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 @ 3:17 PM
Ignite Modification Date: 2025-12-25 @ 1:38 PM
NCT ID: NCT01333592
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01333592
Study Brief: Long-term Study of KAD-1229 in Type 2 Diabetes Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
KAD-1229 / DPP-4 Inhibitors None None None 1 67 34 67 View
KAD-1229 / Biguanides None None None 5 69 47 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
large intestine carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
prostate cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
colonic polyp None Gastrointestinal disorders None View
brain contusion None Injury, poisoning and procedural complications None View
lumbar vertebral fracture None Injury, poisoning and procedural complications None View
skull fracture None Injury, poisoning and procedural complications None View
acute myocardial infarction None Cardiac disorders None View
traumatic lung injury None Respiratory, thoracic and mediastinal disorders None View
rib fracture None Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Upper respiratory tract inflammation None Respiratory, thoracic and mediastinal disorders None View
Dental caries None Gastrointestinal disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Alanine aminotransferase increase None Investigations None View
γ-glutamyltransferase increase None Investigations None View
Blood urine present None Investigations None View
White blood cell count increase None Investigations None View