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| ID | Type | Description | Link |
|---|---|---|---|
| LUD2002-006 | Other Identifier | Ludwig Institute for Cancer Research |
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| Name | Class |
|---|---|
| New York Presbyterian Hospital | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| Memorial Sloan Kettering Cancer Center | OTHER |
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To evaluate the safety of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by particle-mediated epidermal delivery (PMED) in patients with tumor types known to express NY-ESO-1 or LAGE-1.
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 microgram dosage of NY-ESO-1 was administered as 4 X 1 microgram PMEDs in close proximity. Similarly, the 8 microgram dosage was administered as 8 X 1 microgram PMEDs. The third cohort of patients received the 8 microgram dosage as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 microgram PMEDs per day.
Blood samples were to be obtained at baseline, 2 weeks after each vaccination, prior to the second and third vaccination, and 4 weeks after the third vaccination for the assessment of clinical hematology, biochemistry measurements and immunology responses. Patients were to be evaluated for toxicity throughout the study.
Delayed-type hypersensitivity (DTH) testing was to be performed at baseline and at the 2-week visit following the first and third vaccinations.
NY-ESO-1 and/or LAGE-1 specific antibodies were to be assessed in all patients by an enzyme-linked immunosorbent assay (ELISA). NY-ESO-1 specific CD4+ and CD8+ T-cells were to be assessed in all patients by tetramer and/or ELISPOT assays.
Disease status was to be assessed at baseline and 4 weeks after the third vaccination in patients with measurable disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs in close proximity. The vaccine was administered in weeks 1, 5, and 9 of Cycle 1. In the absence of > Grade 3 toxicity and in the absence of progressive disease requiring other treatment or the presence of NY-ESO-1 immunity, patients could receive an additional cycle of vaccinations of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine. |
|
| Cohort 2 | Experimental | 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9 of Cycle 1. In the absence of > Grade 3 toxicity and in the absence of progressive disease requiring other treatment or the presence of NY-ESO-1 immunity, patients could receive an additional cycle of vaccinations of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine. |
|
| Cohort 3 | Experimental | 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9 of Cycle 1. In the absence of > grade 3 toxicity and in the absence of progressive disease requiring other treatment or the presence of NY-ESO-1 immunity, patients could receive an additional cycle of vaccinations of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NY-ESO-1 Plasmid DNA Cancer Vaccine | Biological | NY-ESO-1 Plasmid DNA Cancer Vaccine administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Dose Limiting Toxicities (DLTs) and Number of Patients With Adverse Events | All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003). DLT was defined as
A dose-limiting adverse event must be definitely, probably, or possibly related to the administration of the investigational agent and must occur between first dose and 4 weeks after the last dose. | up to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Tumor Response According to the Response Evaluation Criteria in Solid Tumors (RECIST). | Tumor response was assessed in patients with measurable tumors according to the Response Evaluation Criteria in Solid Tumors (RECIST). Computed tomography (CT) scans were performed at screening and at week 13. Response was assessed using RECIST version 1.0 (Therasse et al, J Natl Cancer Inst 2000; 92:205-16). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria; no evidence of disease (NED): no new lesions in patients who did not have target lesions at baseline. |
Not provided
Inclusion Criteria:
Patients were eligible for enrollment if they fulfilled all of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Padmanee Sharma, MD PhD | UT MD Anderson Cancer Center Genitourinary Med Onc | Principal Investigator |
| Nasser K Altorki, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital | New York | New York | 10021 | United States | ||
| UT MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10655437 | Background | Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | 4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 µg dosage of Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs in close proximity. The vaccine was administered in weeks 1, 5, and 9. |
| FG001 | Cohort 2 | 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9. |
| FG002 | Cohort 3 | 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients who received at least one dose of NY-ESO-1 Plasmid DNA Vaccine.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | 4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9. |
| 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 Patients With Dose Limiting Toxicities (DLTs) and Number of Patients With Adverse Events | All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003). DLT was defined as
A dose-limiting adverse event must be definitely, probably, or possibly related to the administration of the investigational agent and must occur between first dose and 4 weeks after the last dose. | All patients who received at least one dose of NY-ESO-1 Plasmid DNA Vaccine. | Posted | Count of Participants | Participants | up to 13 weeks |
|
up to 13 weeks
All Adverse Events (AEs) were to be documented in the source records and on the respective Case Report Form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study medication, were to be documented on the Pre-existing Signs and Symptoms CRF page. Thereafter, they were documented on the Adverse Event pages. AEs were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003).
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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 | Cohort 1 | 4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Skipper PhD | Ludwig Institute for Cancer Research | 12124501539 | jskipper@lcr.org |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D004938 | Esophageal Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 13 weeks |
| Number of Patients With NY-ESO-1-Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline. | Blood samples were obtained at baseline (prior to the first dose), and in weeks 3, 5, 7, 9, 11 and 13 for the assessment of NY-ESO-1-specific antibodies by an enzyme-linked immunosorbent assay (ELISA). A positive response was a readable optical density at 280 nm. | up to 13 weeks |
| Number of Patients With NY-ESO-1-Specific Cellular Immunity as Measured by an Increase in NY-ESO-1-Specific CD4+ and CD8+ T-Cells Following Treatment. | Blood samples were obtained at baseline (prior to the first dose), and in weeks 3, 5, 7, 9, 11 and 13 for the assessment of NY-ESO-1-specific CD4+ and CD8+ T-cell responses by ELISPOT. | up to 13 weeks |
| Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1 Protein | Delayed-Type Hypersensitivity (DTH) testing was conducted at baseline and on days 15 and 72 of the study. A positive DTH reaction to NY-ESO-1 protein at baseline was absent in all patients. The presence of redness and induration was considered necessary for a positive DTH reaction. | Up to 11 weeks |
| Houston |
| Texas |
| 77030 |
| United States |
| Did not meet eligibility criteria - not dosed |
|
| BG001 | Cohort 2 | 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9. |
| BG002 | Cohort 3 | 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Cohort 2 | 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9. |
| OG002 | Cohort 3 | 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9. |
|
|
| Secondary | Number of Patients With Tumor Response According to the Response Evaluation Criteria in Solid Tumors (RECIST). | Tumor response was assessed in patients with measurable tumors according to the Response Evaluation Criteria in Solid Tumors (RECIST). Computed tomography (CT) scans were performed at screening and at week 13. Response was assessed using RECIST version 1.0 (Therasse et al, J Natl Cancer Inst 2000; 92:205-16). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria; no evidence of disease (NED): no new lesions in patients who did not have target lesions at baseline. | All patients who received at least one dose of NY-ESO-1 Plasmid DNA Vaccine and had valid tumor response measured. | Posted | Count of Participants | Participants | 13 weeks |
|
|
|
| Secondary | Number of Patients With NY-ESO-1-Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline. | Blood samples were obtained at baseline (prior to the first dose), and in weeks 3, 5, 7, 9, 11 and 13 for the assessment of NY-ESO-1-specific antibodies by an enzyme-linked immunosorbent assay (ELISA). A positive response was a readable optical density at 280 nm. | All patients who received at least one dose of NY-ESO-1 Plasmid DNA Vaccine and had baseline and at least one post-treatment sample taken. One patient in Cohort 3 did not have a baseline sample taken. | Posted | Count of Participants | Participants | up to 13 weeks |
|
|
|
| Secondary | Number of Patients With NY-ESO-1-Specific Cellular Immunity as Measured by an Increase in NY-ESO-1-Specific CD4+ and CD8+ T-Cells Following Treatment. | Blood samples were obtained at baseline (prior to the first dose), and in weeks 3, 5, 7, 9, 11 and 13 for the assessment of NY-ESO-1-specific CD4+ and CD8+ T-cell responses by ELISPOT. | All patients who received at least one dose of NY-ESO-1 Plasmid DNA Vaccine and had baseline and at least one post-treatment sample taken. One patient in Cohort 2 did not have samples taken. All patients did not have samples analyzed for CD8+ T-cell responses. | Posted | Count of Participants | Participants | up to 13 weeks |
|
|
|
| Secondary | Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1 Protein | Delayed-Type Hypersensitivity (DTH) testing was conducted at baseline and on days 15 and 72 of the study. A positive DTH reaction to NY-ESO-1 protein at baseline was absent in all patients. The presence of redness and induration was considered necessary for a positive DTH reaction. | All patients who received at least one dose of NY-ESO-1 Plasmid DNA Vaccine and had baseline and at least one post-treatment sample taken. | Posted | Count of Participants | Participants | Up to 11 weeks |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Cohort 2 | 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9. | 0 | 7 | 1 | 7 | 7 | 7 |
| EG002 | Cohort 3 | 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9. | 0 | 7 | 1 | 7 | 7 | 7 |
| Bladder obstruction | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hemorrhage urinary tract | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Anthropod bite | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Aspartate transaminase increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Bilirubin increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Blood phosphorus increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chest pain | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dizziness | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA 9.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Hot flush | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypoglycemia | Endocrine disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Mood alteration | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Perineal pain | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
|
| Peripheral edema | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| Stable Disease (SD) |
|
| Progressive Disease (PD) |
|
| No Evidence of Disease (NED) |
|
|
| Number of patients without an increase in CD4+ T-cells |
|
|
| Number of patients with an increase in CD8+ T-cells |
|
|
| Number of patients without an increase in CD8+ T-cells |
|
|