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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT Number 2006-006739-36 |
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To estimate the effect of KRAS mutation status (Wild-type versus Mutant) on objective response rate and other measures of efficacy for patients treated with panitumumab in combination with a chemotherapy regimen of irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as first-line therapy for metastatic colorectal cancer (mCRC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab plus FOLFIRI | Experimental | Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab | Drug | Administered by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments are based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions. | Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response by 17 Weeks | The percentage of participants with a best response of complete response or partial response by Week 17. Disease assessments are based on investigator review of scans using modified RECIST V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders. |
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Inclusion Criteria:
Exclusion Criteria:
Central nervous system metastases.
Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to initiating study treatment.
Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (e.g. cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g. erlotinib).
Prior radiotherapy within 14 days prior to screening, and for which all signs of early radiological toxicity have not abated.
Significant cardiovascular disease including unstable angina or myocardial infarction within six months before initiating study treatment or a history of ventricular arrhythmia.
History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest computed tomography (CT scan.
Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).
History of Gilbert's syndrome or dihydropyrimidine deficiency.
Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection.
Any investigational agent within 30 days before initiation of study treatment.
Must not have had a major surgical procedure within 28 days prior to initiation of study treatment.
Subject who is pregnant or breast-feeding.
Woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for six months after the last study drug administration for women, and one month for men.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21960318 | Background | Kohne CH, Hofheinz R, Mineur L, Letocha H, Greil R, Thaler J, Fernebro E, Gamelin E, Decosta L, Karthaus M. First-line panitumumab plus irinotecan/5-fluorouracil/leucovorin treatment in patients with metastatic colorectal cancer. J Cancer Res Clin Oncol. 2012 Jan;138(1):65-72. doi: 10.1007/s00432-011-1061-6. Epub 2011 Sep 30. | |
| 23020584 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Participants received a FOLFIRI regimen in combination with panitumumab once every 14 days until diagnosed with radiographic disease progression, at which time the participant was withdrawn from the treatment phase. Participants were to complete a safety follow-up visit 8 weeks after the treatment phase.
A total of 169 patients were screened, of whom 154 were enrolled into this study at 36 study centers in Austria, Belgium, France, Germany, and Sweden from 9 May 2007 through 18 June 2008.
Results are reported through the primary analysis data cut-off date of 18 June 2009 (12 months after the last patient was enrolled).
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab Plus FOLFIRI | Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab Plus FOLFIRI | Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression. |
| 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 | Objective Response Rate | Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments are based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions. | KRAS Tumor Response Analysis Set (all participants who provided informed consent, enrolled, received at least 1 dose of panitumumab, had evaluable KRAS status data, and with at least 1 unidimensionally measurable lesion per modified RECIST by the local investigator) | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks |
The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 6.6 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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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 FOLFIRI | Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.0 | 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 |
Not provided
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| C480833 | IFL protocol |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
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| FOLFIRI | Drug | FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m², leucovorin 400 mg/m², 5-fluorouracil bolus 400 mg/m², 5-fluorouracil infusion 2400 mg/m². |
|
| Up to Week 17 |
| Disease Control Rate | The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST v1.0 criteria as assessed by the Investigator. Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline. | Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks |
| Duration of Response | Duration of response was calculated only for those participants who had a confirmed complete or partial response, and is defined as the time from first confirmed response to first observed progression. For participants who responded and did not progress by the analysis data cut-off date, duration of response was censored at their last evaluable disease assessment date. Duration of response was analyzed using the Kaplan-Meier method. | Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks. |
| Time to Initial Objective Response | Time to response is the time from the date of enrollment to the date of first confirmed complete or partial response. Participants with a best response of stable disease at the analysis data cut-off date were censored at their last assessment of SD and participants with all other categories of best response were censored at the maximum observed time to a first confirmed response among all responders. Time to initial objective response was analyzed using Kaplan-Meier methods. | Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks. |
| Progression-free Survival | Progression-free survival is the time from the date of enrollment to the date of first observed progression or death, whichever comes first. Participants who were alive and did not progress by the analysis data cut-off date were censored at the last evaluable disease assessment date. Progression-free survival was analyzed using Kaplan-Meier methods. | From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks. |
| Time to Disease Progression | Time to progression is the time from the enrollment date to the date of first observed progression. For participants who had not progressed by the analysis data cutoff date, time to progressive disease was censored at their last evaluable disease assessment date. Time to disease progression was analyzed using Kaplan-Meier methods. | From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks. |
| Duration of Stable Disease | Duration of stable disease was calculated only for participants with a best response of stable disease and is defined as the time from enrollment to first observed PD. For participants who did not progress by the analysis data cut-off date, duration of SD was censored at their last evaluable disease assessment date. Duration of stable disease was estimated using Kaplan-Meier methods. | Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks. |
| Time to Treatment Failure | Time to treatment failure is defined as the time from enrollment to the date the decision was made to end the treatment phase for any reason. For participants who remained in the treatment phase at the analysis data cut-off date, time to treatment failure was censored at the date of their last on-study assessment. Time to treatment failure was analyzed using Kaplan-Meier methods. | From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks. |
| Time to Disease Relapse Following Surgical Intervention | Calculated only for those participants who underwent surgical intervention, and defined as the time from the date of first post-intervention radiographic disease assessment to the date of first observed PD. Participants with no post-intervention disease assessment had their time to relapse set to zero and censored in the analysis. Participants that had evidence of progression / recurrence at their first post-intervention disease assessment had a time to relapse of zero. For participants who had not progressed by the analysis data cut-off date, time to relapse was censored at the date of their last evaluable disease assessment. Time to relapse was analyzed using Kaplan-Meier metjhods. | From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks. |
| Resection Rate | The percentage of participants who underwent a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease. | From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks. |
| Thaler J, Karthaus M, Mineur L, Greil R, Letocha H, Hofheinz R, Fernebro E, Gamelin E, Banos A, Kohne CH. Skin toxicity and quality of life in patients with metastatic colorectal cancer during first-line panitumumab plus FOLFIRI treatment in a single-arm phase II study. BMC Cancer. 2012 Sep 29;12:438. doi: 10.1186/1471-2407-12-438. |
| 31515083 | Derived | Taieb J, Geissler M, Rivera F, Karthaus M, Wilson R, Loupakis F, Price T, Tracy M, Burdon P, Peeters M. Relationship Between Tumor Response and Tumor-Related Symptoms in RAS Wild-Type Metastatic Colorectal Cancer: Retrospective Analyses From 3 Panitumumab Trials. Clin Colorectal Cancer. 2019 Dec;18(4):245-256.e5. doi: 10.1016/j.clcc.2019.07.009. Epub 2019 Jul 29. |
| 31300973 | Derived | Kohne CH, Karthaus M, Mineur L, Thaler J, Van den Eynde M, Gallego J, Koukakis R, Berkhout M, Hofheinz RD. Impact of Primary Tumour Location and Early Tumour Shrinkage on Outcomes in Patients with RAS Wild-Type Metastatic Colorectal Cancer Following First-Line FOLFIRI Plus Panitumumab. Drugs R D. 2019 Sep;19(3):267-275. doi: 10.1007/s40268-019-0278-8. |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Protocol-specified Criteria |
|
| Lost to Follow-up |
|
| Other - Not Specified |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Kirsten Rat Sarcoma-2 Virus (KRAS) Mutation Status | Number | participants |
|
|
|
|
|
| Secondary | Objective Response by 17 Weeks | The percentage of participants with a best response of complete response or partial response by Week 17. Disease assessments are based on investigator review of scans using modified RECIST V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders. | KRAS Tumor Response Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Up to Week 17 |
|
|
|
|
| Secondary | Disease Control Rate | The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST v1.0 criteria as assessed by the Investigator. Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline. | KRAS Tumor Response Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks |
|
|
|
|
| Secondary | Duration of Response | Duration of response was calculated only for those participants who had a confirmed complete or partial response, and is defined as the time from first confirmed response to first observed progression. For participants who responded and did not progress by the analysis data cut-off date, duration of response was censored at their last evaluable disease assessment date. Duration of response was analyzed using the Kaplan-Meier method. | KRAS Tumor Response Analysis Set with an objective response (CR or PR) | Posted | Median | 95% Confidence Interval | months | Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks. |
|
|
|
|
| Secondary | Time to Initial Objective Response | Time to response is the time from the date of enrollment to the date of first confirmed complete or partial response. Participants with a best response of stable disease at the analysis data cut-off date were censored at their last assessment of SD and participants with all other categories of best response were censored at the maximum observed time to a first confirmed response among all responders. Time to initial objective response was analyzed using Kaplan-Meier methods. | KRAS Tumor Response Analysis Set | Posted | Median | 95% Confidence Interval | months | Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks. |
|
|
|
|
| Secondary | Progression-free Survival | Progression-free survival is the time from the date of enrollment to the date of first observed progression or death, whichever comes first. Participants who were alive and did not progress by the analysis data cut-off date were censored at the last evaluable disease assessment date. Progression-free survival was analyzed using Kaplan-Meier methods. | Primary Analysis Set (all participants who provided informed consent, enrolled, received at least 1 dose of panitumumab, and had evaluable KRAS status data) | Posted | Median | 95% Confidence Interval | months | From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks. |
|
|
|
|
| Secondary | Time to Disease Progression | Time to progression is the time from the enrollment date to the date of first observed progression. For participants who had not progressed by the analysis data cutoff date, time to progressive disease was censored at their last evaluable disease assessment date. Time to disease progression was analyzed using Kaplan-Meier methods. | Primary Analysis Set | Posted | Median | 95% Confidence Interval | months | From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks. |
|
|
|
|
| Secondary | Duration of Stable Disease | Duration of stable disease was calculated only for participants with a best response of stable disease and is defined as the time from enrollment to first observed PD. For participants who did not progress by the analysis data cut-off date, duration of SD was censored at their last evaluable disease assessment date. Duration of stable disease was estimated using Kaplan-Meier methods. | KRAS Tumor Response Analysis Set with a best response of SD | Posted | Median | 95% Confidence Interval | months | Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks. |
|
|
|
|
| Secondary | Time to Treatment Failure | Time to treatment failure is defined as the time from enrollment to the date the decision was made to end the treatment phase for any reason. For participants who remained in the treatment phase at the analysis data cut-off date, time to treatment failure was censored at the date of their last on-study assessment. Time to treatment failure was analyzed using Kaplan-Meier methods. | Primary Analysis Set | Posted | Median | 95% Confidence Interval | months | From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks. |
|
|
|
|
| Secondary | Time to Disease Relapse Following Surgical Intervention | Calculated only for those participants who underwent surgical intervention, and defined as the time from the date of first post-intervention radiographic disease assessment to the date of first observed PD. Participants with no post-intervention disease assessment had their time to relapse set to zero and censored in the analysis. Participants that had evidence of progression / recurrence at their first post-intervention disease assessment had a time to relapse of zero. For participants who had not progressed by the analysis data cut-off date, time to relapse was censored at the date of their last evaluable disease assessment. Time to relapse was analyzed using Kaplan-Meier metjhods. | Primary Analysis Set participants who underwent surgery | Posted | Median | 95% Confidence Interval | months | From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks. |
|
|
|
| Secondary | Resection Rate | The percentage of participants who underwent a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease. | Primary Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks. |
|
|
|
|
| 84 |
| 154 |
| 154 |
| 154 |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| MYOPERICARDITIS | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| CONJUNCTIVITIS | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| OCULAR TOXICITY | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| ANAL FISSURE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DIARRHOEA HAEMORRHAGIC | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| FAECALOMA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| GASTROINTESTINAL INFLAMMATION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| ILEUS PARALYTIC | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| MELAENA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| SUBILEUS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| CATHETER RELATED COMPLICATION | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| DEATH | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| MULTI-ORGAN FAILURE | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| BILIARY DILATATION | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| CHOLESTASIS | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| HEPATIC LESION | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| CATHETER RELATED INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| ERYSIPELAS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| HERPES SIMPLEX | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| INTERVERTEBRAL DISCITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| PARONYCHIA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| PERITONEAL ABSCESS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| UROSEPSIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| GASTROINTESTINAL STOMA COMPLICATION | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| IATROGENIC INJURY | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| ELECTROLYTE IMBALANCE | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| METABOLIC DISORDER | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| PODAGRA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| BURSITIS | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| OSTEOPOROTIC FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| COLORECTAL CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| HEMIPARESIS | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| INTRACRANIAL VENOUS SINUS THROMBOSIS | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| VASCULITIS CEREBRAL | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| PYELOCALIECTASIS | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| RENAL COLIC | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| PROSTATITIS | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| LARYNGOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| PULMONARY THROMBOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| SKIN FISSURES | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| PHLEBITIS | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| THROMBOSIS | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| VENA CAVA THROMBOSIS | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| CONJUNCTIVITIS | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| DRY EYE | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| LACRIMATION INCREASED | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| APHTHOUS STOMATITIS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| PARONYCHIA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| POLYNEUROPATHY | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| NAIL TOXICITY | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| SKIN FISSURES | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| SKIN TOXICITY | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 12.0 | 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.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |