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 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:56 PM
NCT ID: NCT00984867
Description: Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
Frequency Threshold: 5
Time Frame: Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period if earlier.
Study: NCT00984867
Study Brief: Dapagliflozin DPPIV Inhibitor add-on Study
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 Placebo plus sitagliptin alone or in combination with metformin. Safety analysis set. None None 9 226 14 226 View
Dapagliflozin Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Safety analysis set. None None 10 225 9 225 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Colonic polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Device dislocation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Medical device pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Metastatic squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Eczema nummular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View