Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixabepilone | Drug | Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities at Dose Level | Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for >14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia <25,000 cells/mm3 or bleeding requiring a platelet transfusion. | Measures taken at Cycle 01 (21-day cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation | Adverse events (AEs) and Serious AEs (SAEs) considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Maryland | Baltimore | Maryland | 21201 | United States | ||
| The Cancer Institute Of New Jersey |
A total of 39 participants enrolled and 4 participants were never treated (2 reported serious adverse events [SAEs] prior to the first dose of study medication and were never treated; 1 had rapid decline in performance status and died prior to the first dose of study medication; no reason was given for the remaining participant).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ixabepilone | Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 10 mg/m2 | Ixabepilone |
| BG001 | 20 mg/m2 | Ixabepilone |
| BG002 |
| 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 | Number of Participants With Dose Limiting Toxicities at Dose Level | Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for >14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia <25,000 cells/mm3 or bleeding requiring a platelet transfusion. | All treated participants | Posted | Number | participants | Measures taken at Cycle 01 (21-day cycle) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ixa 10 mg/m2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DRY EYE | Eye disorders | MedDRA 11.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
Not provided
| ID | Term |
|---|---|
| C430592 | ixabepilone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities. |
| Hematology Results - Worst On-Study Grade | Worst on-study grade based on laboratory values graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). | Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution. |
| Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level | Mean concentrations over full time period for the 40 mg/mg2 dose level, established as the Maximum Tolerated Dose. (The Maximum Tolerated Dose was established as 40 mg/m2, based on an investiagtion of Dose Limiting Toxicities, which consisted of Febrile Neutropenia (at 40 mg/m2) in 1 participant and Grade 4 neutropenia lasting ≥5 days (at 45 mg/m2)in 2 participants.) | through 72 hours after start of infusion |
| Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST) | RECIST criteria, wherein complete response = disappearance of all target lesions; partial response = 30% decrease in the sum of the longest diameter of target lesions; progressive disease = 20% increase in the sum of the longest diameter of target lesions, and stable disease = small changes that do not meet above criteria. | At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles. |
| New Brunswick |
| New Jersey |
| 08901 |
| United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Investigator Request |
|
| Study Drug Toxicity |
|
| Withdrawal by Subject |
|
| 30 mg/m2 |
Ixabepilone |
| BG003 | 35 mg/m2 | Ixabepilone |
| BG004 | 40 mg/m2 | Ixabepilone |
| BG005 | 45 mg/m2 | Ixabepilone |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Karnofsky Performance Status | The Karnofsky Performance Status (KPS) measures the ability of cancer patients to perform ordinary tasks. Scores are reported in multiples of 10 and range from 0 to 100; a higher score means the patient is better able to carry out daily activities. | Number | participants |
|
| 20 mg/m2 |
Ixabepilone |
| OG002 | 30 mg/m2 | Ixabepilone |
| OG003 | 35 mg/m2 | Ixabepilone |
| OG004 | 40 mg/m2 | Ixabepilone |
| OG005 | 45 mg/m2 | Ixabepilone |
|
|
| Secondary | Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation | Adverse events (AEs) and Serious AEs (SAEs) considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). | Posted | Number | Participants | From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities. |
|
|
|
| Secondary | Hematology Results - Worst On-Study Grade | Worst on-study grade based on laboratory values graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). | Posted | Number | Participants | Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution. |
|
|
|
| Secondary | Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level | Mean concentrations over full time period for the 40 mg/mg2 dose level, established as the Maximum Tolerated Dose. (The Maximum Tolerated Dose was established as 40 mg/m2, based on an investiagtion of Dose Limiting Toxicities, which consisted of Febrile Neutropenia (at 40 mg/m2) in 1 participant and Grade 4 neutropenia lasting ≥5 days (at 45 mg/m2)in 2 participants.) | All participants treated at the 40 mg/m2 dose level. | Posted | Mean | Standard Deviation | ng/mL | through 72 hours after start of infusion |
|
|
|
| Secondary | Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST) | RECIST criteria, wherein complete response = disappearance of all target lesions; partial response = 30% decrease in the sum of the longest diameter of target lesions; progressive disease = 20% increase in the sum of the longest diameter of target lesions, and stable disease = small changes that do not meet above criteria. | Posted | Number | Participants | At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles. |
|
|
|
| 2 |
| 4 |
| 4 |
| 4 |
| EG001 | Ixa 20 mg/m2 | 2 | 3 | 3 | 3 |
| EG002 | Ixa 30 mg/m2 | 4 | 8 | 8 | 8 |
| EG003 | Ixa 35 mg/m2 | 1 | 4 | 4 | 4 |
| EG004 | Ixa 40 mg/m2 | 5 | 11 | 11 | 11 |
| EG005 | Ixa 45 mg/m2 | 2 | 5 | 5 | 5 |
| HYPOTENSION | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| HEPATORENAL SYNDROME | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| HEMIPARESIS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| UROSEPSIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| GLUCOSE TOLERANCE IMPAIRED | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| TRACHEO-OESOPHAGEAL FISTULA | Congenital, familial and genetic disorders | MedDRA 11.0 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| ECTROPION | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| PHOTOPSIA | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| EYE OEDEMA | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| EYE IRRITATION | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| ERYTHEMA OF EYELID | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| URINE OUTPUT DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| BLOOD ALBUMIN DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| BLOOD CALCIUM DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| BLOOD PHOSPHORUS DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| GASTRIC OCCULT BLOOD POSITIVE | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| WAIST CIRCUMFERENCE INCREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| FLUSHING | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| AGITATION | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| NIGHTMARE | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| ABNORMAL DREAMS | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| TREMOR | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| APHASIA | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPERAESTHESIA | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| MENTAL IMPAIRMENT | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| SYNCOPE VASOVAGAL | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| RESTLESS LEGS SYNDROME | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| LIP DRY | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| RETCHING | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| CHEILITIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| GLOSSITIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| ORAL PAIN | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| LOOSE TOOTH | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| ODYNOPHAGIA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| OESOPHAGITIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| GINGIVAL ERYTHEMA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPOAESTHESIA ORAL | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| STOMACH DISCOMFORT | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| TONGUE DISCOLOURATION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| GASTROINTESTINAL DISORDER | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| IMPAIRED GASTRIC EMPTYING | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPOACUSIS | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| CANDIDIASIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| TINEA PEDIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| FOLLICULITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| TOOTH INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| NOCTURIA | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| POLLAKIURIA | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| ACUTE PRERENAL FAILURE | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| STRESS URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| ONYCHOLYSIS | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| RASH PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| SKIN DISORDER | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| SUBCUTANEOUS NODULE | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| VULVOVAGINAL PRURITUS | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| ANIMAL BITE | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| PAIN IN JAW | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| JOINT STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| MOBILITY DECREASED | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| SENSATION OF HEAVINESS | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| SNEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| THIRST | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| FEELING COLD | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| MUCOSAL HAEMORRHAGE | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| CATHETER RELATED COMPLICATION | General disorders | MedDRA 11.0 | 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.
| Title | Measurements |
|---|---|
|
| Fatigue |
|
| Alopecia |
|
| Diarrhea |
|
| Peripheral sensory neuropathy |
|
| Stomatitis |
|
| Any SAE |
|
| Death within 30 days of last dose |
|
| Any AE leading to discontinuation |
|
| Absolute Neutrophil Count |
|
| Hemoglobin |
|
| Platelets |
|
| Title | Measurements |
|---|---|
|
| Hour 4.00 (n=11) |
|
| Hour 8.00 (n=11) |
|
| Hour 12.00 (n=11) |
|
| Hour 16.00 (n=11) |
|
| Hour 20.00 (n=11) |
|
| Hour 24.00 (n=11) |
|
| Hour 25.00 (n=10) |
|
| Hour 26.00 (n=10) |
|
| Hour 27.00 (n=10) |
|
| Hour 72.00 (n=10) |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Unable to Determine |
|