Adverse Events Module

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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 @ 11:54 PM
Ignite Modification Date: 2025-12-25 @ 9:49 PM
NCT ID: NCT00090051
Description: The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up, whether withdrawn prematurely or not. 272 patients received FC only and 274 patients received FCR.
Frequency Threshold: 5
Time Frame: Adverse Events were collected from study start to 28 days after treatment completion (Median observation time= 26 months). Serious Adverse Events were collected 1 year after treatment completion (Median observation time= 37 months).
Study: NCT00090051
Study Brief: FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fludarabine+Cyclophosphamide (FC) Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles. None None 132 272 232 272 View
Fludarabine+Cyclophosphamide+Rituximab (FCR) Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3. None None 138 274 251 274 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Cardiopulmonary Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Chest Wall Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Chondrosarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Chronic Myelomonocytic Leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Colitis Ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Cytomegalovirus Gastrointestinal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Cytomegalovirus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Endocarditis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Evans Syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Fungal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Gastric Polyps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Gastrointestinal Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Granulocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Haematotoxicity SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Haemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Haemolytic Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Hepatic Neoplasm Malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Hepatitis B SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Hydrothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Interstitial Lung Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Klebsiella Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Laryngeal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Listeria Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Localised Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Lower Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Lung Neoplasm Malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Mesenteric Artery Embolism SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Metastases to Central Nervous System SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Metastatic Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Multi-Organ Failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Multiple Myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Mycobacterium Avium Complex Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Myelodysplastic Syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Neoplasm Malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Neutropenic Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Neutropenic Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Oral Herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Ovarian Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Parainfluenzae Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Paraneoplastic Pemphigus SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Performance Status Decreased SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Plasmacytoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pneumocystis Jiroveci Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumocystis Jiroveci Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia Herpes Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia Primary Atypical SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Prostate Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Pseudomonal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Rectal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Rectal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Squamous Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Squamous Cell Carcinoma of Skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Staphylococcal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Supraventricular Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Tumour Lysis Syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Ventricular Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vulval Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
West Nile Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Wound Infection Staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Cerebral Haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Capsular Warning Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Cerebral Ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Nervous System Disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Peripheral Motor Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Renal Failure Acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Calculus Ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Nephrotic Syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Aortic Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Femoral Artery Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Peripheral Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Palmar Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Rash Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Stevens-Johnson Syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Toxic Epidermal Necrolysis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Intervertebral Disc Disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Dactylitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Metatarsalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Soft Tissue Necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Cholecystitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Hepatitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Anaphylactic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.0 View
Cytokine Release Syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.0 View
Drug Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.0 View
Open Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Radius Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Subdural Haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Diabetes Mellitus Inadequate Control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Metabolic Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Haemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Oxygen Saturation Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 15.0 View
Infective Exacerbation of Chronic Obstructive Airways Disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Zygomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Renal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Thyroid Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Neurological Decompensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Acute Myeloid Leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Mycobacterial Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Aplasia Pure Red Cell SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Anaemia Haemolytic Autoimmune SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Angina Unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Autoimmune Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Bacterial Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Bicytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Bladder Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Bone Marrow Failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Brain Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bronchitis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bronchopulmonary Aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Colon Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Coronary Artery Insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Febrile Bone Marrow Aplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
General Physical Health Deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Gingival Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Hodgkin's Disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Lung Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Cerebral Thrombosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Cystitis Haemorrhagic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Night Sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Acute Coronary Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Acute Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Agranulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Alpha Haemolytic Streptococcal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Granulocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View