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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01597 | Registry Identifier | NCI CTRP | |
| CDR0000567043 | Registry Identifier | PDQ |
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RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with celecoxib may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide together with celecoxib works compared to cyclophosphamide alone in treating patients with recurrent or persistent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
OBJECTIVES:
I. To assess the response rates in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer who are treated with oral cyclophosphamide alone or oral cyclophosphamide with celecoxib.
II. To assess the time to disease progression in this group of patients. III. To further describe the toxicities of oral cyclophosphamide with or without celecoxib in the above patient population.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral cyclophosphamide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive oral cyclophosphamide once daily and oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Active Comparator | Patients receive oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Arm II | Experimental | Patients receive oral cyclophosphamide once daily and oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide | Drug | Given orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | Up to 3 years |
| Time to Treatment Failure | Estimated using the product-limit method of Kaplan and Meier. Time to treatment failure is defined as the time from initial treatment to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, and death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Up to 3 years |
| Overall Survival | Estimated using the product-limit method of Kaplan and Meier. From time of initial treatment to death from any cause. | Up to 5 years |
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Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Chung | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| City of Hope Medical Group Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37185961 | Derived | Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Cyclophosphamide Alone) | Patients receive 50 mg oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
| FG001 | Arm II (Cyclophosphamide + Celecoxib) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2019 |
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| celecoxib | Drug | Given orally |
|
|
| Pasadena |
| California |
| 91105 |
| United States |
Patients receive 50 mg oral cyclophosphamide once daily and 400 mg oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Cyclophosphamide Alone) | Patients receive 50 mg oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
| BG001 | Arm II (Cyclophosphamide + Celecoxib) | Patients receive 50 mg oral cyclophosphamide once daily and 400 mg oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Karnofsky performance status | 100 Normal no complaints; no evidence of disease 90 Normal activity; minor signs\symptoms of disease 80 Normal activity with effort; some signs\symptoms of disease 70 Cares for self; unable to carry on normal activity or to do active work 60 Requires occasional assistance, can care for most personal needs 50 Requires considerable assistance and frequent medical care 40 Disabled; requires special care\assistance 30 Severely disabled; hospital admission is indicated, death not imminent 20 Very sick; hospital admission necessary; active supportive treatment 10 Moribund 0 Dead | Median | Full Range | units on a scale |
|
| 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 | Overall Response | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | Posted | Count of Participants | Participants | Up to 3 years |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Time to Treatment Failure | Estimated using the product-limit method of Kaplan and Meier. Time to treatment failure is defined as the time from initial treatment to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, and death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Posted | Median | 95% Confidence Interval | Months | Up to 3 years |
|
| ||||||||||||||||||||||||||||||
| Primary | Overall Survival | Estimated using the product-limit method of Kaplan and Meier. From time of initial treatment to death from any cause. | Posted | Median | 95% Confidence Interval | Months | Up to 5 years |
|
|
Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Cyclophosphamide Alone) | Patients receive 50 mg oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. | 26 | 26 | 4 | 26 | 26 | 26 |
| EG001 | Arm II (Cyclophosphamide + Celecoxib) | Patients receive 50 mg oral cyclophosphamide once daily and 400 mg oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. | 26 | 26 | 8 | 26 | 26 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal fistula | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| General symptom | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum calcium increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | meddra10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspareunia | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Haemorrhage NOS | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Lymphangiopathy NOS | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Lymphatic disorder | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Transfusion: pRBCs | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Incontinence | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Salivary gland disorder | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Chills | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Edema | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Edema limbs | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fever | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| General symptom | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Localized edema | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Oedema NOS | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pain | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Bladder infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | meddra9.0 | Non-systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | meddra10.0 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Bilirubin increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Leukocyte count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Leukopenia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Weight gain | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Weight loss | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum calcium increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum glucose decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum magnesium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum magnesium increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum phosphate decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum potassium increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra9.0 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Taste alteration | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Psychosis | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Blood urine present | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hematuria (in the absence of vaginal bleeding) | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hemoglobinuria | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Protein urine positive | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | meddra10.0 | Non-systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | meddra10.0 | Non-systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra10.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope | 626-218-5265 | pfrankel@coh.org |
| Mar 22, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| Hispanic |
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| White non-Hispanic |
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| Native American |
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| Unknown |
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