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The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOX + Panitumumab | Experimental | Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity. |
|
| FOLFOX | Active Comparator | Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab | Drug | Panitumumab 6 mg/kg over on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival (PFS), assessed by central radiological assessment, was defined as the time from randomization to disease progression per modified response evaluation criteria in solid tumors (RECIST) criteria or death. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date. Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions. | From randomization until the data cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The definition of overall survival is the time from randomization to death; participants who were alive at the analysis data cutoff were censored at their last contact date. | From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 153 weeks. |
| Percentage of Participants With an Objective Response |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24024839 | Background | Douillard JY, Oliner KS, Siena S, Tabernero J, Burkes R, Barugel M, Humblet Y, Bodoky G, Cunningham D, Jassem J, Rivera F, Kocakova I, Ruff P, Blasinska-Morawiec M, Smakal M, Canon JL, Rother M, Williams R, Rong A, Wiezorek J, Sidhu R, Patterson SD. Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer. N Engl J Med. 2013 Sep 12;369(11):1023-34. doi: 10.1056/NEJMoa1305275. | |
| 24718886 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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First patient enrolled 23 August 2006 and last patient enrolled 01 February 2008.
Participant flow data are reported as of the data cut-off date of 28 August 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | FOLFOX + Panitumumab | Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity. |
| FG001 | FOLFOX Alone | Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FOLFOX + Panitumumab | Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity. |
| BG001 | FOLFOX 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 | Progression-free survival (PFS), assessed by central radiological assessment, was defined as the time from randomization to disease progression per modified response evaluation criteria in solid tumors (RECIST) criteria or death. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date. Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions. | KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed) | Posted | Median | 95% Confidence Interval | months | From randomization until the data cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks. |
|
The median treatment period was around 7.7 months in the Panitumumab arm, and around 6.7 months in the Chemo alone arm.
One participant was randomized to 'Panitumumab Plus FOLFOX', but received 'FOLFOX Alone' so is counted in that group.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
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 FOLFOX | Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity. |
| 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 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | 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 |
| C410216 | Folfox protocol |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| FOLFOX regimen | Drug | The FOLFOX regimen consisted of oxaliplatin 85 mg/m^2 intravenous (IV) infusion on Day 1, leucovorin, 200 mg/m^2 (racemate) on Days 1 and 2 and 5-fluorouracil 400 mg/m^2 IV bolus followed by 600 mg/m^2 IV infusion over 22 hours on Days 1 and 2. Each cycle was 14 days. |
|
Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response by central radiological assessment was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on the first-line treatment, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. |
| Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks. |
| Time to Progression | Time to progression was defined as time from randomization date to date of disease progression per the modified RECIST criteria. | From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks. |
| Duration of Response | Duration of response was calculated only for those participants with a confirmed CR or PR, as the time from the first CR or PR (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified RECIST criteria, based on a blinded central review. | Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks. |
| Number of Participants With Adverse Events (AEs) | A serious adverse event (SAE) is defined as an AE that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the study treatment?" | From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 153 weeks. |
| Background |
| Douillard JY, Siena S, Cassidy J, Tabernero J, Burkes R, Barugel M, Humblet Y, Bodoky G, Cunningham D, Jassem J, Rivera F, Kocakova I, Ruff P, Blasinska-Morawiec M, Smakal M, Canon JL, Rother M, Oliner KS, Tian Y, Xu F, Sidhu R. Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer. Ann Oncol. 2014 Jul;25(7):1346-1355. doi: 10.1093/annonc/mdu141. Epub 2014 Apr 8. |
| 20921465 | Background | Douillard JY, Siena S, Cassidy J, Tabernero J, Burkes R, Barugel M, Humblet Y, Bodoky G, Cunningham D, Jassem J, Rivera F, Kocakova I, Ruff P, Blasinska-Morawiec M, Smakal M, Canon JL, Rother M, Oliner KS, Wolf M, Gansert J. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. J Clin Oncol. 2010 Nov 1;28(31):4697-705. doi: 10.1200/JCO.2009.27.4860. Epub 2010 Oct 4. |
| 25956209 | Background | Douillard JY, Siena S, Peeters M, Koukakis R, Terwey JH, Tabernero J. Impact of early tumour shrinkage and resection on outcomes in patients with wild-type RAS metastatic colorectal cancer. Eur J Cancer. 2015 Jul;51(10):1231-42. doi: 10.1016/j.ejca.2015.03.026. Epub 2015 May 5. |
| 36606664 | Derived | Liu J, Wang X, Sahin IH, Imanirad I, Felder SI, Kim RD, Xie H. Tumor Response-speed Heterogeneity as a Novel Prognostic Factor in Patients With Metastatic Colorectal Cancer. Am J Clin Oncol. 2023 Feb 1;46(2):50-57. doi: 10.1097/COC.0000000000000972. Epub 2022 Dec 26. |
| 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. |
| 31378656 | Derived | Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15. |
| 30679026 | Derived | Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28. |
| 30614531 | Derived | Modest DP, Rivera F, Bachet JB, de Braud F, Pietrantonio F, Koukakis R, Demonty G, Douillard JY. Panitumumab-based maintenance after oxaliplatin discontinuation in metastatic colorectal cancer: A retrospective analysis of two randomised trials. Int J Cancer. 2019 Jul 15;145(2):576-585. doi: 10.1002/ijc.32110. Epub 2019 Jan 24. |
| 30019318 | Derived | Udar N, Lofton-Day C, Dong J, Vavrek D, Jung AS, Meier K, Iyer A, Slaughter R, Gutekunst K, Bach BA, Peeters M, Douillard JY. Clinical validation of the next-generation sequencing-based Extended RAS Panel assay using metastatic colorectal cancer patient samples from the phase 3 PRIME study. J Cancer Res Clin Oncol. 2018 Oct;144(10):2001-2010. doi: 10.1007/s00432-018-2688-3. Epub 2018 Jul 17. |
| 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. |
| 28449055 | Derived | Boeckx N, Koukakis R, Op de Beeck K, Rolfo C, Van Camp G, Siena S, Tabernero J, Douillard JY, Andre T, Peeters M. Primary tumor sidedness has an impact on prognosis and treatment outcome in metastatic colorectal cancer: results from two randomized first-line panitumumab studies. Ann Oncol. 2017 Aug 1;28(8):1862-1868. doi: 10.1093/annonc/mdx119. |
| 27843597 | Derived | Siena S, Tabernero J, Bodoky G, Cunningham D, Rivera F, Ruff P, Canon JL, Koukakis R, Demonty G, Hechmati G, Douillard JY. Quality of life during first-line FOLFOX4+/-panitumumab in RAS wild-type metastatic colorectal carcinoma: results from a randomised controlled trial. ESMO Open. 2016 Mar 31;1(2):e000041. doi: 10.1136/esmoopen-2016-000041. eCollection 2016. |
| 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. |
| 22070868 | Derived | Weeraratne D, Chen A, Pennucci JJ, Wu CY, Zhang K, Wright J, Perez-Ruixo JJ, Yang BB, Kaliyaperumal A, Gupta S, Swanson SJ, Chirmule N, Starcevic M. Immunogenicity of panitumumab in combination chemotherapy clinical trials. BMC Clin Pharmacol. 2011 Nov 9;11:17. doi: 10.1186/1472-6904-11-17. |
| Withdrawal by Subject |
|
| Physician Decision |
|
| Lost to Follow-up |
|
| Protocol-specified criteria |
|
| Other |
|
| Ongoing |
|
Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Geographic Region | Stratification factor. Rest of world includes South America, eastern Europe, South Africa and Mexico | Number | participants |
|
| KRAS Status | KRAS, the human homolog of the Kirsten rat sarcoma-2 virus oncogene | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours; Grade 3: Capable of only limited self care, confined to a bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5: Dead | Number | participants |
|
| Primary tumor type | Number | participants |
|
| OG001 | Wild-type KRAS - FOLFOX | Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity. |
| OG002 | Mutant KRAS - FOLFOX + Panitumumab | Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity. |
| OG003 | Mutant KRAS - FOLFOX | Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity. |
|
|
|
| Secondary | Overall Survival | The definition of overall survival is the time from randomization to death; participants who were alive at the analysis data cutoff were censored at their last contact date. | KRAS Efficacy Analysis Set | Posted | Median | 95% Confidence Interval | months | From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 153 weeks. |
|
|
|
|
| Secondary | Percentage of Participants With an Objective Response | Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response by central radiological assessment was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on the first-line treatment, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. | KRAS Evaluable Central Tumor Response Analysis Set (subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review). | Posted | Number | 95% Confidence Interval | percentage of participants | Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks. |
|
|
|
|
| Secondary | Time to Progression | Time to progression was defined as time from randomization date to date of disease progression per the modified RECIST criteria. | KRAS Efficacy Analysis Set | Posted | Median | 95% Confidence Interval | months | From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks. |
|
|
|
| Secondary | Duration of Response | Duration of response was calculated only for those participants with a confirmed CR or PR, as the time from the first CR or PR (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified RECIST criteria, based on a blinded central review. | KRAS Evaluable Central Tumor Response Analysis Set: Responders | Posted | Median | 95% Confidence Interval | months | Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks. |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) | A serious adverse event (SAE) is defined as an AE that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the study treatment?" | Safety analysis set; One participant was randomized to 'Panitumumab Plus FOLFOX', but received 'FOLFOX Alone' so is counted in that group. | Posted | Number | participants | From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 153 weeks. |
|
|
|
| 262 |
| 585 |
| 577 |
| 585 |
| EG001 | FOLFOX Alone | Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity. | 198 | 584 | 571 | 584 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperviscosity syndrome | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Idiopathic thrombocytopenic purpura | 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 |
|
| Splenic lesion | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gilbert's syndrome | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Amaurosis fugax | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Trichiasis | 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 |
|
| Anal erosion | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anorectal disorder | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colonic obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colonic stenosis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Faecalith | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastric dilatation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intestinal ischaemia | 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 |
|
| Intestinal prolapse | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Obstruction gastric | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rectal perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Retroperitoneal oedema | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Catheter related complication | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Catheter thrombosis | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chills | 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 |
|
| Hyperpyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Inflammation of wound | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Malaise | 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 |
|
| Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pelvic mass | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abscess intestinal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Acne pustular | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Biliary abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Biliary sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Catheter sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Central line infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctivitis infective | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Diabetic gangrene | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Salmonellosis | 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 |
|
| Skin infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Subdiaphragmatic abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Anal injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Device dislocation | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | 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 |
|
| Hepatic haematoma | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Medical device complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Stent occlusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood culture positive | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac enzymes increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoglycaemia | 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 |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal pain | 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 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Colorectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Pelvic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Tumour local invasion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paraparesis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Personality disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oliguria | 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 |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Aspiration | 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 |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Catheter placement | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Arterial thrombosis limb | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Axillary vein thrombosis | Vascular 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 |
|
| Embolism | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Embolism venous | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Iliac artery embolism | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Subclavian vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Venous thrombosis limb | 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 |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctivitis | 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 |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry mouth | 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypocalcaemia | 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 |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anxiety | Psychiatric 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 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 disorder | 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 |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | 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.
| 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 |
| Overall survival comparisons in the mutant KRAS Efficacy Analysis Set was performed at an significance level of 4.99% conditional on a statistically significant difference for PFS in the Mutant KRAS Efficacy Analysis Set. | Stratified log-rank test | 0.0678 | P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2). | Normal score | 1.83 | A normal score <0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time. | Superiority or Other (legacy) |
| Stratified exact test |
Adjusted for geographic region and ECOG score |
| 0.9822 |
| Odds Ratio (OR) |
| 0.98 |
| 2-Sided |
| 95 |
| 0.65 |
| 1.47 |
The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm. |
| Superiority or Other (legacy) |
| Leading to discontinuation of any study drug |
|
| Treatment-related adverse event (TRAE) |
|
| Serious treatment-related adverse event |
|
| TRAE leading to discontinuation of any study drug |
|