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 @ 3:50 PM
Ignite Modification Date: 2025-12-25 @ 1:56 PM
NCT ID: NCT01217892
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 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Study: NCT01217892
Study Brief: Evaluation of Dapagliflozin Taken Twice-daily
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dapagliflozin 2.5mg BID Plus Metformin Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose None None 4 100 8 100 View
Dapagliflozin 5mg BID Plus Metformin Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose None None 1 100 0 100 View
Dapagliflozin 10mg OD Plus Metformin Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \>=1500mg total daily dose None None 2 99 6 99 View
Placebo Plus Metformin Placebo plus Metformin, oral, twice daily, \>=1500mg total daily dose None None 0 101 9 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
SICK SINUS SYNDROME SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
HYPERTENSIVE CRISIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
FEMORAL ARTERY OCCLUSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
ENDOMETRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
HAEMOPTYSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View