assessment. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event. All tests and procedures performed on this study are routine and standard of care except: 68Ga-PSMA-HBED-CC PET/CT scan, administration of investigational agent 177Lu-PSMA-617, research blood samples (CTCs for research, cell-free DNA sample), and PSMA testing on archive tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-PSMA-617 | Drug | 177Lu-PSMA-617 [50mCi (1.85GBq) - 300mCi (11.1GBq)] intravenous X2 doses, 2 weeks apart (Visit 1 and 2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Dose Limiting Toxicity (DLT) of Fractionated Dose of 177Lu-PSMA-617 | Proportion of subjects experiencing a dose limiting toxicity (DLT) of fractionated dose of 177Lu-PSMA-617 by using 3+3 dose escalation was assessed. | Assessed throughout the DLT period, up to 92 days after starting study drug. |
| Number of Subjects That Achieved Cumulative Maximum Tolerated Dose (MTD) Phase II Dose of 177Lu-PSMA-617 | This outcome is measuring the number of subjects that achieved MTD. MTD is defined as the highest dose level with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level. If no DLTs were experienced, then a recommended phase II dose was determined in 2-wk dose-fractionation regimen by using a 3+3 dose escalation design, as no MTD was observed. | from first dose of study drug to at least 12 weeks of subsequent follow-up evaluations, up to 92 days |
| Recommended Phase II Dose of 177Lu-PSMA-617 in a 2-week Dose-fractionation Regimen | Recommended Phase II dose was determined based on the results of the Phase I portion of the study. Since no Maximum Tolerated Dose was achieved given that no Dose Limiting Toxicities occurred, the Recommended Phase II dose was determined based on the Cohort 5 dose. | Duration of Phase I, up to 47 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of PSA Decline Following Fractionated 177Lu-PSMA-617 | Proportion of patients with PSA decline following treatment (fractionated 177Lu-PSMA-617) with the RP2D of fractionated dose 177Lu-PSMA-617 (Phase II). PSA response will be determined by comparing the PSA levels after therapy to the baseline, pre-treatment PSA. | from baseline visit to short term follow up visit, approximately 6 months |
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Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of prostate
Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria:
ECOG performance status of 0-2
Have serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy.
Have previously been treated with at least one of the following:
Have previously received taxane chemotherapy, been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy.
Age > 18 years
Patients must have normal organ and marrow function as defined below:
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Tagawa, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane Cancer Center Clinic | New Orleans | Louisiana | 70112 | United States | ||
| Weill Cornell Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33465252 | Derived | Vlachostergios PJ, Niaz MJ, Skafida M, Mosallaie SA, Thomas C, Christos PJ, Osborne JR, Molina AM, Nanus DM, Bander NH, Tagawa ST. Imaging expression of prostate-specific membrane antigen and response to PSMA-targeted beta-emitting radionuclide therapies in metastatic castration-resistant prostate cancer. Prostate. 2021 Apr;81(5):279-285. doi: 10.1002/pros.24104. Epub 2021 Jan 19. |
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Recruitment took place at at Weill Cornell Medicine New York Presbyterian and Tulane Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 177Lu-PSMA-617 Cohort 1 | Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment |
| FG001 | 177Lu-PSMA-617 Cohort 2 | Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment |
| FG002 | 177Lu-PSMA-617 Cohort 3 | Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment |
| FG003 | 177Lu-PSMA-617 Cohort 4 | Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment |
| FG004 | 177Lu-PSMA-617 Cohort 5 | Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment |
| FG005 | Dose Expansion Cohort | Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 177Lu-PSMA-617 Cohort 1 | Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment |
| BG001 | 177Lu-PSMA-617 Cohort 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Dose Limiting Toxicity (DLT) of Fractionated Dose of 177Lu-PSMA-617 | Proportion of subjects experiencing a dose limiting toxicity (DLT) of fractionated dose of 177Lu-PSMA-617 by using 3+3 dose escalation was assessed. | Posted | Count of Participants | Participants | Assessed throughout the DLT period, up to 92 days after starting study drug. |
|
Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years.
Patients who passed away during the follow up period were also included.
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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 | 177Lu-PSMA-617 Cohort 1 | Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteremia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Tagawa | Weill Cornell Medicine | 646-962-2027 | stt2007@med.cornell.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 | Oct 28, 2021 | Sep 22, 2022 | 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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| ID | Term |
|---|---|
| C000610110 | Pluvicto |
| C000718244 | gallium 68 PSMA-11 |
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| 68Ga-PSMA-HBED-CC | Drug | 68Ga-PSMA-HBED-CC [5 ±2mCi or 185 ±74MBq] intravenous during screening and at 12 weeks with standard imaging |
|
| Count of Patients That Had a Radiographic Response Rate Measured by RECIST 1.1 With PCWG3 Modifications | From start of study to progression of disease with at least 12 weeks of subsequent follow-up evaluations, up to 54 months |
| Progression-free Survival Measured by PCWG3 (Prostate Cancer Working Group3) Criteria | Progression Free Survival, with progression determined based by Radiographic and Biochemical response. Biochemical response was assessed by comparing the PSA levels after therapy to the baseline, pre-treatment PSA. Declines of ≥ 30% confirmed by a second PSA value ≥2 weeks later, are reported. | Duration of time on study, from baseline to last follow up visit, up to 54 months |
| Number of CTC Count Responders | Changes in CTC count as measured by CellSearch and the rate of favorable CTC count and LDH at 12 weeks following fractionated 177Lu-PSMA-617. All subjects in this study will get blood samples drawn (at screening and EOS visit) for CTC enumeration by CellSearch methodology. Participants whose CTC counts drop to less than 5 or stay below 5 (responders) vs. those who remain at least 5 or above (non-responders) at EOS visit are analyzed. | Duration of study, from screening to EOS visit, up to 12 weeks |
| Overall Survival Following Fractionated 177Lu-PSMA-617 | Overall survival was defined as the time from start of 177Lu-PSMA-617 to the date of death from any cause, or last date of follow up. | Up to 5 years |
| Count of Participants That Experience an Adverse Event | From screening to end of study visit, up to 54 months |
| New York |
| New York |
| 10021 |
| United States |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment |
| BG002 | 177Lu-PSMA-617 Cohort 3 | Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment |
| BG003 | 177Lu-PSMA-617 Cohort 4 | Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment |
| BG004 | 177Lu-PSMA-617 Cohort 5 | Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment |
| BG005 | Dose Expansion Cohort | Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | 177Lu-PSMA-617 Cohort 3 | Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment |
| OG003 | 177Lu-PSMA-617 Cohort 4 | Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment |
| OG004 | 177Lu-PSMA-617 Cohort 5 | Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment. |
| OG005 | Dose Expansion Cohort | Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment. |
|
|
| Primary | Number of Subjects That Achieved Cumulative Maximum Tolerated Dose (MTD) Phase II Dose of 177Lu-PSMA-617 | This outcome is measuring the number of subjects that achieved MTD. MTD is defined as the highest dose level with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level. If no DLTs were experienced, then a recommended phase II dose was determined in 2-wk dose-fractionation regimen by using a 3+3 dose escalation design, as no MTD was observed. | Posted | Count of Participants | Participants | from first dose of study drug to at least 12 weeks of subsequent follow-up evaluations, up to 92 days |
|
|
|
| Primary | Recommended Phase II Dose of 177Lu-PSMA-617 in a 2-week Dose-fractionation Regimen | Recommended Phase II dose was determined based on the results of the Phase I portion of the study. Since no Maximum Tolerated Dose was achieved given that no Dose Limiting Toxicities occurred, the Recommended Phase II dose was determined based on the Cohort 5 dose. | Posted | Number | mci | Duration of Phase I, up to 47 months |
|
|
|
| Secondary | The Rate of PSA Decline Following Fractionated 177Lu-PSMA-617 | Proportion of patients with PSA decline following treatment (fractionated 177Lu-PSMA-617) with the RP2D of fractionated dose 177Lu-PSMA-617 (Phase II). PSA response will be determined by comparing the PSA levels after therapy to the baseline, pre-treatment PSA. | Posted | Count of Participants | Participants | from baseline visit to short term follow up visit, approximately 6 months |
|
|
|
| Secondary | Count of Patients That Had a Radiographic Response Rate Measured by RECIST 1.1 With PCWG3 Modifications | Only evaluable subjects were analyzed for this measure. | Posted | Count of Participants | Participants | From start of study to progression of disease with at least 12 weeks of subsequent follow-up evaluations, up to 54 months |
|
|
|
| Secondary | Progression-free Survival Measured by PCWG3 (Prostate Cancer Working Group3) Criteria | Progression Free Survival, with progression determined based by Radiographic and Biochemical response. Biochemical response was assessed by comparing the PSA levels after therapy to the baseline, pre-treatment PSA. Declines of ≥ 30% confirmed by a second PSA value ≥2 weeks later, are reported. | Posted | Mean | Full Range | days | Duration of time on study, from baseline to last follow up visit, up to 54 months |
|
|
|
| Secondary | Number of CTC Count Responders | Changes in CTC count as measured by CellSearch and the rate of favorable CTC count and LDH at 12 weeks following fractionated 177Lu-PSMA-617. All subjects in this study will get blood samples drawn (at screening and EOS visit) for CTC enumeration by CellSearch methodology. Participants whose CTC counts drop to less than 5 or stay below 5 (responders) vs. those who remain at least 5 or above (non-responders) at EOS visit are analyzed. | Posted | Count of Participants | Participants | Duration of study, from screening to EOS visit, up to 12 weeks |
|
|
|
| Secondary | Overall Survival Following Fractionated 177Lu-PSMA-617 | Overall survival was defined as the time from start of 177Lu-PSMA-617 to the date of death from any cause, or last date of follow up. | Posted | Mean | Full Range | days | Up to 5 years |
|
|
|
| Secondary | Count of Participants That Experience an Adverse Event | Posted | Count of Participants | Participants | From screening to end of study visit, up to 54 months |
|
|
|
| 6 |
| 6 |
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | 177Lu-PSMA-617 Cohort 2 | Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment | 6 | 6 | 1 | 6 | 6 | 6 |
| EG002 | 177Lu-PSMA-617 Cohort 3 | Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment | 5 | 5 | 2 | 5 | 5 | 5 |
| EG003 | 177Lu-PSMA-617 Cohort 4 | Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment | 5 | 6 | 1 | 6 | 6 | 6 |
| EG004 | 177Lu-PSMA-617 Cohort 5 | Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment | 6 | 6 | 0 | 6 | 6 | 6 |
| EG005 | Dose Expansion Cohort | Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment. | 19 | 21 | 3 | 21 | 21 | 21 |
| Lower Extremity Weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Death due to disease progression | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Xerostemia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| AST increased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| High Creatinine | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal distention | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| ALP increased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| ALT increased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgias | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bells palsy | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bronchial infection | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Death due to progression | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diplopia | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry eyes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysarthria | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysguesia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Epistaxis | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Facial trauma | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fall | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness LL | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal congestion | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nocturia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peritendinitis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Leukopenia (white blood cell count decreased) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |