Adverse Events Module

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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 @ 5:40 PM
Ignite Modification Date: 2025-12-25 @ 3:09 PM
NCT ID: NCT01894568
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT01894568
Study Brief: A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment
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 administered SC once daily for 26 weeks. None None 5 196 42 196 View
Insulin Peglispro Insulin Peglispro administered SC once daily for 26 weeks. None None 9 192 61 192 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 16.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Haemorrhagic diathesis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Ulna fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Haemarthrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Intervertebral disc displacement SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Synovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.0 View
Fracture treatment SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16.0 View
Glaucoma surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16.0 View
Suprapubic prostatectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View