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| ID | Type | Description | Link |
|---|---|---|---|
| SARCOMA0038 | Other Identifier | OnCore |
Not provided
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this Phase 2 study is to
Primary Objectives:
1) Assess whether the rate of clinical benefit is sufficiently high to merit promise for further study
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipilimumab/nivolumab + cryotherapy | Experimental | 1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab 1 mg/kg, injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response | Clinical benefit was assessed on the basis of clinical response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria:
Clinical benefit was defined as CR + PR. The primary outcome is expressed as the total number of participants who receive clinical benefit within 14 weeks, a number without dispersion. Rates of all clinical responses are reported. | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Related Adverse Events (Toxicity) | Adverse events were assessed per CTCAE version 5. The outcome is those adverse events experienced by participants that were determined to be possibly, probably, or definitely-related to study treatment. Serious adverse events are identified by the term "SAE." Results are presented as the number of related adverse events by preferred term that occurred. The data are numbers without dispersion. |
Not provided
Inclusion Criteria:
Absolute neutrophil count (ANC) ≥ 1,000/mm^3 Platelet count ≥ 75,000/mm^3; Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated (calc.); creatinine clearance > 45 mL/min using the lean body mass formula only; Total bilirubin ≤ 1.5 x ULN in absence of Gilbert disease (total bilirubin ≤ 3 x ULN with Gilbert); also, if hyperbilirubinemia is clearly attributed to liver metastases total bilirubin ≤ 3 x ULN is permitted AST/ALT ≤ 3 x ULN;Thyroid stimulating hormone (TSH) within normal limits (WNL);supplementation is acceptable to achieve a TSH WNL; in subjects with abnormal TSH if free T4 is normal and subject is clinically euthyroid, subject is eligible
Exclusion Criteria:
History of the following:
Hepatitis B can be defined as:
Hepatitis B surface antigen (HBsAg) > 6 months Serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) 20,000 IU/mL (105 copies/mL), lower values 2,000 to 20,000 IU/mL (104 to 105 copies/mL) are often seen in hepatitis B-e antigen (HbeAg)-negative chronic hepatitis B Persistent or intermittent elevation in alanine aminotransferase (ALT)/alanine aminotransferase (AST) levels. Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Ganjoo, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Medical Center | Stanford | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ipilimumab/Nivolumab + Cryotherapy | 1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2 Ipilimumab: Ipilimumab 1 mg/kg, injection Cryoablation: Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures Nivolumab: Nivolumab 3 mg/kg, injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ipilimumab/Nivolumab + Cryotherapy | 1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2 Ipilimumab: Ipilimumab 1 mg/kg, injection Cryoablation: Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures Nivolumab: Nivolumab 3 mg/kg, injection |
| 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 | Clinical Response | Clinical benefit was assessed on the basis of clinical response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria:
Clinical benefit was defined as CR + PR. The primary outcome is expressed as the total number of participants who receive clinical benefit within 14 weeks, a number without dispersion. Rates of all clinical responses are reported. | Does not include participants taken off-study, and not evaluated for the outcome. | Posted | Count of Participants | Participants | 14 weeks |
|
2 years
Not provided
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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 | Ipilimumab/Nivolumab + Cryotherapy | 1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2 Ipilimumab: Ipilimumab 1 mg/kg, injection Cryoablation: Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures Nivolumab: Nivolumab 3 mg/kg, injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Ahern | Stanford Medicine at Stanford University | 650-725-6413 | mahern@stanford.edu |
Not provided
| 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 26, 2020 | Aug 17, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| D060908 | CTLA-4 Antigen |
| D003452 | Cryosurgery |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cryoablation | Procedure | Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures |
|
| Nivolumab | Drug | Nivolumab 3 mg/kg, injection |
|
|
| 24 months |
| Immune-related Clinical Response (irRECIST) Rate | The immune-related (ir) clinical response will be assessed per the immune-related Response Evaluation Criteria in Solid Tumors (ir-RECIST) criteria, as follows:
Note that irRECIST differs from RECIST criteria. The outcome is expressed as the total number of participants who achieve a ir-clinical response (ie, CR + PR) by 16 weeks, a number without dispersion. | 16 weeks |
| Progression-free Survival (PFS) | Progression-free survival (PFS) is a measure of participants remaining alive without disease progression. The outcome is expressed as the total number of participants remaining alive without disease progression at 6 months after consent, a number without dispersion. | 6 months |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| 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 |
|
| Ipilimumab/Nivolumab + Cryotherapy |
1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2 Ipilimumab: Ipilimumab 1 mg/kg, injection Cryoablation: Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures Nivolumab: Nivolumab 3 mg/kg, injection |
|
|
| Secondary | Related Adverse Events (Toxicity) | Adverse events were assessed per CTCAE version 5. The outcome is those adverse events experienced by participants that were determined to be possibly, probably, or definitely-related to study treatment. Serious adverse events are identified by the term "SAE." Results are presented as the number of related adverse events by preferred term that occurred. The data are numbers without dispersion. | Posted | Number | Related adverse events | 24 months |
|
|
|
| Secondary | Immune-related Clinical Response (irRECIST) Rate | The immune-related (ir) clinical response will be assessed per the immune-related Response Evaluation Criteria in Solid Tumors (ir-RECIST) criteria, as follows:
Note that irRECIST differs from RECIST criteria. The outcome is expressed as the total number of participants who achieve a ir-clinical response (ie, CR + PR) by 16 weeks, a number without dispersion. | Immune-related Response Evaluation Criteria in Solid Tumors (ir-RECIST) was not assessed/collected for some subjects, and cannot be reported. Reasons that ir-RECIST was not assessed included death, adverse event, and withdrawal/lost-to-follow-up subsequent to PD determination per RECIST at 14 weeks. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | Progression-free Survival (PFS) | Progression-free survival (PFS) is a measure of participants remaining alive without disease progression. The outcome is expressed as the total number of participants remaining alive without disease progression at 6 months after consent, a number without dispersion. | Does not include participants taken off-study, and not evaluated for the outcome. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 15 |
| 30 |
| 30 |
| 30 |
| 30 |
| 30 |
| Cardiac arrest | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Elevated ALT | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Elevated AST | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Disease Progression (death) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness, right-sided | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Motor deficit, right side | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Right apical pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Right pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Deep vein thrombois (DVT) of catheter | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent heart palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Decreased pulse | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ringing in the ears (tinnitus) | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophysitis | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry eyes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flashing lights | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent brief blurry vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Keratitis | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| L eye redness | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| L eye pain | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| L eye burning sensation | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| L eye blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| R eye blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Corneal abrasion | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent abdominal bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Increased abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea (intermittent) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent nausea/vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Decreased appetite | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Lack of appetite | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Low grade fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu-like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent chest pain to R sternal border exacerbated with deep inhalation | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent chills followed by hot flashes | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gum infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| UTI | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Other, Infectious diarrhea | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Other, Presumed pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Elevated TSH | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| TSH increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Decreased WBC count | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Elevated ALT | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgias | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle and joint aches | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lower back throbbing pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Right neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Right shoulder pain (Pain in extremity) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Gluteal pain and swelling | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Arm pain left | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Muscle aches and fatigue associated with COVID vaccine | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Right thigh pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Soreness to right lateral ribs | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Soreness at site of recent cryoablation (R lung) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Soreness right chest wall | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Soreness to left side at site of recent cryoablation | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Soreness, right shoulder | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Pain to right chest wall at recent site of cryo | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Pelvic bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Intermittent peripheral edema | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Weakness to left shoulder | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Worsening left leg weakness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness, left-sided | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness, right-sided | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy under R axilla | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Intermittent bilateral hand numbness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Motor deficit, left side | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Motor deficit, right side | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Neuropathic pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Occasional twitching sensation to anterior chest wall | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Intermittent left sciatic pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Worsening anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood tinge sputum | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent cough w/chest tightness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent cough with Blood tinge sputum | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Worsening cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Shortness of breath with exertion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hoarse voice | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Right pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Right apical pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tension pneumothorax (requiring ICU stay) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection (COVID-19) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Facial rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Maculo-papular rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Maculo-papular rash to bilateral arms | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Post-inflammatory hyperpigmentation on left breast | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tinea | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Burned hand | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Hair thinning | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Leg ulcer left | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Molluscum contagiousum on left arm | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000082102 | Immune Checkpoint Proteins |
| D061025 | Costimulatory and Inhibitory T-Cell Receptors |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D000945 | Antigens, Differentiation, T-Lymphocyte |
| D000943 | Antigens, Differentiation |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D015415 | Biomarkers |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| Title | Measurements |
|---|---|
|
| Hypothyroidism (diminished levels of thyroxine hormone) |
|
| Hypophysitis (inflammation of the pituitary gland) |
|
| Diarrhea |
|
| Diarrhea (intermittent) |
|
| Dry mouth |
|
| Allergic reaction |
|
| Thyroid stimulating hormone (TSH) elevated |
|
| Alanine aminotransferase (ALT) elevated |
|
| Hyponatremia (blood sodium level decreased) |
|
| Neuropathy, peripheral sensory |
|
| Numbness, bilateral hand, intermittent |
|
| Pain, neuropathic |
|
| Cough, all descriptions |
|
| Dyspnea (shortness of breath) |
|
| Hoarse voice |
|
| Pneumonitis (lung inflammation) |
|
| Pneumonitis (lung inflammation) (SAE) |
|
| Rash, all descriptions |
|
| Progressive disease (PD) |
|