Advanced Cancer
Conditions
Brief summary
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.
Interventions
DRUGCetuximab
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.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced or metastatic malignant disease originating from solid tumors * Adequate recovery from previous therapy or intervention; at least 21 days since major surgery or prior radiation therapy * Measurable or evaluable disease
Exclusion criteria
* Women of childbearing potential (WOCBP) who are breastfeeding, pregnant, or unwilling or unable to use acceptable contraception during the study and for at least 12 weeks after the last on-study dose of cetuximab * Men unwilling to use acceptable contraception during the study if engaged in sexual relations with a WOCBP * Symptomatic brain metastasis * History of myocardial infarction 6 months or less prior to study entry, of severe congestive heart failure, of uncontrolled angina, or of uncontrolled arrhythmias * Clinically relevant abnormality on screening electrocardiogram (ECG), preventing an accurate measurement of the QT interval * Congenital long QT syndrome * History of risk factors for ventricular tachycardia or Torsades de pointes or history of fainting, unexplained loss of consciousness, or convulsions * Prolonged QTc interval on screening ECG (greater than 470 msec) using Fridericia's correction formula * Heart rate slower than 50 bpm or faster than 100 bpm at rest during screening ECG measurements * Implantable pacemaker or automatic implantable cardioverter defibrillator * Sustained supine systolic blood pressure higher than 150 mmHg or lower than 90 mmHg or a diastolic blood pressure lower than 45 mmHg or higher than 95 mmHg at screening * Known history of arterial thrombotic events within 6 months prior to study initiation * Known history of significant peripheral artery disease * Current participation in a clinical trial with another investigational new drug or device * Receipt of an investigational new drug or device within 21 days prior to enrollment in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline | Baseline, Day 1, and then weekly to end of Cycle 1 (28 days) | 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. |
| Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Predose Day 1 (Baseline) to end of Cycle 1 (28 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Baseline through Cycle 1 (28 days), continuously | 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. |
| Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | At screening, at the end of Cycle 1 (28 days) | 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. |
| Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate | Baseline, Day 1, and then weekly to end of Cycle 1 (28 days) | 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. |
| Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up | 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:\<LLN to 10.0, Grade 2:\<10.0 to 8.0, Grade 3:\<8.0 to 6.5, Grade 4:\<6.5. Platelets Grade 1:LLN to 75.0\*10\^9/L, Grade 2:\<75.0 to 50.0\*10\^9/L, Grade 3:\<50.0 to 25.0\*10\^9/L, Grade 4:\<25.0 to 10\^9/L. White blood cells Grade 1:\<LLN to 3.0\*10\^9/L, Grade 2:\<3.0 to 2.0\*10\^9/L, Grade 3:\<2.0 to 1.0\*10\^9/L, Grade 4:\<1.0\*10\^9/L. Neutrophils Grade 1:\<LLN to 1.5\*10\^9/L, Grade 2:\<1.5 to 1.0\*10\^9/L, Grade 3:\<1.0 to 0.5\*10\^9/L, Grade 4:\<0.5\*10\^9/L. |
| Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | At screening, at the end of Cycle 1 (28 days) | 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. |
| 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 | Baseline through Cycle 1 (28 days), continuously | 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. |
Countries
Puerto Rico, United States
Participant flow
Pre-assignment details
Of 79 participants enrolled, 51 received treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Disease progression | 7 |
| Overall Study | Failure to meet eligibility criteria | 2 |
| Overall Study | Other | 2 |
| Overall Study | Study drug toxicity | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Cetuximab |
|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 43 / 51 |
| serious Total, serious adverse events | 16 / 51 |
Outcome results
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.
Time frame: Predose Day 1 (Baseline) to end of Cycle 1 (28 days)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 8 (N=37) 1 hour | 1.9 msec | Standard Error 2.5 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 8 (N=36) 3 hour | 0.8 msec | Standard Error 2.5 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 22 (N=37) Predose | 2.3 msec | Standard Error 3.3 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 1 (N=36) Predose | 3.8 msec | Standard Error 2.5 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 1 (N=37) 1 hour | 1.8 msec | Standard Error 1.9 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 1 (N=37) 2 hour | 0.7 msec | Standard Error 2.1 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 1 (N=36) 3 hour | 1.2 msec | Standard Error 1.6 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 1 (N=37) 6 hour | -2.4 msec | Standard Error 1.8 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 8 (N=37) Predose | 1.3 msec | Standard Error 2.2 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 8 (N=37) 2 hour | 4.5 msec | Standard Error 2.7 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 15 (N=37) Predose | 3.2 msec | Standard Error 2.7 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 15 (N=37) 1 hour | 2.6 msec | Standard Error 3.1 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 15 (N=37) 2 hour | 1.2 msec | Standard Error 3.2 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 15 (N=36) 3 hour | -0.7 msec | Standard Error 3.6 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 22 (N=37) 1 hour | 3.4 msec | Standard Error 2.9 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 22 (N=37) 2 hour | 4.1 msec | Standard Error 3.2 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 22 (N=36) 3 hour | 2.2 msec | Standard Error 2.8 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 22 (N=37) 6 hour | 2.6 msec | Standard Error 2.4 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 29 (N=30) Predose | 0.0 msec | Standard Error 3.4 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 29 (N=30) 1 hour | 3.5 msec | Standard Error 2.9 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 29 (N=30) 2 hour | 3.5 msec | Standard Error 2.7 |
| Cetuximab | Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point | Day 29 (N=29) 3 hour | 4.0 msec | Standard Error 3 |
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.
Time frame: Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cetuximab | Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline | 0 Participants |
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.
Time frame: Baseline through Cycle 1 (28 days), continuously
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Infusion reaction (Any grade) | 6 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Infusion reaction (Grade 3) | 2 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Infusion reaction (Grade 4 or 5) | 0 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Acneform rash (Any grade) | 32 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Acneform rash (Grade 3) | 1 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Acneform rash (Grade 4 or 5) | 0 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Cardiac event (Any grade) | 2 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Cardiac event (Grade 3) | 1 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Cardiac event (Grade 4 or 5) | 0 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Treatment-related infusion reaction (Any grade) | 6 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Treatment-related infusion reaction (Grade 3) | 2 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Treatment-related infusion reaction (Grade 4 or 5) | 0 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Treatment-related acneform rash (Any grade) | 31 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Treatment-related acneform rash (Grade 3) | 1 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Treatment-related acneform rash (Grade 4 or 5) | 0 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Treatment-related cardiac event (Any grade) | 0 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Treatment-related cardiac event (Grade 3) | 0 Participants |
| Cetuximab | Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade | Treatment-related cardiac event (Grade 4 or 5) | 0 Participants |
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.
Time frame: Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cetuximab | Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate | Changes in PR interval | 0 Participants |
| Cetuximab | Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate | Changes in QRS interval | 0 Participants |
| Cetuximab | Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate | Changes in heart rate | 0 Participants |
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.
Time frame: Baseline through Cycle 1 (28 days), continuously
Population: All participants who received at least 1 dose of cetuximab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cetuximab | 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 | Deaths | 6 Participants |
| Cetuximab | 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 | SAEs | 16 Participants |
| Cetuximab | 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 | Treatment-related deaths | 0 Participants |
| Cetuximab | 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 | Treatment-related SAEs | 2 Participants |
| Cetuximab | 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 | AEs leading to discontinuation | 10 Participants |
| Cetuximab | 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 | Treatment-related AEs leading to discontinuation | 3 Participants |
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:\<LLN to 10.0, Grade 2:\<10.0 to 8.0, Grade 3:\<8.0 to 6.5, Grade 4:\<6.5. Platelets Grade 1:LLN to 75.0\*10\^9/L, Grade 2:\<75.0 to 50.0\*10\^9/L, Grade 3:\<50.0 to 25.0\*10\^9/L, Grade 4:\<25.0 to 10\^9/L. White blood cells Grade 1:\<LLN to 3.0\*10\^9/L, Grade 2:\<3.0 to 2.0\*10\^9/L, Grade 3:\<2.0 to 1.0\*10\^9/L, Grade 4:\<1.0\*10\^9/L. Neutrophils Grade 1:\<LLN to 1.5\*10\^9/L, Grade 2:\<1.5 to 1.0\*10\^9/L, Grade 3:\<1.0 to 0.5\*10\^9/L, Grade 4:\<0.5\*10\^9/L.
Time frame: At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up
Population: All participants who received at least 1 dose of cetuximab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Hemoglobin, low (OS, Grades 3 or 4) (N=45) | 2 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Hemoglobin, low (BL, Grade 4) (N=51) | 0 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Platelets, low (BL, Grades 1-4) (N=51) | 8 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Platelets, low (OS, Grades 1-4) (N=45) | 9 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Platelets, low (BL, Grades 3 or 4) (N=51) | 0 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Platelets, low (OS, Grades 3 or 4) (N=45) | 0 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | White blood cells, low (BL, Grade 4) (N=51) | 0 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Hemoglobin, low (BL, Grades 1-4) (N=51) | 35 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Hemoglobin, low (OS, Grades 1-4) (N=45) | 34 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Hemoglobin, low (BL, Grades 3 or 4) (N=51) | 1 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Hemoglobin, low (OS, Grade 4) (N=45) | 0 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Platelets, low (BL, Grade 4) (N=51) | 0 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Platelets, low (OS, Grade 4) (N=45) | 0 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | White blood cells, low (BL, Grades 1-4) (N=51) | 4 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | White blood cells, low (OS, Grades 1-4) (N=45) | 13 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | White blood cells, low (BL, Grades 3 or 4) (N=51) | 0 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | White blood cells, low (OS, Grades 3 or 4) (N=45) | 0 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | White blood cells, low (OS, Grade 4) (N=45) | 0 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Neutrophils, low (BL, Grades 1-4) (N=47) | 0 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Neutrophils, low (OS, Grades 1-4) (N=44) | 5 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Neutrophils, low (BL, Grade 3 or 4) (N=47) | 0 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Neutrophils, low (OS, Grade 3 or 4) (N=44) | 1 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Neutrophils, low (BL, Grade 4) (N=47) | 0 Participants |
| Cetuximab | Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study | Neutrophils, low (OS, Grade 4) (N=44) | 0 Participants |
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.
Time frame: At screening, at the end of Cycle 1 (28 days)
Population: All participants who received at least 1 dose of cetuximab
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | AST, high (OS, Grades 3 or 4) ( N=45) | 2 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Albumin, low (BL, Grades 1-4) ( N=48) | 18 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Albumin, low (OS, Grade 1-4) ( N=45) | 27 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Albumin, low (BL, Grades 3 or 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Albumin, low (OS, Grades 3 or 4) ( N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Albumin, low (BL, Grade 4) (N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Albumin, low (OS, Grade 4) (N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | AST, high (BL, Grades 1-4) ( N=48) | 9 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | AST, high (OS, Grades 1- 4) ( N=45) | 19 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | AST, high (BL, Grades 3 or 4) ( N=48) | 1 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | AST, high (BL, Grade 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | AST, high (OS, Grade 4) ( N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Total bilirubin, high (BL, Grades 1-4) ( N=48) | 2 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Total bilirubin, high (OS, Grades 1-4) ( N=45) | 4 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Total bilirubin, high (OS, Grade 4) ( N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Total bilirubin, high (BL, Grade 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Total bilirubin, high (BL, Grades 3 or 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Total bilirubin, high (OS, Grades 3 or 4) (N=45) | 1 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | ALP, high (BL, Grade 1-4) ( N=48) | 18 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | ALP, high (OS, Grade 1-4) ( N=45) | 25 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | ALP, high (BL, Grade 3 or 4) ( N=48) | 1 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | ALP, high (OS, Grade 3 or 4) ( N=45) | 2 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | ALP, high (BL, Grade 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | ALP, high (OS, Grade 4) ( N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Creatinine, high (BL, Grades 1-4) ( N=48) | 1 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Creatinine, high (OS, Grade 1-4) ( N=45) | 2 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Creatinine, high (BL, Grades 3 or 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Creatinine, high (OS, Grades 3 or 4) ( N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Creatinine, high (BL, Grade 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study | Creatinine, high (OS, Grade 4) ( N=45) | 0 Participants |
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.
Time frame: At screening, at the end of Cycle 1 (28 days)
Population: All participants who received at least 1 dose of cetuximab
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Calcium, low (BL, Grade 1-4) (N=48) | 4 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Calcium, low (OS, Grade 4) (N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Calcium, high (BL, Grades 1-4) (N=48) | 2 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Calcium, high (OS, Grades 1-4) (N=45) | 2 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Calcium, high (BL, Grades 3 or 4) (N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Calcium, high (OS, Grades 3 or 4) (N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Calcium, high (BL, Grade 4) (N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Calcium, high (OS, Grade 4) (N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Magnesium, low (BL, Grades 1-4) (N=41) | 3 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Magnesium, low (OS, Grades 1-4) (N=38) | 11 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Magnesium, low (BL, Grades 3 or 4) (N=41) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Magnesium, low (OS, Grades 3 or 4) (N=38) | 1 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Sodium, low (BL, Grades 1-4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Sodium, low (OS, Grades 1- 4) ( N=45) | 7 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Sodium, low (BL, Grades 3 or 4) ( N=48) | 15 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Sodium, low (OS, Grades 3 or 4) ( N=45) | 2 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Sodium, low (BL, Grade 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Sodium, low (OS, Grade 4) ( N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Sodium, high (BL, Grade 1-4) ( N=48) | 1 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Sodium, high (OS, Grades 1-4) ( N=45) | 5 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Sodium, high (BL, Grades 3 or 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Sodium, high (OS, Grades 3 or 4) ( N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Sodium, high (BL, Grade 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Sodium, high (OS, Grade 4) ( N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Potassium, high (BL, Grades 1-4) ( N=48) | 2 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Potassium, high (OS, Grades 1-4) ( N=45) | 3 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Potassium, high (BL, Grade 3 or 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Potassium, high (OS, Grade 3 or 4) ( N=45) | 1 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Potassium, high (BL, Grade 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Potassium, high (OS, Grade 4) ( N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Glucose, low (BL, Grades 1- 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Glucose, low (OS, Grades 1-4) ( N=45) | 2 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Glucose, low (BL, Grades 3 or 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Glucose, low (OS, Grades 3 or 4) ( N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Glucose, low (BL, Grade 4) ( N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Glucose, low (OS, Grade 4) ( N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Glucose, high (BL, Grades 1- 4) ( N=48) | 29 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Glucose, high (OS, Grades 1- 4) ( N=45) | 37 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Glucose, high (BL, Grades 3 or 4) (N=48) | 2 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Glucose, high (OS, Grades 3 or 4) (N=45) | 4 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Glucose, high (BL, Grade 4) (N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Glucose, high (OS, Grade 4) (N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Calcium, low (OS, Grade 1-4) (N=45) | 14 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Calcium, low (BL, Grade 3 or 4) (N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Calcium, low (OS, Grades 3 or 4) (N=45) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Calcium, low (BL, Grade 4) (N=48) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Magnesium, low (BL, Grade 4) (N=41) | 0 Participants |
| Cetuximab | Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) | Magnesium, low (OS, Grade 4) (N=38) | 1 Participants |