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: 2025-12-25 @ 5:09 AM
Ignite Modification Date: 2025-12-26 @ 4:13 AM
NCT ID: NCT00315627
Description: None
Frequency Threshold: 1
Time Frame: 3 years
Study: NCT00315627
Study Brief: Steroid-free and Long-term Calcineurin-free Trial in Islet Cell Transplantation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Islet Transplantation Islet transplantation alone under alentuzumab (Campath1H) induction. None None 3 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hair loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Displastic Nevus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acne/Folliculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Microalbuminuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Overt Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gallblader polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pulpitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Flu like symptoms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right foot injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Toe sprain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Yeast infection SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Uterine fibroids SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hot Flashes SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Abnormal Papsmear SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Ovarian Cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Tremors SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory deficit SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombophlebitis Right arm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Capsular opacity SYSTEMATIC_ASSESSMENT Eye disorders None View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View