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: 2025-12-25 @ 4:33 AM
Ignite Modification Date: 2025-12-26 @ 3:35 AM
NCT ID: NCT01792518
Description: None
Frequency Threshold: 5
Time Frame: From first drug administration until 28 days after the last drug administration, up to 240 days
Study: NCT01792518
Study Brief: MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period. None None 8 178 27 178 View
Linagliptin 5 mg Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period. None None 17 182 39 182 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Sudden hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Vestibular disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Gastrointestinal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Arteriovenous graft site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Peripheral nerve injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Postpericardiotomy syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Calculus urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Aortic occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Necrosis ischaemic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View