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The purpose of this study was to determine whether ixabepilone is effective in the treatment of unresectable or metastatic gastric cancer in Asian participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixabepilone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixabepilone | Drug | Vial, Injection, Intravenous (IV), 40 mg/m^2, Every 21 days, Up to 8 cycles or until disease progression or intolerable toxicity. Additional treatment was given in agreement by both the investigator and sponsor. Ixabepilone 40 mg/m^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day (3 week) cycle provided the participant met the retreatment criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST) | Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to modified RECIST, as determined by investigator. CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node, the lesions short axis of all nodes measuring <10 mm. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A 2-sided confidence interval (CI) was computed using Clopper-Pearson method. | During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Response | Time to response is defined as the time in weeks from the first dose of study therapy until measurement criteria are first met for PR or CR (whichever status is recorded first). CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node lesions, the short axis of all nodes should measure <10 mm. PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks of initial assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Best Response as Assessed With Modified RECIST | Best overall response that any participant can have is the best response recorded from the start of treatment until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. PR criteria should be met again after 4 weeks and before 6 weeks. Stable disease (SD)=Neither PR or progressive disease (PD) are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 4 for definition of PD. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Hong Kong | B | Hong Kong | |||
| Local Institution |
Of 58 participants enrolled in this study, 6 failed screening criteria, and 52 received treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ixabepilone 40 mg/m^2 IV | ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ixabepilone 40 mg/m^2 IV | ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST) | Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to modified RECIST, as determined by investigator. CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node, the lesions short axis of all nodes measuring <10 mm. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A 2-sided confidence interval (CI) was computed using Clopper-Pearson method. | Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction). | Posted | Number | 95% Confidence Interval | percentage of participants | During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks) |
Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Not provided
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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 | Ixabepilone 40 mg/m^2 IV | ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C430592 | ixabepilone |
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|
|
| Assessed every 6 weeks (± 1 week) starting from the first dose of study therapy until CR or PR (up to 12.1 weeks.) |
| Duration of Response | Defined as the period in months from the time measurement criteria are first met for PR or CR until the first date of documented PD or death. Refer to outcome measure 1 for CR and PR. PD=≥20% increase in the sum of LD of target lesions and an absolute increase of at least 5 mm of tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated by Kaplan-Meier product limit method and a 2-sided 95% CI for median duration was computed by Brookmeyer and Crowley method. | From the date of first PR or CR assessment to the date of progression, death, or last tumor assessment (maximum: 4.1 months) |
| Progression Free Survival (PFS) | PFS=the time interval from date of randomization to the earliest (first) progression or date of death. Participants who progressed or died were counted as events. PD=≥20% increase in sum of LD of target lesions and an absolute increase ≥5 mm in tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated using the Kaplan-Meier product-limit method for all treated participants and a 2-sided 95% CI for the median PFS was computed by Brookmeyer and Crowley method). | From the date of initiation of study therapy to the date of progression (up to 8.1 months). |
| Percentage of Participants With Disease Control Rate | Defined as percentage of participants whose best response was PR, CR, or SD as determined by the investigator. SD=Neither PR or PD are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 1 for definition of CR or PR and refer to outcome measure 4 for definition of PD. A 2-sided 95% CI was computed using Clopper-Pearson method. | During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks) |
| Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 | AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade (GR) 3=Severe; and GR4=Life-threatening or disabling. DR=Drug-related. Any Peripheral Neuropathy includes peripheral sensory and motor neuropathies, including muscle weakness, and hypoaesthesia. | Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3 to 30 weeks) |
| Number of Participants With Hematology Abnormalities | Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. White blood cell (WBC):GR1=\ | Assessed once every week for first 3 weeks, as clinically indicated, start of each 3 week cycle (maximum time that any participant was on therapy was 30 weeks). |
| Number of Participants With Serum Chemistry Abnormalities | Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. ULN=upper limit of normal. | Assessed within 2 weeks of first dose and every 3 weeks before therapy dose (maximum time that any participant was on therapy was 30 weeks). |
| During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (to a maximum follow up for tumor response of 30 weeks) |
| Nagoya |
| Aichi-ken |
| 4648681 |
| Japan |
| Local Institution | Sunto-Gun | Shizuoka | 4118777 | Japan |
| Local Institution | Singapore | 169610 | Singapore |
| Local Institution | Seoul | 135-710 | South Korea |
| Local Institution | Seoul | 136-705 | South Korea |
| Local Institution | Seoul | 138-736 | South Korea |
| Local Institution | Taipei | 112 | Taiwan |
| Local Institution | Taoyuan Hsien | 333 | Taiwan |
| participants |
|
| Age, Customized | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | The ECOG PS is used to assess disease severity. A score of 0 is normal activity; 1=symptoms, but fully ambulatory; 2=symptomatic, but in bed <50% of the day; 3=needs to be in bed > 50% of the day, but not bedridden; 4=unable to get out of bed; 5=dead. | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Ixabepilone 40 mg/m^2 IV | ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity. |
|
|
| Secondary | Time to Response | Time to response is defined as the time in weeks from the first dose of study therapy until measurement criteria are first met for PR or CR (whichever status is recorded first). CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node lesions, the short axis of all nodes should measure <10 mm. PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks of initial assessment. | Participants who received at least 1 dose of study therapy and had a response of either CR or PR. | Posted | Median | Full Range | weeks | Assessed every 6 weeks (± 1 week) starting from the first dose of study therapy until CR or PR (up to 12.1 weeks.) |
|
|
|
| Secondary | Duration of Response | Defined as the period in months from the time measurement criteria are first met for PR or CR until the first date of documented PD or death. Refer to outcome measure 1 for CR and PR. PD=≥20% increase in the sum of LD of target lesions and an absolute increase of at least 5 mm of tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated by Kaplan-Meier product limit method and a 2-sided 95% CI for median duration was computed by Brookmeyer and Crowley method. | Participants who received at least 1 dose of ixabepilone and had either CR or PR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment. | Posted | Median | 95% Confidence Interval | months | From the date of first PR or CR assessment to the date of progression, death, or last tumor assessment (maximum: 4.1 months) |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS=the time interval from date of randomization to the earliest (first) progression or date of death. Participants who progressed or died were counted as events. PD=≥20% increase in sum of LD of target lesions and an absolute increase ≥5 mm in tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated using the Kaplan-Meier product-limit method for all treated participants and a 2-sided 95% CI for the median PFS was computed by Brookmeyer and Crowley method). | Participants who received at least 1 dose of ixabepilone. Participants who died without reporting prior progression were considered to have progressed on their death day. Participants who did not progress or die were censored on their last tumor assessment day. Participants without on-study tumor assessments were censored at start date of therapy. | Posted | Median | 95% Confidence Interval | months | From the date of initiation of study therapy to the date of progression (up to 8.1 months). |
|
|
|
| Secondary | Percentage of Participants With Disease Control Rate | Defined as percentage of participants whose best response was PR, CR, or SD as determined by the investigator. SD=Neither PR or PD are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 1 for definition of CR or PR and refer to outcome measure 4 for definition of PD. A 2-sided 95% CI was computed using Clopper-Pearson method. | Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction). | Posted | Number | 95% Confidence Interval | percentage of participants | During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks) |
|
|
|
| Secondary | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 | AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade (GR) 3=Severe; and GR4=Life-threatening or disabling. DR=Drug-related. Any Peripheral Neuropathy includes peripheral sensory and motor neuropathies, including muscle weakness, and hypoaesthesia. | Participants who received at least 1 dose of study therapy. | Posted | Number | participants | Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3 to 30 weeks) |
|
|
|
| Other Pre-specified | Number of Participants With Best Response as Assessed With Modified RECIST | Best overall response that any participant can have is the best response recorded from the start of treatment until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. PR criteria should be met again after 4 weeks and before 6 weeks. Stable disease (SD)=Neither PR or progressive disease (PD) are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 4 for definition of PD. | Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction). | Posted | Number | participants | During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (to a maximum follow up for tumor response of 30 weeks) |
|
|
|
| Secondary | Number of Participants With Hematology Abnormalities | Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. White blood cell (WBC):GR1=\ | Participants who received at least 1 dose of ixabepilone and had at least one measurement available during the study therapy period. | Posted | Number | participants | Assessed once every week for first 3 weeks, as clinically indicated, start of each 3 week cycle (maximum time that any participant was on therapy was 30 weeks). |
|
|
|
| Secondary | Number of Participants With Serum Chemistry Abnormalities | Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. ULN=upper limit of normal. | Participants who received at least 1 dose of ixabepilone. n=number of participants with at least 1 measurement available during the study therapy period. | Posted | Number | participants | Assessed within 2 weeks of first dose and every 3 weeks before therapy dose (maximum time that any participant was on therapy was 30 weeks). |
|
|
|
| 30 |
| 52 |
| 51 |
| 52 |
| NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| HYPOPHAGIA | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| OBSTRUCTION GASTRIC | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| COLONIC OBSTRUCTION | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| MALABSORPTION | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| Title | Measurements |
|---|---|
|
| At least one SAE (Any GR) |
|
| At least one SAE (GR 3-4) |
|
| At least one DR SAE (Any GR) |
|
| At least one DR SAE (GR 3-4) |
|
| At least one AE (Any GR) |
|
| At least one AE (GR 3-4) |
|
| At least one DR AE (Any GR) |
|
| At least one DR AE (GR 3-4) |
|
| AEs leading to study drug discontinuation (Any GR) |
|
| AEs leading to study drug discontinuation (GR 3-4) |
|
| DRAEs leading to study drug discontinuation:Any GR |
|
| DRAEs leading to study drug discontinuation: GR3-4 |
|
| Any Peripheral Neuropathy (Any GR) |
|
| Any Peripheral Neuropathy (GR 3-4) |
|
| DR Peripheral Neuropathy (Any GR) |
|
| DR Peripheral Neuropathy (GR 3-4) |
|
| Title | Measurements |
|---|---|
|
| Unable to Determine (No tumor assessment) |
|
| Unable to Determine (Other) |
|
| Title | Measurements |
|---|
|
| WBC GR4 |
|
| ANC GR1 |
|
| ANC GR2 |
|
| ANC GR3 |
|
| ANC GR4 |
|
| Platelet Count GR1 |
|
| Platelet Count GR2 |
|
| Platelet Count GR3 |
|
| Platelet Count GR4 |
|
| Hemoglobin GR1 |
|
| Hemoglobin GR2 |
|
| Hemoglobin GR3 |
|
| Hemoglobin GR4 |
|
| Title | Measurements |
|---|---|
|
| ALP GR4 (n=49) |
|
| AST GR1 (n=49) |
|
| AST GR2 (n=49) |
|
| AST GR3 (n=49) |
|
| AST GR4 (n=49) |
|
| ALT GR1 (n=50) |
|
| ALT GR2 (n=50) |
|
| ALT GR3 (n=50) |
|
| ALT GR4 (n=50) |
|
| Total bilirubin GR1 (n=49) |
|
| Total bilirubin GR2 (n=49) |
|
| Total bilirubin GR3 (n=49) |
|
| Total bilirubin GR4 (n=49) |
|
| Creatinine GR1 (n=51) |
|
| Creatinine GR2 (n=51) |
|
| Creatinine GR3 (n=51) |
|
| Creatinine GR4 (n=51) |
|