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| ID | Type | Description | Link |
|---|---|---|---|
| C-935788-017 | Other Identifier | Rigel Pharmaceuticals |
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Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19 patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients exhibit a response at Week 8 or later in the study. All enrolled patients will be treated with Fostamatinib Disodium until disease progression. Efficacy will be assessed by tumor measurements using CT and PET (when indicated) scans and physical exam at baseline, and scans and physical exam of all disease-involved areas every 8 weeks until progression. Safety will be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All patients will have a follow-up visit 30 days following last study drug treatment. Blood samples for PK assessment will be obtained from all patients enrolled in Stage 1 at protocol defined intervals.
Up to 61 patients (male and female) meeting the inclusion and exclusion criteria will be enrolled into this trial in two stages. All enrolled patients will be treated with R788 at 200 mg PO bid until disease progression. In the initial stage of the study, a total of 19 patients will be enrolled and treated with Fostamatinib Disodium. Should at least 4 patients exhibit a response at Week 8 or later of the study, the second stage of 36 patients will open to enrollment. Efficacy will be assessed by CT and PET scans (when indicated) and physical exam at baseline, and CT scans and physical exam of all disease-involved areas every 8 weeks until progression. Safety will be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All patients will have a follow-up visit 30 days following last study drug treatment. Blood samples for PK assessment will be obtained from all patients enrolled in Stage 1 at protocol-defined intervals. Patients with accessible tumor tissue will be asked to undergo a biopsy for a fresh tissue sample for assessment of Syk activity in tumor tissue. Archived tissue samples from the initial diagnostic biopsy and the most recent biopsy for lymphoma will be obtained in the event a fresh tumor biopsy cannot be obtained. Patients who have accessible tumor tissue will be asked to consent to a second tumor biopsy at Week 8, to assess the impact of Fostamatinib Disodium treatment on the activity of Syk and its downstream markers. All baseline fresh or archived tumor tissue samples will undergo central pathology review to confirm the diagnosis of TCL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostamatinib Disodium | Drug | 200 mg PO BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Efficacy Endpoint for This Study is Overall Regressive Response Rate (ORRR): Proportion of Patients With a Best Response of Complete Response (CR), Partial Response (PR), or Regressive Stable Disease (RSD). | Overall regressive response rate (ORRR) is the proportion of patients with a best response of Complete Response (CR), Partial Response (PR) (per Cheson 2007), or Regressive Stable Disease (RSD) defined as regressive disease that does not meet the criteria for partial response. | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate is the Proportion of Patients With Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD). | Clinical benefit rate is the proportion of patients with best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD). | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Skolnik, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Francisco | California | 94143 | United States | ||
| Research Site |
Not provided
| Label | URL |
|---|---|
| D4300C00024 Clinical Study Report | View source |
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There was a screening period of up to 28 days, after which if all inclusion/exclusion criteria were met, patients were dosed with fostamatinib treatment for a treatment period of 8 weeks. Patients could continue treatment until disease progression, toxicity or withdrawal from the study
A total of 18 patients with T-Cell lymphoid malignancy were enrolled in this study from 05 March 2009 until 04 January 2010. As of 19 May 2010, no patients remain on study. All enrolled patients received at least one dose of fostamatinib. This study was conducted at 9 sites in the U.S. and Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | 1-fostamatinib 200mg, BID, Oral |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | 1-fostamatinib 200mg, BID, Oral |
| 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 | The Primary Efficacy Endpoint for This Study is Overall Regressive Response Rate (ORRR): Proportion of Patients With a Best Response of Complete Response (CR), Partial Response (PR), or Regressive Stable Disease (RSD). | Overall regressive response rate (ORRR) is the proportion of patients with a best response of Complete Response (CR), Partial Response (PR) (per Cheson 2007), or Regressive Stable Disease (RSD) defined as regressive disease that does not meet the criteria for partial response. | Posted | Number | Participants | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days) |
|
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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 | Overall Study | 1-fostamatinib 200mg, BID, Oral |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system 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 |
This is a small, non-randomized study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne-Marie Duliege, MD | Rigel | 650-624-1100 | clinicaltrials@rigel.com |
Not provided
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
Not provided
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| ID | Term |
|---|---|
| C523665 | fostamatinib |
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| Overall Response Rate (ORR) is the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR). | Overall response rate (ORR) is the proportion of patients with a best response of Complete Response (CR) or Partial Response (PR). | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days) |
| Duration of Overall Response is the Time From First Documentation of Complete or Partial Response, Whichever Occurs Earlier, to Discontinuation of Study Drug. | Duration of Overall Response is the time from first documentation of Complete or Partial Response (Cheson 2007), whichever occurs earlier, to discontinuation of study drug. | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days) |
| Stanford |
| California |
| 94305 |
| United States |
| Research Site | Atlanta | Georgia | 30322 | United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | Rochester | Minnesota | 55905 | United States |
| Research Site | Omaha | Nebraska | 68198 | United States |
| Research Site | New York | New York | 10021 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Research Site | Toronto | Ontario | M5G 2M9 | Canada |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Clinical Benefit Rate is the Proportion of Patients With Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD). | Clinical benefit rate is the proportion of patients with best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD). | Posted | Number | Participants | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days) |
|
|
|
| Secondary | Overall Response Rate (ORR) is the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR). | Overall response rate (ORR) is the proportion of patients with a best response of Complete Response (CR) or Partial Response (PR). | Posted | Number | Participants | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days) |
|
|
|
| Secondary | Duration of Overall Response is the Time From First Documentation of Complete or Partial Response, Whichever Occurs Earlier, to Discontinuation of Study Drug. | Duration of Overall Response is the time from first documentation of Complete or Partial Response (Cheson 2007), whichever occurs earlier, to discontinuation of study drug. | Posted | Median | Standard Deviation | Days | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days) |
|
|
|
| 11 |
| 18 |
| 18 |
| 18 |
| Dysphagia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hepatic Failure | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Lobar Pneumonia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Skin Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Wound Secretion | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Inappropriate Antidiuretic Hormone Secretion | Endocrine disorders | MedDRA 9.0 | Systematic Assessment |
|
| Eye Irritation | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Eye Pain | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Lacrimation Increased | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Defaecation Urgency | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Gingival Bleeding | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Oral Mucosal Blistering | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Tongue Ulceration | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Face Oedema | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Localised Oedema | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Mucosal Inflammation | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Central Line Infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Fungal Infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Fungal Skin Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Nail Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Skin Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Urinary Tract Infection Bacterial | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Wound Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Wound Secretion | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Blood Albumin Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Blood Bicarbonate Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Blood Bilirubin Increased | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Blood Creatine Increased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Blood Glucose Increased | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Blood Lactate Dehydrogenase Increased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Blood Magnesium Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Blood Phosphorus Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Blood Potassium Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Blood Potassium Increased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Blood Sodium Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Blood Sodium Increased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Haemoglobin Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Platelet Count Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Urine Output Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Weight Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| White Blood Cell Count Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| White Blood Cell Count Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Buttock Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Shoulder Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Memory Impairment | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Poor Quality Sleep | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Sinus Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Oedema Genital | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Nasal Dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Upper Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pain Of Skin | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Periorbital Oedema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Skin Disorder | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
An Investigator agrees to provide a copy of the publication to AstraZeneca for review at least 30 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AstraZeneca authorized MC publication or a period up to 18 months from study completi
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |