Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-25 @ 12:52 PM
NCT ID:
NCT00446095
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00446095
Study Brief:
Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase II: DLBCL | Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II | None | None | 14 | 23 | 22 | 23 | View |
| Phase II: 250mg R788 BID | Patients who received 250mg R788 orally twice daily (PO BID) in Phase II | None | None | 7 | 21 | 21 | 21 | View |
| Phase II: Other Lymphomas | Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II | None | None | 10 | 24 | 24 | 24 | View |
| Phase I: 200mg R788 BID | Patients who received 200mg R788 orally twice daily (PO BID) in Phase I | None | None | 6 | 6 | 6 | 6 | View |
| Phase I: 250mg R788 BID | Patients who received 250mg R788 orally twice daily (PO BID) in Phase I | None | None | 3 | 7 | 6 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.0 | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.0 | View |
| Cardio-Respiratory Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.0 | View |
| Cardiac Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.0 | View |
| Myocardial Ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Gastroenteritis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Lung Infection Pseudomonal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Pneumococcal Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Staphylococcal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Pathological Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Spinal Cord Compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Mental Status Changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.0 | View |
| Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 9.0 | View |
| Renal Failure Acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 9.0 | View |
| Acute Respiratory Distress Syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Dyspnoea Exacerbated | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Superior Vena Caval Occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 9.0 | View |
| Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Cardiac failure | None | Cardiac disorders | None | View |
| Duodenal obstruction | None | Gastrointestinal disorders | None | View |
| Klebsiella bacteraemia | None | Infections and infestations | None | View |
| Multifocal motor neuropathy | None | Nervous system disorders | None | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Squamous cell carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Tumour necrosis | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.0 | View |
| Conjunctival Haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 9.0 | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 9.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Frequent Bowel Movements | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Hypoaesthesia Oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Axillary Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Gastroenteritis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Procedural Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Blood Lactate Dehydrogenase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Blood Alkaline Phosphatase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Blood Bilirubin Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Blood Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Blood Bicarbonate Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Blood Phosphorus Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Blood Sodium Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Haemoglobin Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Weight Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| White Blood Cell Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Increased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Muscle Spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Muscular Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Musculoskeletal Chest Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Musculoskeletal Discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Shoulder Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Neuropathy Peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 9.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Sinus Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Dyspnoea Exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Nasal Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Pharyngolaryngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Productive Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Night Sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 9.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.0 | View |
| Chest discomfort | None | General disorders | None | View |
| Malaise | None | General disorders | None | View |
| Chest pain | None | General disorders | None | View |
| Early satiety | None | General disorders | None | View |
| Discomfort | None | General disorders | None | View |
| Nodule | None | General disorders | None | View |
| Secretion discharge | None | General disorders | None | View |
| Dry mouth | None | Gastrointestinal disorders | None | View |
| Gastrooesophageal reflux disease | None | Gastrointestinal disorders | None | View |
| Haemorrhoidal haemorrhage | None | Gastrointestinal disorders | None | View |
| Rectal haemorrhage | None | Gastrointestinal disorders | None | View |
| Stomach discomfort | None | Gastrointestinal disorders | None | View |
| Abdominal discomfort | None | Gastrointestinal disorders | None | View |
| Faeces discoloured | None | Gastrointestinal disorders | None | View |
| Toothache | None | Gastrointestinal disorders | None | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Rales | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | None | View |
| Bone marrow failure | None | Blood and lymphatic system disorders | None | View |
| Confusional state | None | Psychiatric disorders | None | View |
| Mental status changes | None | Psychiatric disorders | None | View |
| Balance disorder | None | Nervous system disorders | None | View |
| Lethargy | None | Nervous system disorders | None | View |
| Peripheral sensory neuropathy | None | Nervous system disorders | None | View |
| Carpal tunnel syndrome | None | Nervous system disorders | None | View |
| Dizziness postural | None | Nervous system disorders | None | View |
| Multifocal motor neuropathy | None | Nervous system disorders | None | View |
| Sensory disturbance | None | Nervous system disorders | None | View |
| Heart rate increased | None | Investigations | None | View |
| Blood potassium decreased | None | Investigations | None | View |
| Breath sounds abnormal | None | Investigations | None | View |
| Cardioactive drug level increased | None | Investigations | None | View |
| Heart sounds abnormal | None | Investigations | None | View |
| Renal failure acute | None | Renal and urinary disorders | None | View |
| Nocturia | None | Renal and urinary disorders | None | View |
| Eye swelling | None | Eye disorders | None | View |
| Lacrimation increased | None | Eye disorders | None | View |
| Visual disturbance | None | Eye disorders | None | View |
| Cellulitis | None | Infections and infestations | None | View |
| Sepsis | None | Infections and infestations | None | View |
| Gastroenteritis | None | Infections and infestations | None | View |
| Herpes simplex | None | Infections and infestations | None | View |
| Clostridium difficile colitis | None | Infections and infestations | None | View |
| Klebsiella bacteraemia | None | Infections and infestations | None | View |
| Pneumonia primary atypical | None | Infections and infestations | None | View |
| Viral infection | None | Infections and infestations | None | View |
| Wound infection | None | Infections and infestations | None | View |
| Hypophosphataemia | None | Metabolism and nutrition disorders | None | View |
| Food craving | None | Metabolism and nutrition disorders | None | View |
| Joint swelling | None | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal stiffness | None | Musculoskeletal and connective tissue disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| Orthostatic hypotension | None | Vascular disorders | None | View |
| Subclavian vein thrombosis | None | Vascular disorders | None | View |
| Pallor | None | Vascular disorders | None | View |
| Thrombosis | None | Vascular disorders | None | View |
| Erythema | None | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | None | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | None | View |
| Hyperhidrosis | None | Skin and subcutaneous tissue disorders | None | View |
| Petechiae | None | Skin and subcutaneous tissue disorders | None | View |
| Ecchymosis | None | Skin and subcutaneous tissue disorders | None | View |
| Photodermatosis | None | Skin and subcutaneous tissue disorders | None | View |
| Pruritus generalised | None | Skin and subcutaneous tissue disorders | None | View |
| Atrial fibrillation | None | Cardiac disorders | None | View |
| Cardiac failure congestive | None | Cardiac disorders | None | View |
| Cardiac failure | None | Cardiac disorders | None | View |
| Myocardial ischaemia | None | Cardiac disorders | None | View |
| Palpitations | None | Cardiac disorders | None | View |
| Arrhythmia | None | Cardiac disorders | None | View |
| Intracardiac thrombus | None | Cardiac disorders | None | View |
| Ventricular tachycardia | None | Cardiac disorders | None | View |
| Rib fracture | None | Injury, poisoning and procedural complications | None | View |
| Donor site complication | None | Injury, poisoning and procedural complications | None | View |
| Excoriation | None | Injury, poisoning and procedural complications | None | View |
| Wound | None | Injury, poisoning and procedural complications | None | View |
| Tinnitus | None | Ear and labyrinth disorders | None | View |
| Lymphoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Skin neoplasm bleeding | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Squamous cell carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Tumour necrosis | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |