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 @ 12:55 PM
Ignite Modification Date: 2025-12-25 @ 12:18 PM
NCT ID: NCT00895661
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00895661
Study Brief: High Dose Rituximab for Initial Treatment of Indolent B-Cell Lymphomas
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 single-arm, open-label, interventional rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2). None None 4 40 40 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Decubitus ulcer None Skin and subcutaneous tissue disorders None View
Small bowel obstruction None Gastrointestinal disorders None View
Cellulitis (toe) None Infections and infestations None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Insomnia None General disorders None View
Neutrophils None Blood and lymphatic system disorders None View
Allergic reaction None Immune system disorders None View
Infection-other None Infections and infestations None View
Tumor lysis syndrome None Metabolism and nutrition disorders None View
Fatigue None General disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hemoglobin None Blood and lymphatic system disorders None View
Diarrhea w/o prior colostomy None Gastrointestinal disorders None View
Leukocytes None Blood and lymphatic system disorders None View
Rash/desquamation None Skin and subcutaneous tissue disorders None View
Infection Gr0-2 neut- upper airway None Infections and infestations None View
Fever w/o neutropenia None General disorders None View
Abdomen- pain None General disorders None View
Nausea None Gastrointestinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Dizziness None Nervous system disorders None View
Allergic rhinitis None Immune system disorders None View
Head/headache None General disorders None View
Sweating None General disorders None View
Skin-other None Skin and subcutaneous tissue disorders None View
Back-pain None General disorders None View
Lymphopenia None Blood and lymphatic system disorders None View
Pain-other None General disorders None View
Neuropathy-sensory None Nervous system disorders None View
Alkaline phosphatase None Metabolism and nutrition disorders None View
ALT- SGPT None Metabolism and nutrition disorders None View
Extremity-limb- pain None General disorders None View
Rash: acne/acneiform None Skin and subcutaneous tissue disorders None View
Infection Gr0-2 neut- sinus None Infections and infestations None View
Neck- pain None General disorders None View
Vomiting None Gastrointestinal disorders None View
Hyperuricemia None Metabolism and nutrition disorders None View
Urinary frequency/urgency None Renal and urinary disorders None View
Constipation None Gastrointestinal disorders None View
Creatinine None Metabolism and nutrition disorders None View
GI-other None Gastrointestinal disorders None View
Hearing-other None Ear and labyrinth disorders None View
Edema head and neck None Blood and lymphatic system disorders None View
Hematologic-other None Blood and lymphatic system disorders None View
Pulmonary/Upper Respiratory-other None Respiratory, thoracic and mediastinal disorders None View
Bronchospasm- wheezing None Respiratory, thoracic and mediastinal disorders None View
Chest/thoracic pain NOS None General disorders None View
Muscle- pain None General disorders None View
Flu-like syndrome None General disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Musculoskeletal/soft tissue-other None Musculoskeletal and connective tissue disorders None View
Palpitations None Cardiac disorders None View
Arthritis None Musculoskeletal and connective tissue disorders None View
Sinus bradycardia None Cardiac disorders None View
Dysphagia None Gastrointestinal disorders None View
Sinus tachycardia None Cardiac disorders None View
Cholecystitis None Hepatobiliary disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Muco/stomatitis (symptom) oral cavity None Gastrointestinal disorders None View
Dry mouth None Gastrointestinal disorders None View
Esophagitis None Gastrointestinal disorders None View
Hyopthyroidism None Endocrine disorders None View
Hypoglycemia None Metabolism and nutrition disorders None View
Infection Gr0-2 neut- skin None Infections and infestations None View
Infection Gr0-2 neut- urinary tract None Infections and infestations None View
Otitis- middle ear (non-infectious) None Ear and labyrinth disorders None View
Taste disturbance None Gastrointestinal disorders None View
Chest wall- pain None General disorders None View
Dehydration None Gastrointestinal disorders None View
Edema limb None Blood and lymphatic system disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Infection Gr0-2 neut- lung None Infections and infestations None View
Metabolic/Laboratory-other None Metabolism and nutrition disorders None View
Ocular-other None Eye disorders None View
Voice changes/dysarthria None Respiratory, thoracic and mediastinal disorders None View
Weight gain None General disorders None View
Weight loss None General disorders None View
Pelvic-pain None General disorders None View
Joint-pain None General disorders None View
Anxiety None Nervous system disorders None View
Anorexia None Gastrointestinal disorders None View
AST- SGOT None Metabolism and nutrition disorders None View
Dyspepsia None Gastrointestinal disorders None View
Platelets None Blood and lymphatic system disorders None View
Infection Gr0-2 neut- bronchus None Infections and infestations None View
Rigors/chills None General disorders None View