Adverse Events Module

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: 2025-12-25 @ 12:54 AM
Ignite Modification Date: 2025-12-25 @ 11:09 PM
NCT ID: NCT01697267
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
Study: NCT01697267
Study Brief: Rituximab Vasculitis Maintenance Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rituximab Maintenance Rituximab maintenance: 1g at 4, 8, 12, 16 \& 20 months with standardised steroid taper Rituximab: Rituximab IV infusion 1000 mg x 1 dose at months 4, 8, 12, 16 and 20 and glucocorticoids. Four - six hour infusion. Treatment with rituximab will cease at month 20. 3 None 19 85 42 85 View
Azathioprine Maintenance Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation) (200 mg maximum daily dose). Azathioprine withdrawn at month 27. Azathioprine: Oral dosage form. Target dose is 2mg/kg; maximum daily dose is 200mg. This should be continued until month 24. The dose should then by reduced by 50% and azathioprine completely withdrawn at month 27. The dose should be rounded down to the nearest 25mg. The dose may vary on alternate days e.g. 100mg one day, 150mg the next for patients on an overall dose of 125mg daily. If patients are aged over 60 years, reduce the dose by 25%. If patients are aged over 75 years, reduce the dose by 50%. 1 None 31 85 43 85 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (19.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (19.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Periorbital oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (19.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Oesophageal spasm SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Enterovesical fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Perforated ulcer SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Stenosis SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (19.0) View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (19.0) View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (19.0) View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (19.0) View
Pulmonary vasculitis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (19.0) View
Vasculitis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (19.0) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Dacryocystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Pneumonia klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Periorbital abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Infective exacerbation of chronic obstructive airways disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Metapneumovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
Intra-abdominal haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
Medical observation SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (19.0) View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (19.0) View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (19.0) View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (19.0) View
Myasthenia gravis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (19.0) View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (19.0) View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (19.0) View
Myasthenia gravis crisis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (19.0) View
Pubis fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (19.0) View
Bladder papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (19.0) View
Lung adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (19.0) View
Pancreatic carcinoma metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (19.0) View
Sarcoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (19.0) View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (19.0) View
Colon neoplasm 1 SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (19.0) View
Anal squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (19.0) View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
Subdural haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
Conversion disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (19.0) View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (19.0) View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (19.0) View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (19.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (19.0) View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Laryngeal stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Aortic valve replacement SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Bunion operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Cholecystectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Colostomy closure SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Dacryocystorhinostomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Lung lobectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Renal transplant SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Spinal decompression SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Renal and pancreas transplant SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Sigmoidectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Cardiac ablation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Infusion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Colporrhaphy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Thyroidectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Joint resurfacing surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Vascular anastomosis SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.0) View
Haemoptysis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.0) View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.0) View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.0) View
Vascular injury SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.0) View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.0) View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Staphylococcal impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (19.0) View
Bacterial dacryocystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Beta haemolytic streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Bronchitis haemophilus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Cellulitis orbital SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Citrobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Cystitis escherichia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Cystitis klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Enterococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Haemophilus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Pneumonia haemophilus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Pneumonia klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Pneumonia pneumococca SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Pneumonia pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Proteus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Pseudomonas bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Tonsillitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Urinary tract infection enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Body tinea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Tinea infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Mastoiditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Prostate infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Root canal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Systemic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Varicella zoster virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Streptococcus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (19.0) View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (19.0) View