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| ID | Type | Description | Link |
|---|---|---|---|
| NCCTG-N04C7 | |||
| CDR0000471238 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| North Central Cancer Treatment Group | NETWORK |
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RATIONALE: Calcium gluconate and magnesium sulfate may prevent or lessen neurotoxicity caused by oxaliplatin. It is not yet known whether calcium gluconate and magnesium sulfate are more effective than a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy.
PURPOSE: This randomized phase III trial is studying calcium gluconate and magnesium sulfate to see how well they work compared to a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy for stage II, stage III, or stage IV colorectal cancer that has been completely removed by surgery.
OBJECTIVES:
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to age (< 65 vs > 65), gender, and chemotherapy regimen (FOLFOX4 vs modified FOLFOX6). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues until chemotherapy is discontinued (approximately 6 months).
Patients complete quality of life questionnaires on day 1, a symptom experience diary on days 2-5 of their chemotherapy regimen, and questionnaires at 1 and 3 months after completion of study treatment.
Blood samples are collected at baseline and tested for the GSTP1 gene.
After completion of study treatment, patients are followed for at least 3 months.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ca/Mg | Experimental | Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen. |
|
| Placebo | Placebo Comparator | Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcium gluconate | Drug | Given IV |
| |
| magnesium sulfate |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event | Neuropathic adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Neurotoxicity evaluation grade: loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function (Grade 1); objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living (Grade 2); sensory alteration or paresthesia interfering with activities of daily living (Grade 3); permanent sensory losses that are disabling (Grade 4) | 127 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of Grade 2+ Chronic Neurotoxicity | Neurotoxicity were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. | 127 days |
| Time to Onset of Grade 3+ Chronic Neurotoxicity |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon or rectum
Must have undergone curative resection for stage II or III disease
Scheduled to receive 6 months of adjuvant treatment with either of the following FOLFOX chemotherapy regimens:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Axel Grothey, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia | 30912 | United States | ||
| Mercy Capitol Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21189381 | Result | Grothey A, Nikcevich DA, Sloan JA, Kugler JW, Silberstein PT, Dentchev T, Wender DB, Novotny PJ, Chitaley U, Alberts SR, Loprinzi CL. Intravenous calcium and magnesium for oxaliplatin-induced sensory neurotoxicity in adjuvant colon cancer: NCCTG N04C7. J Clin Oncol. 2011 Feb 1;29(4):421-7. doi: 10.1200/JCO.2010.31.5911. Epub 2010 Dec 28. | |
| Result | Nikcevich DA, Grothey A, Sloan JA, et al.: Effect of intravenous calcium and magnesium (IV CaMg) on oxaliplatin-induced sensory neurotoxicity (sNT) in adjuvant colon cancer: results of the phase III placebo-controlled, double-blind NCCTG trial N04C7. [Abstract] J Clin Oncol 26 (Suppl 15): A-4009, 2008. | ||
| 26282635 |
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Two participants in Calcium/Magnesium arm canceled prior to study medication begins. These two participants were excluded from all analysis.
One-hundred and four (104) participants were recruited between January 2006 and June 2007 from 20 North Central Cancer Treatment Group (NCCTG) member sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ca/Mg | Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Given IV |
|
| placebo | Other | Given IV |
|
Neurotoxicity was assessed by CTCAE v3.0.
| 127 days |
| Average Duration of Chronic Neuropathic Toxicity | Neuropathic adverse events were assessed by CTCAE v3.0. | 127 days |
| Percentage of Patients Discontinuing Therapy for Chronic Neurotoxicity | Neurotoxicity were assessed by CTCAE v3.0. | 127 days |
| Average Cumulative Oxaliplatin Dose | 127 days |
| Average Duration of Oxaliplatin-containing Treatment | 127 days |
| Percentage of Patients With Acute Neuropathic Adverse Event | Acute neuropathic toxicities were measured using the Symptom Experience Diary and supplemental quality of life questions in the scale of 0 (no symptom) to 10 (worst symptom). The item score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Any score greater than 0 was considered having acute neuropathy. | 127 days |
| Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event | Adverse Events were measured using CTCAE V3.0. | 127 days |
| Percentage of Patients Experiencing Impact on Activities of Daily Living (ADL) | Activities of daily living were measured using the Symptom Experience Diary and supplemental quality of life questions. The questionnaires' items were in the scale of 0 (no symptom) to 10 (worst symptom). | 127 days |
| Change From Baseline in Fatigue Score at One Month | Fatigue was measured by Brief Fatigue Inventory in the scale of 0 (no fatigue) to 10 (fatigue as bad as you can imagine). The item score was reversed and transformed into 0 (low quality of life (QOL)) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline. | Baseline and One month |
| Change From Baseline in Quality of Life (QOL) at One Month | Quality of Life (QOL) were measured using the Symptom Experience Diary and supplemental quality of life questions. Item score range: 0 (no symptom) to 10 (worst symptom). The score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline. | Baseline and One month |
| Des Moines |
| Iowa |
| 50307 |
| United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | 50314 | United States |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| Bismarck Cancer Center | Bismarck | North Dakota | 58501 | United States |
| Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | 58501 | United States |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| Derived |
| Pachman DR, Qin R, Seisler DK, Smith EM, Beutler AS, Ta LE, Lafky JM, Wagner-Johnston ND, Ruddy KJ, Dakhil S, Staff NP, Grothey A, Loprinzi CL. Clinical Course of Oxaliplatin-Induced Neuropathy: Results From the Randomized Phase III Trial N08CB (Alliance). J Clin Oncol. 2015 Oct 20;33(30):3416-22. doi: 10.1200/JCO.2014.58.8533. Epub 2015 Aug 17. |
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ca/Mg | Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen. |
| BG001 | Placebo | Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||
| Regimen | Number | 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 | Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event | Neuropathic adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Neurotoxicity evaluation grade: loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function (Grade 1); objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living (Grade 2); sensory alteration or paresthesia interfering with activities of daily living (Grade 3); permanent sensory losses that are disabling (Grade 4) | Efficacy analyses use all patients that reported at least one value after baseline. | Posted | Number | Percentage of participants | 127 days |
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| Secondary | Time to Onset of Grade 2+ Chronic Neurotoxicity | Neurotoxicity were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. | Includes all patients that reported at least one value after baseline. | Posted | Median | 95% Confidence Interval | Days | 127 days |
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| Secondary | Time to Onset of Grade 3+ Chronic Neurotoxicity | Neurotoxicity was assessed by CTCAE v3.0. | Includes all patients that reported at least one value after baseline. | Posted | Median | 95% Confidence Interval | Days | 127 days |
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| Secondary | Average Duration of Chronic Neuropathic Toxicity | Neuropathic adverse events were assessed by CTCAE v3.0. | Includes all patients that reported at least one value after baseline. | Posted | Median | 95% Confidence Interval | days | 127 days |
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| Secondary | Percentage of Patients Discontinuing Therapy for Chronic Neurotoxicity | Neurotoxicity were assessed by CTCAE v3.0. | Includes all patients that reported at least one value after baseline. | Posted | Number | Percentage of Participants | 127 days |
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| Secondary | Average Cumulative Oxaliplatin Dose | Because of the early closure of this trial, no reliable data were available for this outcome. | Posted | 127 days |
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| Secondary | Average Duration of Oxaliplatin-containing Treatment | Because of the early closure of this trial, no reliable data were available for this outcome. | Posted | 127 days |
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| Secondary | Percentage of Patients With Acute Neuropathic Adverse Event | Acute neuropathic toxicities were measured using the Symptom Experience Diary and supplemental quality of life questions in the scale of 0 (no symptom) to 10 (worst symptom). The item score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Any score greater than 0 was considered having acute neuropathy. | Includes all patients that reported at least one value after baseline. | Posted | Number | Percentage of participants | 127 days |
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| Secondary | Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event | Adverse Events were measured using CTCAE V3.0. | Analyses of adverse events includes all patients. Adverse event data is not available on one patient in Placebo arm, which leads to the total of 51 in Placebo arm for analysis. | Posted | Number | Percentage of Participants | 127 days |
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| Secondary | Percentage of Patients Experiencing Impact on Activities of Daily Living (ADL) | Activities of daily living were measured using the Symptom Experience Diary and supplemental quality of life questions. The questionnaires' items were in the scale of 0 (no symptom) to 10 (worst symptom). | Data was collected but not analyzed for this outcome. | Posted | 127 days |
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| Secondary | Change From Baseline in Fatigue Score at One Month | Fatigue was measured by Brief Fatigue Inventory in the scale of 0 (no fatigue) to 10 (fatigue as bad as you can imagine). The item score was reversed and transformed into 0 (low quality of life (QOL)) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline. | Includes all patients with at least one assessment after baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline and One month |
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| Secondary | Change From Baseline in Quality of Life (QOL) at One Month | Quality of Life (QOL) were measured using the Symptom Experience Diary and supplemental quality of life questions. Item score range: 0 (no symptom) to 10 (worst symptom). The score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline. | Includes all patients with at least one assessment after baseline. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and One month |
|
|
Adverse events data reported as of June 2, 2008, when data is frozen for study analysis.
Analyses of adverse events includes all patients.
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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 | Ca/Mg | Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen. | 2 | 50 | 48 | 50 | ||
| EG001 | Placebo | Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen. | 1 | 52 | 46 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Esophageal mucositis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 6 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 6 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Colitis, infectious (e.g., Clostridium difficile) | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum calcium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum magnesium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum magnesium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
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| Ischemia cerebrovascular | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
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| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pharyngeal examination abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
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| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
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| Hand-and-foot syndrome | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
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| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
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| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 6 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
Data cutoff was done after 127 days because of premature study closure and because of the protocol modification mandating that the Ca/Mg therapy be discontinued.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Axel Grothey | Mayo Clinic | 507-184-2779 | grothey.axel@mayo.edu |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D020258 | Neurotoxicity Syndromes |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D002125 | Calcium Gluconate |
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D005942 | Gluconates |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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| Title | Measurements |
|---|---|
|
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Modified FOLFOX6 |
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