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 @ 9:45 PM
Ignite Modification Date: 2025-12-25 @ 7:25 PM
NCT ID: NCT02756832
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 0
Time Frame: From first dose of study drug administration up to Month 6
Study: NCT02756832
Study Brief: An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alogliptin Benzoate Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months. 0 None 5 1399 69 1399 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vertebrobasilar insufficiency SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Endometrial adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Vulval cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
HbA1C increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Pyelonephritis chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dyslipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
High density lipoprotein decrease SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Drug ineffective SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Autonomic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Diabetic retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Disease risk factor SYSTEMATIC_ASSESSMENT Social circumstances MedDRA View
Vestibular disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View