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 @ 2:50 AM
Ignite Modification Date: 2025-12-26 @ 1:32 AM
NCT ID: NCT02098733
Description: At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 5
Time Frame: For 12 months
Study: NCT02098733
Study Brief: Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pioglitazone/Glimepiride Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast. None None 23 1158 0 1158 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Oesophageal carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 17.0 View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 17.0 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 17.0 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 17.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 17.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.0 View
Marasmus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.0 View
Completed suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 17.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.0 View
Mallory-Weiss syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 17.0 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 17.0 View
Bile duct obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 17.0 View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 17.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 17.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 17.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Drowning SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.0 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.0 View
Other Events(If Any):