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 @ 5:33 PM
Ignite Modification Date: 2025-12-25 @ 3:06 PM
NCT ID: NCT02315768
Description: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Frequency Threshold: 0
Time Frame: 3 years
Study: NCT02315768
Study Brief: Ibrutinib in Combination With GA101 (Obinutuzumab) in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GA101+Ibrutinib Ibrutinib 420 mg (140 mg capsules 3 times) orally once daily for up to 6 cycles. GA101 (Obinutuzumab) by Intravenous infusion for up to 6 cycles (28 day cycles) as follows: * Cycle 1, Day 1,100 mg GA101 obinutuzumab will be administered. * Cycle 1, Day 2, 900 mg of GA101 obinutuzumab will be administered. * Cycle 1, Days 8 and 15,1,000 mg of GA101 obinutuzumab will be administered. * Cycles 2-6, Day 1, 1,000 mg of GA101 obinutuzumab will be administered. GA101 ibrutinib 0 None 3 32 32 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fever/Sepsis (IRR) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SAE SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
AST elevated SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back and neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bleeding from auditory cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Brittle nails SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bruising SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chest congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Chronic cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ear bleeding SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
edema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Elevated AST SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Elevated Bilirubin SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Elevated creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Elevated Phosphorus SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Elevated uric acid SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT General disorders None View
Eye Infection SYSTEMATIC_ASSESSMENT Eye disorders None View
Facial bruise SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Finger Nail Fragility SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Fragile Nails SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gastro-intestinal bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hair Loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hand inflammation SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hand lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Heart palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperuricema SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infected nose ulcer SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infusion reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Infusion-related reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Jaw discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Light-headedness SYSTEMATIC_ASSESSMENT General disorders None View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Mild bruising SYSTEMATIC_ASSESSMENT Vascular disorders None View
Mouth sores SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Muscle cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle soreness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nail Fragility SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nose bleed SYSTEMATIC_ASSESSMENT General disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paronychia in right toe SYSTEMATIC_ASSESSMENT Infections and infestations None View
Petechia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Prostate CA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Rapid heart rate SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rib pain (bruise) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Scalp inflammation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin lesions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stomach pain (left side) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tachypnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
UTI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Visual Change SYSTEMATIC_ASSESSMENT Eye disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Albumin decreased SYSTEMATIC_ASSESSMENT General disorders None View
Alkaline Phosphatasee Increase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
ALT elevated SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View