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The purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.
Panitumumab was administered once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons (eg, administrative decision). Participants then attended a safety follow-up visit 4 weeks from the last panitumumab infusion. Participants were subsequently contacted every 3 months from the last panitumumab infusion through month 24 to assess disease status and survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab | Experimental | Participants received panitumumab 6 mg/kg once every 2 weeks weeks administered by intravenous (IV) infusion until progressive disease, inability to tolerate the investigational product, or discontinuation of treatment for other reasons. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab | Biological | Panitumumab 6 mg/kg every once 2 weeks weeks administered by intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Objective Tumor Response Through Week 16 | Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, through week 16. Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease. | 16 weeks |
| Duration of Response | The time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first); participants who respond and have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date. Response (complete or partial response) was assessed per modified WHO criteria by the central IRC. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease. | Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Objective Tumor Response Throughout Study | Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, throughout the duration of the study Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34213592 | Derived | Liao MZ, Prenen H, Dutta S, Upreti VV. The impact of hepatic and renal function on panitumumab exposures in patients with metastatic RAS wild-type colorectal cancer. Cancer Chemother Pharmacol. 2021 Oct;88(4):665-672. doi: 10.1007/s00280-021-04319-w. Epub 2021 Jul 2. |
| Label | URL |
|---|---|
| FDA-approved Drug Labeling | View source |
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Participants were enrolled from 1 March 2004 through 19 Jul 2006. Patient disposition is reported up until the data cut-off date of 22 December 2006. Completed study is defined as participants who either died on study or completed the safety follow-up visit (30 days after the last dose of panitumumab).
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab (ABX-EGF) | Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks. |
| Time to Response | Median time from enrollment to objective tumor response for participants who responded. | Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks. |
| Progression-free Survival Time | Kaplan-Meier estimate of median time from enrollment to death or first observed disease progression (whichever comes first). Participants who did not progress while on study and did not die while on study were censored at the last evaluable disease assessment date. | Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. |
| Time to Disease Progression | Kaplan-Meier estimate of the median time from enrollment to first observed disease progression or death if death was due to disease progression (whichever comes first). Participants who did not progress while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date. | Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. |
| Time to Treatment Failure | Kaplan-Meier estimate of median time from enrollment to treatment failure, defined as the date the decision was made to end treatment. Participants remaining in the treatment phase at the time of the analysis were censored on their last visit date. | Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. |
| Duration of Stable Disease | Kaplan-Meier estimates of the median time from enrollment to the date of first observed disease progression or death due to disease progression among those participants with a best outcome of stable disease. Stable disease (SD): Neither sufficient shrinkage of Index lesions to qualify for partial response nor sufficient increase to qualify for progressive disease (PD) taking as reference the nadir sum of the products of the longest diameters (SPD) since the treatment started and the disappearance of or persistence of one or more non-index lesions not qualifying for PD. | Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. |
| Overall Survival | Kaplan-Meier estimate of median time from enrollment to death from any cause. Deaths were recorded during treatment, safety follow-up and long term follow-up. | Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. |
| AmgenTrials clinical trials website | View source |
| Received Study Medication |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab | Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons. |
| 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/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Objective Tumor Response Through Week 16 | Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, through week 16. Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease. | Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC) | Posted | Number | Participants | 16 weeks |
|
|
| ||||||||||||||||||||||||||
| Primary | Duration of Response | The time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first); participants who respond and have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date. Response (complete or partial response) was assessed per modified WHO criteria by the central IRC. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease. | Subset of the Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed obective tumor response | Posted | Median | 95% Confidence Interval | Weeks | Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks. |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Objective Tumor Response Throughout Study | Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, throughout the duration of the study Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease. | Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC) | Posted | Number | Participants | Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks. |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Response | Median time from enrollment to objective tumor response for participants who responded. | Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response | Posted | Median | Inter-Quartile Range | Weeks | Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks. |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival Time | Kaplan-Meier estimate of median time from enrollment to death or first observed disease progression (whichever comes first). Participants who did not progress while on study and did not die while on study were censored at the last evaluable disease assessment date. | Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC) | Posted | Median | 95% Confidence Interval | Weeks | Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Disease Progression | Kaplan-Meier estimate of the median time from enrollment to first observed disease progression or death if death was due to disease progression (whichever comes first). Participants who did not progress while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date. | Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC) | Posted | Median | 95% Confidence Interval | Weeks | Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure | Kaplan-Meier estimate of median time from enrollment to treatment failure, defined as the date the decision was made to end treatment. Participants remaining in the treatment phase at the time of the analysis were censored on their last visit date. | Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC) | Posted | Median | 95% Confidence Interval | Weeks | Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Stable Disease | Kaplan-Meier estimates of the median time from enrollment to the date of first observed disease progression or death due to disease progression among those participants with a best outcome of stable disease. Stable disease (SD): Neither sufficient shrinkage of Index lesions to qualify for partial response nor sufficient increase to qualify for progressive disease (PD) taking as reference the nadir sum of the products of the longest diameters (SPD) since the treatment started and the disappearance of or persistence of one or more non-index lesions not qualifying for PD. | Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), with a best outcome of stable disease | Posted | Median | 95% Confidence Interval | Weeks | Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Kaplan-Meier estimate of median time from enrollment to death from any cause. Deaths were recorded during treatment, safety follow-up and long term follow-up. | Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC) | Posted | Median | 95% Confidence Interval | months | Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. |
|
|
From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Panitumumab | 62 | 182 | 176 | 182 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Early satiety | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Endocarditis staphylococcal | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Septic embolus | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Anoxic encephalopathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| 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 |
Not provided
Not provided
| Black or African American |
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| Hispanic or Latino |
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| Japanese |
|
| Native Hawaiian or Other Pacific Islander |
|
| White or Caucasian |
|
| Other |
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| Aborigine |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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