Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:06 PM
Ignite Modification Date: 2025-12-25 @ 12:49 PM
NCT ID: NCT01145495
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01145495
Study Brief: Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin 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
Treatment (Lenalidomide, Rituximab) lenalidomide: Given orally 0 None 0 65 65 65 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders ctcae 4 View
Blood and lymph sys disorders - Oth Spec SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders ctcae 4 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders ctcae 4 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders ctcae 4 View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders ctcae 4 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders ctcae 4 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders ctcae 4 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders ctcae 4 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders ctcae 4 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders ctcae 4 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders ctcae 4 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders ctcae 4 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders ctcae 4 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders ctcae 4 View
Extraocular muscle paresis SYSTEMATIC_ASSESSMENT Eye disorders ctcae 4 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders ctcae 4 View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders ctcae 4 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Gastrointestinal disorders - Oth spec SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Ileal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Lip pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Oral hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ctcae 4 View
Chills SYSTEMATIC_ASSESSMENT General disorders ctcae 4 View
Edema face SYSTEMATIC_ASSESSMENT General disorders ctcae 4 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders ctcae 4 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders ctcae 4 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders ctcae 4 View
Fever SYSTEMATIC_ASSESSMENT General disorders ctcae 4 View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders ctcae 4 View
Gen disord and admin site conds-Oth spec SYSTEMATIC_ASSESSMENT General disorders ctcae 4 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders ctcae 4 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders ctcae 4 View
Pain SYSTEMATIC_ASSESSMENT General disorders ctcae 4 View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders ctcae 4 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders ctcae 4 View
Serum sickness SYSTEMATIC_ASSESSMENT Immune system disorders ctcae 4 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Gum infection SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Infections and infestations - Oth spec SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Lip infection SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations ctcae 4 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications ctcae 4 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications ctcae 4 View
Activated partial throm time prolonged SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
CO diffusing capacity decreased SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
Hemoglobin increased SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
INR increased SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations ctcae 4 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Metabolism, nutrition disord - Oth spec SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Tumor lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ctcae 4 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ctcae 4 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ctcae 4 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ctcae 4 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ctcae 4 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ctcae 4 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ctcae 4 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ctcae 4 View
Joint range of motion decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ctcae 4 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ctcae 4 View
Musculoskeletal, conn tissue - Oth spec SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ctcae 4 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ctcae 4 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ctcae 4 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ctcae 4 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) ctcae 4 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders ctcae 4 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders ctcae 4 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders ctcae 4 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders ctcae 4 View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders ctcae 4 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders ctcae 4 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders ctcae 4 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders ctcae 4 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders ctcae 4 View
Spasticity SYSTEMATIC_ASSESSMENT Nervous system disorders ctcae 4 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders ctcae 4 View
Vasovagal reaction SYSTEMATIC_ASSESSMENT Nervous system disorders ctcae 4 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders ctcae 4 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders ctcae 4 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders ctcae 4 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders ctcae 4 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders ctcae 4 View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders ctcae 4 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders ctcae 4 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders ctcae 4 View
Cystitis noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders ctcae 4 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders ctcae 4 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders ctcae 4 View
Renal and urinary disorders - Oth spec SYSTEMATIC_ASSESSMENT Renal and urinary disorders ctcae 4 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders ctcae 4 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders ctcae 4 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders ctcae 4 View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders ctcae 4 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ctcae 4 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ctcae 4 View
Reproductive system and breast -Oth spec SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ctcae 4 View
Vaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ctcae 4 View
Vaginal hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ctcae 4 View
Vaginal inflammation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ctcae 4 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Bronchopulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Sinus pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ctcae 4 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ctcae 4 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ctcae 4 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ctcae 4 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ctcae 4 View
Scalp pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ctcae 4 View
Skin and subcut tissue disord - Oth spec SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ctcae 4 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ctcae 4 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ctcae 4 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders ctcae 4 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders ctcae 4 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders ctcae 4 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders ctcae 4 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders ctcae 4 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders ctcae 4 View
Vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders ctcae 4 View
Penile pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ctcae 4 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ctcae 4 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ctcae 4 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ctcae 4 View
Palmar-plantar erythrodysesthesia syndrm SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ctcae 4 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ctcae 4 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders ctcae 4 View