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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006979-72 | EudraCT Number | ||
| U1111-1187-6616 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the anti-tumour activity of alisertib (MLN8237) in the treatment of participants with platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinomas.
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. This study looked at the antitumor activity by response rate who would take alisertib.
The study enrolled 31 patients. Participants were categorized as per the disease state into 2 categories, refractory and resistant. Participants received:
• Alisertib 50 mg
All participants took alisertib 50 mg capsules every 12 hours each day for 7 days followed by a 14-day rest period in a 21-day cycle (up to 26 cycles).
This multi-center trial was conducted in France, Poland and the United States. The overall time to participate in this study was 12 months, unless it is determined that a participant would benefit from continued therapy beyond 12 months. Participants made multiple visits to the clinic, and were contacted up to a maximum of every 12 weeks up to 12 months after last dose of study drug for follow-up assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alisertib 50 mg | Experimental | Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alisertib | Drug | Alisertib capsules |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined Best Overall Response Rate Based on Investigator Assessment | Combined objective response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 or response by Cancer antigen (CA) 125 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. CA 125 response criteria is defined as either: A 50% decrease from 2 initially elevated samples; the sample demonstrating the 50% decrease must have been confirmed by a fourth sample 28 days later (a total of 4 samples required) or A serial decrease of > 75% over 3 samples; the third sample was to be obtained 28 days after the second (a total of 3 samples required). | Every 2 cycles up to 12 months until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU)-every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as the time in days from the date of first study drug administration to the date of first documented Progressive Disease (PD) or death. PD is defined as 20% increase in the sum of the longest diameter of target lesions. CA 125 progression for participants with normal CA 125 levels is defined as a CA 125 level > 2 times the upper limit of normal and for participants with elevated values during the trial, is defined as a CA 125 level greater than 2 times the nadir value of CA 125. For a participant who has not progressed and has not died, PFS is censored at the last response assessment that is stable disease (SD) or better. |
Not provided
Inclusion Criteria:
Female participants 18 years or older.
Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Postmenopausal at least 1 year, OR
Able to provide written informed consent.
Within 7 days before study:
Platinum-refractory or -resistant disease.
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) OR Cancer antigen (CA) 125 level of > 40 units/mL AND clinical evidence disease.
Recovered from effects of prior therapy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Summit Medical Group | Berkeley Heights | New Jersey | 07922 | United States |
Participants with a diagnosis of Platinum-refractory and Platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma received 50 mg alisertib twice daily for 7 days in 21-day cycles.
Participants took part in the study at 17 investigative sites in France, Poland and the United States from 23 March 2009 to 27 January 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alisertib 50 mg (Platinum-Refractory) | Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy. |
| FG001 | Alisertib 50 mg (Platinum-Resistant) | Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population is defined as all participants who receive any amount of alisertib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Alisertib 50 mg (Platinum-Refractory) | Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy. |
| 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 | Combined Best Overall Response Rate Based on Investigator Assessment | Combined objective response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 or response by Cancer antigen (CA) 125 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. CA 125 response criteria is defined as either: A 50% decrease from 2 initially elevated samples; the sample demonstrating the 50% decrease must have been confirmed by a fourth sample 28 days later (a total of 4 samples required) or A serial decrease of > 75% over 3 samples; the third sample was to be obtained 28 days after the second (a total of 3 samples required). | Response-evaluable population is defined as all participants who have measurable neoplastic disease according to the RECIST criteria OR participants with a CA 125 level > 40 units/milliliter (mL) and clinical evidence of neoplastic disease and received at least 1 dose of alisertib and have at least 1 post-baseline response assessment. | Posted | Number | percentage of participants | Every 2 cycles up to 12 months until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU)-every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months) |
First dose of study drug to 30 past last dose of study drug (Up to18.9 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study 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 | Alisertib 50 mg (Platinum-Refractory) | Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomatitis | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.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
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| ID | Term |
|---|---|
| C550258 | MLN 8237 |
Not provided
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| Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months) |
| Duration Of Response (DOR) | DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions. | Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months) |
| Time To Progression (TTP) | TTP is defined as the time in days from the date of first study drug administration to the date of first documentation of PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions. | Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months) |
| Clinical Benefit Rate | Clinical benefit rate is defined as the percentage of participants with response and stable disease (SD), where in order for SD to qualify as having clinical benefit, there must be no progression of neoplastic disease for at least 4 treatment cycles. | Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months) |
| Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | First dose to 30 days past last dose (Up to 18.9 Months) |
| Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events | Vital signs included blood pressure, pulse rate, and oral temperature collected throughout the study. . A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug. | Baseline, Cycle 1 Days 8 and 15, then Day 1 of every cycle (21 days), End of Treatment, End of Study/FU every 12 weeks for up to 12 months (Up to 22 Months) |
| Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events | Laboratory tests included Hematology and Chemistry. Abnormal laboratory value were assessed as an AE if the value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Baseline, Cycle 1 Days 8 and 15, then Every cycle Days 1, 8 and 15 to End of Treatment Up to 18.0 Months |
| Reason Not Specified |
|
| BG001 | Alisertib 50 mg (Platinum-Resistant) | Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Primary diagnosis | Number | participants |
|
| Years Since Initial Diagnosis | Mean | Standard Deviation | years |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance is defined as: 0=Normal activity (fully active, able to carry on all predisease performance without restriction); 1=Symptoms but ambulatory (restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature); 2=In bed <50% of the time (ambulatory and capable of all self-care, but unable to carry out any work activities); 3=In bed >50% of the time (capable of only limited self-care); 4=100% bedridden (completely disabled, cannot carry on any selfcare, totally confined to bed or chair). | Number | participants |
|
| Height | Mean | Standard Deviation | centimeter (cm) |
|
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Body Surface Area (BSA) | Body Surface Area = square root [height (cm)*weight (kg) / 3600 ]. | Mean | Standard Deviation | meter (m)^2 |
|
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS is defined as the time in days from the date of first study drug administration to the date of first documented Progressive Disease (PD) or death. PD is defined as 20% increase in the sum of the longest diameter of target lesions. CA 125 progression for participants with normal CA 125 levels is defined as a CA 125 level > 2 times the upper limit of normal and for participants with elevated values during the trial, is defined as a CA 125 level greater than 2 times the nadir value of CA 125. For a participant who has not progressed and has not died, PFS is censored at the last response assessment that is stable disease (SD) or better. | Response-evaluable population is defined as all participants who have measurable neoplastic disease according to RECIST criteria OR participants with CA 125 level > 40 units/mL and clinical evidence of neoplastic disease and received at least 1 dose of alisertib and have at least 1 post-baseline response assessment. | Posted | Median | 95% Confidence Interval | days | Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months) |
|
|
|
| Secondary | Duration Of Response (DOR) | DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions. | Due to study termination, there was insufficient data to perform this analysis. | Posted | Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months) |
|
|
| Secondary | Time To Progression (TTP) | TTP is defined as the time in days from the date of first study drug administration to the date of first documentation of PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions. | Due to study termination, there was insufficient data to perform this analysis. | Posted | Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months) |
|
|
| Secondary | Clinical Benefit Rate | Clinical benefit rate is defined as the percentage of participants with response and stable disease (SD), where in order for SD to qualify as having clinical benefit, there must be no progression of neoplastic disease for at least 4 treatment cycles. | Response-evaluable population is defined as all participants who have measurable neoplastic disease according to the RECIST criteria OR participants with a CA 125 level > 40 units/mL and clinical evidence of neoplastic disease and receive at least 1 dose of alisertib and have at least 1 post-baseline response assessment | Posted | Number | percentage of participants | Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months) |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Safety Population is defined as all participants who received any amount of alisertib. | Posted | Number | participants | First dose to 30 days past last dose (Up to 18.9 Months) |
|
|
|
| Secondary | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events | Vital signs included blood pressure, pulse rate, and oral temperature collected throughout the study. . A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug. | Safety Population is defined as all participants who received any amount of alisertib. | Posted | Number | participants | Baseline, Cycle 1 Days 8 and 15, then Day 1 of every cycle (21 days), End of Treatment, End of Study/FU every 12 weeks for up to 12 months (Up to 22 Months) |
|
|
|
| Secondary | Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events | Laboratory tests included Hematology and Chemistry. Abnormal laboratory value were assessed as an AE if the value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Safety Population is defined as all participants who received any amount of alisertib. | Posted | Number | participants | Baseline, Cycle 1 Days 8 and 15, then Every cycle Days 1, 8 and 15 to End of Treatment Up to 18.0 Months |
|
|
|
| 4 |
| 6 |
| 6 |
| 6 |
| EG001 | Alisertib 50 mg (Platinum-Resistant) | Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen. | 7 | 25 | 24 | 25 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Abdominal mass | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Clostridium colitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Abdominal rigidity | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 8.1 | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
| 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 |
| Weight decreased |
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| Tachycardia |
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| Hypertension |
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| Dyspnoea exertional |
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| Bradycardia |
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| Shock |
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| Leukopenia |
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| Thrombocytopenia |
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| Dehydration |
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| Hypokalaemia |
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| Alanine aminotransferase increased |
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| Aspartate aminotransferase increased |
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| Hyperglycaemia |
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| Hypomagnesaemia |
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| Blood alkaline phosphatase increased |
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| Febrile neutropenia |
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| Hyponatraemia |
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| Haemoglobin decreased |
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| Granulocytopenia |
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| Neutrophil count increased |
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| White blood cell count increased |
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| Hyperbilirubinaemia |
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| Lymphopenia |
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| Hyperkalaemia |
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| Hypernatraemia |
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| Hypercholesterolaemia |
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| Transaminases increased |
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| Granulocyte count decreased |
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| Blood calcium increased |
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| Blood magnesium decreased |
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| Platelet count decreased |
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| Blood albumin decreased |
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| Creatinine renal clearance decreased |
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| Hypoxia |
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| Bacteraemia |
|