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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Massachusetts General Hospital | OTHER |
| Brigham and Women's Hospital | OTHER |
| Roswell Park Cancer Institute |
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Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. This study will determine if Velcade is effective in treating patients with multiple myeloma that have had no prior treatment for the disease. We will also use whole-genome scanning to identify drug response biomarkers in bone marrow samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and after treatment with Velcade.
Primary Objective
• To evaluate the objective response rate (CR + PR) to bortezomib alone in patients with newly diagnosed multiple myeloma.
Secondary Objectives
Exploratory Objectives
• To perform pharmacogenomic analysis of molecular markers associated with response or non-response.
Statistical Design A one stage design is used to evaluate ORR. With 60 evaluable participants, if at least 27 objective responses are observed then bortezomib will be considered promising. The probability of concluding the treatment promising is >0.95 with a true ORR of 55% and <0.07 with a true ORR of 35%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bortezomib | Experimental | Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bortezomib | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response (OR) Rate | Objective response was defined as complete response (CR) or partial response (PR) according to European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). CR required all of the following: Negative immunofixation on the serum and urine at two consecutive times for minimum 6 weeks; Disappearance of soft tissue plasmacytomas for at least 6 weeks; <5% plasma cells in bone marrow on 2 determinations for a minimum of 6 weeks; No increase in the size or number of lytic bone lesions. PR required all the following: ≥50% reduction in the level of the serum monoclonal protein on 2 determinations for minimum 6 weeks; If present, reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg on 2 determinations for minimum 6 weeks; ≥50% reduction size of soft tissue plasmacytomas for minimum 6 weeks; No increase in the number or size of lytic bone lesions. Development of a compression fracture does not exclude response in either category. | Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1). |
| Measure | Description | Time Frame |
|---|---|---|
| Very Good Partial Response (VGPR) Rate | Very good partial response or better was defined per International Uniform Response criteria (Durie B, Harousseau JL, Miquel JS, et al Leukemia 2006). See CR requirements in primary outcome measure plus if serum and urine M protein were unmeasurable then immunoglobulin free light chain (FLC) must be in a normal ratio of 0.26-1.65 at two consecutive times. VGPR required the following: Serum and urine M-component detectable by immunofixation but not on electrophoresis; >=90% reduction in serum M-component plus urine M-component <100 mg per 24 hours (by SPEP and UPEP); if the serum and urine M protein were unmeasurable then a >90% decrease in the difference between involved and uninvolved FLC levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Richardson, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Winship Cancer Institute | Atlanta | Georgia | 30322 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19528374 | Result | Richardson PG, Xie W, Mitsiades C, Chanan-Khan AA, Lonial S, Hassoun H, Avigan DE, Oaklander AL, Kuter DJ, Wen PY, Kesari S, Briemberg HR, Schlossman RL, Munshi NC, Heffner LT, Doss D, Esseltine DL, Weller E, Anderson KC, Amato AA. Single-agent bortezomib in previously untreated multiple myeloma: efficacy, characterization of peripheral neuropathy, and molecular correlations with response and neuropathy. J Clin Oncol. 2009 Jul 20;27(21):3518-25. doi: 10.1200/JCO.2008.18.3087. Epub 2009 Jun 15. |
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66 participants were enrolled between December 2003 and September 2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bortezomib | Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population is comprised of eligible and treated participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bortezomib | Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 (OR) Rate | Objective response was defined as complete response (CR) or partial response (PR) according to European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). CR required all of the following: Negative immunofixation on the serum and urine at two consecutive times for minimum 6 weeks; Disappearance of soft tissue plasmacytomas for at least 6 weeks; <5% plasma cells in bone marrow on 2 determinations for a minimum of 6 weeks; No increase in the size or number of lytic bone lesions. PR required all the following: ≥50% reduction in the level of the serum monoclonal protein on 2 determinations for minimum 6 weeks; If present, reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg on 2 determinations for minimum 6 weeks; ≥50% reduction size of soft tissue plasmacytomas for minimum 6 weeks; No increase in the number or size of lytic bone lesions. Development of a compression fracture does not exclude response in either category. | The analysis population is comprised of eligible and treated participants. | Posted | Number | 95% Confidence Interval | proportion of participants | Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1). |
Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
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 | Bortezomib | Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul G. Richardson | Dana-Farber Cancer Institute | 617.632.2104 | Paul_Richardson@dfci.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
| OTHER |
| Emory University | OTHER |
| Memorial Sloan Kettering Cancer Center | OTHER |
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
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| Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1). |
| Time to Progression (TTP) | TTP based on the Kaplan-Meier method is defined as the time from start of treatment to documentation of disease progression (PD). Participants without evidence of PD were censored at the latest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: >25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); >25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); >25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing or new soft tissue plasmacytomas and/or lytic lesions; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL not attributable to other cause). | Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months. |
| Progression-Free Survival (PFS) | PFS based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the earliest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: >25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); >25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); >25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing soft tissue plasmacytomas and/or lytic lesions or new; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL not attributable to other cause). | Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months as of the data analysis. |
| Number of Participants With Treatment-Emergent Sensory Neuropathy | Number of participants experiencing any grade treatment-emergent sensory neuropathy events based on CTCAEv3 as reported on case report forms. | Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1). |
| Number of Participants With Treatment-Emergent Neuropathic Pain | Number of participants experiencing any grade treatment-emergent neuropathic pain events based on CTCAEv3 as reported on case report forms. | Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1). |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 04263 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Lack of Response |
|
| Death |
|
| Withdrawal by Subject |
|
| Non-Protocol Therapy |
|
| Withdrawal of Consent before Trt |
|
| Progressive Disease before Trt |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| ISS Stage | International Staging System (ISS) Stage I: serum ß2-M < 3.5 mg/L and serum albumin >/= 3.5 g/dL Stage II: Neither stage I nor stage III Stage III: serum ß2-M >/= 5.5 mg/L | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Bortezomib | Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment. |
|
|
| Secondary | Very Good Partial Response (VGPR) Rate | Very good partial response or better was defined per International Uniform Response criteria (Durie B, Harousseau JL, Miquel JS, et al Leukemia 2006). See CR requirements in primary outcome measure plus if serum and urine M protein were unmeasurable then immunoglobulin free light chain (FLC) must be in a normal ratio of 0.26-1.65 at two consecutive times. VGPR required the following: Serum and urine M-component detectable by immunofixation but not on electrophoresis; >=90% reduction in serum M-component plus urine M-component <100 mg per 24 hours (by SPEP and UPEP); if the serum and urine M protein were unmeasurable then a >90% decrease in the difference between involved and uninvolved FLC levels. | The analysis population is comprised of eligible and treated participants. | Posted | Number | 95% Confidence Interval | proportion of participants | Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1). |
|
|
|
| Secondary | Time to Progression (TTP) | TTP based on the Kaplan-Meier method is defined as the time from start of treatment to documentation of disease progression (PD). Participants without evidence of PD were censored at the latest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: >25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); >25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); >25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing or new soft tissue plasmacytomas and/or lytic lesions; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL not attributable to other cause). | The analysis population is comprised of eligible and treated participants. | Posted | Median | 95% Confidence Interval | months | Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months. |
|
|
|
| Secondary | Progression-Free Survival (PFS) | PFS based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the earliest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: >25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); >25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); >25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing soft tissue plasmacytomas and/or lytic lesions or new; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL not attributable to other cause). | The analysis population is comprised of eligible and treated participants. | Posted | Median | 95% Confidence Interval | months | Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months as of the data analysis. |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Sensory Neuropathy | Number of participants experiencing any grade treatment-emergent sensory neuropathy events based on CTCAEv3 as reported on case report forms. | The analysis population is comprised of eligible and treated participants. | Posted | Number | participants | Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1). |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Neuropathic Pain | Number of participants experiencing any grade treatment-emergent neuropathic pain events based on CTCAEv3 as reported on case report forms. | The analysis population is comprised of eligible and treated participants. | Posted | Number | participants | Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1). |
|
|
|
| 33 |
| 64 |
| 62 |
| 64 |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever w/o neutropenia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema limb | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain-other | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection-other | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy-motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy-sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathic, pain | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection w/ unk ANC upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematologic-other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphatics-other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Double vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vision-blurred | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tearing | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ocular-other | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Distention/bloating, abdominal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muco/stomatitis by exam, oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GI-other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Oral cavity, hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdomen, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Stomach, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever w/o neutropenia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constitutional, other | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema head and neck | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema limb | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain-other | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Allergy-other | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, eye NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, skin | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection-other | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| ALT, SGPT | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Amylase | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| AST, SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nonneuropathic lower extr muscle weak | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nonneuropathic generalized weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest wall, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Extremity-limb, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste disturbance | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ataxia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy-motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy-sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neurologic-other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathic, pain | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal/GU-other | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Breast, pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pelvic, pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Testicle, pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Uterus, pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Erectile impotence | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sexual/Reproductive function-Other | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nose, hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin-other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |