Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amgen | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (HNC).
This study consisted of 2 phases. The acute oral mucositis (OM) evaluation phase includes the time from randomization to the time of severe OM (WHO Grade 3 or 4) resolution (up to Week 12 or up to Week 15 for participants whose severe OM is not resolved at Week 12). In the acute OM evaluation phase, participants were randomized to receive either a single IV dose of palifermin or placebo at 180 μg/kg, 3 days before the start of radiotherapy, plus 7 once-weekly palifermin or placebo doses at the same dose level during a 7-week radio/chemotherapy course. In the long-term follow up phase, participants are followed until death, withdrawal of consent, or loss to follow-up. The long-term follow up phase is still ongoing.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palifermin | Experimental | Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course. |
|
| Placebo | Placebo Comparator | Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| palifermin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Severe (Grade 3 or 4) Oral Mucositis | Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral & lateral tongue; left ventral & lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible. | Up to Week 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Severe (WHO Grade 3 or 4) Oral Mucositis | The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
- Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for greater than 3 years)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
Not provided
This study was conducted from 03 August 2005 (first participant enrolled) to 11 September 2007 (last participant's last visit at 4 months of follow-up) at 46 study centers in the United States, Canada, and Europe At the time of this report, the long-term safety follow-up period is ongoing.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m^2 cisplatin administered by IV infusion on Days 1, 22, and 43. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| cisplatin chemotherapy | Drug | Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m^2 on Days 1, 22, and 43. |
|
| Radiotherapy | Radiation | Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week. |
|
| Up to 15 weeks |
| Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis | Time to onset of severe (WHO Grade 3 or 4) oral mucositis (OM) was analyzed using the Kaplan-Meier procedure. Participants without an assessed event by the end of the acute OM evaluation phase were censored at the date of last assessment for severe OM. | Up to 15 weeks |
| Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher) | The number of participants with grade 2 or higher xerostomia (dryness of the oral mucosa) at the Month 4 visit, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Dry Mouth/Xerostomia scale. | Month 4 |
| Patient-Reported Mouth and Throat Soreness Score | The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer [OMWQ-HN]): "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments. | Assessed twice a week for up to 15 weeks. |
| Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks | The total dose of opioid analgesics (mg of intravenous [IV] morphine equivalents) used by all participants. Participants with at least one reported administration of opioid analgesic (parenteral, peroral or transdermal) were considered to have received opioid analgesics. The total dose of opioid analgesics is the sum of all opioid analgesic administrations that have been converted to morphine equivalents. | Up to 15 weeks |
| Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment | Cisplatin was administered on Days 1, 22, and 43. An unplanned break in cisplatin refers to a delay of ≥ 5 days from the scheduled Day 22 or Day 43 cisplatin administration or a discontinuation of cisplatin for any reason. | During the 7 weeks of chemotherapy treatment |
| Number of Participants With Unplanned Breaks in Radiotherapy | Participants with a duration of 5 days or more without an administration of radiotherapy or who discontinue radiotherapy prior to completion of planned radiotherapy were considered to have an unplanned break in radiotherapy. | During the 7 weeks of radiotherapy |
| Palifermin |
Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m^2 cisplatin administered by IV infusion on Days 1, 22, and 43. |
| Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course. |
| BG001 | Palifermin | Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Weight | Data available for 91 and 94 participants in each treatment group respectively. | Mean | Standard Deviation | kilograms |
| ||||||||||||||
| Disease Stage | American Joint Committee on Cancer staging system. | Number | participants |
| |||||||||||||||
| Tumor Site | Number | participants |
|
| 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 | Number of Participants With Severe (Grade 3 or 4) Oral Mucositis | Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral & lateral tongue; left ventral & lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible. | The Full Analysis Set included all randomized participants. | Posted | Number | participants | Up to Week 15 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Severe (WHO Grade 3 or 4) Oral Mucositis | The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study. | Full analysis set | Posted | Median | Inter-Quartile Range | days | Up to 15 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis | Time to onset of severe (WHO Grade 3 or 4) oral mucositis (OM) was analyzed using the Kaplan-Meier procedure. Participants without an assessed event by the end of the acute OM evaluation phase were censored at the date of last assessment for severe OM. | Full analysis set | Posted | Median | Inter-Quartile Range | days | Up to 15 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher) | The number of participants with grade 2 or higher xerostomia (dryness of the oral mucosa) at the Month 4 visit, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Dry Mouth/Xerostomia scale. | Full Analysis Set | Posted | Number | participants | Month 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient-Reported Mouth and Throat Soreness Score | The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer [OMWQ-HN]): "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments. | The Patient Reported Outcome-evaluable analysis set included all randomized patients with a valid Baseline assessment for MTS question 3 of the OMWQ-HN and either:
| Posted | Mean | Standard Deviation | units on a scale | Assessed twice a week for up to 15 weeks. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks | The total dose of opioid analgesics (mg of intravenous [IV] morphine equivalents) used by all participants. Participants with at least one reported administration of opioid analgesic (parenteral, peroral or transdermal) were considered to have received opioid analgesics. The total dose of opioid analgesics is the sum of all opioid analgesic administrations that have been converted to morphine equivalents. | Full analysis set | Posted | Mean | Standard Deviation | mg of IV morphine equivalents | Up to 15 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment | Cisplatin was administered on Days 1, 22, and 43. An unplanned break in cisplatin refers to a delay of ≥ 5 days from the scheduled Day 22 or Day 43 cisplatin administration or a discontinuation of cisplatin for any reason. | Full analysis set | Posted | Number | participants | During the 7 weeks of chemotherapy treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Unplanned Breaks in Radiotherapy | Participants with a duration of 5 days or more without an administration of radiotherapy or who discontinue radiotherapy prior to completion of planned radiotherapy were considered to have an unplanned break in radiotherapy. | Full analysis set | Posted | Number | participants | During the 7 weeks of radiotherapy |
|
|
Approximately 8 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
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 | Placebo | Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course. | 25 | 91 | 81 | 91 | ||
| EG001 | Palifermin | Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course. | 35 | 94 | 89 | 94 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Haemoglobinaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Bronchitis acute | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Colitis pseudomembranous | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Infected epidermal cyst | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Device occlusion | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Injury asphyxiation | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Tracheostomy malfunction | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Blood bilirubin abnormal | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Blood creatinine abnormal | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase abnormal | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Blood sodium abnormal | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase abnormal | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Food intolerance | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Laryngeal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
| |
| Peritoneal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Psychotic disorder due to a general medical condition | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Cryptogenic organizing pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits sponsor a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Sponsor may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hans Olivecrona, MD PhD | Biovitrum | +46 8 697 20 00 | hans.olivecrona@sobi.com |
| ID | Term |
|---|---|
| D052016 | Mucositis |
| D013280 | Stomatitis |
| D006258 | Head and Neck Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D007818 | Laryngeal Diseases |
| D019226 | Oral Ulcer |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012466 | Salivary Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D051523 | Fibroblast Growth Factor 7 |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D005346 | Fibroblast Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Black |
|
| Hispanic |
|
| American Indian/ Alaska Native |
|
| Stage IV A |
|
| Stage IV B |
|
| Oropharynx |
|
| Nasopharynx |
|
| Larynx |
|
| Hypopharynx |
|
| Unknown |
|
| No |
| Superiority or Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|