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The purpose of this study is to determine whether corrected QT (QTc) interval changes occur on an electrocardiogram (ECG) when cetuximab is administered to the study population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | Cetuximab administered by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline | 12-Lead continuous digital electrocardiogram (ECG) data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The corrected QTc is the QT interval corrected for heart rate. Prolongation of the QTc was identified as clinically meaningful at the investigator's discretion. | Baseline, Day 1, and then weekly to end of Cycle 1 (28 days) |
| Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The QTc is the QT interval corrected for heart rate. The QTcF=QT/RR^1/3, where RR=RR interval in seconds. Baseline=predose. Mean change in QTc interval from baseline to time t=QTc interval at time t minus QTc interval at baseline. | Predose Day 1 (Baseline) to end of Cycle 1 (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate | 12-Lead continuous digital ECG data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The PR interval is the time from the onset of the P wave to the beginning of the QRS complex. The QRS interval=deflections in the ECG, comprising Q, R, and S waves, that represent depolarization of the ventricles. Clinically significant was determined at the investigator's discretion. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Alabama Cancer Center | Muscle Shoals | Alabama | 35661 | United States | ||
| Donald W. Hill, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23589315 | Derived | Deeken JF, Shimkus B, Liem A, Hill D, Gurtler J, Berghorn E, Townes L, Lu H, Trifan O, Zhang S. Evaluation of the relationship between cetuximab therapy and corrected QT interval changes in patients with advanced malignancies from solid tumors. Cancer Chemother Pharmacol. 2013 Jun;71(6):1473-83. doi: 10.1007/s00280-013-2146-5. Epub 2013 Apr 16. |
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Of 79 participants enrolled, 51 received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cetuximab | Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline, Day 1, and then weekly to end of Cycle 1 (28 days) |
| Number of Participants With Death, Treatment-related Death, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs Leading to Discontinuation | AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment. | Baseline through Cycle 1 (28 days), continuously |
| Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs of special interest have been sponsor-selected based on the known clinical effects of cetuximab. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment. CTC Grade 1: Mild. Grade 2: Moderate. Grade 3: Severe or medically significant but not immediately life-threatening. Grade 4: Life-threatening. | Baseline through Cycle 1 (28 days), continuously |
| Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | BL=baseline; OS=on-study; ULN=upper level of normal. Albumin,low (g/dL) Grade 1:<LLN-30, Grade 2:<30-20, Grades 3&4:<20. Aspartate aminotransferase (AST)(U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Total bilirubin, high Grade 1:ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-10.0*ULN, Grade 4:>10.0*ULN. Alkaline phosphatase (ALP) (U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Creatinine (mg/dL) Grade 1:>ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-6.0*ULN, Grade 4:>6.0*ULN. | At screening, at the end of Cycle 1 (28 days) |
| Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | BL=baseline; OS=on-study; LLN=lower level of normal; ULN=upper level of normal. Sodium, low(mmol/L) Grades 1&2:<LLN-130, Grade 3:<130-120, Grade 4:<120. Sodium, high (mmol/L) Grade 1:>ULN-150, Grade 2:>150-155, Grade 3:>155-160, Grade 4:>160. Potassium, high (mmol/L) Grade 1:>ULN-5.5, Grade 2:>5.5-6.0, Grade 3:>6.0-7.0, Grade 4:>7.0. Glucose, low(mg/dL) Grade 1:<LLN-55, Grade 2:<55-40, Grade 3:<40-30, Grade 4:<30. Glucose, high (mg/dL) Grade 1:>ULN-160, Grade 2:>160-250, Grade 3:>250-500, Grade 4:>500. Calcium, high(mg/dL) Grade 1:>ULN-11.5, Grade 2:>11.5-12.5, Grade 3:>12.5-13.5, Grade 4:>13. | At screening, at the end of Cycle 1 (28 days) |
| Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | BL=baseline; OS=on-study; LLN=lower level of normal. Laboratory values assessed using CTC for AEs, Version 3.0. Hemoglobin (g/dL) Grade 1:\ | At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up |
| Casa Grande |
| Arizona |
| 85222 |
| United States |
| Compassionate Cancer Care Medical Group, Inc | Corona | California | 92879 | United States |
| Compassionate Cancer Care Medical Group Inc | Fountain Valley | California | 92708 | United States |
| Pacific Shores Medical Group | Long Beach | California | 90813 | United States |
| Desert Hospital Comprehensive Cancer Center | Palm Springs | California | 92262 | United States |
| Compassionate Cancer Care Medical Group, Inc | Riverside | California | 92501 | United States |
| American Institute Research | Whittier | California | 90603 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | United States |
| Ocala Oncology Center | Ocala | Florida | 34471 | United States |
| Brinz, Burroff, Gurtler, & Russo | Metairie | Louisiana | 70006 | United States |
| Cancer Specialists Of Oklahoma | Oklahoma City | Oklahoma | 73112 | United States |
| Pharma Resource | East Providence | Rhode Island | 02915 | United States |
| Austin Cancer Centers | Austin | Texas | 78759 | United States |
| Local Institution | San Juan | Pr | 00910 | Puerto Rico |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cetuximab | Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline | 12-Lead continuous digital electrocardiogram (ECG) data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The corrected QTc is the QT interval corrected for heart rate. Prolongation of the QTc was identified as clinically meaningful at the investigator's discretion. | Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23. | Posted | Number | Participants | Baseline, Day 1, and then weekly to end of Cycle 1 (28 days) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate | 12-Lead continuous digital ECG data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The PR interval is the time from the onset of the P wave to the beginning of the QRS complex. The QRS interval=deflections in the ECG, comprising Q, R, and S waves, that represent depolarization of the ventricles. Clinically significant was determined at the investigator's discretion. | Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23. | Posted | Number | Participants | Baseline, Day 1, and then weekly to end of Cycle 1 (28 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Death, Treatment-related Death, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs Leading to Discontinuation | AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment. | All participants who received at least 1 dose of cetuximab. | Posted | Number | Participants | Baseline through Cycle 1 (28 days), continuously |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs of special interest have been sponsor-selected based on the known clinical effects of cetuximab. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment. CTC Grade 1: Mild. Grade 2: Moderate. Grade 3: Severe or medically significant but not immediately life-threatening. Grade 4: Life-threatening. | Posted | Number | Participants | Baseline through Cycle 1 (28 days), continuously |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | BL=baseline; OS=on-study; ULN=upper level of normal. Albumin,low (g/dL) Grade 1:<LLN-30, Grade 2:<30-20, Grades 3&4:<20. Aspartate aminotransferase (AST)(U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Total bilirubin, high Grade 1:ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-10.0*ULN, Grade 4:>10.0*ULN. Alkaline phosphatase (ALP) (U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Creatinine (mg/dL) Grade 1:>ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-6.0*ULN, Grade 4:>6.0*ULN. | All participants who received at least 1 dose of cetuximab | Posted | Number | Participants | At screening, at the end of Cycle 1 (28 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | BL=baseline; OS=on-study; LLN=lower level of normal; ULN=upper level of normal. Sodium, low(mmol/L) Grades 1&2:<LLN-130, Grade 3:<130-120, Grade 4:<120. Sodium, high (mmol/L) Grade 1:>ULN-150, Grade 2:>150-155, Grade 3:>155-160, Grade 4:>160. Potassium, high (mmol/L) Grade 1:>ULN-5.5, Grade 2:>5.5-6.0, Grade 3:>6.0-7.0, Grade 4:>7.0. Glucose, low(mg/dL) Grade 1:<LLN-55, Grade 2:<55-40, Grade 3:<40-30, Grade 4:<30. Glucose, high (mg/dL) Grade 1:>ULN-160, Grade 2:>160-250, Grade 3:>250-500, Grade 4:>500. Calcium, high(mg/dL) Grade 1:>ULN-11.5, Grade 2:>11.5-12.5, Grade 3:>12.5-13.5, Grade 4:>13. | All participants who received at least 1 dose of cetuximab | Posted | Number | Participants | At screening, at the end of Cycle 1 (28 days) |
|
| |||||||||||||||||||||||||||
| Primary | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The QTc is the QT interval corrected for heart rate. The QTcF=QT/RR^1/3, where RR=RR interval in seconds. Baseline=predose. Mean change in QTc interval from baseline to time t=QTc interval at time t minus QTc interval at baseline. | Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23. | Posted | Mean | Standard Error | msec | Predose Day 1 (Baseline) to end of Cycle 1 (28 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | BL=baseline; OS=on-study; LLN=lower level of normal. Laboratory values assessed using CTC for AEs, Version 3.0. Hemoglobin (g/dL) Grade 1:\ | All participants who received at least 1 dose of cetuximab. | Posted | Number | Participants | At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up |
|
|
Baseline through Cycle 1 (28 days) and up to 30 following last dose of study medication (totaling up to 58 days)
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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 | Cetuximab | Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes. | 16 | 51 | 43 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DISTAL INTESTINAL OBSTRUCTION SYNDROME | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
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| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| LUNG INFILTRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| PAIN | General disorders | MedDRA 12.1 | Systematic Assessment |
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| DISEASE PROGRESSION | General disorders | MedDRA 12.1 | Systematic Assessment |
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| INFUSION RELATED REACTION | General disorders | MedDRA 12.1 | Systematic Assessment |
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| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| NASOPHARYNGEAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| WEIGHT DECREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA 12.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 12.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 12.1 | 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 | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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