Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab plus best supportive care | Experimental | Panitumumab will be administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants develop progressive disease or are unable to tolerate study drug. Participants will also receive best supportive care (BSC) as judged appropriate by the investigator and according to institutional guidelines. |
|
| Best Supportive Care | Other | Best supportive care will be defined in this study as the best care available as judged appropriate by the investigator and according to institutional guidelines and will include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care will not include anti-neoplastic chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best supportive care | Other | Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr(Epidermal growth factor receptor) targeting agents other than ABX-EGF(Panitumumab), experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception of radiotherapy for pain control limited to bone metastases). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival Time | Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression, whichever occurred first. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions. | From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Kaplan-Meier estimates of median time from randomization to death. | From randomization until the data cut-off date for overall survival of 15 March 2006. The median actual follow-up time was 30 weeks for the panitumumab plus BSC group and 31 weeks for the BSC alone group. |
| Objective Tumor Response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21448748 | Background | Bai JP, Bell R, Buckman S, Burckart GJ, Eichler HG, Fang KC, Goodsaid FM, Jusko WJ, Lesko LL, Meibohm B, Patterson SD, Puig O, Smerage JB, Snider BJ, Wagner JA, Wang J, Walton MK, Weiner R. Translational biomarkers: from preclinical to clinical a report of 2009 AAPS/ACCP Biomarker Workshop. AAPS J. 2011 Jun;13(2):274-83. doi: 10.1208/s12248-011-9265-x. Epub 2011 Mar 30. | |
| 21190026 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
Participants were enrolled from 16 January 2004 through 16 March 2005. Data are up until the data cutoff of 15 March 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab Plus BSC | Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug. |
| FG001 | BSC Alone | Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab Plus BSC | Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug. |
| BG001 | BSC Alone |
| 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 | Progression-free Survival Time | Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression, whichever occurred first. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions. | Intention-to-treat (ITT) | Posted | Median | 95% Confidence Interval | weeks | From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group. |
|
First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Safety Analysis set includes all randomized patients, analyzed according to the treatment they actually received. Hence, 2 patients randomized to Panitumumab Plus BSC treatment group are analyzed in the BSC Alone group for safety.
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 Plus BSC | Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | 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 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| D012004 | Rectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Panitumumab | Drug | Intravenous infusion at a dose of 6 mg/kg once every 2 weeks. |
|
|
Defined as the number of participants with a confirmed complete or partial tumor response, confirmed by a scan no less than 4 weeks after the criteria for response were first met. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): disappearance of all target lesions, and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, with no progressive disease of non-target lesions. |
| From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. |
| Duration of Response | Kaplan-Meier estimate of the median time from first confirmed objective tumor response to first observed progression of disease or death due to progression of disease (whichever comes first). | From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. |
| Time to Response | Time to response was defined as the time from randomization to first partial or complete response, subsequently confirmed ≥ 4 weeks after the criteria for response were first met. | From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. |
| Time to Disease Progression | Kaplan-Meier estimates of median time from randomization to disease progression or death due to disease progression (whichever occurs first) | From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. |
| Time to Treatment Failure | Kaplan-Meier estimate of the median time from randomization to the date the decision was made to end treatment for any reason. | From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. |
| Duration of Stable Disease | Kaplan-Meier estimate of the median time from randomization to date of first observed progression of disease or death due to progression of disease (whichever comes first) for those participants with a best response of stable disease. Stable disease defined as neither sufficient shrinkage to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir longest diameter since the treatment started, no unequivocal progression of existing non-target lesions, and no new lesions. | From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. |
| Background |
| Odom D, Barber B, Bennett L, Peeters M, Zhao Z, Kaye J, Wolf M, Wiezorek J. Health-related quality of life and colorectal cancer-specific symptoms in patients with chemotherapy-refractory metastatic disease treated with panitumumab. Int J Colorectal Dis. 2011 Feb;26(2):173-81. doi: 10.1007/s00384-010-1112-5. Epub 2010 Dec 29. |
| 19189371 | Background | Peeters M, Siena S, Van Cutsem E, Sobrero A, Hendlisz A, Cascinu S, Kalofonos H, Devercelli G, Wolf M, Amado RG. Association of progression-free survival, overall survival, and patient-reported outcomes by skin toxicity and KRAS status in patients receiving panitumumab monotherapy. Cancer. 2009 Apr 1;115(7):1544-54. doi: 10.1002/cncr.24088. |
| 18040272 | Background | Siena S, Peeters M, Van Cutsem E, Humblet Y, Conte P, Bajetta E, Comandini D, Bodoky G, Van Hazel G, Salek T, Wolf M, Devercelli G, Woolley M, Amado RG. Association of progression-free survival with patient-reported outcomes and survival: results from a randomised phase 3 trial of panitumumab. Br J Cancer. 2007 Dec 3;97(11):1469-74. doi: 10.1038/sj.bjc.6604053. Epub 2007 Nov 27. |
| 17470858 | Background | Van Cutsem E, Peeters M, Siena S, Humblet Y, Hendlisz A, Neyns B, Canon JL, Van Laethem JL, Maurel J, Richardson G, Wolf M, Amado RG. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol. 2007 May 1;25(13):1658-64. doi: 10.1200/JCO.2006.08.1620. |
| 37596461 | Derived | Safari M, Esmaeili H, Mahjub H, Roshanaei G. Estimation of treatment effect in presence of noncompliance and competing risks: a simulation study. Sci Rep. 2023 Aug 18;13(1):13477. doi: 10.1038/s41598-023-40538-2. |
| 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. |
| 29627309 | Derived | Boeckx N, Koukakis R, Op de Beeck K, Rolfo C, Van Camp G, Siena S, Tabernero J, Douillard JY, Andre T, Peeters M. Effect of Primary Tumor Location on Second- or Later-line Treatment Outcomes in Patients With RAS Wild-type Metastatic Colorectal Cancer and All Treatment Lines in Patients With RAS Mutations in Four Randomized Panitumumab Studies. Clin Colorectal Cancer. 2018 Sep;17(3):170-178.e3. doi: 10.1016/j.clcc.2018.03.005. Epub 2018 Mar 8. |
| 26049686 | Derived | Peeters M, Kafatos G, Taylor A, Gastanaga VM, Oliner KS, Hechmati G, Terwey JH, van Krieken JH. Prevalence of RAS mutations and individual variation patterns among patients with metastatic colorectal cancer: A pooled analysis of randomised controlled trials. Eur J Cancer. 2015 Sep;51(13):1704-13. doi: 10.1016/j.ejca.2015.05.017. Epub 2015 Jun 3. |
| 23625191 | Derived | Poulin-Costello M, Azoulay L, Van Cutsem E, Peeters M, Siena S, Wolf M. An analysis of the treatment effect of panitumumab on overall survival from a phase 3, randomized, controlled, multicenter trial (20020408) in patients with chemotherapy refractory metastatic colorectal cancer. Target Oncol. 2013 Jun;8(2):127-36. doi: 10.1007/s11523-013-0271-z. Epub 2013 Apr 27. |
| 18316791 | Derived | Amado RG, Wolf M, Peeters M, Van Cutsem E, Siena S, Freeman DJ, Juan T, Sikorski R, Suggs S, Radinsky R, Patterson SD, Chang DD. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008 Apr 1;26(10):1626-34. doi: 10.1200/JCO.2007.14.7116. Epub 2008 Mar 3. |
| FDA-approved Drug Labeling | View source |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other |
|
| Non-compliance |
|
| Ongoing |
|
Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Central and Eastern Europe includes the Czech Republic, Greece, Hungary, and the Slovak Republic. Rest of World includes Australia, Canada and New Zealand. Western Europe includes Austria, Belgium, France, Germany, Italy, Portugal, Spain, Switzerland, and the Netherlands. | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) performance status | Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead. | Number | participants |
|
Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug. |
| OG001 | BSC Alone | Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy. |
|
|
|
| Secondary | Overall Survival | Kaplan-Meier estimates of median time from randomization to death. | Intention-to-treat (ITT) | Posted | Median | 95% Confidence Interval | months | From randomization until the data cut-off date for overall survival of 15 March 2006. The median actual follow-up time was 30 weeks for the panitumumab plus BSC group and 31 weeks for the BSC alone group. |
|
|
|
|
| Secondary | Objective Tumor Response | Defined as the number of participants with a confirmed complete or partial tumor response, confirmed by a scan no less than 4 weeks after the criteria for response were first met. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): disappearance of all target lesions, and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, with no progressive disease of non-target lesions. | Intention-to-treat (ITT) | Posted | Number | participants | From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. |
|
|
|
| Secondary | Duration of Response | Kaplan-Meier estimate of the median time from first confirmed objective tumor response to first observed progression of disease or death due to progression of disease (whichever comes first). | Intention-to-treat participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm. | Posted | Median | 95% Confidence Interval | weeks | From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. |
|
|
|
| Secondary | Time to Response | Time to response was defined as the time from randomization to first partial or complete response, subsequently confirmed ≥ 4 weeks after the criteria for response were first met. | Intention-to-treat (ITT) participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm. | Posted | Median | Inter-Quartile Range | weeks | From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. |
|
|
|
| Secondary | Time to Disease Progression | Kaplan-Meier estimates of median time from randomization to disease progression or death due to disease progression (whichever occurs first) | Intention-to-treat | Posted | Median | 95% Confidence Interval | weeks | From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. |
|
|
|
| Secondary | Time to Treatment Failure | Kaplan-Meier estimate of the median time from randomization to the date the decision was made to end treatment for any reason. | Intention-to-treat (ITT) | Posted | Median | 95% Confidence Interval | weeks | From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. |
|
|
|
| Secondary | Duration of Stable Disease | Kaplan-Meier estimate of the median time from randomization to date of first observed progression of disease or death due to progression of disease (whichever comes first) for those participants with a best response of stable disease. Stable disease defined as neither sufficient shrinkage to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir longest diameter since the treatment started, no unequivocal progression of existing non-target lesions, and no new lesions. | Participants who had a best overall response of stable disease | Posted | Median | 95% Confidence Interval | weeks | From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. |
|
|
|
| Post-Hoc | Progression-free Survival Time (Wild-type KRAS) | Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions. | Wild-type KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. | Posted | Median | 95% Confidence Interval | weeks | From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with wild-type KRAS was 36.8 weeks in the panitumumab plus BSC group and 35.7 weeks in the BSC alone group. |
|
|
|
| Post-Hoc | Progression-free Survival Time (Mutant KRAS) | Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions. | Mutant KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. | Posted | Median | 95% Confidence Interval | weeks | From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with mutant KRAS was 24.4 weeks in the panitumumab plus BSC group and 23.9 weeks in the BSC alone group. |
|
|
|
| 101 |
| 229 |
| 224 |
| 229 |
| EG001 | BSC Alone | Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy. | 62 | 234 | 171 | 234 |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| ARRHYTHMIA SUPRAVENTRICULAR | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| CARDIOMYOPATHY | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| PERICARDITIS | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| ENDOPHTHALMITIS | Eye 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 LOWER | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| DUODENAL STENOSIS | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| GASTROINTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| MELAENA | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| PERITONITIS | 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 |
|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| CATHETER RELATED COMPLICATION | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| HYPERTHERMIA | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| MULTI-ORGAN FAILURE | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| OEDEMA | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| PELVIC MASS | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| PERFORMANCE STATUS DECREASED | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| BILE DUCT STENOSIS | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| CHOLESTASIS | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| HEPATOMEGALY | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| HEPATORENAL FAILURE | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| JAUNDICE | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| JAUNDICE CHOLESTATIC | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| LIVER DISORDER | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA 9.0 | Systematic Assessment |
|
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| BACTERIAL SEPSIS | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| CYSTITIS | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| DIARRHOEA INFECTIOUS | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| EPSTEIN-BARR VIRUS INFECTION | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| EYE INFECTION STAPHYLOCOCCAL | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| HAEMOPHILUS INFECTION | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| LOCALISED INFECTION | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| LUNG INFECTION | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| PARONYCHIA | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| SEPTIC SHOCK | 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 |
|
| WOUND INFECTION | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| CACHEXIA | 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 |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| FAILURE TO THRIVE | 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 |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| BONE PAIN | 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 |
|
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| COLON CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| COLORECTAL CANCER | 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 |
|
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| METASTASES TO LIVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| METASTASES TO LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| METASTASES TO PERITONEUM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| METASTASES TO PLEURA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| METASTASES TO SPINE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| PERITONEAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| TUMOUR INVASION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| TUMOUR NECROSIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| COMA | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| COMA HEPATIC | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| EPILEPSY | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| HEMIPARESIS | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| HEPATIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| LETHARGY | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| SOMNOLENCE | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| STUPOR | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| ALCOHOLISM | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| OLIGURIA | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| URETHRAL OBSTRUCTION | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| FEMALE GENITAL TRACT FISTULA | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
|
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
|
| PERINEAL PAIN | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
|
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| AXILLARY VEIN THROMBOSIS | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| HAEMORRHAGE | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| JUGULAR VEIN THROMBOSIS | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| GROWTH OF EYELASHES | Eye 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 |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| NAUSEA | 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 |
|
| FATIGUE | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| HEPATOMEGALY | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| JAUNDICE | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| PARONYCHIA | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| ACNE | 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 |
|
| NAIL DISORDER | 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 |
|
| 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 ULCER | Skin and subcutaneous tissue disorders | MedDRA 9.0 | 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.
| 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |