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The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 2 | Active Comparator | Arm 2 consists of Cisplatin and 5-FU |
|
| ARM 1 | Experimental | ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARM 2 | Drug | Subjects will receive Cisplatin plus 5FU |
| |
| ARM 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from randomization to death | Upto 56 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size. | Every 6 weeks until disease progression, up to 56 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bach B, et al.SPECTRUM biomarkers HPV.Journal-004521; | ||
| 23746666 | Background | Vermorken JB, Stohlmacher-Williams J, Davidenko I, Licitra L, Winquist E, Villanueva C, Foa P, Rottey S, Skladowski K, Tahara M, Pai VR, Faivre S, Blajman CR, Forastiere AA, Stein BN, Oliner KS, Pan Z, Bach BA; SPECTRUM investigators. Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial. Lancet Oncol. 2013 Jul;14(8):697-710. doi: 10.1016/S1470-2045(13)70181-5. Epub 2013 Jun 6. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Subjects were enrolled from 25 May 2007 to 10 March 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab Plus Chemotherapy | Consists of Panitumumab plus Cisplatin and 5-FU |
| FG001 | Chemotherapy Alone | Consists of Cisplatin and 5-FU |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab Plus Chemotherapy | Consists of Panitumumab plus Cisplatin and 5-FU |
| BG001 | Chemotherapy Alone | Consists of Cisplatin and 5-FU |
| 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 | Overall Survival | Time from randomization to death | Intention to treat (ITT) | Posted | Median | 95% Confidence Interval | months | Upto 56 months |
|
|
The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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 Chemotherapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
Not provided
| 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 |
Not provided
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| Drug |
Subjects will receive Panitumumab plus cisplatin and 5FU |
|
| Duration of Response | Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H). | Every 6 weeks until disease progression, up to 56 months |
| Time to Progression | Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H) | Every 6 weeks until disease progression, up to 56 months |
| Time to Response | Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0. | Every 6 weeks until disease progression, upto 56 months |
| Progression Free Survival | Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death. | Every 6 weeks until disease progression or deaths, upto 56 months |
| Withdrawal by Subject |
|
| Ongoing |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | subjects |
|
| Previously treated with chemotherapy and/or radiotherapy, Yes/No | Number | subjects |
|
| ECOG perfomance score, 0/1/2 | Number | subjects |
|
| Primary tumor site, oropharynx&larynx/oral cavity&hypopharynx | Number | subjects |
|
| Participants |
|
|
|
| Secondary | Overall Response Rate | An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size. | The subset of subjects in the ITT analysis set with at least one baseline uni-dimensionally measurable lesion using a modified version of the RECIST v1.0 (see protocol Appendix H) | Posted | Number | subjects | Every 6 weeks until disease progression, up to 56 months |
|
|
|
|
| Secondary | Duration of Response | Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H). | Included only those subjects with a confirmed complete or partial response. | Posted | Median | 95% Confidence Interval | months | Every 6 weeks until disease progression, up to 56 months |
|
|
|
| Secondary | Time to Progression | Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H) | ITT | Posted | Median | 95% Confidence Interval | months | Every 6 weeks until disease progression, up to 56 months |
|
|
|
| Secondary | Time to Response | Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0. | Included only those subjects with a confirmed complete response or partial response. | Posted | Median | Inter-Quartile Range | months | Every 6 weeks until disease progression, upto 56 months |
|
|
|
| Secondary | Progression Free Survival | Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death. | ITT | Posted | Median | 95% Confidence Interval | months | Every 6 weeks until disease progression or deaths, upto 56 months |
|
|
|
|
| 157 |
| 325 |
| 311 |
| 325 |
| EG001 | Chemotherapy Alone | 139 | 325 | 301 | 325 |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haematotoxicity | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Intracardiac thrombus | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sinus arrhythmia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ichthyosis | Congenital, familial and genetic disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| Papilloedema | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Retinal artery occlusion | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Aphagia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Necrotising colitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abasia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Device occlusion | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperpyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Abscess neck | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Aspergillosis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Bronchiectasis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Campylobacter infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| H1N1 influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Herpes zoster ophthalmic | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Laryngotracheitis obstructive | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Lung infection pseudomonal | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Myiasis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pleural infection bacterial | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Respiratory moniliasis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Contrast media reaction | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Spinal cord injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Spinal shock | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Feeding disorder | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Head and neck cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Hypopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Oropharyngeal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Pharyngeal cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Motor dysfunction | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Radiculitis lumbosacral | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Anoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Increased viscosity of bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Laryngeal dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Iliac artery embolism | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Infarction | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
| D009370 |
| Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| 1.69 |
| 95 |
| 1.15 |
| 2.44 |
| No |
| Superiority or Other |