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| Name | Class |
|---|---|
| R-Pharm US LLC. | INDUSTRY |
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This is a randomized, two-arm, open-label Phase II multicenter study designed to examine the effects of adding bevacizumab to ixabepilone for the treatment of patients who have recurrent or persistent platinum-resistant/refractory epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. Its primary objective is to assess whether adding bevacizumab to ixabepilone improves progression-free survival in its target population. Study participants will be stratified by (a) study site and (b) previous receipt of bevacizumab prior to randomization.
The primary objective of this study is as follows:
The secondary objectives of this study are as follows:
In addition to the primary and secondary objectives of this study, there are additional exploratory/correlative objectives. The exploratory/correlative objectives of this study are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixabepilone | Active Comparator | Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days |
|
| Ixabepilone + Bevacizumab | Experimental | Ixabepilone 20 mg/m2 days 1, 8, 15 + Bevacizumab 10 mg/kg days 1, 15 Q 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixabepilone | Drug | Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab | Progression-free survival (PFS), the primary endpoint, will be defined as the length of time from randomization to disease recurrence, disease progression, or death for any reason. The timeframe was updated upon results entry. | Up to 37 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Treatment response will be based on RECIST v1.1 Guidelines for measurable lesions. Objective response rate (ORR) includes evaluation for partial response (PR) or complete response (CR). Time frame was updated upon results entry. | Up to 37 months |
| Overall Survival (OS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab |
Not provided
Inclusion Criteria:
Patients may have serous, endometrioid, clear cell, carcinosarcoma, or transitional cell/malignant Brenner, mixed, or undifferentiated histologies.
Patients must have specimen available for immunohistochemistry for class III β-tubulin status; recurrent tumor specimen is preferred, though this may be performed on primary tumor if no recurrent tumor is available.
All patients must have measurable disease. Measurable disease is defined as lesions that can be measured by physical examination or by means of medical imaging techniques. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation or plain x-ray, or ≥ 10 mm when measured by spiral CT and/or MRI. Ascites and pleural effusions are not to be considered measurable disease.
Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST v1.1 Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
At the time of initial surgery, patients may have been optimally (<1 cm diameter residual disease) or sub-optimally (≥1 cm diameter of residual disease) debulked.
Patients with measurable recurrent disease of any previous stage (I-IV) are eligible to enrollment.
The diagnosis must be histologically confirmed by a gynecologic pathologist.
Patients must have adequate bone marrow, kidney, and liver function:
Patients must have an ECOG performance status of 0-2.
Patients must have signed an approved informed consent.
Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy. They should be free of significant infection.
Patients must have received prior treatment with taxanes. There is no limit on the number of prior lines of therapy.
Patients may have received prior bevacizumab therapy alone or in combination with chemotherapy. A 3-week washout period is required.
Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the study entry and be practicing an effective form of contraception (section 7.5.3).
Patients must be at least 18 years of age.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro D. Santin, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | 06510 | United States | ||
| Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of Maryland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35149854 | Result | Roque DM, Siegel ER, Buza N, Bellone S, Silasi DA, Huang GS, Andikyan V, Clark M, Azodi M, Schwartz PE, Rao GG, Reader JC, Hui P, Tymon-Rosario JR, Harold J, Mauricio D, Zeybek B, Menderes G, Altwerger G, Ratner E, Santin AD. Randomised phase II trial of weekly ixabepilone +/- biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer. Br J Cancer. 2022 Jun;126(12):1695-1703. doi: 10.1038/s41416-022-01717-6. Epub 2022 Feb 11. | |
| 39516558 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixabepilone | Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response |
| FG001 | Ixabepilone + Bevacizumab | Ixabepilone 20 mg/m2 days 1, 8, 15 + Bevacizumab 10 mg/kg days 1, 15 Q 28 days Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only those that remained on study are included in the baseline characteristics.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ixabepilone | Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response |
| 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 | Progression-free Survival (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab | Progression-free survival (PFS), the primary endpoint, will be defined as the length of time from randomization to disease recurrence, disease progression, or death for any reason. The timeframe was updated upon results entry. | Those completing treatment post randomization | Posted | Median | Inter-Quartile Range | months | Up to 37 months |
|
Up to 37 months
Not provided
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 | Ixabepilone | Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Santin, MD | Yale School of Medicine/Yale Cancer Center | (203) 737-4450 | alessandro.santin@yale.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 | Feb 18, 2021 | Mar 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C430592 | ixabepilone |
| D000068258 | Bevacizumab |
| 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
|
|
| Bevacizumab | Drug | Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response. |
|
|
Overall survival (OS) is defined as time from randomization to death from any cause. Time frame was updated upon results entry. |
| Up to 37 months |
| Number of Participants With Treatment Related SAEs | Safety profile of Ixabepilone in combination with Bevacizumab as defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Presented are the number of participants that experienced SAE's related to study drug. Full reporting of adverse events is presented in the Adverse Events module. Time frame was updated upon results entry. | Up to 37 months |
| Differences in Response to the Combination of Ixabepilone and Bevacizumab in Relationship to Previous Treatment With Bevacizumab and Taxanes | Assess whether prior treatment with Taxanes impacts future response to Bevacizumab in combination with Ixabepilone. BEST RESPONSE using RECIST Criteria- Complete Response (CR): The disappearance of all target lesions. There should be no evidence of disease, and any pathological lymph nodes must have reduced in size to normal (short axis less than 10 mm). Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesion | Up to 41 months |
| Durable Disease Control Rate (DDCR) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab | Treatment response will be based on RECIST v1.1 Guidelines for measurable lesions. Objective response rate (ORR) includes evaluation for partial response (PR) or complete response (CR). Durable Disease Control (DDC) is defined as complete response (CR), partial response (PR), or stable disease (SD) ≥6 months from date of best response. Presented are the counts of those that achieved DDC. | 5 Years |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Derived |
| Roque DM, Siegel ER, Buza N, Bellone S, Huang GS, Altwerger G, Andikyan V, Clark M, Azodi M, Schwartz PE, Rao GG, Ratner E, Santin AD. Randomized phase II trial of weekly ixabepilone +/- biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer (NCT03093155): Updated survival and subgroup analyses. BJC Rep. 2024 Jun 20;2(1):43. doi: 10.1038/s44276-024-00067-5. |
| 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. |
| BG001 | Ixabepilone + Bevacizumab | Ixabepilone 20 mg/m2 days 1, 8, 15 + Bevacizumab 10 mg/kg days 1, 15 Q 28 days Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ECOG Performance Status | The Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale ranges from 0 to 5. 0: Fully active; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework or office work; 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4: Completely disabled. Cannot carry out any self-care. Totally confined to bed or chair; 5: Dead. | Count of Participants | Participants |
|
| Histology | Count of Participants | Participants |
|
| Prior Lines of Chemotherapy | Count of Participants | Participants |
|
| Prior Bevacizumab | Count of Participants | Participants |
|
| OG001 | Ixabepilone + Bevacizumab | Ixabepilone 20 mg/m2 days 1, 8, 15 + Bevacizumab 10 mg/kg days 1, 15 Q 28 days Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response. |
|
|
|
| Secondary | Objective Response Rate (ORR) | Treatment response will be based on RECIST v1.1 Guidelines for measurable lesions. Objective response rate (ORR) includes evaluation for partial response (PR) or complete response (CR). Time frame was updated upon results entry. | Those completing treatment post randomization | Posted | Count of Participants | Participants | Up to 37 months |
|
|
|
|
| Secondary | Overall Survival (OS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab | Overall survival (OS) is defined as time from randomization to death from any cause. Time frame was updated upon results entry. | Those completing treatment post randomization | Posted | Median | Inter-Quartile Range | months | Up to 37 months |
|
|
|
|
| Secondary | Number of Participants With Treatment Related SAEs | Safety profile of Ixabepilone in combination with Bevacizumab as defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Presented are the number of participants that experienced SAE's related to study drug. Full reporting of adverse events is presented in the Adverse Events module. Time frame was updated upon results entry. | Those completing treatment post randomization | Posted | Count of Participants | Participants | Up to 37 months |
|
|
|
|
| Secondary | Differences in Response to the Combination of Ixabepilone and Bevacizumab in Relationship to Previous Treatment With Bevacizumab and Taxanes | Assess whether prior treatment with Taxanes impacts future response to Bevacizumab in combination with Ixabepilone. BEST RESPONSE using RECIST Criteria- Complete Response (CR): The disappearance of all target lesions. There should be no evidence of disease, and any pathological lymph nodes must have reduced in size to normal (short axis less than 10 mm). Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesion | Those with prior Taxanes treatment. | Posted | Count of Participants | Participants | Up to 41 months |
|
|
|
|
| Secondary | Durable Disease Control Rate (DDCR) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab | Treatment response will be based on RECIST v1.1 Guidelines for measurable lesions. Objective response rate (ORR) includes evaluation for partial response (PR) or complete response (CR). Durable Disease Control (DDC) is defined as complete response (CR), partial response (PR), or stable disease (SD) ≥6 months from date of best response. Presented are the counts of those that achieved DDC. | Those completing treatment post randomization | Posted | Count of Participants | Participants | 5 Years |
|
|
|
| 36 |
| 37 |
| 24 |
| 37 |
| 36 |
| 37 |
| EG001 | Ixabepilone + Bevacizumab | Ixabepilone 20 mg/m2 days 1, 8, 15 + Bevacizumab 10 mg/kg days 1, 15 Q 28 days Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response. | 34 | 39 | 16 | 39 | 39 | 39 |
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Colonic obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Colonic perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Duodenal perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Edema limbs | General disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Lung infection | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Skin infection | Infections and infestations | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Creatinine increased | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
|
| Presyncope | Nervous system disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Confusion | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | Non-systematic Assessment |
|
| Eye disorders - Other, specify | Eye disorders | Non-systematic Assessment |
|
| Cataract | Eye disorders | Non-systematic Assessment |
|
| Dry eye | Eye disorders | Non-systematic Assessment |
|
| Watering eyes | Eye disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fecal incontinence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Colonic fistula | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | Non-systematic Assessment |
|
| Edema limbs | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Infusion related reaction | General disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Flu like symptoms | General disorders | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Gait disturbance | General disorders | Non-systematic Assessment |
|
| Infusion site extravasation | General disorders | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | Non-systematic Assessment |
|
| Catheter related infection | Infections and infestations | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | Non-systematic Assessment |
|
| Rhinitis infective | Infections and infestations | Non-systematic Assessment |
|
| Soft tissue infection | Infections and infestations | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Weight loss | Investigations | Non-systematic Assessment |
|
| Creatinine increased | Investigations | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Investigations - Other, specify | Investigations | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | Non-systematic Assessment |
|
| Stroke | Nervous system disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Nail discoloration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Nail loss | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Vascular disorders - Other, specify | Vascular disorders | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Stable Disease (SD) |
|
| Progressive Disease (PD) |
|
| Not Assessed |
|