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 @ 1:38 PM
Ignite Modification Date: 2025-12-25 @ 12:36 PM
NCT ID: NCT00813995
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00813995
Study Brief: A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sitagliptin None None None 7 197 10 197 View
Placebo None None None 5 198 13 198 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
POST PROCEDURAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
SPINAL CORD INJURY CERVICAL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
TENOSYNOVITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
COLON CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
LIP AND/OR ORAL CAVITY CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
CEREBRAL INFARCTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
IIIrd NERVE PARALYSIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
TRANSIENT ISCHAEMIC ATTACK SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
EPIGLOTTIC CYST SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View