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 @ 3:45 PM
Ignite Modification Date: 2025-12-25 @ 1:53 PM
NCT ID: NCT02749292
Description: All adverse events will be reported per PHRC guidelines which includes unanticipated problems involving risks to subjects/others, including adverse events, within 5 working days/7 calendar days of the date that the investigator first became aware of the problem.
Frequency Threshold: 0
Time Frame: June 1 2016 to December 2021 (5 years and 6 months). The earliest Adverse event reported was on 2/6/2017 and the latest adverse event reported was on 12/25/2021
Study: NCT02749292
Study Brief: Maintenance of ANCA Vasculitis Remission by Intermittent Rituximab Dosing
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
B Cell Reconstitution Subjects will not receive their regularly-scheduled every-six-month dose of rituximab (1000mg IV) and will instead receive rituximab 1000 mg IV x 1 dose only once peripheral B cells return ( ≥ 10 B cells/mm3). This cycle will then re-start. Subjects will be seen in clinic every three months. Patients will continue to be dosed with rituximab (1 dose of 1000mg IV) each time the B cell count rises to 10 cells/mm3. In the unique scenario that the B cells are detectable, but less than the threshold of 10 cells/mm3, subjects will be asked to return in 6 weeks for repeat B cell testing. Rituximab: re-dosing dependent on interventional arm parameter. 2 None 15 58 46 58 View
Serologic ANCA Flare Subjects will not receive regularly scheduled every six-month doses of rituximab (1000mg IV) and will instead be seen in clinic for ANCA titer monitoring every 3 months. Re-dosing will occur upon a significant ANCA titer increase. For MPO, a significant rise will be defined as a 5-fold rise in ANCA titer and a level greater than 4 times the cutoff value for the assay. For PR3, a significant rise will be defined as a 4-fold rise in ANCA titer to a level at least twofold above the cutoff for the assay. Subjects who sustain a significant increase in ANCA titer will receive rituximab 1000mg IV x 2 doses, spaced \~2-3 weeks apart. If the ANCA titer remains two-fold above baseline and above a specified threshold (the cutoff value of the assay for PR3 and 4 times the cutoff value for MPO) , subjects will continue to receive rituximab 1000mg IV every 6 months for a maximum of 2 doses, at which time a new baseline ANCA titer will be established and the cycle will re-start. In this arm, rituximab administration is not contingent upon B cell levels but on significant ANCA titer rise as described above. Baseline ANCA titer will be recalculated to an average of the two highest of the last four values if all four are less than the original baseline. Patients in the ANCA arm will move to once yearly CD20 testing after CD20 levels return to normal levels (\>90 cells/uL). 0 None 14 57 44 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Track Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gallstone pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pulmonary edema in setting of fluid resuscitation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gallbladder pain NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Psychiatric Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Transient ischemic attacks NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Urinary retention and elevated creatinine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rectal bleeding status post colonoscopy NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
bleeding gastric nodule NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asymptomatic AKI NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Lumbar disc herniation, cervical and lumbar stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Renal Calculi NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
New elevated IgM in setting of longstanding pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation with rapid ventricular response NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain, LAD stenosis and RAD stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease- Three-vessel disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocarditis and Heart failure with preserved ejection fraction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cancer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tooth infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Infection (Cold) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Track Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Gout flare NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 Positive NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Allergic Reaction to Rituximab Infusion NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Allergic reaction unrelated to Rituximab NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Vaginitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Asymptomatic Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Right thigh pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Heart murmurs NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
pleural infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myalgias and arthralgias. Severe pains and frank arthritis in knees. NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pleuritic chest pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Mild fatty replacement of the liver NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Metacarpophalangeal tenderness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache/ Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conduction disorder (LBBB) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fall injury NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
colonoscopy finding:tubulovillous adenomatous colon poplyp NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal calculi NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash in distribution of trigeminal nerve - consistent with zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypotension, fatigue, cough, HA, fever, malaise, volume depletion from high dose valtrex reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urine cx positive for E.coli NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Paronychia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Elevated Liver Function Tests NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Mandibular pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Jaw swelling, NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Distal Ventricular Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stomach discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RLL possibe airspace disease and/or atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Degenerative disk disease of c-spine NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lung opacity and nodule NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Investigations None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Leg Edema NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ear pain NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Surgical procedure NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Skin rash on arms and legs NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Achilles tendon pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shoulder cyst NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Muscle weakness lower limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Exertional dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Prostatic Obstruction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Herpes simplex virus rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Heart palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Adrenal incidentaloma NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Conduction disorder- Non-specific intraventricular block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bilateral impacted cerumen NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Herpes simplex cold sore NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Balanitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Ankle soreness and swelling post exercize NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bilateral swelling in the ankle and high blood pressure NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Knee arthritis NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Esophageal narrowing NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Recurrent Lightheadedness NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cardiac arrythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sores in mouth NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Infection lower eye lid NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Polyarticular arthritis NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Infection on left side of the face NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Epigastric pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eye and face swelling NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arm, shoulder and neck pains NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shingles NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncopal episode NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rash on chest - Allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Scleritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View