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This is a single-arm open-label multi-cohort Phase II study evaluating the safety/tolerability and clinical activity of the combination of nab-paclitaxel and the antibody against programmed cell death 1 (PD-1), pembrolizumab, in patients with human epidermal growth factor receptor (HER-2) negative metastatic breast cancer (n=50). There will be two cohorts of patients consisting of a triple negative breast cancer (TNBC) cohort with 30 subjects and a hormone receptor (HR)-positive cohort with 20 subjects. There will be an initial safety run-in with 12 subjects from the TNBC and HR-positive cohort (~ 6 patients from each cohort). If no unexpected toxicity is observed (as defined in the study protocol), then enrollment will continue to complete both cohorts (30 total TNBC, 20 total in HR positive cohort). The subjects from the run in safety part will be included in the Phase II analysis. Tumor expression of programmed cell death ligand 1 (PD-L1) is not required for enrollment in the study, but will be assessed as possible predictive marker.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR-Positive Participants | Experimental | Participants with HR-positive metastatic breast cancer will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day treatment cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle. |
|
| cTNBC Participants | Experimental | Participants with TNBC-positive metastatic breast cancer who in the chemotherapy run-in group (cNTBC) will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle. |
|
| iTNBC Participants | Experimental | Participants with TNBC-positive metastatic breast cancer in the immunotherapy run-in group (cNTBC) will receive pembrolizumab 200mg IV on day 1 of the first 21-day treatment cycle. nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day cycle, the participants will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle, in addition to pembrolizumab 200mg IV on day 1 of the cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best Overall Response Rate (BORR) of Complete Response or Partial Response | Overall response measured by RECIST version 1.1 and will be used in this study for assessment of tumor response. Complete response (CR) defined as disappearance of all target lesions; and partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Up to Year 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS defined as the time from initial treatment to documented disease progression or death. | Up to Year 2 |
| Overall Survival (OS) | OS defined as the time from initial treatment to death due to any cause. |
Not provided
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Klar, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Perlmutter Cancer Center | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HR-Positive Participants | Participants with HR-positive metastatic breast cancer will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day treatment cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle. Pembrolizumab Nab-Paclitaxel |
| FG001 | cTNBC Participants | Participants with TNBC-positive metastatic breast cancer who in the chemotherapy run-in group (cNTBC) will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle. Pembrolizumab Nab-Paclitaxel |
| FG002 | iTNBC Participants | Participants with TNBC-positive metastatic breast cancer in the immunotherapy run-in group (cNTBC) will receive pembrolizumab 200mg IV on day 1 of the first 21-day treatment cycle. nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day cycle, the participants will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle, in addition to pembrolizumab 200mg IV on day 1 of the cycle. Pembrolizumab Nab-Paclitaxel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HR-Positive Participants | Participants with HR-positive metastatic breast cancer will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day treatment cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle. Pembrolizumab Nab-Paclitaxel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Best Overall Response Rate (BORR) of Complete Response or Partial Response | Overall response measured by RECIST version 1.1 and will be used in this study for assessment of tumor response. Complete response (CR) defined as disappearance of all target lesions; and partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Posted | Count of Participants | Participants | Up to Year 2 |
|
2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
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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 | HR-Positive Participants | Participants with HR-positive metastatic breast cancer will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day treatment cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle. Pembrolizumab Nab-Paclitaxel |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sylvia Adams, MD | NYU Langone Health | 212-731-5795 | Sylvia.Adams@nyulangone.org |
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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 | Aug 3, 2021 | Dec 22, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
Not provided
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| Nab-Paclitaxel | Drug |
|
|
| Up to Year 2 |
| Disease Control Rate (DCR) | Percentage of patients whose disease shrinks or remains stable over a certain time period. | Up to Year 2 |
| Duration of Response (DOR) | Defined as the time from onset of response to progression or death due to any reason, whichever occurs earlier. | Up to Year 2 |
| BG001 | cTNBC Participants | Participants with TNBC-positive metastatic breast cancer who in the chemotherapy run-in group (cNTBC) will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle. Pembrolizumab Nab-Paclitaxel |
| BG002 | iTNBC Participants | Participants with TNBC-positive metastatic breast cancer in the immunotherapy run-in group (cNTBC) will receive pembrolizumab 200mg IV on day 1 of the first 21-day treatment cycle. nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day cycle, the participants will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle, in addition to pembrolizumab 200mg IV on day 1 of the cycle. Pembrolizumab Nab-Paclitaxel |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
| OG001 | cTNBC Participants | Participants with TNBC-positive metastatic breast cancer who in the chemotherapy run-in group (cNTBC) will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle. Pembrolizumab Nab-Paclitaxel |
| OG002 | iTNBC Participants | Participants with TNBC-positive metastatic breast cancer in the immunotherapy run-in group (iNTBC) will receive pembrolizumab 200mg IV on day 1 of the first 21-day treatment cycle. nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day cycle, the participants will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle, in addition to pembrolizumab 200mg IV on day 1 of the cycle. Pembrolizumab Nab-Paclitaxel |
|
|
| Secondary | Progression Free Survival (PFS) | PFS defined as the time from initial treatment to documented disease progression or death. | Not Posted | Jun 2025 | Up to Year 2 | Participants |
| Secondary | Overall Survival (OS) | OS defined as the time from initial treatment to death due to any cause. | Not Posted | Jun 2025 | Up to Year 2 | Participants |
| Secondary | Disease Control Rate (DCR) | Percentage of patients whose disease shrinks or remains stable over a certain time period. | Not Posted | Jun 2025 | Up to Year 2 | Participants |
| Secondary | Duration of Response (DOR) | Defined as the time from onset of response to progression or death due to any reason, whichever occurs earlier. | Not Posted | Jun 2025 | Up to Year 2 | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 20 |
| 20 |
| EG001 | cTNBC Participants | Participants with TNBC-positive metastatic breast cancer who in the chemotherapy run-in group (cNTBC) will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle. Pembrolizumab Nab-Paclitaxel | 0 | 30 | 0 | 30 | 30 | 30 |
| EG002 | iTNBC Participants | Participants with TNBC-positive metastatic breast cancer in the immunotherapy run-in group (iNTBC) will receive pembrolizumab 200mg IV on day 1 of the first 21-day treatment cycle. nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day cycle, the participants will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle, in addition to pembrolizumab 200mg IV on day 1 of the cycle. Pembrolizumab Nab-Paclitaxel | 0 | 20 | 0 | 20 | 20 | 20 |
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | Systematic Assessment |
|
| Alopecia | Immune system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Thrombocytopenia | Investigations | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Blurred vision | Eye disorders | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Creatinine increased | Investigations | Systematic Assessment |
|
| Delirium | Psychiatric disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dry eye | Eye disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ear and labyrinth disorder | Ear and labyrinth disorders | Systematic Assessment |
|
| Edema limbs | General disorders | Systematic Assessment |
|
| Increased LDH | Endocrine disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Esophageal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Eye Infection | Eye disorders | Systematic Assessment |
|
| Light Flash | Eye disorders | Systematic Assessment |
|
| Vision Change | Eye disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Flu like symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gait disturbance | General disorders | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| Esophageal Spams | Gastrointestinal disorders | Systematic Assessment |
|
| Oral Swelling (Jaw/Gum) | Gastrointestinal disorders | Systematic Assessment |
|
| Early Satiety | Gastrointestinal disorders | Systematic Assessment |
|
| Stomatitis (Mouth Sores) | Gastrointestinal disorders | Systematic Assessment |
|
| Lip Mouth Sores Right Buccal, Tongue | Gastrointestinal disorders | Systematic Assessment |
|
| Biopsy Site Pain | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hot flashes | Vascular disorders | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypotension | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Seasonal allergies | Immune system disorders | Systematic Assessment |
|
| chest discomfort- upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
|
| Chest discomfort-UTI | Infections and infestations | Systematic Assessment |
|
| chest discomfort-Periocular/Orbital Rash Bilateral | Infections and infestations | Systematic Assessment |
|
| chest discomfort-viral gastroenteritis | Infections and infestations | Systematic Assessment |
|
| chest discomfort-Oral Thrush | Infections and infestations | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Irregular menstruation | Reproductive system and breast disorders | Systematic Assessment |
|
| Lip infection | Infections and infestations | Systematic Assessment |
|
| Localized edema | Vascular disorders | Systematic Assessment |
|
| Lymphedema | Vascular disorders | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
|
| joint stiffness-left fingers | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Leg Cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Aching Feet | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nail ridging | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Aggitation | Nervous system disorders | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Oral hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | Systematic Assessment |
|
| Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Papulopustular rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Paresthesia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Periorbital edema | Eye disorders | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| hesitancy | Renal and urinary disorders | Systematic Assessment |
|
| dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Vaginal Irritation Desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Scalp Folliculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema (Mediport Site) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Contrast Initiated Right Hand Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritic Rash - Upper Chest | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythematous Patches AC + Popliteal Fossa | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Left Foot Bottom Skin Peeling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Soft Tissue Lump (Left Flank) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | Systematic Assessment |
|
| Vaginal dryness | Reproductive system and breast disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Weight gain | Investigations | Systematic Assessment |
|
| Weight loss | Investigations | Systematic Assessment |
|
| White blood cell decreased | Investigations | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dermatitis radiation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Edema face | General disorders | Systematic Assessment |
|
| decreased T4 Free | Endocrine disorders | Systematic Assessment |
|
| increased TSH | Endocrine disorders | Systematic Assessment |
|
| T3 Increased | Endocrine disorders | Systematic Assessment |
|
| T4 Increased | Endocrine disorders | Systematic Assessment |
|
| TSH decreased | Endocrine disorders | Systematic Assessment |
|
| decreased visual activity (when reading small print) | Eye disorders | Systematic Assessment |
|
| Right upper eye swelling | Eye disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Systematic Assessment |
|
| Facial pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Floaters | Eye disorders | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| blood on toilet tissue | Gastrointestinal disorders | Systematic Assessment |
|
| gas | Gastrointestinal disorders | Systematic Assessment |
|
| loose stool | Gastrointestinal disorders | Systematic Assessment |
|
| Ulcers | Gastrointestinal disorders | Systematic Assessment |
|
| Lower leg extremity edema | Gastrointestinal disorders | Systematic Assessment |
|
| left hand edema | Gastrointestinal disorders | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | Systematic Assessment |
|
| Glaucoma | Eye disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Influenza A | Infections and infestations | Systematic Assessment |
|
| Parotitis | Infections and infestations | Systematic Assessment |
|
| possible device related infection | Infections and infestations | Systematic Assessment |
|
| Rhinovirus | Infections and infestations | Systematic Assessment |
|
| sinus infection | Infections and infestations | Systematic Assessment |
|
| Left Ankle Sprained | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Irritability | Psychiatric disorders | Systematic Assessment |
|
| Lung infection | Infections and infestations | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Baker's cyst L.popliteal fossa | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Baker's cyst right leg | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Feet Soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Left Toes Cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Right Toes Cramping (Curling) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nail discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nail infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Right Breast Feeling Swollen | Reproductive system and breast disorders | Systematic Assessment |
|
| Spotting | Reproductive system and breast disorders | Systematic Assessment |
|
| Scalp pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bilateral Redness of Feet | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Chest induration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ecchymosis Right Heel | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ingrown Toe Nails | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Left Breast Burning Sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Lesion on Right Chest | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Lipoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| LLE erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Neck Rash - Left Trapezium | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| onycholysis loose nails | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| right breast/chest erythema (dermatitis) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tinea Capitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Verrusa Vulgaris | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | Systematic Assessment |
|
| Vulval infection | Reproductive system and breast disorders | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Albumin | Blood and lymphatic system disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Breast infection | Infections and infestations | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cardiac troponin I increased | Investigations | Systematic Assessment |
|
| Cardiac troponin T increased | Investigations | Systematic Assessment |
|
| CD4 lymphocytes decreased | Investigations | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| DVT | Vascular disorders | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
|
| Edema Cerebral Peritumoral | Nervous system disorders | Systematic Assessment |
|
| Mouth Abrasions (Oral Mucosa) | Gastrointestinal disorders | Systematic Assessment |
|
| Heart failure | Cardiac disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | Systematic Assessment |
|
| Folic Acid Deficiency | Metabolism and nutrition disorders | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | Systematic Assessment |
|
| Oral dysesthesia | Gastrointestinal disorders | Systematic Assessment |
|
| Pain- Lower Back | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain Right Breast | Reproductive system and breast disorders | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | Systematic Assessment |
|
| Left Nipple Discharge | Reproductive system and breast disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute Hypoxic Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Right neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
|
| Left Breast scarring | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Heat Rash Arms | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Facial acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash Right Nare | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| skin infection | Infections and infestations | Systematic Assessment |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| tachycardia | Cardiac disorders | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |