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Feasibility study to assess a novel combination of cytotoxic agents, docetaxel and oxaliplatin, as first-line therapy in the treatment of ovarian cancer and the impact of angiogenesis inhibition for the progression and prognosis of ovarian cancer by concurrent addition of bevacizumab (Avastin®).
Participants were
Participants were followed for survival for a minimum 3 years from the date of enrollment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxaliplatin/Docetaxel/Bevacizumab | Experimental | Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab (Avastin®) | Drug | 15 mg/kg bevacizumab administered intravenously (IV) over 30 to 90 minutes on Day 1 of every 3 week cycle for 12 months or until disease progression or unacceptable toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Twelve-month Progression-free Survival (PFS) Rate in Participants | Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following:
Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS. | up to 12 months following treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Twenty Four-month Progression-free Survival (PFS) Rate in Participants | Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following:
Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS. |
Not provided
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Participants with a current diagnosis of epithelial ovarian tumor of low malignant potential (Borderline carcinomas) are not eligible. Participants with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for any ovarian tumor.
Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from other sites to the ovary and low malignant potential tumors including so called micropapillary serous carcinomas are not eligible.
Participants who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the skin is permitted, provided that it was completed more than 5 years prior to enrollment, and the participant remains free of recurrent or metastatic disease.
Participants who have received any prior anticancer chemotherapy or biologic therapy for any malignancy are excluded.
Participants with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: Stage not greater than I-B; Less than 3 mm invasion without vascular or lymphatic invasion; No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO Grade 3 lesions.
Participants with any history of cancer, with the exception of inclusion criteria #2 and #3, and non-melanoma skin cancer, who are cancer free for the last 5 years, are excluded.
Participant with acute hepatitis or active infection that requires parenteral antibiotics.
Participants with serious, non-healing wound, ulcer, or bone fracture. This includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.
Participants with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations.
Participants with active bleeding or pathologic conditions that carry high risk of bleeding,such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
Participants with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.
Participants with clinically significant cardiovascular disease.
Participants with clinically significant proteinuria. Urine protein should be screened by urinalysis. Participants discovered to have a urine protein: serum creatinine ratio greater than or equal to 1 should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 1000 mg protein/24 hr to allow participation in the study.
Participants with or with anticipation of invasive procedures.
Participants with GOG Performance Grade of 3 or 4.
Participants who are pregnant or nursing.
Participants with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies and hypersensitivity to polysorbate 80 or hypersensitivity to any of the study drugs and its ingredients.
Participants who participated in a study with any investigational product/device within the last 30 days.
Any medical condition that in the judgment of the investigator would jeopardize any participant safety or the study drug evaluation for efficacy and safety.
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| Name | Affiliation | Role |
|---|---|---|
| Phyllis Diener, BS, MT (ASCP) | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States |
Not provided
152 participants were screened for the study. 20 were screen failures. 132 participants met eligibity criteria and were treated with study medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxaliplatin/Docetaxel/Bevacizumab | Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Oxaliplatin/Docetaxel/Bevacizumab (Measurable Disease) | Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, with a measurable disease at baseline. Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Twelve-month Progression-free Survival (PFS) Rate in Participants | Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following:
Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS. | Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 12 months following treatment initiation |
|
Not provided
AEs were collected up to 30 days after the administration of the last study dose.
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 | Oxaliplatin/Docetaxel/Bevacizumab | Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 |
One site closed prematurely during the study. Every effort was made to collect, at minimum, any outstanding safety data for the participants at this site. As a result, participants from this site were included only in the safety analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Trans[parency Team | Sanofi | Contact_us@sanofi.com |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077143 | Docetaxel |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
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| Docetaxel (Taxotere®) | Drug | 75 mg/m^2 docetaxel was administered IV over 1 hour on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity |
|
| Oxaliplatin (Eloxatin®) | Drug | 85 mg/m^2 Oxaliplatin was administered IV over 2 hours on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity |
|
| up to 24 months following treatment initiation |
| Median Time to Progression-free Survival (PFS) | Time to PFS was the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first. Time of PFS was censored
Median PFS was estimated from a Kaplan-Meier curve. | up to approximately 1300 days following treatment initiation |
| Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) | Tumors were assessed by CT and MRI. Tumor response was evaluated by GOG RECIST in which:
Participants with a response (CR or PR) were to have the initial response confirmed by tumor imaging in 4-6 weeks. | up to 12 months following treatment initiation |
| Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline | Participants with Recurrence-free survival (RFS) were participants with a non-measurable disease at baseline, who had not achieved disease progression nor had died. Disease progression included the following:
RFS rate was the percent of participants in the non-measurable disease subgroup who achieved RFS. | up to 12 months following treatment initiation |
| Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline | The time to RFS was programmatically defined as the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first. Participants were
| up to approximately 1500 days following treatment initiation |
| CA-125 Response Rate | A CA-125 response was considered at least a 50% reduction in the level of the biomarker, CA-125, from a pretreatment level, which was confirmed and maintained for at least 28 days. The overall CA-125 biomarker response rate was defined as the number of participants in the measurable disease subgroup who met the above criteria at least once within the study treatment period +21 days, divided by the number of evaluable participants in the disease subgroup. | up to 12 months after treatment initiation |
| Overall Survival Rate | Survival was the observed length of life from entry into the study to death or the date of last contact. The overall survival rate (percentage of participants showing survival) at 12 and 24-months is reported here. | up to up to approximately 1700 days after treatment initiation |
| Median Overall Survival Time | Survival was the observed length of life from entry into the study to death or the date of last contact. The median overall survival time was estimated using Kaplan-Meier Curve. | up to approximately 1700 days after treatment initiation |
| Non-compliance |
|
| Missing for end of treatment |
|
| Progression based on CA-125 (biomarker) |
|
| Poor performance status |
|
| Relocation to Florida |
|
| Noncompliance/decision to discontinue |
|
| Urine protein/creatinine ratio delay |
|
| Neuropathy/patient preference |
|
| Proteinuria |
|
| ineligibility due to radiation treatment |
|
| BG001 | Oxaliplatin/Docetaxel/Bevacizumab (Non-Measurable Disease) | Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, who did not have a measurable disease at baseline. Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Primary Tumor Site | Number | participants |
|
| FIGO stage at diagnosis | Ovarian cancer staging at diagnosis was based on the International Federation of Gynecology and Obstetrics (FIGO).
| Number | participants |
|
Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery |
|
|
| Secondary | Twenty Four-month Progression-free Survival (PFS) Rate in Participants | Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following:
Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS. | Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 24 months following treatment initiation |
|
|
|
| Secondary | Median Time to Progression-free Survival (PFS) | Time to PFS was the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first. Time of PFS was censored
Median PFS was estimated from a Kaplan-Meier curve. | Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available. | Posted | Median | 95% Confidence Interval | days | up to approximately 1300 days following treatment initiation |
|
|
|
| Secondary | Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) | Tumors were assessed by CT and MRI. Tumor response was evaluated by GOG RECIST in which:
Participants with a response (CR or PR) were to have the initial response confirmed by tumor imaging in 4-6 weeks. | Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available. | Posted | Number | participants | up to 12 months following treatment initiation |
|
|
|
| Secondary | Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline | Participants with Recurrence-free survival (RFS) were participants with a non-measurable disease at baseline, who had not achieved disease progression nor had died. Disease progression included the following:
RFS rate was the percent of participants in the non-measurable disease subgroup who achieved RFS. | All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 12 months following treatment initiation |
|
|
|
| Secondary | Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline | The time to RFS was programmatically defined as the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first. Participants were
| All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures. | Posted | Median | 95% Confidence Interval | days | up to approximately 1500 days following treatment initiation |
|
|
|
| Secondary | CA-125 Response Rate | A CA-125 response was considered at least a 50% reduction in the level of the biomarker, CA-125, from a pretreatment level, which was confirmed and maintained for at least 28 days. The overall CA-125 biomarker response rate was defined as the number of participants in the measurable disease subgroup who met the above criteria at least once within the study treatment period +21 days, divided by the number of evaluable participants in the disease subgroup. | All participants with non-measurable and measurable disease at baseline, and a pretreatment sample that was at least twice the ULN value for CA-125 within 2 weeks of first study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 12 months after treatment initiation |
|
|
|
| Secondary | Overall Survival Rate | Survival was the observed length of life from entry into the study to death or the date of last contact. The overall survival rate (percentage of participants showing survival) at 12 and 24-months is reported here. | Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available. | Posted | Number | 95% Confidence Interval | percentage of participants | up to up to approximately 1700 days after treatment initiation |
|
|
|
| Secondary | Median Overall Survival Time | Survival was the observed length of life from entry into the study to death or the date of last contact. The median overall survival time was estimated using Kaplan-Meier Curve. | Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available. | Posted | Median | 90% Confidence Interval | days | up to approximately 1700 days after treatment initiation |
|
|
|
| 33 |
| 132 |
| 130 |
| 132 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.1 |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 13.1 |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 13.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 13.1 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 |
|
| Colitis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Colonic fistula | Gastrointestinal disorders | MedDRA 13.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Ileus | Gastrointestinal disorders | MedDRA 13.1 |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 13.1 |
|
| Peritoneal adhesions | Gastrointestinal disorders | MedDRA 13.1 |
|
| Fatigue | General disorders | MedDRA 13.1 |
|
| Non-cardiac chest pain | General disorders | MedDRA 13.1 |
|
| Oedema peripheral | General disorders | MedDRA 13.1 |
|
| Pain | General disorders | MedDRA 13.1 |
|
| Pyrexia | General disorders | MedDRA 13.1 |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 13.1 |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 13.1 |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 13.1 |
|
| Abdominal abscess | Infections and infestations | MedDRA 13.1 |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 |
|
| Wound infection | Infections and infestations | MedDRA 13.1 |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 |
|
| Encephalopathy | Nervous system disorders | MedDRA 13.1 |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 13.1 |
|
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 13.1 |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Hypertension | Vascular disorders | MedDRA 13.1 |
|
| Poor venous access | Vascular disorders | MedDRA 13.1 |
|
| Venous thrombosis | Vascular disorders | MedDRA 13.1 |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 13.1 |
|
| Lacrimation increased | Eye disorders | MedDRA 13.1 |
|
| Vision blurred | Eye disorders | MedDRA 13.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 13.1 |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 13.1 |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 13.1 |
|
| Oral pain | Gastrointestinal disorders | MedDRA 13.1 |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 |
|
| Flatulence | Gastrointestinal disorders | MedDRA 13.1 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 |
|
| Fatigue | General disorders | MedDRA 13.1 |
|
| Oedema peripheral | General disorders | MedDRA 13.1 |
|
| Asthenia | General disorders | MedDRA 13.1 |
|
| Pain | General disorders | MedDRA 13.1 |
|
| Malaise | General disorders | MedDRA 13.1 |
|
| Pyrexia | General disorders | MedDRA 13.1 |
|
| Chest pain | General disorders | MedDRA 13.1 |
|
| Mucosal inflammation | General disorders | MedDRA 13.1 |
|
| Temperature intolerance | General disorders | MedDRA 13.1 |
|
| Hypersensitivity | Immune system disorders | MedDRA 13.1 |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 |
|
| Sinusitis | Infections and infestations | MedDRA 13.1 |
|
| Rhinitis | Infections and infestations | MedDRA 13.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 |
|
| Neutrophil count | Investigations | MedDRA 13.1 |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.1 |
|
| Weight decreased | Investigations | MedDRA 13.1 |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.1 |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.1 |
|
| Headache | Nervous system disorders | MedDRA 13.1 |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 13.1 |
|
| Dysgeusia | Nervous system disorders | MedDRA 13.1 |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.1 |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 |
|
| Depression | Psychiatric disorders | MedDRA 13.1 |
|
| Anxiety | Psychiatric disorders | MedDRA 13.1 |
|
| Proteinuria | Renal and urinary disorders | MedDRA 13.1 |
|
| Dysuria | Renal and urinary disorders | MedDRA 13.1 |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 13.1 |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Hypertension | Vascular disorders | MedDRA 13.1 |
|
| Flushing | Vascular disorders | MedDRA 13.1 |
|
| Hot flush | Vascular disorders | MedDRA 13.1 |
|
The sponsor encourages the publication of the results of their studies, using only clean, checked and validated data in order to ensure the accuracy of the results.
At least 45 days in advance of proposed submission, the Investigator should forward a copy of the manuscript or abstract for review by the sponsor, and, if necessary, delay publication or communication for a limited time in order to protect the confidentiality or proprietary nature of any information contained therein.
| 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| Title | Measurements |
|---|---|
|
| Unconfirmed progressive disease (PD) |
|
| Confirmed response (CR+PR) |
|
| Confirmed complete response (CR) |
|
| Confirmed partial response (PR) |
|