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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01939 | Registry Identifier | NCI CTRP |
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Low accrual; target accrual not met
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The number of melanoma cases has been steadily increasing over the past few decades. For many patients with metastatic melanoma, there are no effective therapies. The goal of this study is to determine whether a combination drug treatment of carboplatin, paclitaxel and temozolomide is effective in the treatment of metastatic or recurrent melanoma.
Over the past several decades, significant research has been conducted to try to identify active chemotherapeutic agents for the treatment of melanoma. The rationale for combining taxanes and platinum agents is that both have activity in melanoma; in vitro and clinical data suggest synergy between these drugs when used in combination in a wide variety of tumors, including melanoma; and the toxicity profiles of these agents do not overlap. Temozolomide (a drug approved for the treatment of melanoma) has been combined with other drugs, including taxanes and platinums, in previous clinical trials for melanoma. Specifically, a previous phase I study of the combination of temozolomide, paclitaxel, and carboplatin in melanoma showed objective responses. The efficacy of this combination is now being studied in this phase II trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy Combination | Experimental | Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel, carboplatin, temozolomide | Drug | Combination chemotherapy was administered for up to 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Objective Response Rate (ORR) is the sum of the percentages of patients achieving CR or PR. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The time from treatment initiation to death by any cause. | 2 years |
| Safety Profile | All toxicities encountered during the study by patients who receive at least one on-study treatment will be graded according to the NCI CTCAE (Version 3.0). The number of patients experiencing adverse events will be reported according to grade. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Montasur Shaheen, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Oncology Associates | Albuquerque | New Mexico | 87106 | United States | ||
| University of New Mexico Cancer Center |
Not provided
| Label | URL |
|---|---|
| University of New Mexico Cancer Center | View source |
| New Mexico Cancer Care Alliance | View source |
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Subjects were recruited from sites in the New Mexico Cancer Care Alliance from October, 2009 to March, 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy Combination | Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle. Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy Combination | Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle. Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Objective Response Rate (ORR) | Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Objective Response Rate (ORR) is the sum of the percentages of patients achieving CR or PR. | The 16 patients who completed treatment were evaluable for the endpoint of overall response rate. | Posted | Number | participants | 6 months |
|
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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 | Chemotherapy Combination | Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle. Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | CTCAE 3.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Montaser Shaheen, MD, PhD | University of New Mexico | 505-925-0404 | MoShaheen@salud.unm.edu |
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009362 | Neoplasm Metastasis |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Up to 30 days after last on-study treatment, for up to 2 years |
| Time to Progression | The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 2 years |
| Albuquerque |
| New Mexico |
| 87106 |
| United States |
| The Cancer Center at Presbyterian | Albuquerque | New Mexico | 87110 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Site of Metastasis | Number | participants |
|
| Previous Therapy | Number | participants |
|
| Chemotherapy Combination |
Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle. Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles |
|
|
| Secondary | Overall Survival | The time from treatment initiation to death by any cause. | The 16 patients who completed treatment were evaluable for survival analysis. | Posted | Median | 95% Confidence Interval | weeks | 2 years |
|
|
|
| Secondary | Safety Profile | All toxicities encountered during the study by patients who receive at least one on-study treatment will be graded according to the NCI CTCAE (Version 3.0). The number of patients experiencing adverse events will be reported according to grade. | All patients who had received at least one dose of on-study treatment were evaluable for toxicity. | Posted | Number | participants | Up to 30 days after last on-study treatment, for up to 2 years |
|
|
|
| Secondary | Time to Progression | The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | The 16 patients who completed treatment were evaluable for progression-free survival. | Posted | Median | 95% Confidence Interval | weeks | 2 years |
|
|
|
| 6 |
| 19 |
| 14 |
| 19 |
| Death | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Induration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Skin infection | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Hemoglobin levels decreased | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Leukopenia (leukocytes decreased) | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Lymphopenia (lymphocytes decreased) | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Neutrophils decreased | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Platelets decreased | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Hypotension (Low blood pressure) | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Sinus tachycardia | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Weight loss | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Alopecia (Hair loss) | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Dermatology/Skin - Other: Folliculitis | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Pruritus (Itching) | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Increased sweating | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Abdominal distention | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Anorexia (Decreased appetite) | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Dyspepsia (Indigestion) | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Taste alteration | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Bladder hemorrhage | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Bladder infection | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
|
| Edema limbs | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Localized edema | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Hyperbilirubinemia (high bilirubin levels) | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Hypercalcemia (high calcium levels) | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Hyperglycemia (high blood sugar) | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Hyperkalemia (high potassium levels) | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Hypermagnesemia (high magnesium levels) | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Hypoalbuminemia (low albumin protein levels) | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Hypocalcemia (low calcium levels) | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Hypokalemia (low potassium levels) | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Hypomagnesemia (low magnesium levels) | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Hyponatremia (low sodium levels) | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Hypophosphatemia (low phosphate levels) | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Increased lactate dehydrogenase levels | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Laboratory test abnormal | Investigations | CTCAE 3.0 | Non-systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Depressed level of consciousness | Psychiatric disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Headache | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Ear, nose and throat examination abnormal | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Abdominal pain | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Back pain | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Bone pain | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Buttock pain | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Chest wall pain | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Joint pain | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Neck pain | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Pain - Other | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Pain in extremity | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain (throat pain) | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Hypoxia (low blood oxygen) | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Urinary frequency increased | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Urinary frequency decreased | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE 3.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Fever (Grade 3-4) |
|
| Weight loss (Grade 1-2) |
|
| Weight loss (Grade 3-4) |
|
| Anorexia (Grade 1-2) |
|
| Anorexia (Grade 3-4) |
|
| Diarrhea (Grade 1-2) |
|
| Diarrhea (Grade 3-4) |
|
| Aspartate aminotransferase increased (Grade 1-2) |
|
| Aspartate aminotransferase increased (Grade 3-4) |
|
| Vomiting (Grade 1-2) |
|
| Vomiting (Grade 3-4) |
|
| Gastrointestinal Bleed (Grade 1-2) |
|
| Gastrointestinal Bleed (Grade 3-4) |
|
| Nausea (Grade 1-2) |
|
| Nausea (Grade 3-4) |
|
| Alanine aminotransferase increased (Grade 1-2) |
|
| Alanine aminotransferase increased (Grade 3-4) |
|
| Hyperbilirubinemia (Grade 1-2) |
|
| Hyperbilirubinemia (Grade 3-4) |
|
| Neutropenia (Grade 1-2) |
|
| Neutropenia (Grade 3-4) |
|
| Anemia (Grade 1-2) |
|
| Anemia (Grade 3-4) |
|
| Lymphopenia (Grade 1-2) |
|
| Lymphopenia (Grade 3-4) |
|
| Leukopenia (Grade 1-2) |
|
| Leukopenia (Grade 3-4) |
|
| Thrombocytopenia (Grade 1-2) |
|
| Thrombocytopenia (Grade 3-4) |
|
| Hyperglycemia (Grade 1-2) |
|
| Hyperglycemia (Grade 3-4) |
|
| Hypophosphatemia (Grade 1-2) |
|
| Hypophosphatemia (Grade 3-4) |
|
| Hypokalemia (Grade 1-2) |
|
| Hypokalemia (Grade 3-4) |
|
| Hyponatremia (Grade 1-2) |
|
| Hyponatremia (Grade 3-4) |
|
| Chest wall pain (Grade 1-2) |
|
| Chest wall pain (Grade 3-4) |
|
| Bone pain (Grade 1-2) |
|
| Bone pain (Grade 3-4) |
|
| Muscle weakness, lower limb (Grade 1-2) |
|
| Muscle weakness, lower limb (Grade 3-4) |
|
| Joint pain (Grade 1-2) |
|
| Joint pain (Grade 3-4) |
|
| Drowsiness (Grade 1-2) |
|
| Drowsiness (Grade 3-4) |
|
| Peripheral Sensory Neuropathy (Grade 1-2) |
|
| Peripheral Sensory Neutropenia (Grade 3-4) |
|
| Pericardial effusion (Grade 1-2) |
|
| Pericardial effusion (Grade 3-4) |
|
| Edema limbs (Grade 1-2) |
|
| Edema limbs (Grade 3-4) |
|
| Alopecia (Grade 1-2) |
|
| Alopecia (Grade 3-4) |
|
| Rash (Grade 1-2) |
|
| Rash (Grade 3-4) |
|
| Dry mouth (Grade 1-2) |
|
| Dry mouth (Grade 3-4) |
|