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 @ 10:52 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT02061969
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT02061969
Study Brief: ADA Linagliptin in Long Term Care
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Insulin Glargine Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period. Insulin glargine 0 None 6 73 16 73 View
Linagliptin Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period. linagliptin: 5mg linagliptin tablets 2 None 4 67 12 67 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalized for repair craninectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalization for pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization for congestive heart failure ( exacerbation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Right stump infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalized for brain edema NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hospitalized for severe aortic stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Amputation of the left 2nd toe NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalized for Altered Mental Status NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalized for aspiration pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Shingels NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bradicardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Penile infection NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View