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To estimate the effect of second-line panitumumab monotherapy on objective response in patients with metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab | Experimental | articipants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab | Drug | Panitumumab was administered over a 1 hour intraveneous (IV) infusion at a dose of 9 mg/kg every 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Assessments are based on investigator's review of scans using a modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate was defined as the percentage of participants with a best tumor response of complete response (CR) or partial response (PR) prior to initiation of subsequent anti-cancer therapy. CR or PR was confirmed no less than 28 days after the criteria for response were first met. CR: Disappearance of all target lesions, non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions and no progression of existing non-target lesions (defined as an increase in lesion size of ≥ 20%) and no new lesions, or, the disappearance of all target lesions and the persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) and no new lesions. | From first dose of study drug until the data cut-off date of 16 December 2010. Median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Response | Time to response was defined as the time from Study Day 1 to the first CR or PR that was subsequently confirmed. | From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks) |
| Duration of Response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subject received > 1 chemotherapy regimen for the treatment of metastatic or recurrent disease
Concomitant chemotherapy for recurrent disease administered solely for the purpose of radiation sensitization during re-irradiation will not be counted towards this chemotherapy regimen
Nasopharyngeal carcinoma, salivary gland and primary skin SCCHN, or symptomatic central nervous system (CNS) metastases
History of interstitial lung disease, significant cardiovascular disease, or another primary cancer
Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection
Known allergy or hypersensitivity to any component of panitumumab
Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib) for recurrent or metastatic disease with the following exceptions:
Significant thromboembolic event ≤ 8 weeks prior to enrollment
Subjects not recovered from all previous acute radiotherapy-related toxicities
History of severe skin disorder that in the opinion of the investigator may interfere with study conduct
History of any medical, or psychiatric condition, or laboratory abnormality that may interfere with the interpretation of study results
Subject is currently in a clinical trial ≤ 30 days prior to enrollment
Subjects requiring use of immunosuppressive agents however corticosteroids are allowed
Man or woman of child-bearing potential who do not consent to use adequate contraceptive precautions during the course of the study
Female subject who is pregnant or breast-feeding
Subject requiring major surgery using general/spinal anesthesia ≤ 28 days prior to enrollment, or minor surgery ≤ 14 days prior to enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26681429 | Background | Rischin D, Spigel DR, Adkins D, Wein R, Arnold S, Singhal N, Lee O, Murugappan S. PRISM: Phase 2 trial with panitumumab monotherapy as second-line treatment in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Head Neck. 2016 Apr;38 Suppl 1:E1756-61. doi: 10.1002/hed.24311. Epub 2015 Dec 17. | |
| Background | Spigel D. Second-line panitumumab monotherapy for treatment of advanced head and neck cancer: the PRISM Trial. Community Oncology. 2008;5(Supp 11):1-4. | ||
| 29703606 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Results are reported for the primary analysis with a data cut-off date of 16 December 2010.
A total of 65 patients with metastatic or recurrent squamous cell carcinoma of the head and neck were screened of whom 52 were enrolled at 22 study centers in North America (20 study centers) and Australia (2 study centers) between October 2007 and December 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab | Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab | Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study. |
| 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 | Assessments are based on investigator's review of scans using a modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate was defined as the percentage of participants with a best tumor response of complete response (CR) or partial response (PR) prior to initiation of subsequent anti-cancer therapy. CR or PR was confirmed no less than 28 days after the criteria for response were first met. CR: Disappearance of all target lesions, non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions and no progression of existing non-target lesions (defined as an increase in lesion size of ≥ 20%) and no new lesions, or, the disappearance of all target lesions and the persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) and no new lesions. | Full analysis set (all enrolled participants who received at least 1 dose of panitumumab) with measurable disease at Baseline | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until the data cut-off date of 16 December 2010. Median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). |
The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date date. The median time frame is 2.4 months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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 | Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D006258 | Head and Neck Neoplasms |
| D009362 | Neoplasm Metastasis |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009371 | Neoplasms by Site |
| D009385 | Neoplastic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
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Duration of response was defined as the time from first confirmed CR or PR to the earliest date of disease progression per a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Duration of response was analyzed using the Kaplan-Meier method. PD: At least a 20% increase in the size of target lesions, or an increase of 20% or greater of non-target lesions and the lesion(s) measure ≥ 10 mm in one dimension at the time of progression, or any new lesions. |
| From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks) |
| Rate of Disease Control | Rate of disease control was defined as the percentage of participants with CR, PR, or stable disease (SD), as defined by a modified version of the RECIST criteria (version 1.0), prior to initiation of subsequent anti-cancer therapy. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of non-target lesions and no new lesions, or, if no target lesions were identified at screening, the persistence of one or more non-target lesion(s) not qualifying for either CR or PD. | From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). |
| Time to Progression | Time to progression was defined as the time from Day 1 to the date of disease progression using a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Time to progression was analyzed using the Kaplan-Meier method. | From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). |
| Progression Free Survival (PFS) | PFS was defined as the time from Day 1 to the first date of disease progression, as defined by a modified version of the RECIST criteria (version 1.0), or death due to any cause (whichever comes first). Participants who were alive who did not meet the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. PFS was analyzed using the Kaplan-Meier method. | From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). |
| Overall Survival (OS) | Overall Survival was defined as the time from Day 1 to the date of death. For participants who did not die while on study, or were lost to follow-up, survival was censored at the end of study, or the date of last contact (whichever was first). | From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). |
| Number of Participants With Adverse Events | The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (where grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal) with the exception of some dermatology/skin AEs that were graded using the CTCAE v3.0 with modifications. Serious AEs include any event that was fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related adverse events (TRAEs) are those for which the investigator considered there to be a reasonable possibility that the event may have been caused by study drug. | The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date date. The median time frame is 2.4 months. |
| Background |
| Kim TW, Elme A, Park JO, Udrea AA, Kim SY, Ahn JB, Valencia RV, Krishnan S, Manojlovic N, Guan X, Lofton-Day C, Jung AS, Vrdoljak E. Final Analysis of Outcomes and RAS/BRAF Status in a Randomized Phase 3 Study of Panitumumab and Best Supportive Care in Chemorefractory Wild Type KRAS Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2018 Sep;17(3):206-214. doi: 10.1016/j.clcc.2018.03.008. Epub 2018 Mar 21. |
| Disease Progession |
|
| Adverse Event |
|
| On Treatment at Time of Data Cut-off |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Primary Tumor Site | Number | participants |
|
| Cancer Stage of Diagnosis | Number | participants |
|
| Prior Treatment for Head and neck Cancer | Participants may have received more than one prior treatment. | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction;
| Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Panitumumab | Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study. |
|
|
| Secondary | Time to Response | Time to response was defined as the time from Study Day 1 to the first CR or PR that was subsequently confirmed. | Full analysis set participants with objective responses | Posted | Median | Inter-Quartile Range | weeks | From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks) |
|
|
|
| Secondary | Duration of Response | Duration of response was defined as the time from first confirmed CR or PR to the earliest date of disease progression per a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Duration of response was analyzed using the Kaplan-Meier method. PD: At least a 20% increase in the size of target lesions, or an increase of 20% or greater of non-target lesions and the lesion(s) measure ≥ 10 mm in one dimension at the time of progression, or any new lesions. | Full analysis set participants with an objective response | Posted | Median | 95% Confidence Interval | months | From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks) |
|
|
|
| Secondary | Rate of Disease Control | Rate of disease control was defined as the percentage of participants with CR, PR, or stable disease (SD), as defined by a modified version of the RECIST criteria (version 1.0), prior to initiation of subsequent anti-cancer therapy. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of non-target lesions and no new lesions, or, if no target lesions were identified at screening, the persistence of one or more non-target lesion(s) not qualifying for either CR or PD. | Full analysis set with measurable disease at Baseline | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). |
|
|
|
| Secondary | Time to Progression | Time to progression was defined as the time from Day 1 to the date of disease progression using a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Time to progression was analyzed using the Kaplan-Meier method. | Full analysis set | Posted | Median | 95% Confidence Interval | months | From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from Day 1 to the first date of disease progression, as defined by a modified version of the RECIST criteria (version 1.0), or death due to any cause (whichever comes first). Participants who were alive who did not meet the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. PFS was analyzed using the Kaplan-Meier method. | Full analysis set | Posted | Median | 95% Confidence Interval | months | From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). |
|
|
|
| Secondary | Overall Survival (OS) | Overall Survival was defined as the time from Day 1 to the date of death. For participants who did not die while on study, or were lost to follow-up, survival was censored at the end of study, or the date of last contact (whichever was first). | Full analysis set | Posted | Median | 95% Confidence Interval | months | From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). |
|
|
|
| Secondary | Number of Participants With Adverse Events | The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (where grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal) with the exception of some dermatology/skin AEs that were graded using the CTCAE v3.0 with modifications. Serious AEs include any event that was fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related adverse events (TRAEs) are those for which the investigator considered there to be a reasonable possibility that the event may have been caused by study drug. | Safety analysis set (all enrolled participants who received at least 1 dose of panitumumab) | Posted | Number | participants | The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date date. The median time frame is 2.4 months. |
|
|
|
| 14 |
| 52 |
| 50 |
| 52 |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| MOUTH HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| OBSTRUCTIVE AIRWAYS DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| UPPER AIRWAY OBSTRUCTION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| ORAL PAIN | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| PARONYCHIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| SWELLING FACE | Skin and subcutaneous tissue disorders | MedDRA 13.1 | 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.
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018307 | Neoplasms, Squamous Cell |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Worst grade of 5 |
|
| Serious adverse event |
|
| Leading to discontinuation of panitumumab |
|
| Leading to removal from study |
|
| Treatment-related adverse event |
|
| Treatment-related worst grade of 3 |
|
| Treatment-related worst grade of 4 |
|
| Treatment-related worst grade of 5 |
|
| Serious treatment-related adverse event |
|
| TRAE leading to discontinuation of panitumumab |
|
| Treatment-related leading to removal from study |
|