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The purpose of this study is to determine if panitumumab, in combination with irinotecan, leucovorin, and 5-fluorouracil (5-FU) is safe and efficacious in patients with metastatic colorectal cancer.
Indication Metastatic Colorectal Cancer Primary Objective To assess the safety of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (The primary objective in the original protocol was to assess progression free survival after treatment with ABX-EGF in combination with the Saltz regimen in subjects with metastatic colorectal cancer).
Secondary Objective(s) To assess the clinical efficacy of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (Secondary objectives in the original protocol were to assess safety and additional measures of the clinical efficacy of ABX-EGF in combination with the Saltz regimen in subjects with metastatic colorectal cancer).
To assess the pharmacokinetics (PK) of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (Secondary objectives in the original protocol were to assess the PK of ABX-EGF in combination with the Saltz regimen, and the PK of irinotecan (IR) and its active metabolite SN-38 when IR is given in combination with ABX-EGF, leucovorin (LV), and 5-fluorouracil (5-FU) in subjects with metastatic colorectal cancer)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Panitumumab + IFL | Experimental | Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil (5-FU)and leucovorin (IFL chemotherapy regimen) |
|
| Part 2: Panitumumab + FOLFIRI | Experimental | Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan | Drug | Part 1: 125 mg/m^2 IV infusion once a week on weeks 1 through 4 of each 6-week treatment cycle. Part 2: 180 mg/m^2 IV infusion every other week until disease progression or unable to tolerate. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 2) | The number of participants with grade 3 or grade 4 diarrhea in Part 2 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC). | Until disease progression (median 47 weeks) |
| Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 1) | The number of participants with grade 3 or grade 4 diarrhea in Part 1 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC). | Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Objective Tumor Response (Part 2) | Objective tumor response (complete or partial) in Part 2 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease. | Until disease progression (median 47 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
Female (of childbearing potential, post-menopausal for less than 6 months, not surgically sterilized, or not abstinent) not consenting to use adequate contraceptive precautions during the course of the study and for 6 months after the last ABX-EGF infusion
Female who is breast-feeding or pregnant
Any kind of disorder that compromises the ability of the patient to give written informed consent and/or comply with the study procedures
History of any chronic medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study drug administration or may interfere with compliance or the interpretation of study results
Untreated brain metastases
Therapy for colorectal cancer other than surgery and 5-FU-based adjuvant therapy
Prior treatment for metastatic colorectal cancer
Prior irinotecan
Prior or concurrent radiation therapy for colorectal cancer, including prior adjuvant radiation therapy to the pelvis
Known allergy to irinotecan, 5-fluorouracil, or leucovorin
Known Gilbert's disease
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Prior EGFr-targeting agents
Use of investigational therapy used with adjuvant intent within 30 days before the first ABX-EGF infusion
If prior history of cancer other than colorectal carcinoma, basal cell carcinoma, or cervical carcinoma in situ, no treatment or active disease within 5 years
Active inflammatory bowel disease or other bowel disease (other than colorectal carcinoma) causing chronic diarrhea (defined as greater than 4 stools per day)
Partial or complete bowel obstruction, known chronic malabsorption, total colectomy, or other major abdominal surgery that might result in substantial alteration in transit to absorption of oral medication
Ascites or pleural effusion requiring therapeutic paracentesis or thoracentesis; subject with small, stable, asymptomatic pleural effusions or ascites may be enrolled; subject who has been rendered asymptomatic by successful sclerosis of an effusion may be enrolled.
Active interstitial pneumonia or interstitial fibrosis
Left ventricular ejection fraction (LVEF) less than 45%, as measured by multiple-gated acquisition (MUGA) scan - Myocardial infarction within 1 year before the first ABX-EGF infusion
Any of the following within 6 months before the first study drug dose:
Subject known to be human immunodeficiency virus (HIV) positive
History of any chronic medical or psychiatric condition or laboratory abnormality that, in the opinion of the Investigator, may increase the risks associated with study participation or study drug administration or may interfere with patient compliance or the interpretation of study results
Unwilling or unable to comply with study requirements
Known allergy to the ingredients of the study drug or to Staphylococcus protein A
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17531105 | Background | Berlin J, Posey J, Tchekmedyian S, Hu E, Chan D, Malik I, Yang L, Amado RG, Hecht JR. Panitumumab with irinotecan/leucovorin/5-fluorouracil for first-line treatment of metastatic colorectal cancer. Clin Colorectal Cancer. 2007 Mar;6(6):427-32. doi: 10.3816/CCC.2007.n.011. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were enrolled from 19 Jul 2002 through 20 April 2004
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab With FOLFIRI | Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen) |
| FG001 | Panitumumab With IFL | Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 |
|
| |||||||||||||||||||||
| Part 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab With IFL | Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen) |
| BG001 | Panitumumab With FOLFIRI | Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen) |
| 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 | Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 2) | The number of participants with grade 3 or grade 4 diarrhea in Part 2 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC). | Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy. | Posted | Number | Participants | Until disease progression (median 47 weeks) |
|
|
First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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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 | Panitumumab Plus IFL |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D000077544 | Panitumumab |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
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| Panitumumab | Biological | Intravenous (IV) infusions of panitumumab 2.5 mg/kg once a week delivered in 6-week cycles. |
|
|
| 5-Fluorouracil | Drug | Part 1: IV bolus 500 mg/m^2 on weeks 1 through 4 of each 6-week cycle. Part 2: IV bolus 400 mg/m^2 and infusional 2400-3000 mg/m^2 over 46 hours once every other week until disease progression or unable to tolerate. |
|
| Leucovorin | Drug | Part 1: IV bolus 20 mg/m^2 on weeks 1 through 4 of each 6-week cycle. Part 2: 400 mg/m^2 every other week until disease progression or unable to tolerate. |
|
| Time to Disease Progression (Part 2) | Kaplan-Meier estimate of median time from the first dose of study drug to first observed disease progression or death if the death was due to disease progression (whichever comes first) in Part 2 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date. | From enrollment until death or diease progression. Maximum follow-up time was 16 months. |
| Progression-free Survival Time (Part 2) | Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 2 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date. | From enrollment until disease progression or death. Maximum follow-up time was 16 months. |
| Survival Time (Part 2) | Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date. | From enrollment until death. Maximum follow-up time was 16 months. |
| Number of Participants Who Died (Part 2) | The number of participants in Part 2 who died during the study. | From enrollment until last contact. Maximum follow-up was 16 months. |
| Number of Participants With Objective Tumor Response (Part 1) | Objective tumor response (complete or partial) in Part 1 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease. | Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first |
| Progression-free Survival Time (Part 1) | Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 1 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date. | From enrollment until disease progression or death. Maximum follow-up time was 25 months. |
| Time to Disease Progression (Part 1) | Kaplan-Meier estimate of the median time from the first dose of study drug to disease progression or death if due to disease progression (whichever comes first) in Part 1 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date. | From enrollment until disease progression or death. Maximum follow-up time was 25 months. |
| Survival Time (Part 1) | Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date. | From enrollment until death. Maximum follow-up time was 25 months. |
| Time to Treatment Failure (Part 1) | Kaplan-Meier estimate of the median time from the date of first dose of panitumumab or chemotherapy to the date the decision was made to end treatment for any reason in Part 1 of the study. | Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first |
| Time to Initial Objective Tumor Response (Part 1) | Median time to first observed objective tumor response (complete or partial) among responders in Part 1 of the study. | Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first |
| FDA-approved Drug Labeling | View source |
| Other |
|
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 1) | The number of participants with grade 3 or grade 4 diarrhea in Part 1 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC). | Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy. | Posted | Number | Participants | Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first |
|
|
|
|
| Secondary | Number of Participants With an Objective Tumor Response (Part 2) | Objective tumor response (complete or partial) in Part 2 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease. | Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy | Posted | Number | Participants | Until disease progression (median 47 weeks) |
|
|
|
|
| Secondary | Time to Disease Progression (Part 2) | Kaplan-Meier estimate of median time from the first dose of study drug to first observed disease progression or death if the death was due to disease progression (whichever comes first) in Part 2 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date. | Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy | Posted | Median | 95% Confidence Interval | weeks | From enrollment until death or diease progression. Maximum follow-up time was 16 months. |
|
|
|
| Secondary | Progression-free Survival Time (Part 2) | Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 2 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date. | Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy | Posted | Median | 95% Confidence Interval | weeks | From enrollment until disease progression or death. Maximum follow-up time was 16 months. |
|
|
|
| Secondary | Survival Time (Part 2) | Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date. | Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy. | Posted | Median | 95% Confidence Interval | weeks | From enrollment until death. Maximum follow-up time was 16 months. |
|
|
|
| Secondary | Number of Participants Who Died (Part 2) | The number of participants in Part 2 who died during the study. | Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy | Posted | Number | participants | From enrollment until last contact. Maximum follow-up was 16 months. |
|
|
|
| Secondary | Number of Participants With Objective Tumor Response (Part 1) | Objective tumor response (complete or partial) in Part 1 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease. | Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy. | Posted | Number | Participants | Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first |
|
|
|
|
| Secondary | Progression-free Survival Time (Part 1) | Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 1 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date. | Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy. | Posted | Median | 95% Confidence Interval | weeks | From enrollment until disease progression or death. Maximum follow-up time was 25 months. |
|
|
|
| Secondary | Time to Disease Progression (Part 1) | Kaplan-Meier estimate of the median time from the first dose of study drug to disease progression or death if due to disease progression (whichever comes first) in Part 1 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date. | Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy. | Posted | Median | 95% Confidence Interval | weeks | From enrollment until disease progression or death. Maximum follow-up time was 25 months. |
|
|
|
| Secondary | Survival Time (Part 1) | Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date. | Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy. | Posted | Median | 95% Confidence Interval | weeks | From enrollment until death. Maximum follow-up time was 25 months. |
|
|
|
| Secondary | Time to Treatment Failure (Part 1) | Kaplan-Meier estimate of the median time from the date of first dose of panitumumab or chemotherapy to the date the decision was made to end treatment for any reason in Part 1 of the study. | Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy. | Posted | Median | 95% Confidence Interval | Weeks | Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first |
|
|
|
| Secondary | Time to Initial Objective Tumor Response (Part 1) | Median time to first observed objective tumor response (complete or partial) among responders in Part 1 of the study. | Subset of Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy, who had an objective tumor response. | Posted | Median | Inter-Quartile Range | weeks | Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first |
|
|
|
| 12 |
| 19 |
| 19 |
| 19 |
| EG001 | Panitumumab Plus FOLFIRI | 11 | 24 | 24 | 24 |
| Cardiac failure congestive | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Intestinal fistula | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Coagulation time prolonged | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| Colorectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Growth of eyelashes | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Keratoconjunctivitis sicca | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Anal discomfort | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Defaecation urgency | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypertrophy of tongue papillae | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Intestinal stenosis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Loose stools | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rectal discharge | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Infusion site reaction | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rigors | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Cellulitis orbital | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Genital candidiasis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Nail infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Ejection fraction abnormal | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Facial pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Local swelling | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Cholinergic syndrome | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rash follicular | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. 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.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| 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 |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |