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The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for patients with locally advanced squamous cell carcinoma of the head and neck but additional improvements to treatment regimens are needed. The study is investigating if the addition of a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding unmanageable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab Plus Chemoradiation | Experimental | Participants received standard radiation therapy for 7 weeks and cisplatin 75 mg/m^2 and panitumumab 9 mg/kg on Days 1, 22 and 43. |
|
| Chemoradiotherapy Alone | Active Comparator | Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Administered intravenously (IV; in a vein) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Regional Control Rate at 2 Years | In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local Regional Control Rate at 6 Months and 12 Months | Participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25596660 | Derived | Mesia R, Henke M, Fortin A, Minn H, Yunes Ancona AC, Cmelak A, Markowitz AB, Hotte SJ, Singh S, Chan AT, Merlano MC, Skladowski K, Zhang A, Oliner KS, VanderWalde A, Giralt J. Chemoradiotherapy with or without panitumumab in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-1): a randomised, controlled, open-label phase 2 trial. Lancet Oncol. 2015 Feb;16(2):208-20. doi: 10.1016/S1470-2045(14)71198-2. Epub 2015 Jan 15. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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153 patients were enrolled with 89 patients on panitumumab plus chemoradiation arm, and 64 patients on chemoradiotherapy alone arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab Plus Chemoradiation | Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43. |
| FG001 | Chemoradiotherapy Alone | Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab Plus Chemoradiation | Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43. |
| BG001 | Chemoradiotherapy 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 | Local Regional Control Rate at 2 Years | In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control. | Efficacy Analysis Set (all randomized participants who received at least 1 dose of protocol-specified treatment according to treatment randomization regardless of treatment received.) | Posted | Number | 95% Confidence Interval | proportion of paticipants | 2 years |
|
The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
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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 Chemoradiation | Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Standard Fractionation Radiotherapy | Radiation | 70 Gy administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions) |
|
| Panitumumab | Drug | Administered intravenously |
|
|
| 6 months and 12 months |
| Duration of Local-regional Control | Duration of local regional control is calculated from the first day of any study treatment (radiotherapy, chemotherapy, or panitumumab) administration to the date of first local-regional failure or to death due to any cause (whichever occurs first). Local-regional failure includes persistent disease and local-regional recurrence of disease. Participants who did not meet the criteria for LRC recurrence after achieving a response by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who never achieved LRC were considered to have a duration of 0. | From first dose up to 37 months |
| Progression-Free Survival | Progression-free survival time is defined as time from the first day of any study treatment to date of first progresive disease using a modified version of the World Health Organization (WHO) criteria or death. Progressive Disease is defined as at least a 25% increase in the size of index lesions or unequivocal progression of existing non-index lesions or the presence of one or more new lesions. Participants not meeting these criteria by the cutoff date were censored at their last evaluable disease assessment date. | From first dose date to 37 months |
| Overall Survival | Survival time is defined as time from the first day of any study treatment to date of death. Participants who had not died by the cutoff date were censored at their last contact date. | From first dose date up to 37 months |
| Percentage of Participants With an Objective Response at 6 Months | Objective response by 6 months is defined as a complete response or partial response based on central review of scans using a a modification of the WHO criteria during the first 6 months. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the size of index lesions with no progression in non-index lesions, or the disappearance of all index lesions and persistence of 1 or more non-index lesions not qualifying for either CR or progressive disease and no new lesions. | 6 months |
| Percentage of Participants With a Complete Response at 6 Months | Response assessment based on central review of scans using a a modification of the WHO criteria, during the first 6 months. Complete Response is defined as the disappearance of all index and non-index lesions and no new lesions. | 6 months |
| Administrative decision |
|
| Lost to Follow-up |
|
| Other |
|
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Radiotherapy delivery modality | Number | Participants |
|
| Primary tumor site | Number | Participants |
|
| Nodal status | N0: No regional lymph node metastasis. N+: Metastasis in one or more regional lymph nodes | Number | Participants |
|
| Tumor stage | Staged according to the American Joint Committee on Cancer (AJCC) Staging Manual (6th edition). | Number | Participants |
|
| OG001 | Chemoradiotherapy Alone | Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43. |
|
|
|
| Secondary | Local Regional Control Rate at 6 Months and 12 Months | Participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control. | Efficacy Analysis Set | Posted | Number | 95% Confidence Interval | proportion of paticipants | 6 months and 12 months |
|
|
|
|
| Secondary | Duration of Local-regional Control | Duration of local regional control is calculated from the first day of any study treatment (radiotherapy, chemotherapy, or panitumumab) administration to the date of first local-regional failure or to death due to any cause (whichever occurs first). Local-regional failure includes persistent disease and local-regional recurrence of disease. Participants who did not meet the criteria for LRC recurrence after achieving a response by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who never achieved LRC were considered to have a duration of 0. | Efficacy Analysis Set | Posted | Median | 95% Confidence Interval | months | From first dose up to 37 months |
|
|
|
|
| Secondary | Progression-Free Survival | Progression-free survival time is defined as time from the first day of any study treatment to date of first progresive disease using a modified version of the World Health Organization (WHO) criteria or death. Progressive Disease is defined as at least a 25% increase in the size of index lesions or unequivocal progression of existing non-index lesions or the presence of one or more new lesions. Participants not meeting these criteria by the cutoff date were censored at their last evaluable disease assessment date. | Efficacy Analysis Set | Posted | Median | 95% Confidence Interval | months | From first dose date to 37 months |
|
|
|
|
| Secondary | Overall Survival | Survival time is defined as time from the first day of any study treatment to date of death. Participants who had not died by the cutoff date were censored at their last contact date. | Efficacy Analysis Set | Posted | Median | 95% Confidence Interval | months | From first dose date up to 37 months |
|
|
|
|
| Secondary | Percentage of Participants With an Objective Response at 6 Months | Objective response by 6 months is defined as a complete response or partial response based on central review of scans using a a modification of the WHO criteria during the first 6 months. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the size of index lesions with no progression in non-index lesions, or the disappearance of all index lesions and persistence of 1 or more non-index lesions not qualifying for either CR or progressive disease and no new lesions. | Evaluable for Central Tumor Response Analysis Set: the subset of participants in the Efficacy Analysis Set with at least one bi-dimensionally measurable lesion at baseline using a modified version of the WHO criteria per blinded central review. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
|
|
| Secondary | Percentage of Participants With a Complete Response at 6 Months | Response assessment based on central review of scans using a a modification of the WHO criteria, during the first 6 months. Complete Response is defined as the disappearance of all index and non-index lesions and no new lesions. | Evaluable for Central Tumor Response Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
|
|
| 37 |
| 87 |
| 87 |
| 87 |
| EG001 | Chemotherapy Plus Radiotherapy | 20 | 63 | 63 | 63 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Sialoadenitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Stomatitis radiation | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diabetic ketoacidotic hyperglycaemic coma | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.1 | 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.
| D009370 |
| Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D061067 |
| Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Difference between treatment groups at 12 months |
| Difference in Kaplan-Meier estimate |
| -0.03 |
| 2-Sided |
| 95 |
| -1.09 |
| 0.12 |
The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone. |
| Superiority or Other |
| Difference in rate |
| -10.99 |
| 2-Sided |
| 95 |
| -24.56 |
| 4.14 |
Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm. |
| Superiority or Other |
| Difference in rate |
| 1.33 |
| 2-Sided |
| 95 |
| -13.23 |
| 14.71 |
Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm. |
| Superiority or Other |