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 @ 6:41 PM
Ignite Modification Date: 2025-12-25 @ 4:12 PM
NCT ID: NCT00366457
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00366457
Study Brief: Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gemcitabine, Bevacizumab and Erlotinib single-arm, no masking Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. None None 11 30 30 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pumonary embolism None Respiratory, thoracic and mediastinal disorders None View
Death from disease progression None Endocrine disorders None View
Death from infection or sepsis None Infections and infestations None View
Hyperbilirubinemia None Metabolism and nutrition disorders None View
Brain Infarct None Nervous system disorders None View
Neutropenia None Immune system disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue None General disorders None View
Leukocytes None Blood and lymphatic system disorders None View
Nausea None Gastrointestinal disorders None View
Rash: acne/acneiform None Skin and subcutaneous tissue disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Platelets None Blood and lymphatic system disorders None View
ALT- SGPT None Metabolism and nutrition disorders None View
Hemoglobin None Blood and lymphatic system disorders None View
Neutrophils None Blood and lymphatic system disorders None View
AST- SGOT None Metabolism and nutrition disorders None View
Abdomen - pain None General disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Diarrhea w/o prior colostomy None Gastrointestinal disorders None View
Weight loss None General disorders None View
Vomiting None Gastrointestinal disorders None View
Rigors/chills None General disorders None View
Lymphopenia None Blood and lymphatic system disorders None View
Alkaline phosphatase None Metabolism and nutrition disorders None View
Nose- hemorrhage None General disorders None View
Fever w/o neutropenia None General disorders None View
Bilirubin None Metabolism and nutrition disorders None View
Rash/desquamation None Skin and subcutaneous tissue disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Insomnia None General disorders None View
Muco/stomatitis (symptom) oral cavity None Gastrointestinal disorders None View
Pruritus/itching None Skin and subcutaneous tissue disorders None View
Skin-other None Skin and subcutaneous tissue disorders None View
Dehydration None Gastrointestinal disorders None View
Head/headache None General disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Muco/stomatitis by exam- oral cavity None Gastrointestinal disorders None View
Dry skin None Skin and subcutaneous tissue disorders None View
Extremity-limb- pain None General disorders None View
Hyperkalemia None Metabolism and nutrition disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Hypertension None Cardiac disorders None View
Proteinuria None Metabolism and nutrition disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Depression None Nervous system disorders None View
Flatulence None Gastrointestinal disorders None View
Edema limb None Blood and lymphatic system disorders None View
Voice changes/dysarthria None Respiratory, thoracic and mediastinal disorders None View
Bicarbonate None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Muscle- pain None General disorders None View
GI-other None Gastrointestinal disorders None View
Back- pain None General disorders None View
Dizziness None Nervous system disorders None View
Infection Gr0-2 neut- upper airway None Infections and infestations None View
Chest/thoracic pain NOS None General disorders None View
Neurologic-other None Nervous system disorders None View
Allergic reaction None Immune system disorders None View
Anxiety None Nervous system disorders None View
Hypoglycemia None Metabolism and nutrition disorders None View
Pain-other None General disorders None View
Pulmonary/Upper Respiratory-other None Respiratory, thoracic and mediastinal disorders None View
Throat/pharynx/larynx- pain None General disorders None View
Allergic rhinitis None Respiratory, thoracic and mediastinal disorders None View
Nonneuropathic generalized weakness None Musculoskeletal and connective tissue disorders None View
Ocular-other None Eye disorders None View
Pain NOS None General disorders None View
Taste disturbance None Gastrointestinal disorders None View
Distention/bloating- abdominal None Gastrointestinal disorders None View
Arthritis None Musculoskeletal and connective tissue disorders None View
Neuropathy-sensory None Nervous system disorders None View
Bruising None Skin and subcutaneous tissue disorders None View
Burn None Skin and subcutaneous tissue disorders None View
Dry mouth None Gastrointestinal disorders None View
Flu-like syndrome None General disorders None View
Hiccoughs None Respiratory, thoracic and mediastinal disorders None View
Hypomagnesemia None Metabolism and nutrition disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Joint- pain None General disorders None View
Musculoskeletal/soft tissue-other None Musculoskeletal and connective tissue disorders None View
Rectum- hemorrhage None General disorders None View
Rectum- pain None General disorders None View
Renal/GU-other None Renal and urinary disorders None View
Sweating None General disorders None View
Thrombosis/thrombus/embolism None Vascular disorders None View
Anorexia None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View