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: 2025-12-24 @ 11:07 PM
Ignite Modification Date: 2025-12-25 @ 8:39 PM
NCT ID: NCT01995669
Description: None
Frequency Threshold: 0
Time Frame: from consent up to 30 days post last dose, up to 4 years
Study: NCT01995669
Study Brief: Lenalidomide and Obinutuzumab in Treating Patients With Relapsed Indolent 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
Phase I Dose Level 10mg Lenolidomide + 1000mg Obinutuzimab Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma 0 None 1 3 3 3 View
Phase I Dose Level 20mg Lenolidomide + 1000mg Obinutuzimab Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma 0 None 1 3 3 3 View
Phase I Dose Level 15mg Lenolidomide + 1000mg Obinutuzimab Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma 1 None 3 3 3 3 View
Ph. II: Expansion Len 20 mg Plus Obin 1000 mg Participants with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma, marginal zone lymphoma and small lymphocytic lymphoma 6 None 34 57 57 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Unintented Pregnancy SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Gastroeophogeal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Tumor Lysis Syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Sick Sinus Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Sinus Tackycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Heart Faliure SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Pacemaker implant SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Bactermia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Cellulitis - left Mandible SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Cellulitis - right calf SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Infection - JC Virus SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Infection, pacemaker infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Gait disturbance SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Vertigo SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Gallbladder obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Reproductive system and breast disorder - testicular pain and dysuria SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Squamous Cell Carcinoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Testicular pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Right toe strain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Difficulty Urinating SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Renal Insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Vaginal discharge SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Renal cell carcinoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Sinus pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Erythroderma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Insect bite SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Wasp bite SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Abcess SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Color change on abdomen SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Plantar's wart SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Plaque psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Allergic reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Anxiety SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Appetite Change, Increase SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Blurred Vision SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Cataract SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Chills SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Confusion SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Conjunctivitis SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Creatinine increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Deconditioning SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Decreased Visual Acuity SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Depression SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dizziness SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Edema - Face SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Edema - Limbs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Edema - Trunk SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Eye disorders - Double Vision SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Eye disorders -Watery eye (1 #9) SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Eye Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Eye Stye SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fall SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Floaters SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Flushing SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Gallbladder obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Glaucoma SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hepatic enzyme elevation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Hypogammaglobulinemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Hypomagnesmia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Infections and infestations - Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Investigations Other - Elevated LDH SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Lung Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Memory Impairment SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Mucositis Oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Oral Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Pacemaker Placed SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Respiratory, thoracic and mediastinal disorders - Chest congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Respiratory, thoracic and mediastinal disorders - Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sinus infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Thromboembolic event SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Tinnitus SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Twitching SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Unintended Pregnancy SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
White Blood Cell Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Hearing Impaired SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Hot flashes SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Hypersensitive smell SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Influenza SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Insomnia SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Localized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Paresthesia SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Sleep disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Swollen eye SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Toothache SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Visual disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Watering eyes SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Weight gain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Weight loss SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Migraine SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Facial Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Mycobacterial Avium infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Epididymoorchitis with possible abscess SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Scratchy throat-closing SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Staph infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Gait disturbance SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View