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The purpose of the study is to evaluate the efficacy and safety of eribulin mesylate in subjects with soft tissue sarcoma who received at least one standard chemotherapy (an anthracycline or an ifosfamide monotherapy or a combination therapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eribulin mesylate 1.4 mg/m^2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eribulin mesylate | Drug | Administration of eribulin mesylate at a dose of 1.4 mg/m^2 as an IV bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Rate at 12 Weeks (PFR12wks) | The PFR at 12 weeks was the percentage of participants with progression-free survival (success) measured as a binary variable based on the tumor response assessed at Week 12 after the start of study treatment. Participants were considered a success if one radiological evaluation performed at least Week 12 after start of therapy indicated stable disease (SD), or complete response (CR) or partial response (PR), as defined according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1); all other cases were considered as failures (including disease progression or death before the Week 12 evaluation, or had unknown disease status at Week 12). If new anticancer treatments were started before the Week 12 evaluation, participants were considered failures. A 2-sided 90% confidence interval (CI) was calculated using the exact method of binomial distribution. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-free survival was defined as the time from the date of treatment start to the first documented date of event (disease progression or death from any cause, whichever occurred first). PFS was assessed every six weeks (until disease progression was confirmed, or sooner, if clinically indicated) and was based on Investigator and Independent Review Committee (IRC) assessments according to RECIST v1.1. Disease progression was measured using computed tomography (CT) or magnetic resonance imaging (MRI) on targeted tumors and defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. A 95% CI was calculated using Kaplan-Meier estimate and Greenwood Formula. A generalized Brookmeyer and Crowley method was used to construct a log-log-transformed 95% CI. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Hiroshi Obaishi | Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | All Treated Participants (Arm 1 and Arm 2) | Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Cycle 1 (Day 1) to progressive disease (PD) or death, or date of study cutoff (14 Nov 2014) up to 3 years |
| Overall Survival (OS) | Overall survival was defined as the time from the date of treatment start to the date of death from any cause. Participants were followed for survival every twelve weeks after PD. In the absence of confirmation of death, participants were censored either at the date that the participant was last known alive or the date of study cutoff, whichever came earlier. Participants censored before database cutoff included those who were lost to follow up and who withdrew consent. A 95% CI was calculated using Kaplan-Meier estimate and Greenwood Formula. A generalized Brookmeyer and Crowley method is used to construct a log-log-transformed 95% CI. | Cycle 1 (Day 1) to death, or date of study cutoff, (14 Nov 2014), up to 3 years |
| Objective Response Rate (ORR) | Objective response rate was defined as the percentage of participants who had a best overall rate (BOR) of CR or PR. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. The BOR of CR and PR in this study required confirmation by a subsequent assessment of response at least four weeks (28 days) later. CR and PR were determined by the Investigator and IRC using RECIST v1.1 for target lesions assessed by MRI/CT scans. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A 95% CI was calculated using exact method of binomial distribution. | Date of CR or PR to the date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years |
| Disease Control Rate (DCR) | Disease control rate was defined as the percentage of participants who had BOR of CR + PR + SD. BOR of SD must have manifested at least five weeks (35 days) after the first dose of study treatment. Tumor assessment was performed at Week 6 and Week 12 after the start of treatment, and every six weeks thereafter. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started. A 95% CI was calculated using exact method of binomial distribution. | Date of CR, PR, or SD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years |
| Clinical Benefit Rate (CBR) | CBR was defined as the percentage of participants who had a BOR of CR + PR + dSD (duration of SD greater than or equal to 11 weeks [77 days] after the first dose of study treatment). Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. For participants whose BOR was SD, the duration of SD was defined as the time from the date of the first dose of study treatment to the first documented PD or death, whichever occurred first (i.e., same definition of PFS). If the dSD was censored at a time less than 11 weeks, the participant was considered as not having a clinical benefit. A 95% CI was calculated using exact method of binomial distribution. | First dose of study treatment to the date of CR, PR, or dSD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years |
| Durable Stable Disease (SD) Rate (dSDR) | Durable stable disease rate was defined as the percentage of participants who manifested durable stable disease (the duration of stable disease for greater than or equal to eleven weeks) and was estimated based on the tumor response assessments performed according to RECIST v1.1. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. A 2-sided 95% CI was calculated using the exact method of binomial distribution. | Date of dSD to date of PD or death, whichever is first, or date of study cutoff (24 Nov 2014), up to 3 years |
| Best Overall Response (BOR) | The best overall response categories (CR, PR, SD [including non-CR/non-PD], PD, not evaluable [NE], and unknown [UNK]) were derived based on time point tumor responses during the study as assessed by the IRC as well as the investigator. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. BOR of SD must have occurred at least 35 days (at least 5 weeks) after the first dose of study drug. If a participant had a BOR of non-CR/non-PD, the participant's BOR was grouped with the SD category. | Date of CR, PR, SD to PD or death of any cause, whichever is first, or date of study cutoff (14 Nov 2014), or up to 3 years |
| Kashiwa |
| Chiba |
| Japan |
| Fukuoka | Fukuoka | Japan |
| Hidaka | Hokkaido | Japan |
| Sapporo | Hokkaido | Japan |
| Tsu | Mie-ken | Japan |
| Okayama | Okayama-ken | Japan |
| Osaka | Osaka | Japan |
| Suita | Osaka | Japan |
| Bunkyo | Tokyo | Japan |
| Chuo-ku | Tokyo | Japan |
| Shinjuku | Tokyo | Japan |
| Participants Treated |
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| COMPLETED |
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| NOT COMPLETED |
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|
Full analysis set included all participants who received at least one dose of study drug. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with OTH.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Participants With ADI or LMS | Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS) |
| BG001 | Arm 2: Participants With OTH | Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Rate at 12 Weeks (PFR12wks) | The PFR at 12 weeks was the percentage of participants with progression-free survival (success) measured as a binary variable based on the tumor response assessed at Week 12 after the start of study treatment. Participants were considered a success if one radiological evaluation performed at least Week 12 after start of therapy indicated stable disease (SD), or complete response (CR) or partial response (PR), as defined according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1); all other cases were considered as failures (including disease progression or death before the Week 12 evaluation, or had unknown disease status at Week 12). If new anticancer treatments were started before the Week 12 evaluation, participants were considered failures. A 2-sided 90% confidence interval (CI) was calculated using the exact method of binomial distribution. | Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH). | Posted | Number | 90% Confidence Interval | Percentage of participants | Week 12 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | Progression-free survival was defined as the time from the date of treatment start to the first documented date of event (disease progression or death from any cause, whichever occurred first). PFS was assessed every six weeks (until disease progression was confirmed, or sooner, if clinically indicated) and was based on Investigator and Independent Review Committee (IRC) assessments according to RECIST v1.1. Disease progression was measured using computed tomography (CT) or magnetic resonance imaging (MRI) on targeted tumors and defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. A 95% CI was calculated using Kaplan-Meier estimate and Greenwood Formula. A generalized Brookmeyer and Crowley method was used to construct a log-log-transformed 95% CI. | Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH). | Posted | Median | 95% Confidence Interval | Months | Cycle 1 (Day 1) to progressive disease (PD) or death, or date of study cutoff (14 Nov 2014) up to 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival was defined as the time from the date of treatment start to the date of death from any cause. Participants were followed for survival every twelve weeks after PD. In the absence of confirmation of death, participants were censored either at the date that the participant was last known alive or the date of study cutoff, whichever came earlier. Participants censored before database cutoff included those who were lost to follow up and who withdrew consent. A 95% CI was calculated using Kaplan-Meier estimate and Greenwood Formula. A generalized Brookmeyer and Crowley method is used to construct a log-log-transformed 95% CI. | Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH). | Posted | Median | 95% Confidence Interval | Months | Cycle 1 (Day 1) to death, or date of study cutoff, (14 Nov 2014), up to 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | Objective response rate was defined as the percentage of participants who had a best overall rate (BOR) of CR or PR. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. The BOR of CR and PR in this study required confirmation by a subsequent assessment of response at least four weeks (28 days) later. CR and PR were determined by the Investigator and IRC using RECIST v1.1 for target lesions assessed by MRI/CT scans. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A 95% CI was calculated using exact method of binomial distribution. | Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH). | Posted | Number | 95% Confidence Interval | Percentage of participants | Date of CR or PR to the date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | Disease control rate was defined as the percentage of participants who had BOR of CR + PR + SD. BOR of SD must have manifested at least five weeks (35 days) after the first dose of study treatment. Tumor assessment was performed at Week 6 and Week 12 after the start of treatment, and every six weeks thereafter. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started. A 95% CI was calculated using exact method of binomial distribution. | Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH). | Posted | Number | 95% Confidence Interval | Percentage of participants | Date of CR, PR, or SD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) | CBR was defined as the percentage of participants who had a BOR of CR + PR + dSD (duration of SD greater than or equal to 11 weeks [77 days] after the first dose of study treatment). Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. For participants whose BOR was SD, the duration of SD was defined as the time from the date of the first dose of study treatment to the first documented PD or death, whichever occurred first (i.e., same definition of PFS). If the dSD was censored at a time less than 11 weeks, the participant was considered as not having a clinical benefit. A 95% CI was calculated using exact method of binomial distribution. | Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH). | Posted | Number | 95% Confidence Interval | Percentage of participants | First dose of study treatment to the date of CR, PR, or dSD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Durable Stable Disease (SD) Rate (dSDR) | Durable stable disease rate was defined as the percentage of participants who manifested durable stable disease (the duration of stable disease for greater than or equal to eleven weeks) and was estimated based on the tumor response assessments performed according to RECIST v1.1. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. A 2-sided 95% CI was calculated using the exact method of binomial distribution. | Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH). | Posted | Number | 95% Confidence Interval | Percentage of participants | Date of dSD to date of PD or death, whichever is first, or date of study cutoff (24 Nov 2014), up to 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Best Overall Response (BOR) | The best overall response categories (CR, PR, SD [including non-CR/non-PD], PD, not evaluable [NE], and unknown [UNK]) were derived based on time point tumor responses during the study as assessed by the IRC as well as the investigator. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. BOR of SD must have occurred at least 35 days (at least 5 weeks) after the first dose of study drug. If a participant had a BOR of non-CR/non-PD, the participant's BOR was grouped with the SD category. | Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH). | Posted | Number | Percentage of participants | Date of CR, PR, SD to PD or death of any cause, whichever is first, or date of study cutoff (14 Nov 2014), or up to 3 years |
|
All adverse events (AEs) were collected beginning from the time of informed consent through 30 days after the last dose of study drug or until resolution, whichever came first. Participants were followed for an average of 18 weeks.
Safety data was based on the safety analysis set which included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation. Treatment-emergent Serious AEs (SAEs) and non-serious AEs are reported in the safety section.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Treated Participants (Arm 1 and Arm 2) | Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). | 15 | 51 | 51 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic haemorrhage | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Tumour embolism | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sun Asami | Eisai Co., Ltd. | +81-3-3817-5252 | 5252 |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C490954 | eribulin |
Not provided
Not provided
Not provided
| Male |
|
| OG001 | Arm 2: Participants With OTH | Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH) |
|
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| OG001 | Arm 2: Participants With OTH | Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH) |
|
|
| OG001 | Arm 2: Participants With OTH | Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH) |
|
|
| Arm 2: Participants With OTH |
Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH) |
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