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| ID | Type | Description | Link |
|---|---|---|---|
| CP11-1114 | Other Identifier | ImClone Systems | |
| I4X-IE-JFCI | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine whether treatment with necitumumab monotherapy affects the QT/QTc interval among participants with advanced solid tumors refractory to standard treatment or for which no standard treatment is available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Necitumumab | Experimental | 800 mg necitumumab, administered once per week as an intravenous infusion (IV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Necitumumab | Biological | 800 mg necitumumab, administered once per week IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | The corrected QT interval was calculated using Fridericia's correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QT intervals measured at each timepoint and the average was calculated for each participant at each timepoint. For each timepoint, a participant's corresponding baseline (Day -1, pretreatment) QTcF interval was subtracted from the average QTcF intervals to create the change from time-matched baseline in the QTcF interval | Baseline, Cycle1 Day 1, 8,15, 22, 29, and 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Time-Matched Baseline ≥ 25% and Absolute Value of QRS >110 Msec (Electrocardiographic Parameters: QRS Interval) | Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion | |
| PR Change From Time-Matched Baseline ≥25% and Absolute Value of PR > 200 Msec (Electrocardiographic Parameters: PR Interval) |
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ann Arbor | Michigan | 48109 |
Completers are defined as the QTc complete participants who received full doses of necitumumab for ≥1 full 6-week cycle or did not complete the first cycle because of QTc prolongation, and had pretreatment and post-infusion triplicate ECGs at the times specified in all versions of the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Necitumumab | 800 milligram (mg) necitumumab, administered once per week as an intravenous infusion (IV) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
All QTc evaluable participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Necitumumab | 800 mg necitumumab, administered once per week IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | The corrected QT interval was calculated using Fridericia's correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QT intervals measured at each timepoint and the average was calculated for each participant at each timepoint. For each timepoint, a participant's corresponding baseline (Day -1, pretreatment) QTcF interval was subtracted from the average QTcF intervals to create the change from time-matched baseline in the QTcF interval | QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG. | Posted | Mean | 90% Confidence Interval | milliseconds (msec) | Baseline, Cycle1 Day 1, 8,15, 22, 29, and 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion |
|
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All participants who received at least 1 dose of study drug.
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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 | Necitumumab | 800 mg necitumumab, administered once per week as an intravenous infusion (IV) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| C527969 | necitumumab |
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| Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion |
| Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR]) | Change in HR from time-matched measures performed at baseline. | Baseline, Cycle1 Day 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion |
| Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Necitumumab From Zero to Infinity (AUC[0-∞]) | Cycle1 (Days 1 and 36): Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours |
| Pharmacokinetics: Maximum Drug Concentration (Cmax) of Necitumumab | Cycle 1 (Days 1 and 36); Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours |
| Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) (Tumor Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST 1.1]) | ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1,CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100. PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. | Baseline to Measured Progressive Disease (up to 21 Months) |
| Number of Participants With an Incidence of Anti-Necitumumab Antibodies | Baseline to Post Infusion 30 Day Follow-up |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Detroit | Michigan | 48201 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Las Vegas | Nevada | 89169 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | New Brunswick | New Jersey | 08901 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Huntersville | North Carolina | 28078 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cleveland | Ohio | 44195 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pittsburgh | Pennsylvania | 15213 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Salt Lake City | Utah | 84112 | United States |
| Progressive Disease |
|
| Per Sponsor Requirement |
|
| Subject Withdrew from Treatment |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Change From Time-Matched Baseline ≥ 25% and Absolute Value of QRS >110 Msec (Electrocardiographic Parameters: QRS Interval) | QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG | Posted | Number | participants | Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion |
|
|
|
| Secondary | PR Change From Time-Matched Baseline ≥25% and Absolute Value of PR > 200 Msec (Electrocardiographic Parameters: PR Interval) | QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG. | Posted | Number | percentage of participants | Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion |
|
|
|
| Secondary | Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR]) | Change in HR from time-matched measures performed at baseline. | QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG | Posted | Mean | Standard Deviation | Beats/minute | Baseline, Cycle1 Day 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Necitumumab From Zero to Infinity (AUC[0-∞]) | All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1 on Days 1 and 36. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour/milliliter (μg*h/ml) | Cycle1 (Days 1 and 36): Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours |
|
|
|
| Secondary | Pharmacokinetics: Maximum Drug Concentration (Cmax) of Necitumumab | All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1, Days 1 and 36. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter (μg/mL) | Cycle 1 (Days 1 and 36); Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours |
|
|
|
| Secondary | Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) (Tumor Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST 1.1]) | ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1,CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100. PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. | All participants who received any study drug and had CR or PR. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Measured Progressive Disease (up to 21 Months) |
|
|
|
| Secondary | Number of Participants With an Incidence of Anti-Necitumumab Antibodies | All participants who received at least 1 dose of study drug and had at least 1 post-infusion blood sample. | Posted | Number | participants | Baseline to Post Infusion 30 Day Follow-up |
|
|
|
| 33 |
| 75 |
| 75 |
| 75 |
| Sinus tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Epiploic appendagitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Disease recurrence | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Klebsiella bacteraemia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Electrocardiogram qt prolonged | Investigations | MedDRA 16.0 | Systematic Assessment |
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| International normalised ratio increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
|
| Cycle 1, D36, 2 hr Post-Infusion (n=50) |
|
| Cycle 1, D36, 4 hr Post-Infusion (n=49) |
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| Cycle 1, D36, 24 hr Post-Infusion (n=49) |
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| Cycle 1, D36, 48 hr Post-Infusion, (n=50) |
|
| Cycle 1, D36, 72 hr Post-Infusion (n=50) |
|
| Cycle 1, D36, 168 hr Post-Infusion (n=11) |
|